INTERNATIONAL ISO

STANDARD 17966

First edition
2016-01-15

Assistive products for personal

hygiene that support users —
Requirements and test methods
Produits d’assistance pour l’hygiène personnelle soutenant les
utilisateurs — Exigences et méthodes d’essai

Reference number
ISO 17966:2016(E)

© ISO 2016
ISO 17966:2016(E)

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© ISO 2016, Published in Switzerland

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ii © ISO 2016 – All rights reserved

 ISO 17966:2016(E)

Contents Page

Foreword ...................................................................................................................................................................................................................................... vii

Introduction............................................................................................................................................................................................................................ viii
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 2
..................................................................................................................................................................................... 3
4 General requirements and test methods .................................................................................................................................... 6
.............................................................................................................................................................................................. 6
4.2 Intended performance...................................................................................................................................................................... 6
4.3 Clinical evaluation and investigation ................................................................................................................................... 6
................................................................ 6
4.5 Fasteners ...................................................................................................................................................................................................... 7
4.6 Means to prevent falling out ........................................................................................................................................................ 7
4.7 User mass/load limits ....................................................................................................................................................................... 7
4.8 Apparatus .................................................................................................................................................................................................... 7
4.9 Test conditions ..................................................................................................................................................................................... 17
5 Materials .................................................................................................................................................................................................................... 18
5.1 General ........................................................................................................................................................................................................ 18
.......................................................................................................................................................................................... 18
5.2.1 General................................................................................................................................................................................... 18
5.2.2 Moulded parts used as enclosures for electrical equipment .................................................. 18
5.2.3 Upholstered parts and moulded parts ....................................................................................................... 18
.................................................................................................................................................. 18
5.4 Infection and microbiological contamination ........................................................................................................... 19
5.4.1 Cleaning and disinfection ...................................................................................................................................... 19
5.4.2 Resistance against temperature alternations ...................................................................................... 19
5.4.3 Animal tissue.................................................................................................................................................................... 19
5.5 Resistance to corrosion ................................................................................................................................................................ 19
6 Emitted sound and vibration ................................................................................................................................................................19
6.1 Noise and vibration .......................................................................................................................................................................... 19
6.2 Sound pressure levels and frequencies of audible warning devices ..................................................... 20
7 Electromagnetic compatibility ...........................................................................................................................................................20
7.1 General ........................................................................................................................................................................................................ 20
7.2 Emissions .................................................................................................................................................................................................. 20
................................................................................................................................................................................................... 20
................................................................................................................. 20
8 Electrical safety................................................................................................................................................................................................... 21
8.1 General ........................................................................................................................................................................................................ 21
.............................................................................................................................................................................. 21
8.3 Safe positioning ................................................................................................................................................................................... 21
............................................................................................................................................................................... 21
8.5 Hold to run activation .................................................................................................................................................................... 21
............................................................................................................................................... 21
....................................................................................................................................................... 22
............................................................................. 23
........................................................................................................................................................... 23
8.8.2 Connection ......................................................................................................................................................................... 23
8.8.3 Charge level indicator ............................................................................................................................................... 23
8.9 Circuit protection ............................................................................................................................................................................... 23
.................................... 24
8.11 Ingress of liquids ................................................................................................................................................................................ 24
................................................................................................................................. 24

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ISO 17966:2016(E)

9.1 Ingress of liquids ................................................................................................................................................................................ 24

9.1.1 Requirements .................................................................................................................................................................. 24
9.1.2 Test method....................................................................................................................................................................... 24
..................................................................................................................................................................... 24
9.2.1 General................................................................................................................................................................................... 24

fault conditions............................................................................................................................................................... 25
......................................................................... 25
11 Safety of moving and folding parts .................................................................................................................................................26
11.1 Squeezing.................................................................................................................................................................................................. 26
....................................................................................... 27
11.2.1 Requirements .................................................................................................................................................................. 27
11.2.2 Test method....................................................................................................................................................................... 27
11.3 Mechanical wear ................................................................................................................................................................................. 27
11.4 Trapping zones for feet in relation to moving parts ............................................................................................ 27
12 Prevention of traps for parts of the human body ............................................................................................................ 28
12.1 Holes and clearances ...................................................................................................................................................................... 28
12.2 V-shaped openings ............................................................................................................................................................................ 29
13 Folding and adjusting mechanisms................................................................................................................................................29
13.1 General ........................................................................................................................................................................................................ 29
13.2 Locking mechanisms....................................................................................................................................................................... 29
14 Lifting and carrying means.....................................................................................................................................................................30
14.1 General ........................................................................................................................................................................................................ 30
14.2 Requirement .......................................................................................................................................................................................... 30
14.3 Test method ............................................................................................................................................................................................ 30
15 Portable and hand-held products for personal hygiene or hand-held parts......................................31
........................................................................................................................................ 32
16.1 General ........................................................................................................................................................................................................ 32
16.2 Formulae ................................................................................................................................................................................................... 32
16.2.1 Formulae for calculating forces........................................................................................................................ 32
.................................................................................................................................. 33
............. 33
16.4.1 Requirements .................................................................................................................................................................. 33
16.4.2 Test methods .................................................................................................................................................................... 34
.................................................................................................................................................................................................. 40
16.5.1 Requirements .................................................................................................................................................................. 40
16.5.2 Test methods .................................................................................................................................................................... 41
16.6 Impact .......................................................................................................................................................................................................... 46
16.6.1 Requirements .................................................................................................................................................................. 46
16.6.2 Test methods .................................................................................................................................................................... 46
17 Stability ....................................................................................................................................................................................................................... 49
.......................................................................................................................................... 49
.............................................................................................................................................. 49
.................................................................................................................. 50
19 Small parts ............................................................................................................................................................................................................... 50
20 Forces in soft tissues of the human body..................................................................................................................................50
21 Ergonomic principles ................................................................................................................................................................................... 50
22 Mobile APPHs........................................................................................................................................................................................................51
22.1 General ........................................................................................................................................................................................................ 51
22.2 Immobilizing means ........................................................................................................................................................................ 51
22.2.1 General................................................................................................................................................................................... 51
22.2.2 Requirements for locking devices .................................................................................................................. 51

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22.2.3 Test methods for locking devices ................................................................................................................... 52

........................................................................................................ 52
..................................................................................................................................... 52
..................................................................................................................................... 52
22.3.1 Power-driven mobile APPHs .............................................................................................................................. 52
22.4 Rough handling and movement............................................................................................................................................. 52
22.4.1 General................................................................................................................................................................................... 52
22.4.2 Requirements .................................................................................................................................................................. 52
22.4.3 Test method for movement over a threshold ....................................................................................... 53
22.4.4 Test method for door frame shock ................................................................................................................ 53
22.5 Functional requirements for mobile APPHs ............................................................................................................... 53
22.5.1 Foot supports ................................................................................................................................................................... 53
22.5.2 Position of push handles/points ..................................................................................................................... 53
22.5.3 Turning diameter of mobile APPHs .............................................................................................................. 53
22.6 Moving forces ........................................................................................................................................................................................ 54
22.6.1 Requirements for moving forces ..................................................................................................................... 54
22.6.2 Test methods for moving forces....................................................................................................................... 54
23 Fixed APPHs ............................................................................................................................................................................................................ 55
23.1 General ........................................................................................................................................................................................................ 55
23.2 Requirements ........................................................................................................................................................................................ 55
23.3 Shower seats (09 33 03) .............................................................................................................................................................. 56
23.3.1 Description......................................................................................................................................................................... 56
................. 56
23.4 Bathing stretchers, shower tables and diaper changing tables (09 33 12) ..................................... 57
23.4.1 Description......................................................................................................................................................................... 57

shower tables and diaper changing tables ............................................................................................. 57

23.5 Bath/shower chairs (without wheels), bath boards, stools, back supports and
seats (09 33 03) .................................................................................................................................................................................. 58
23.5.1 Description......................................................................................................................................................................... 58
.................................................................................................................................... 58
23.6 Raised toilet seats (09 12 18).................................................................................................................................................. 59
23.6.1 Description......................................................................................................................................................................... 59
23.6.2 Requirements for static strength for raised toilet seats ............................................................. 59
.......................... 59
23.7 Handrails, grab bars and handgrips (18 18 03 and 18 18 06).................................................................... 60
23.7.1 Description......................................................................................................................................................................... 60
23.7.2 Ergonomic principles for handrails, grab bars and handgrips ............................................. 60

and handgrips.................................................................................................................................................................. 61
23.8 Removable grab rails and handgrips (18 18 10) .................................................................................................... 62
23.8.1 Description......................................................................................................................................................................... 62
23.8.2 Ergonomic principles for removable grab rails and handgrips ............................................ 62

and handgrips.................................................................................................................................................................. 62
23.9 Hinged rails and arm supports (18 18 11) .................................................................................................................. 63
23.9.1 Description......................................................................................................................................................................... 63
23.9.2 General................................................................................................................................................................................... 63
23.9.3 Test method for static strength for hinged rails and arm supports .................................. 63
23.10 Height-adjustable plinths and brackets (18 15 06) ............................................................................................. 64
23.10.1 Description......................................................................................................................................................................... 64

plinths and brackets................................................................................................................................................... 64

24 Static APPHs ........................................................................................................................................................................................................... 65
24.1 General ........................................................................................................................................................................................................ 65
............................................................................................................. 65
................................................................................................................... 65

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24.3.1 Description......................................................................................................................................................................... 65
24.3.2 Impact .................................................................................................................................................................................... 65
24.4 Toilet seats with built-in raising mechanism to help standing up and sitting down
................................................................................................................................................................... 68
24.4.1 Description......................................................................................................................................................................... 68
............................................................................................................................................................................ 68
24.5 Bath/shower chairs (without wheels), bath boards, stools, back supports and
seats (09 33 03) .................................................................................................................................................................................. 68
24.5.1 Description......................................................................................................................................................................... 68
24.5.2 Materials .............................................................................................................................................................................. 68
................................................................................................................................................................................. 68
........ 68
24.5.5 Strength test of brackets ........................................................................................................................................ 73
24.5.6 Friction test of bath board/seat ....................................................................................................................... 76
24.5.7 Static horizontal force test on handle ......................................................................................................... 77
24.5.8 Static vertical force test of handle of bath and transfer boards ........................................... 77
25 Requirements for information supplied by the manufacturer .........................................................................78
25.1 General ........................................................................................................................................................................................................ 78
25.2 Instructions for use .......................................................................................................................................................................... 78
25.2.1 Pre-sale information .................................................................................................................................................. 78
25.2.2 User information........................................................................................................................................................... 79
25.2.3 Service information .................................................................................................................................................... 80
25.3 Labelling .................................................................................................................................................................................................... 80
.................................................................................................................................................................................................................. 80
27 Test report ................................................................................................................................................................................................................81
Annex A (informative) Cognitive impairment ..........................................................................................................................................82
Annex B (informative) General recommendations .............................................................................................................................83
Annex C (informative) Environmental and consumer-related requirements ........................................................90
Annex D (informative) Periodic inspection ................................................................................................................................................95
Bibliography .............................................................................................................................................................................................................................96

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 ISO 17966:2016(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards

committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

on the ISO list of patent declarations received (see www.iso.org/patents).

constitute an endorsement.

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL:
The committee responsible for this document is ISO/TC 173, Assistive products for persons with disability.

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ISO 17966:2016(E)

Introduction

of the devices can be used in more than one environment. This means that different requirements and
test methods can be applied to the same product depending on the environment. Clauses 1 to 21 and
Clause 25 Clauses 22 to 24

requirements to the general clauses. In order for a product to claim compliance with this International

products do not include electrical components; therefore, the clauses related to electrical components

In addition to the requirements in this International Standard, Annex B gives general recommendations.

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INTERNATIONAL STANDARD ISO 17966:2016(E)

Assistive products for personal hygiene that support

users — Requirements and test methods

1 Scope

following divisions of ISO 9999:2011:

09 12 03 Commode chairs;
NOTE This covers mobile and static products.

09 12 06 Toilets with built in raising and height adjustable mechanism;

09 12 09 Toilet seats;
09 12 12 Raised toilet seats mounted on frame;
09 12 15 Toilet seats inserts;

09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down;
09 12 24 Toilet arm supports and toilet back supports mounted on toilet;
09 12 25 Toilet arm supports and toilet back supports, free standing;

09 33 03 Bath/shower chairs (with and without wheels), bath boards, stools, back supports
and seats;
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
18 15 06 Height adjustable plinths and brackets;
NOTE Refers to height adjustable plinths and brackets when used as an assistive product for personal

18 18 03 Handrails and support rails;

18 18 06 Fixed grab bars and handgrips;
18 18 10 Removable grab rails and handgrips;
3.27.

18 18 11 Hinged rails and arm supports;

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ISO 17966:2016(E)

This International Standard does not encompass requirements regarding:

— safe mounting in building structures;

— 09 33 21 Bathtubs of ISO 9999:2011;

— products that have been customised or custom-made for an individual user.

2 Normative references
The following referenced documents are indispensable for the application of this document. For dated

CISPR 11,
disturbance characteristics — Limits and methods of measurement
ISO 3746, Acoustics — Determination of sound power levels and sound energy levels of noise sources using

ISO 8191-1, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source:
smouldering cigarette
ISO 8191-2, Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source:

ISO 9227,
ISO 9999:2011,
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 12100,
ISO 13850,
ISO 14155,
ISO 14971,
ISO 15223-1,

ISO 22442-1,
management
IEC 60335-1,
IEC 60529,
IEC 60601-1:2005+A1:2012,
and essential performance
IEC 60601-1-2:2014,

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 ISO 17966:2016(E)

IEC 60601-2-35,
pads and mattresses, intended for heating in medical use
IEC 61000-3-2,

IEC 61000-3-3,

IEC 61000-4-3,

IEC 61000-4-8,

IEC 60695-11-10,
methods
EN 614-1,
EN 1041, Information supplied by the manufacturer of medical devices
EN 12527:1998,

3.1
applied part

perform its function

3.2
APPH
assistive product for personal hygiene
assistive product (3.3
3.3
assistive product

— for participation;

3.4
assistant

3.5

180° to the forward direction of travel

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ISO 17966:2016(E)

3.6
cleaning
removal of foreign materials from a surface
3.7
disinfection

organisms capable of infection

3.8
essential performance

degradation would result in an unacceptable risk.

3.9

3.10
forward

3.11
foreseeable misuse

3.12
hand-held product

3.13
home care
care provided in a domestic area where the assistive product is used to alleviate or compensate for an

3.14
institution

3.15
intended use
intended purpose

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3.16
maximum load

3.17
maximum user mass

assistive product
3.18
mobile product

its own wheels or equivalent means

3.19
normal use

transport, etc.
3.20
occupant
person in or on an assistive product with a support surface
3.21
operator
person who operates the assistive product

3.22
permanent deformation

test is completed
3.23
portable product
transportable equipment intended to be moved from one location to another while being carried
3.24
public use

3.25

3.26
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is present
3.27
static product

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ISO 17966:2016(E)

3.28
system
set or series of interconnected or interdependent parts or entities that act together in a common

3.29
test cycle

3.30
user
person who uses/occupies the device

4 General requirements and test methods

4.2 Intended performance

appropriate test standards and their test results.

characteristics, its application(s) and conditions of use.

standards and their test results.

4.3 Clinical evaluation and investigation

If the risk management demonstrates a need for a clinical evaluation, a clinical evaluation shall be done

investigation, the clinical investigation shall conform to the requirements of ISO 14155. A clinical

4.4 Assistive products for personal hygiene that can be dismantled

If it is intended that an APPH can be dismantled for storage or transportation, it shall not be possible to
reassemble it in a manner that presents a hazard.

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4.5 Fasteners
The fasteners which are loosened or removed to allow this dismantling shall not be single use fasteners.
EXAMPLE Single use fasteners include wood screws and self-tapping screws. Bolts are examples of fasteners
that can be used more than once.

inadvertent detachment.

4.6 Means to prevent falling out

If there is a risk of the user falling out of the product during normal use, means to prevent the user
falling out shall be available, e.g. side rails, a seat belt or a harness.

4.7 User mass/load limits

the manufacturer.

relevant test methods of this International Standard.

When the loading pad is used for testing, the mass thereof shall be taken into account for the test
value of loading.

4.8 Apparatus

4.8.1 Means to apply a force

application less than 5 N/s.

4.8.2 Means to measure force

4.8.3 Means to measure distance

whichever is the greater.

4.8.4 Means to measure angles

4.8.5 Means to measure torque

0,5 Nm to 10 Nm.

4.8.6 Means to measure sound levels and frequencies calibrated in accordance with the
manufacturer’s instructions, using an acoustic calibrator class 1 as described in ISO 3746 with an

4.8.7 A hard horizontal and inclinable test plane

non-adjustable test plane can be used, if it is set to the correct angle.

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ISO 17966:2016(E)

NOTE A hardwood board (e.g. > 600 kg/m3) is an example of material used.

4.8.8 Stoppers, for mobile APPHs not smaller than half of the wheel diameter and not greater than the
wheel diameter. See Figure 1.
For static APPH the stopper shall be designed to prevent the APPH from sliding, and not to prevent
it from overturning. The height of the stopper shall be 12 mm or less. In the case where a stopper
larger than 12 mm is required because of the construction of the APPH, it shall be the minimum height
required to prevent the APPH from sliding.

Figure 1 — Wheel-stopper

4.8.9 Equipment capable of simulating human body parts

4.8.10 Equipment for applying loads

4.8.12 Loading pads, as follows.

4.8.12.1 Concave loading pad.

The concave loading pad for static loads shall be made of metal or hard wood as shown in Figure 2.

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 ISO 17966:2016(E)

Dimensions in millimetres

Key
A front view
B side view
1 loading surface

Figure 2 — Concave loading pad for static loads

4.8.12.2 Convex loading pad.

The convex loading pad shall be circular and made of metal or hard wood, as shown in Figure 3.
Dimensions in millimetres

Key
1 loading surface

Figure 3 — Convex loading pad for static loads

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ISO 17966:2016(E)

The loading pad shall be made of metal or hard wood and have the shape and dimensions as shown in
Figure 4.
Dimensions in millimetres

4.8.12.4 Seat loading pad.

The loading pad shall be made of metal or hard wood and have the shape and dimensions as shown in
Figure 5 with rounded edges, with various diameters depending on the test item.

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350 mm, 250 mm or 200 mm

Figure 5 — Loading pad for seat support

4.8.13 , which shall meet the requirements shown in Figures 6 or 7.

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ISO 17966:2016(E)

Dimensions in millimetres

Key
1 steel block
2 3; Hardness: 80+ shore A; Resilience:

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 ISO 17966:2016(E)

Dimensions in millimetres

Key
1 threaded bar
2 3.5

60 N (ISO 2439)
3 washer

4.8.14 Toilet seat impact test pendulum, with the following properties:

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ISO 17966:2016(E)

The impact test pendulum shown in Figure 8

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Dimensions in millimetres

Key
1 centre adjustment
2 steel tube
3 steel block
4
5 centre of percussion side face
6 reference dimension

Figure 8 — Example of toilet seat impact test pendulum

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ISO 17966:2016(E)

4.8.15 Supporting stands

Figure 9). The stands shall have an adjustable width and angle seen from distance at the bottom and top
in order to accommodate for positioning of different designs.

different angles.
Example A bathtub can have sloped sides which the supporting stands can simulate.

Dimensions in millimetres

Key
1 supporting stand

Figure 9 — Supporting stand

4.8.16 Lying support impactor, with the following properties.

central area of the striking surface.

convex spherical curvature of 300 mm radius with a 12 mm front edge radius. See Figure10.

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 ISO 17966:2016(E)

Key
1 joint of lifting device not inhibiting free fall
2 striking surface

Figure 10 — Lying support impactor

4.9 Test conditions

The product shall be tested in the as-delivered state (to the customer). However if the product is of a
multi-purpose design that can be assembled in different formats, it shall be assembled according to

then the most adverse combination shall be tested. If the product is delivered disassembled it shall be
assembled according to manufacturer’s instructions before testing.
EXAMPLE A shower seat converted into a toilet seat.

— with temperatures between 15°C and 30°C;

All tests shall be performed on a single product. A new product can be chosen if the original test object
breaks down, and cannot be repaired. Some tests relevant to the safe functioning of the product might
have to be repeated on the new product. This is up to the manufacturer of the product to consider in
each separate case.

important.

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ISO 17966:2016(E)

5 Materials

5.1 General

5.2 Flammability

5.2.1 General

NOTE For guidance see B.5.2.

5.2.2 Moulded parts used as enclosures for electrical equipment

5.2.3 Upholstered parts and moulded parts

parts of an assistive product are tested in accordance with ISO 8191-1 and ISO 8191-2.

accordance with IEC 60695-11-10.

5.3 Biocompatibility and toxicity

the guidance in ISO 10993-1.

4.1).

high concern (SVHCs).

The assessment should follow the guidance given in Annex C.

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5.4 Infection and microbiological contamination

5.4.1 Cleaning and disinfection

If an APPH is intended to be cleaned and/or disinfected, the method and suitable cleaning or disinfection

NOTE For guidance see B.5.4.1.

of cleaning/rinsing solution shall be described in the instructions for use. Where practicable, the

labelling and an example of testing of machine washable APPH in B.5.4.1.

5.4.2 Resistance against temperature alternations

If an APPH is intended to be heated up during the disinfection or washing process, it shall pass the
following test.

exposition can be used:

a) a temperature of 90°C for 1 minute;
b) a temperature of 85°C for 3 minutes;
c) a temperature of 80°C for 10 minutes.

reducing changes.

5.4.3 Animal tissue

Where a device has been manufactured utilising tissues of animal origin or their derivatives, a risk
assessment shall be performed and documented according to ISO 22442-1.
NOTE For guidance see B.5.4.3.

5.5 Resistance to corrosion

duration of 72 hours.

6 Emitted sound and vibration

6.1 Noise and vibration

If noise and vibration are not part of the intended performance of an APPH, hazards and nuisance from
4.1).

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ISO 17966:2016(E)

Measurements of noise from a power operated APPH shall be made in accordance with ISO 3746, and
the result of the measurement shall be recorded in the pre-sale information of instructions for use.
NOTE For guidance see B.6.1.

6.2 Sound pressure levels and frequencies of audible warning devices

disabilities the range will be less and in severe cases down to 500 Hz to 3 000 Hz.

A-weighted sound pressure levels shall be at least 65 dB for audible alarms.

7 Electromagnetic compatibility

7.1 General
An APPH containing electrical or electronic devices/components shall conform to IEC 60601-1-2 and
shall, in addition, conform to 7.2, 7.3 and 7.4.

7.2 Emissions

for group 1, class B equipment.

The APPH shall meet the requirements of IEC 61000-3-2 and IEC 61000-3-3, if applicable.

7.3 Immunity

shall be performed in accordance with IEC 61000-4-3.

operation of the APPH, the APPH fails the test.

intended use of the APPH.

50 Hz or 60 Hz:

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 ISO 17966:2016(E)

For guidance see B.7.4.

8 Electrical safety

8.1 General
Table 1
connected to mains shall be either of class I (protective earth) or class II (double isolation). For APPHs

to IEC 60601-1-11.

Table 1 — Applicable standards for electrical safety

APPH that fall within the scope of APPH that fall within the scope of IEC 60335-1
IEC 60601-1:2005 are tested according to:
are tested according to:
IEC 60601-1 IEC 60335-1
IEC 60601-1-11 IEC 60335-2-xx
IEC 60601-2-xx

8.2 Electrical systems

Table 1.

8.3 Safe positioning

8.4 Single fault safety

The APPH shall be so designed and manufactured that it remains single fault safe, or the risk remains

8.5 Hold to run activation

8.6 Emergency stopping functions

— the APPH shall be designed to prevent accidental damage. If this is not feasible the APPH shall stop
moving;

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ISO 17966:2016(E)

situation within one action;

a designated procedure;

8.7 Continuity of power supply

— In case of a power cut, it shall be possible to return the APPH to a position enabling safe transfer

further actions.
— If it is feasible, a method of non-electrical operation shall be provided that reduces the risk to

together with a means to signal power failure to the operator/assistant who is intended for such

possible and have a performance time long enough to bring the user into a position to enable safe transfer.

and/or beeps).

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8.8 Battery powered assistive products for personal hygiene

8.8.1 Battery housings

risks to occur.
4.1) and

2) ventilation of gases generated during charging and/or use;

when operated in accordance with the conditions of use.

b) Housings containing batteries from which gases can escape during charging or discharging, shall
be ventilated.

8.8.2 Connection

8.8.3 Charge level indicator

operators with different functional limitations, e.g. persons with a vision or hearing impairment.

For guidance see ISO/IEC Guide 71:2001, Tables 5 and 6.

8.9 Circuit protection

The APPH shall meet the requirements and test methods for circuit protection as in IEC 60601-
1+A1:2012:2005.
For guidance, see B.8.9.

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ISO 17966:2016(E)

IEC 60601-2-35 with a maximum temperature according to Table 2.

8.11 Ingress of liquids

detailed in IEC 60529.

for normal use.

during the cleaning process) shall at least be protected to IPX2.

public areas at least IPX5.

9.1 Ingress of liquids

9.1.1 Requirements

4.1).
NOTE 1 See B.9.1.

8.11.

NOTE 3 Hazards might be risk of corrosion or bacterial growth.

9.1.2 Test method

9.2.1 General

The requirements given in 9.2.2

for its function (e.g. oil and grease).

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 ISO 17966:2016(E)

The assessment should follow the guidance given in Annex C.

in user care, transport and storage); or

biological hazard.

NOTE 2 An example of a method of protection from a hazardous substance is where batteries are placed in a
container made from acid resistant material.

4.1
temperature of parts which can come into contact with human skin during the intended conditions of use.

a) the range of ambient temperatures to be expected during the intended use and foreseeable misuse;
NOTE These temperatures could include direct exposure to sunshine, hot water, hot air, extreme
cold, saunas, etc.

c) the ergonomic data on acceptable temperatures of touchable surfaces in IEC 60601-1:2005+A1:2012,

and/or damaged skin for a duration of 10 min or more. In this case the maximum temperature
shall not exceed 41 °C (see Table 2
1:2005+A1:2012.
If a manufacturer cannot meet the requirement of c) without impairing the intended performance of the

Table 2
offset the increased risk.

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Maximum temperature a
°C
Applied parts of APPH Moulded
Metal
and liquids vitreous material
wood
t < 1 min 51 56 60
Applied part having
contact with a person t < 10 min 48 48 48
for a time “t ”
t 41 41 41
a

11 Safety of moving and folding parts

11.1 Squeezing
Unless the intended purpose of an APPH, or part of an APPH, is to grip, cut, squeeze etc., or if the
intended use cannot be achieved without a hazard such as risk of squeezing:

b) the gap between exposed parts of an assistive product that move relative to each other shall be
maintained throughout the range of movement at less than the minimum value or more than the
maximum value set out in Table 3.

Table 3 — Safe distances between moving parts

To avoid Safe distances for adults Safe distances for childrena
Finger traps Less than 8 mm or Less than 4 mm or
more than 25 mm more than 25 mm
Foot traps Less than 35 mm or Less than 25 mm or
more than 120 mm more than 120 mm
Head traps Less than 120 mm or Less than 60 mm or
more than 300 mm more than 300 mm
Genitalia traps Less than 8 mm or Less than 8 mm or
more than 75 mm more than 75 mm
a
of less than 17.

d) the APPH shall incorporate a control device which initiates the movement when it is operated and
stops the movement when it is released (e.g. a spring loaded control device that returns to the stop
position when released); or
e) the APPH shall incorporate a means for detecting that a person is in danger of being trapped and

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For moving parts that can cause squeezing, manufacturers shall take into consideration those

distances can be applied.

shall be assessed:
— the APPH shall incorporate means to protect the user from trapping and/or squeezing hazards; or
— the gap between exposed parts of an APPH that move relative to each other shall be maintained
throughout the range of movement at less than the minimum value or more than the maximum
value set out in Table 3; or
— if the intended purpose of an APPH cannot be met without a hazard such as squeezing, a warning

If guards are applied, the design of a guard shall take into consideration the forces that can be applied
in normal use.

11.2 Velocity of powered lifting and lowering movements

11.2.1 Requirements

a) the rate of lifting or lowering shall not exceed 0,15 m/s when loaded;
b) the rate of lifting or lowering shall not exceed 0,25 m/s when unloaded.

11.2.2 Test method

in 11.2.1 a).
11.2.1 b).

11.3 Mechanical wear

11.4 Trapping zones for feet in relation to moving parts

Figures 11 and 12 shall be considered as trapping zones for feet.
For the area in Figure 11 where B = 130 mm; the distance A
For the area in Figure 12 where the distance B1 and B2 is between 130 mm to 180 mm; the distance C

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Key
A
B

Key
B1, B2
C

12 Prevention of traps for parts of the human body

12.1 Holes and clearances

Table 4.

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Table 4 — Safe distances between stationary parts

To avoid Safe distances for adults Safe distances for childrena
Finger traps Less than 8 mm or Less than 5 mm or
more than 25 mm more than 12 mm
Foot traps Less than 35 mm or Less than 25 mm
more than 100 mm or more than 45 mm
Head traps Less than 120 mm or Less than 60 mm or
more than 250 mm more than 250 mm
Genitalia traps Less than 8 mm or Less than 8 mm or
more than 75 mm more than 75 mm
a Also includes adults with a height of less than 146 cm, or a mass of less than 40 kg, or a BMI of less than 17.

shall be provided in the instructions for use.

user/user
can be applied.

applied in normal use.

Table 4.

into account.
16.4.2.4.

12.2 V-shaped openings

13 Folding and adjusting mechanisms

13.1 General

parts and be trapped when the gap is closed. See Clause 11 for further requirements.
If an APPH incorporates folding and/or adjusting mechanisms it shall conform to 13.2.
If a product is able to be height adjustable the increments shall not exceed 25 mm.

user or assistant. It shall be protected against unintended release.

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14 Lifting and carrying means

14.1 General

the following.
If an APPH or a part of an APPH has a mass of 10 kg or more and the intended use is for it to be portable
or to be handled according to manufacturer’s instuctions, it shall either:

14.2 Requirement

14.3.

14.3 Test method

handles or grips, determine the force on each handle or grip when it is carried or lifted.
If an APPH has more than one handle or grip, determine the force on each handle or grip when the APPH
is carried or lifted in the intended manner.

%
tolerance of . If there is more than one intended manner determine the highest force.
%

%
grip, equal to twice that determined above with a tolerance of
%
Figure 13).
Maintain the force for between 60 s and 70 s.

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Key
1 APPH
2 restraints
3 test force

Figure 13 — Carrying handle test (example)

15 Portable and hand-held products for personal hygiene or hand-held parts

Table 5 on to a hard surface.

Table 5 — Drop height

Mass (m)
Drop height
of portable APPH or its parts
cm
kg
m 100
0,2 < m 20
1<m 5
10 < m 3
m > 50 2

To avoid dropping and to have an ergonomic grip the hand-held APPH shall be assessed for grip, mass,

The sample to be tested is lifted to a height as indicated in Table 5 above the test plane (4.8.7) positioned

the intended use.

Hand-held control devices for a powered APPH shall be capable of withstanding being dropped 1 000

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16.1 General

the forces in the different tests are dealt with in 16.2. Each subclause starts with its own requirements

16.2 Formulae

16.2.1 Formulae for calculating forces

The formulae in Table 6 shall be used to calculate the force, F, in the test methods within this
International Standard.

Table 6 — Formulae for calculating forces

Test Formula Maximum force
(calculation based on md 130 kg)
Static strength on a seat surface
F=m×g×
-
face F=m×g×

F=md×g
Static strength of back support
Static strength on arm support down- 950 N
warda

- 635 N
warda

Static strength on foot support down- F=md×g 1200 N

warda
Static strength on foot support re- , 200 N
maining gap
where
md is maximum user mass in kg
m

F is the force to be applied in Newton

g is the gravitational constant = 9,807 m/s2.
a The result of the calculation or the maximum force, whichever is lower.

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16.3 Number of test cycles for durability

be calculated according to the following formula.

nTC = uUC × uTD × 365 × tDL

where

nTC

uUC

uTD

tDL

the instructions for use and also in the label.

in Tables 7 and 8 shall be used.

The manufacturer shall indicate in the instructions for use the intended life time and the environment(s)
of intended use.

Table 7 — uuc for different functions

Arm support 2
Seat support 1
1
Grab support 1
Foot support 1
Brakes 2

Table 8 — utd for different environments

Activity type Home care Institutions Public use
5 10 10
2 10 5

16.4.1 Requirements
During and after the static strength tests in 16.4.2 no parts of the APPH shall:
— become unstable;

— have visible deformations or gaps disturbing the function;

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— become detached.
Further depending on the APPH:
— there shall be no permanent tilt;
— all adjustable parts shall function as intended;

— the foot support shall either have means to prevent the feet from sliding into the gap between them,
or have a gap that is less than stated in Table 4;

16.4.2 Test methods

16.4.2.1 Static strength of a lying support surface

The tests shall be performed on a horizontal surface with the load applied for 20 minutes.

The APPH shall be kept stable during the whole test.

First test. Attach the load according to Table 6
to Figure 14.
Second test. This test(s) shall be performed on the most critical part of the surface where it is possible for
the user to put the maximum load while transferring according to Figure 15. If it is possible to transfer

Remove the test load and inspect the APPH for damage.

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Dimensions in millimetres

Key
A drain
B foot
C head
D centre line

NOTE Values shown are percentages of maximum load.

Figure 14 — Placing of loads on a lying support surface

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ISO 17966:2016(E)

Dimensions in millimetres

Key
A drain
B foot
C head

NOTE Values shown are percentages of maximum load.

Figure 15 — Placing of load on a lying support surface — Maximum load transfer

16.4.2.2 Static strength of an arm support downwards

Calculate downward force to be applied to an arm support using the formulae in Table 6.
Each arm support is loaded for a minimum of 60 s in a point 50 mm from the front edge.

support surface of the arm support as shown in Figure 18 and 19 using a loading pad selected as
4.8.12.1 and 4.8.12.2.
NOTE Figure 18

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Before commencing the test set-up, the means to prevent the assistive product from tipping and the
means to prevent the assistive product from moving backwards and forwards are applied.

Set up the APPH according to manufacturer’s instructions.

1) according to Table 6, using a

4.8.12.4 for 20 min to the part of the APPHs seat support surface according
to Figure 16.
If the APPH has a seat lid, the load shall be placed on the upper surface of the lid due to foreseeable misuse.

2) according to Table 6,
4.8.12.3 for 20 min to the part of the APPH’s back support surface
according to Figure 16
tilt during the test.
The test shall be done with the back support in the most adverse position if it has an adjustable
recline function.

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ISO 17966:2016(E)

Dimensions in millimetres

Key
1 loading pad

16.4.2.4 Static strength of foot supports

Before commencing the test set-up, the means to prevent the APPH from tipping and the means to
prevent the APPH from moving backward and forward are applied.
Calculate downward forces to be applied to the foot support using the formulae in Table 6. With the
Table 6, “Static force on

Figure 17.
Use a convex loading pad (see Figure 3
Figure 2) on foot
supports consisting of a single tube.

hole in the foot plate to secure the loading actuator.

If the foot support is height adjustable it shall be positioned in the most adverse position of intended use.

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If foot supports are of an open construction so that a standard loading pad cannot transmit load to the

support nearest to the loading point.

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ISO 17966:2016(E)

Figure 17 — Location of foot support load

F2 Table 6 or the

Remove the load.

16.5 Durability

16.5.1 Requirements
16.5.2 no parts of the APPH shall:
— become unstable;

— have visible deformations or gaps disturbing the function;

— become detached.
Further, depending on the APPH:
— there shall be no permanent tilt;
— all adjustable parts shall function as intended;

— the foot support shall either have means to prevent the feet from sliding into the gap between them,
or have a gap that is smaller than stated in Table 4;

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1) Readjustment of postural supports is allowed.

manufacturer’s instructions.

16.5.2 Test methods

16.3 (see Tables 7 and 8) regarding the intended area of

16.5.2.1 Durability of the arm support

in Table 6
support surface of the arm support as shown in Figure 18 and 19 using the concave loading pad selected
4.8.12.1.
NOTE Figure 17
will change as the test deforms the arm support.

Table 6, or the

After the test remove the load.

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ISO 17966:2016(E)

Dimensions in millimetres

Key
1 pivots for load application

Figure 18 — Downward forces on arm supports: Front view

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Figure 19 — Downward forces on arm supports: Side view

16.5.2.2 Durability of seat surface

Table 6 Figure 16.

Use a suitable loading pad (see 4.8.12.4

16.3 and in Table 7 and Table 8

regarding the intended area of use.
After the test remove the load.

16.5.2.3 Durability of a power operated height adjustment mechanism

as indicated in Figure 14 16.4.2.3 (Figure 16) for a sitting surface. A test

16.3 and Table 7 and

Table 8 regarding the intended area of use.
After the test remove the load.

16.5.2.4 Durability of power operated movable sections

Figure 14 16.4.2.3
(Figure 16
also be used.
Each of the movable sections is operated through their full range of travel as in normal use.

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ISO 17966:2016(E)

Table 7 and Table 8 in 16.3 regarding

the intended area of use.

After application of the load, no elements of the product shall become loose, fractured or present

measurements taken before the application of the load is not acceptable.

16.5.2.5 Durability of the frame of an APPH with a sitting surface equipped with legs/wheels

Set the wheels/legs according to Figure 20, against the stopper.

backwards directions.

The box (350 mm wide, 350 mm deep and 300 mm high) shall be fastened at the centre of the seat and
secured against sliding.

Table 7 and Table 8 in 16.3 regarding the intended area of

use. It shall not exceed 10 000 times in each direction.
The force is applied perpendicular to the box.
The APPH is tilted at the box (see Figure 20
4.8.7). Test 1 is in the backwards direction, test 2 in the forwards

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Figure 20 — Durability test for frame of APPH

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ISO 17966:2016(E)

16.6 Impact

16.6.1 Requirements

After performing the tests in 16.6.2

a) No component shall be fractured or have become detached, with the following exceptions:
— readjustment of postural supports is allowed;

constitute a failure.

connector shall be crushed or disconnected.

manufacturer.

g) Handgrips shall not be displaced.

16.6.2 Test methods

This test applies to products where the back support height is 320 mm or greater above the seat.
The measurement of the 320 mm is taken from the upper surface of the seat base at an angle of 90 °
from the centre of the seat.

in Figure 21, position the back support impact test pendulum (see 4.8.13) with the bar vertical so that
the mass is touching the back support on a horizontal line passing through the back support pivot.

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so that the mass is touching the centre line of the back support at a point 30 mm below the top of the
back support as shown in Figure 22.

Position a rigid stopper (see 4.8.8) against the rear wheels/legs of the product and attach a loose

Figure 22
If the manufacturer claims that the product exceeds the minimum requirements, use the angle claimed

If the back support is height adjustable the test shall be performed in worst case position.
For products where the back support is mounted on two supporting members repeat the test twice
with the pendulum repositioned so that it strikes the centre line of each back support 20 mm below the
top of the back support.
For products where the back support is mounted on a single central support repeat the test with the
pendulum positioned to strike the back support at points located 0,4 times the back support maximum
width from each side of its centre line.

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ISO 17966:2016(E)

Dimensions in millimetres

16.6.2.2 Test method for a lying support surface

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Dimensions in millimetres

Figure 23 — Impact test of a lying support surface

the possible range of the adjustment.

4.8.16) onto
the APPH 20 times onto each of the locations marked “A” in Figure 23. The impactor shall be allowed

recommended locations.

17 Stability

17.1 Requirements for static stability

17.2, a mobile and static APPH loaded with the maximum load shall

17.2 Test method for static stability

manufacturer on the inclined test plane (4.8.7) according to the required angle for each test. If for

manufacturer.
4.8.8
and Figure 1).
Figure 14
Figure 16,
force F1, but not more than 350 mm from the front edge of the seat.

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ISO 17966:2016(E)

distributed as indicated in Figure 15 both at the ends and at the sides, one test at a time. The tests shall
be carried out with the APPH in its most adverse position regarding the position of wheels, support
surface, base and brakes, if applicable.

If not required for the intended function of an APPH, all accessible edges, corners and surfaces shall be
smooth and be free from burrs and sharp edges.

NOTE For guidance, see B.18.

19 Small parts

a danger of small children being choked.

NOTE Small children are considered to be under the age of 5.

20 Forces in soft tissues of the human body

4.1).
NOTE For guidance, see B.20.

21 Ergonomic principles

use and meet the following requirements (where applicable, the APPH shall be loaded with the
maximum load):

buttons shall be more than 10 mm;

the APPH shall have a vertical toe clearance of not less than 75 mm;

shall be between 19 mm and 43 mm;

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e) for an APPH operated from a standing position, pedals shall be placed not more than 300 mm above

f) for an APPH operated from a standing position, hand operated controls shall be placed at a height

while seated shall be within the occupant’s reach space;

use of the APPH.

h) the operating forces or torques required for those parts of the device that are designed to be
Table 9.

Table 9 — Operating forces

Operation Force/torque
5N
60 N
300 N
1,9 Nm
rotation of seat surface 60 N

22 Mobile APPHs

22.1 General

Clauses 4 to 21.

an occupant in place within the following examples of divisions of ISO 9999:2011 (in brackets):
— commode chairs (09 12 03);
— bath/shower chairs, bath boards, stools, back supports and seats (09 33 03);
— bathing stretchers, shower tables and diaper-changing tables (09 33 12).

22.2 Immobilizing means

22.2.1 General

Mobile APPH shall not result in an unacceptable risk due to unwanted movement when tested in
accordance with 22.2.3 and 22.2.4. When the product has come to a total standstill, there shall be no
movement of the mobile APPH greater than 50 mm (in relation to the inclined plane) within 1 min.

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ISO 17966:2016(E)

Prior to the test, the mobile APPH is prepared with the following in the most adverse position of normal
use:
— the height and length;
— castors/wheels.
The mobile APPH is placed with the maximum load in place distributed as indicated in Figures 14, and 16
and the locking device (e.g. brakes) activated, on a test plane (4.8.7
initial movement shall not result in an unacceptable risk, taking into account the normal use of the APPH.
Adjust the locking device (e.g. brakes) in accordance with the manufacturer’s instructions for use
without exceeding the operating force requirements stated in Table 9.

Set up the mobile APPH as in 22.2.3 on a horizontal surface.

16.3 (see Table 7 and Table 8

EN 12527:1998.
22.2.2.

shall not protrude above the unoccupied seat.

22.3 Electrical safety for mobile APPHs

22.3.1 Power-driven mobile APPHs

Power-driven mobile APPHs for transportation shall have a means (e.g. free wheeling) to allow

22.4 Rough handling and movement

22.4.1 General

22.4.2 Requirements
22.4.3 and 22.4.4 the mobile APPH, product parts and accessories shall

entrapment or pinching.
The mobile APPH shall go over the obstruction and shall not overbalance (tip over) when tested
according to 22.4.3. The mobile APPH or product parts shall not present an unacceptable risk.

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22.4.3 Test method for movement over a threshold

All accessories intended for normal use during transport shall be attached to the APPH and with the
height in the worst case position and with the maximum load in place distributed as indicated in
Figures 14 and 16

at least 80 mm wide with a radius of 2 mm at the top edges.

The APPH shall be moved at a speed of 0,8 m/s m/s, or for motor-driven mobile APPHs for
transportation, the maximum speed shall be used, while all castors shall impact and pass over the

all castors, shall then be pulled back over the obstruction and back to the starting position of the test.
This is repeated 10 times.

This is repeated 10 000 times.

NOTE See also a proposal for an alternative test in B.22.4.3.

All accessories intended for normal use during transport shall be attached to the mobile APPH and with
the maximum load in place distributed as indicated in Figures 14 and 16 and the height in the worst

support (e.g. concrete). The height of the vertical obstacle shall be at the same level as the height of the
APPHs contact point(s). The direction of movement is perpendicular to the face of the obstacle. The

capable of being maintained, against the obstacle.

22.5 Functional requirements for mobile APPHs

22.5.1 Foot supports

If a mobile APPH is provided with a foot support, it shall be designed to minimize the risk of the user’s
feet being injured from rotation of the wheels.
4.1).

22.5.2 Position of push handles/points

Handles for pushing and/or

22.5.3 Turning diameter of mobile APPHs

The turning diameter and reversing width of a mobile APPH shall be included in the instructions for use

a) Minimum distance between two vertical and parallel walls between which a APPH can turn 180° in
one constant forward drive (see Figure 9).

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ISO 17966:2016(E)

constant forward drive with maximum steering effect.

c) Minimum distance between two vertical and parallel walls between which an APPH can turm 180°
allowing for reversing movements.

adjustable barriers. Place the APPH into the corridor and orient it parallel to the walls.
— Turn the APPH around in the corridor in the most suitable manner for the particular APPH involved.
The test drive is completed when the APPH has turned through 180°.

APPH can be turned around without touching the walls.

22.6 Moving forces

22.6.1 Requirements for moving forces

The maximum forces required for moving the mobile APPH shall be as follows when tested according to
22.6.2 with the maximum load on the mobile APPH positioned as indicated in Figures 14 and 16.
a) Starting force maximum160 N.
b) Driving (pushing/pulling) force maximum 85 N.

22.6.2 Test methods for moving forces

The test shall be carried out on a hard and horizontal test plane (4.8.7).
The mobile APPH shall be loaded with the maximum load in place distributed as indicated in Figures 14
and 16 at the support surface.
For the test of the starting force in the forward and backward direction, the castors shall be set at 180°
to the direction of pushing/pulling.

shall be recorded as the starting force.

Remain a constant force at 1 m/s for 1 m, as the mobile product is moving and measure the force
needed for driving.
The starting force shall be recorded as follows:
a) in the forward direction;
b) in the backward direction.
The driving force shall be recorded as follows:
a) in the forward direction;
b) in the backward direction.

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23 Fixed APPHs

23.1 General

Clauses 4 to 21.

ISO 9999:2011 (in brackets):

— shower seats (09 33 03)
— bath/shower chairs (without wheels), bath boards, stools, back supports and seats (09 33 03)
— bathing stretchers, shower tables and diaper-changing tables (09 33 12)
— raised toilet seats (09 12 12 / 09 12 18)
— handrails, handles (18 18 03)
— suction handles, bath clamp handles (18 18 10)
— hinged rails and arm supports (18 18 11)
— height adjustable plinths and brackets (18 15 06)

16.3 (see
Table 7 and Table 8
appropriate intervals.
In case of a hinged APPH, the test method shall include folding from the complete upright position to the
complete down position.

23.2 Requirements
16.4.1 and
16.5.1

manufacturer’s instructions for use.

fastener shall sustain.

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23.3 Shower seats (09 33 03)

23.3.1 Description

support, arm supports and/or supporting legs. For testing of back supports and arm supports, if
applicable, see Clause 16.

23.3.2.1 Test method for static strength

Table 6 for 60s (F1 of the distance

from the front edge (see Figure 24). The load shall be applied with a loading pad (see 4.8.12.4).

Figure 24 — Static strength shower seat

To test both sides of the seat, the loading pad is then placed in turn on left (F2) and right (F3) hand side
of the seat as close to the edge as possible. See Figure 24).

23.3.2.2 Test method for durability

The seat shall be tested with a load according to Figure 16
16.5.2.2.
The load shall be applied using the loading pad (4.8.12.4) in the position of intended use.
If the seat is foldable, it shall be folded from the complete upright position to the complete down position
16.3 and Table 7 and Table 8 and at appropriate intervals.

23.3.2.3 Test method for impact

The shower seat shall be able to resist horizontal sideward impacts. The test is performed using the
25 kg test pendulum (see 4.8.13 and Figure 6), 50 mm from the front, F1, according to Figure 25.

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Figure 25 — Impact strength shower seat

23.4.1 Description

height-adjustable.

diaper changing tables

23.4.2.1 Test methods for static strength

The support surface is loaded according to Table 6, for minimum 60 s. The load F1 is distributed over
the support surface according to Figure 14 and 16
load F1 (according to Figure 26) test where the entire load is placed on each side of the table one at the
time, in the worst case position. If the intended use of the table is also to contain water while a person is

The test is repeated for both sides.

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ISO 17966:2016(E)

Figure 26 — Asymetric static strength test

23.4.2.2 Test method for durability of support surface and folding mechanism

4.7.
The load shall be placed on the Table according to Figure 14
If the APPH is foldable, it shall be folded from the complete upright position to the complete down position
16.3 and Table 7 and Table 8 and at appropriate intervals.

23.5 Bath/shower
seats (09 33 03)

23.5.1 Description

APPHs aimed for supporting sitting during bathing or showering. Seats without back support placed
on the rim of the bathtub. The seat is at the level of the rim of the bathtub. Seats placed on the rim of or

23.5.2 Test method for durability

The seat/board shall be tested according to 16.5.2.2
as stated in Table 6 (see Figure 27). The load shall be applied using the loading pad in 4.8.12.4.
The load F1 according to 4.8.12.2 shall be placed on the seat.

given in Table 9 when loaded with maximum user weight.

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Key
1 APPH
2 supporting stand

Figure 27 — Durability test of bath tub seat/board

23.6 Raised toilet seats (09 12 18)

23.6.1 Description
An APPH to elevate the sitting height of a toilet seat (without raising the toilet itself) to facilitate lowering

23.6.2 Requirements for static strength for raised toilet seats

Additional to 23.2, the raised toilet insert shall be equipped with facilities which keep the raised toilet

the raised toilet seat shall not come loose from the toilet.

23.6.3 Test methods for static strength and durability for raised toilet seats

23.6.3.1 Test method for static strength

shape and surface texture.

Table 6 for at least 60 s. The load (F1
4.8.12.4) over the whole surface (see Figure 28). The seat, if adjustable,
shall be raised to the most adverse position.

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Key
1 commode chair or other mean of holding the raised toilet seat
2 seat

Figure 28 — Static strength raised toilet seat

23.6.3.2 Test method for durability

Additional to 16.5.2.2.
The test does not have to be done on a toilet.
The loading pad according to 4.8.12.2 has to be placed on the seat or the lid, if provided.

23.7.1 Description

Handrails and handgrips are designed to aid balance and prevent people who are weak or unstable
from falling.

means for a person to support or stabilize himself/herself using hands or arms while in the bathroom.

Additional to Clause 21 (Ergonomic principles).

The handrail/handle can be round, with a diameter of 25 mmto 45 mm. If it is not round the

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shall furthermore follow the requirements within Table 4.

Suction cup attachments shall be tested and have the same requirements as for attachments above.

23.7.3.1 Test method for static strength

1) using the formula for static force on seat surface in

Table 6
indicated in Table 6. See Figure 29.
The handrail shall be attached to a solid wall, with material strong enough to withstand the forces of

NOTE The order of vertical and horizontal is not critical.

Figure 29 — Handrails/handles

23.7.3.2 Test method for durability

surface in Table 6 Table 7 and Table 8 in

16.3 (see Figure 29).

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The handrail shall be attached on a solid wall, with material strong enough to withstand the forces of

NOTE The order of vertical and horizontal tests is not critical.

23.8 Removable grab rails and handgrips (18 18 10)

23.8.1 Description

to a person while changing position.

23.8.2 Ergonomic principles for removable grab rails and handgrips

Additional to Clause 21 (Ergonomic principles).

The handle can be round, with a diameter of 25 mm to 45 mm. If it is not round the bar shall have an

the wall and the grab bar shall be at least 35 mm and shall furthermore follow the requirements
within Table 4.

force (= maximum user mass).

substructure.
The suction/bath clamp handle shall not come loose while tested.
NOTE 1 Different material and different frictions will give different results.

23.8.3 Test methods for static strength and durability for removable grab rails and handgrips

23.8.3.1 Test method for static strength

Attach the test equipment onto the supporting stands (4.8.15).
Suction handrails are loaded (F1

Figure 29 as an example).
Bath clamp handles are loaded (F1

Figure 29 as an example).

23.8.3.2 Test method for durability

Attach the test equipment onto the supporting stands (4.8.15).

Suction handles are loaded in the middle of the handle under an angle of 15° outward-upward and
Table 7 and Table 8 in 16.3 (see Figure 30
as an example).

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user weight according to the formula and Table 7 and Table 8 in 16.3, see Figure 29.
NOTE 1 The order of vertical and horizontal tests is not critical.

23.9 Hinged rails and arm supports (18 18 11)

23.9.1 Description
APPHs that provide support to a person when changing her/his

are not needed.

23.9.2 General
Hinged rails/arm supports shall be secured to prevent unintentional folding down.

23.9.3 Test method for static strength for hinged rails and arm supports
Hinged rails/arm supports are loaded (F1) according to the test force in Table 6 regarding arm support

downward for at least 60 s (see Figure 30).

Figure 30 — Hinged rails/arm support static test

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23.9.3.1 Test method for durability for hinged rails and arm supports
Hinged rails/arm supports are loaded (F1

in Table 6 and Table 7 and Table 8 in 16.3 (see Figure 30).

23.10.1 Description

height adjustment of e.g. wash basins or toilets.

23.10.2.1 Test method for static strength

A bracket/plinth used for adjusting the height of an APPH intended to support the weight of a person is
Table 6 for 60 s as close to the front edge as possible. See Figure 31.
The load shall be applied with a loading pad, see 4.8.12.4.

the manufacturer. In addition, the bracket/plinth shall be able to bear the weight of a user supporting

the front edge as possible.

23.10.2.2 Test method for durability

Table 7 and Table 8 in 16.3 (see Figure 31).

The bracket/plinth used for height adjustment of an APPH shall be tested with a load equal to the
Table 7 and Table 8 in 16.3 (see Figure 31).

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24 Static APPHs

24.1 General

Clauses 4 to 21.

ISO 9999:2011 (in brackets):

— raised toilet seats mounted on frame (09 12 12);

— bath/shower chairs (without wheels), bath boards, stools, back supports and seats (09 33 03).

24.2 Stability and strength tests for static APPHs

General conditions for the relevant tests in addition to the general part shall be as follows:

c) for an APPH that has a dimension adjustment mechanism, the APPH shall be adjusted to the most
adverse position in relation to the test.

24.3.1 Description

24.3.2 Impact

24.3.2.1 Requirements
The APPH shall meet the requirements in 16.6.1 and 24.2.
In addition to the requirements in 16.6.1, the APPH shall not fall from the position of intended use.
If the product becomes dislocated from the position of intended use, it shall go back into the position
of intended use after placing the 60 kg test mass on the front edge of the product as described below
(see Figure 34).

24.3.2.2 Test methods

4.1).
Set up the APPH in the position of its intended use onto a suitable surface with characteristics to
represent standard toilets in shape and surface texture. Position the raised toilet seat impact test

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pendulum (see 4.8.14 and 4.8.15) with the edge of the pendulum in contact with the surface of the APPH
on either the front or side (see Figure 33).

fall once F1
one of its sides (see Figure 32).

Key
1 standard toilet
2 toilet seat

Figure 32 — Seat impact test

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Key
1 test pendulum

Figure 33 — Impact test pendulum

Figure 34 — Dislocation positioner

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24.4 Toilet seats with built-in raising mechanism to help standing up and sitting down

24.4.1 Description
Toilet seats that have a built-in lifting mechanism to help a person to sit down onto and get up from the
toilet.

24.4.2 Durability

16.3 together with

Table 7 and Table 8.
The tests are to be performed according to 16.5.2.3 with requirements stated in 16.5.1.

24.5 Bath/shower
seats (09 33 03)

24.5.1 Description

APPHs for supporting sitting during bathing or showering.

24.5.2 Materials

24.5.3 Stability

Clause 17.

24.5.4. In addition, such APPHs which also

24.5.4.5.

Clause 17.

24.5.4 Stability tests for APPHs designed to be supported by the sides of a bathtub

24.5.4.1 Requirements

The APPH shall not overturn after the force is applied.

24.5.4.2 Forward stability test method

The transfer bench or bath board/seat shall be placed on the supporting stand (4.8.15) in the position
of intended use. The angle of the supporting stands will be adjusted, if required, for the intended use
of the APPH. A force of 600 N (F1
(4.8.12.4). In addition, a force of 60 N (F2
(see Figure 35) to test for overturn.
APPHs with height adjustable legs shall have the height set to the maximum level or the most
adverse position.

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Dimensions in millimetres

Key
1 rim-mounted bath bench or bath board
2 supporting stands

24.5.4.3 Sideward stability test method for transfer bench without a handle
The transfer bench or bath board/seat without a handle shall be placed on the supporting stand (4.8.15)
in the position of intended use. The angle of the supporting stands will be adjusted, if required, for
the intended use of the APPH. A force of 600 N (F1
seat loading pad (4.8.12.4), according to Figure 36. In addition, a force of 60 N (F2) shall be applied
Figure 36) to test for overturn.
APPHs with height adjustable legs shall have the height set to the maximum level or the most
adverse position.

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Dimensions in millimetres

Key
1 transfer bench
2 supporting stand

Figure 36 — Sideward stability test of transfer bench without handle

24.5.4.4 Sideward stability test method for transfer bench with a handle
The transfer bench or bath board/seat with handle shall be placed on the supporting stand (see 4.8.15)
in the position of intended use. The angle of the supporting stands will be adjusted, if required, for the
intended use of the APPH. A force of 250 N (F1
loading pad in a postion for intended use (4.8.12.4), according to Figure 37. Next, a force of 350 N (F2)
4.8.12.4). In addition, a

Figure 37 for horizontal handle and Figure 38 for vertical handle).

APPHs with height adjustable legs shall have the height set to the maximum level or the most
adverse position.

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Dimensions in millimetres

Key
1 transfer bench
2 handle
3 supporting stand

Figure 37 — Sideward stability test of transfer bench with horizontal handle

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Dimensions in millimetres

Key
1 transfer bench
2 handle
3 supporting stand

Figure 38 — Sideward stability test of transfer bench with vertical handle

The transfer bench or bath board/seat shall be placed on the supporting stand (4.8.15) in the position
of intended use. The angle of the supporting stands will be adjusted, if required, for the intended use of
the APPH. The weight of 60 kg (F1) shall be put at the position 175 mm forward from the centre of rear
edge of the seat according to Figure 39. A force of 140 N (F2
direction from the centre of the top edge of the back support (see Figure 39) to test for overturn.
APPHs with height adjustable legs shall have the height set to the maximum level or the most
adverse position.

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Dimensions in millimetres

Key
1 back support
2 transfer bench
3 supporting stand

24.5.5.1 Requirements

See 16.4.1.

24.5.5.2 Test method

stand(s) (4.8.15) in the position of intended use. The angle of the supporting stands will be adjusted,
if required, for the intended use of the APPH. The force of 200 N (F1
centre of the seat using the seat loading pad (4.8.12.4). Next, a force of 400 N (F2) shall be applied

be maintained each time for at least 10 s. After removing the test force, the APPH and its parts shall
meet the requirements listed in 16.4.1 (see Figure 40, Figure 41 and Figure 42).
APPHs with height adjustable legs shall have the height set to the maximum.

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Key
1 bench
2 bracket
3 supporting stand

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Key
1 bench
2 bracket
3 supporting stand

Key
1 bench
2 bracket
3 supporting stand

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24.5.6 Friction test of bath board/seat

24.5.6.1 Requirements

24.5.6.2 Test method

The bath board/seat shall be placed on the supporting stand(s) (4.8.15) in the position of intended use.
The angle of the supporting stands will be adjusted, if required, for the intended use of the APPH. A
force of 200 N (F1 4.8.12.4), according
to Figure 43 2) (see Figure 44).
Measure three times the force at which the bath board/seat starts to slip along the support stand.

following formula:

where

F mean value of forces at start of slip (N);

total mass (kg).

Dimensions in millimetres

Key
1 bench
2 supporting stand

Figure 43 — Slip resistance test of bath board

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24.5.7 Static horizontal force test on handle

24.5.7.1 Requirements
See 16.4.1.

24.5.7.2 Test method

The transfer bench or bath board/seat shall be placed on the supporting stand (4.8.15) in the position
of intended use and prevented from movement. The angle of the supporting stands will be adjusted,
if required, for the intended use of the APPH. A force of 400 N (F1
handle using the loading pad (4.8.12.1) according to Figure 43, at the centre of the handle, 10 times. The
horizontal force shall be maintained each time for at least 10 s. After removing the test force, the APPH
and its handle shall meet the requirements listed in 16.4.1 APPHs with height adjustable legs shall have
the height set to the maximum.

Key
1 bench
2 handle
3 supporting stand

Figure 44 — Static horizontal and vertical force test of handle on transfer bench

24.5.8 Static vertical force test of handle of bath and transfer boards

24.5.8.1 Requirements
See 16.4.1.

24.5.8.2 Test method

The transfer bench or bath board/seat shall be placed on the supporting stand (4.8.15) in the position
of intended use and prevented from movement. The angle of the supporting stands will be adjusted, if
required, for the intended use of the APPH. A force of 800 N (F2
using the loading pad (4.8.12.1) 10 times using the loading pad (see 4.8.12.4) at the centre of the handle,
according to Figure 44. The vertical force shall be maintained each time for at least 10 s. After removing

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the test force, the APPH and its handle shall meet the requirements listed in 16.4.1. APPHs with height
adjustable legs shall have the height set to the maximum.

25 Requirements for information supplied by the manufacturer

25.1 General

details on the label.

The information applied to, and supplied with, APPHs shall conform to EN 1041.

dealing with information regarding electrical aspects of the product, if applicable.

effective use of the product.

and the design and presentation of warnings.

Annex A.
In addition, the manufacturer should provide the information in the instructions for use in three
25.2,1, 25.2.2 and 25.2.3.

individual users or their assistants.

Further guidance on the preparation of instructions for use can be found in IEC 82079-1.

25.2 Instructions for use

25.2.1 Pre-sale information

In addition to the requirements of 25.1, pre-sale information shall include the following:
NOTE Presale information does not have to be in a brochure. It might also be in a website as a PDF.

a) information on the intended user;

visual, reading or cognitive disabilities;

c) all information available in pictogram(s) as far as possible;
d) a description of the intended use and the intended environment(s);
e) maintenance instructions, if applicable;
f) if an APPH is intended to be cleaned, a description of the method and suitable cleaning materials,
including precautions needed to avoid corrosion, if applicable;
g) if an APPH is intended to be disinfected, a description of the method and suitable materials,

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h) the overall dimensions (width, length and height) of the APPH, expressed in millimetres, and its mass,

i) the turning diameter and minimum distance that the APPH can be turned 180 ° for a mobile product;

parts that have a mass heavier than 10 kg, the mass of those parts shall be included);
k) if the APPH is supposed to be used in combination with other products, the manufacturer shall

m) if applicable, a warning about dangerous combinations of devices (e.g. cushions for the prevention

n) a list of accessories, detachable parts and materials that the manufacturer has determined as being
intended for use with the APPH;

p) a warning if the APPH might disturb the operation of devices in its environment that emit

r) operator control adjustments;

s) whether and how the APPH can be folded or dismantled to assist in storage or transport;
t) instructions regarding transport of the APPH (e.g. in a car or aeroplane);
u) measured sound pressure level;
v) expected lifetime of the APPH;
w) maximum user mass and maximum load.

25.2.2 User information

pre-sale warnings and information and the following as applicable for each APPH:

adjustments or settings affect the APPH;

d) instructions on operation of all controls;

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i) the positions of points where the component parts can be gripped for safe moving and handling

j) a warning if surface temperatures can increase/decrease when exposed to external sources of heat
or cold (e.g. sunlight, outdoor environment);
k) if the intended purpose of an APPH cannot be met without a hazard (e.g. holes, V-shaped openings),

l) if the intended purpose of an APPH cannot be met without a hazard due to moving parts such as

m) the level of resistance to ignition of materials and assemblies;

It is recommended to include instructions on how to solve simple problems for the ease of use.

25.2.3 Service information

The service information shall contain all the pre-sale information, user information and instructions

The service information shall contain all the pre-sale information and the user information, unless
provided in three different documents.

For periodic inspection see also Annex D.

The service information shall provide information for the safe performance of such routine maintenance

about the actual performance of such maintenance.

25.3 Labelling
In addition to the requirements of 25.1
production for the product.
Detachable parts of an APPH with a mass of more than 10 kg shall be marked with the actual mass on

markings, the effect of normal use shall be taken into account.

Attach a unique serial number on products where possible.

4.1).
NOTE For guidance see B.26.

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27 Test report
The test report shall at least contain the following information:
a) unique report number;

c) the date of issue of the test report;

d) a reference to this edition of this International Standard, i.e. ISO 17966:2015;
e) the name and address of the manufacturer of the APPH;

g) the source of the sample;

h) the ambient temperature at which each test was carried out;
i) where the controller is programmable, the settings used while testing;
j) a photograph of the sample equipped as during the test;

l) a statement of whether or not the tested sample met all of the applicable requirements of this
International Standard and a list of all the failed requirements.

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Annex A
(informative)

Cognitive impairment

Further information can be found in ISO/IEC Guide 71:2014, .

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Annex B
(informative)

General recommendations

The numbering of the subclauses in this annex corresponds to the numbers of the subclauses in the
main text to which the guidance applies (e.g. B.5.2 refers to subclause 5.2 in the main text).
B.5.2 Flammability

Hazards which should be considered include:

— smoker’s materials;

— electrostatic charges.

B.5.4.1 Cleaning and disinfection

and/or
contaminated material, except where the intended function of the APPH is to retain such material.

in Figure B.1

in Figure B.2.

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stream/steam cleaning

The present test method is representing a basic procedure for disinfection of an APPH in a washing
machine.

detached/opened without the use of a tool should be detached/opened as follows:

rated storage temperature, if higher, is carried out;

2) the APPH should then be kept at room temperature for not less than 16 hours.

or consisting of:

solution according to the data of the manufacturer;

3) cooling for 10 mins at 20 °C ambient temperature.
Acceptance criteria are as follows.

movements should arise.

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c) Perform dielectric strength and leakage current tests according to IEC 60601-1 at the following
intervals:

shorting of isolation barriers and violation of creepage distances.

B.5.4.3 Animal tissue

should examine them for signs of disease or contamination. This is of particular importance when there

— leather (shoes, arm support);

— sheepskin (supporting surfaces);
— pig bristle (brushes).
B.6.1 Noise and vibration

of test are available in other standards and supplement these with a panel consisting of disabled users,

Noise levels should be related to the circumstances in which an APPH is used.

Noise should be reduced as much as possible at its source.
Manufacturers should consider the following standards relating to the effects of vibration:
— ISO 2631-1
— ISO 5349-1
— ISO 5349-2

— residential, commercial and light industrial;

— industrial;

A user should be able to use an APPH in all the manufacturer’s intended environments of use for the
APPH with the minimum of limitation. The manufacturer should make it clear in simple language

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B.8.9 Circuit protection

If an APPH can be overloaded in use, and operation of a circuit protection device could leave the person

within the reach of the user or automatic resetting circuit breakers.

group of circuits should have separate circuit protection.

B.9.1 Ingress of liquids

The requirements set in EN 1888:2003, subclause 6.1.3, should be applied.

For guidance on test methods for protruding parts see EN 716-2:2008, subclause 5.9
B.20 Forces in soft tissues of the human body

susceptible to develop pressure ulcers. In general there is a high prevalence of pressure ulcers among
hospital patients, nursing home patients and home care residents.

a) Overview of causes

factors causing pressure ulcers as follows:

b) Effects of posture

heels and elbows; and during sitting, to the sacrum and ischial tuberosities.
c) Pressure

to the plane of the tissues.

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below which pressure ulcers will not occur.

d) Time

changes of posture and move between different support surfaces at regular intervals. Some support

e) Shear forces
Shear forces are also considered to be a major contributor to the causes of pressure ulcers and in

surface or chair.

forces will be reduced. But in positions with the head/back section elevated more than 20° it will be

the heels and give a more comfortable sitting position (relaxing the hamstring muscles and tendons).

f) Friction
Skin injuries similar to pressure ulcers can occur when people are slid over support surfaces, e.g.

so that their skin is lifted clear of the surfaces and never dragged across them.

decreases the friction between the skin and the support surface.
g) Temperature
Higher temperatures cause the metabolic rate of tissues to increase along with a corresponding increase

cause increased temperatures.

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i) Risk assessment

against the risks of other adverse effects of use of the device.

j) For further information regarding these issues also look at:

— Australian Wound Management Association;

— References[17 18
B.21 Ergonomic principles

13 N;

a “pulling direction” and 100 N in a “pushing direction”;

exceed 5 N.

facilitate the operation of a particular feature and also to avoid accidental operations certain ergonomic

is advisable; size, position and spacing between control mechanisms should be appropriate. The user

B.22.4. Rough handling and movement

requirements in 22.4.2 and the test methods in 22.4.3.

B.22.4.2 Additional requirements for movement over a threshold
22.4.3 the mobile APPH, product parts and accessories shall present no

The mobile APPH need not go over the 40 mm obstruction in B.22.4.3 a).

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The mobile APPH shall go over the obstruction in B.22.4.3 b).

B.22.4.3 Additional test method for moving over a threshold

The APPH is tested in the transport position according to the instructions for use with maximum load
in place and in the most adverse condition permitted in normal use or according to Figures 14 and 16.
a) Ascending step shock

b) Descending step shock

direction of movement is perpendicular to the face of the descending step. During performance of the
descending step shock test, if a part other than the castor comes in contact with the obstruction before

The packaging of an APPH is intended to provide appropriate protection against damage, deterioration
or contamination during storage and transportation to the point of use. The various forms of storage

effectiveness of the packaging checked.

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Annex C
(informative)

Environmental and consumer-related requirements

C.1 Assesment of hazardous substances in APPHs for persons with disability —

General aspects
This annex provides some general guidance to minimize hazardous chemicals in APPHs for persons with

C.2

found in all materials and products.

C.3 to C.6 contain recommendations for textiles, plastics, metals and wood.

C.2 Hazardous substances in all materials or products

C.2.1 Substances of very high concern (SVHC): the European approach on chemicals

C.2.1.1 General

Restriction of Chemicals (REACH, 1907/2006) was adopted. REACH requires an authorisation for

(carcinogenic, mutagenic and toxic for reproduction), PBTs/vPvBs (persistent, bio accumulating and

serious and irreversible effects to humans or the environment equivalent to the effects mentioned on

Annex XIV of the relevant Directive.

C.2.1.2 CMR chemicals

described as follows.

causal association between human exposure to a substance and the development of cancer.

— appropriate long-term animal studies,

— other relevant information.

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For mutagenic substances and substances toxic to reproduction the categories 1, 2 and 3 are described

The applicable risk phrases (R-phrases) for CMR chemicals are listed in Table C.1.

Table C.1 — R-phrases covering CMR chemicals (Annex VI of directive 67/548/EEC)

CARCINOGENIC SUBSTANCES SUBSTANCES TOXIC FOR REPRODUCTION
R40 Limited evidence of carcinogenic effects (cat-

MUTAGENIC SUBSTANCES

The applicable H-phrases for CMR chemicals are listed in Table C.2.

Table C.2 — H-phrases covering CMR chemicals (Annex I of regulation 1272/2008)

CARCINOGENIC SUBSTANCES SUBSTANCES TOXIC FOR REPRODUCTION

MUTAGENIC SUBSTANCES

C.2.1.3 PBT and vPvB substances

C.2.1.4 Substances of equivalent concern

Substances such as those having endocrine disrupting properties or those having persistent, bio

effects to human health or the environment which give rise to an equivalent level of concern as CMR,

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C.2.2 Recommendations

C.2.2.1 General

is advisable, as a matter of prudence, to eliminate such substances wherever possible as soon as

http://echa.europa.eu/web/guest/candidate-list-table

C.2.2.2 CMR chemicals

used here as a starting point. However, some CMR substances are of concern at much lower levels. It is

C.2.2.3 PBT and vPvB substances

C.2.2.4 Substances of equivalent concern

levels seem to be warranted.

C.3 Hazardous substances in textiles

C.3.1 Relevant substances

For textiles, several ecolabel criteria exist at European and national levels that should be considered

The Oeko-Tex®1) 100 standard for textile end-products has received broad recognition on the market
place as representing the state-of-the-art.
Limit values are included for:

— pesticides;
— chlorinated phenols;
— phthalates;
— organic tin compounds;
— other chemical residues;
— colourants;
— chlorinated benzenes and toluences;

1) This information is given for the convenience of users of this document and does not constitute an endorsement

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— biological active products;

— colour fastness;
— emission of volatiles;
— odours.
The Oeko-Tex Association has developed different criteria for textile products: for babies, for products
with and without direct skin contact and for decoration materials.

C.3.2 Recommendation

considered.

C.4 Hazardous substances in plastic materials

C.4.1 Relevant substances

which can be taken as a basis when establishing requirements for plastic components of APPHs for

— halogenated organic materials;

— phthalates.

C.4.2 Recommendation

compounds

The European Council Directive on packaging and packaging waste (94/62/EC) has set a limit of

C.4.2.2 Organic halogenated compounds

C.4.2.3 Phthalates

to exclude phthalates. For medical devices there are alternatives for phthalates on the market. However,

have health impacts on patients. It is therefore proposed that plastic parts of APPHs for persons with

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product cannot be produced using other plastic materials.

C.5 Metals

C.5.1 Relevant substances

Of particular importance are criteria for metal coatings including:
— cadmium;
— chromium;
— nickel
and their compounds.

with skin such coatings should be avoided. Cadmium should not be used at all.

C.5.2 Recommendations
Metal parts should not be coated with cadmium, chromium, nickel and their compounds. In exceptional

does not include parts that are intended to come into frequent contact with skin and the treated parts

NOTE Criteria for other coatings such as paints will be considered in the next revision of this
International Standard.

C.6 Wood

C.6.1 Relevant substances

carcinogenic substance, in wood-based panels.

C.6.2 Recommendations

method should be:

3 air.

NOTE Criteria for other substances contained in coatings or wood preservatives will be considered in the
next revision of this International Standard.

94 © ISO 2016 – All rights reserved

 ISO 17966:2016(E)

Annex D
(informative)

Periodic inspection

D.1

e.g. adjustment of brakes, tightening of fasteners. This should be done according to the manufacturers
instructions for use.

D.2
well acquainted with the design, use and care of the APPH. The scope of the periodic inspection should
be included in the instructions for use supplied.

D.3

The date when corrective actions are taken, in response to noted observations, should also be noted
in the logbook.

D.4 A record of the date of inspection result should be noted in the logbook together with the signature
of the inspector.

D.5

D.6

D.7 Defects and damages should be reported back to the manufacturer for action. This feedback should
be reported in the logbook.

D.8

D.9

D.10 The inspection record should include the following information:

— date of inspection;

— information about the condition of the APPH;

— date next inspection is due;

© ISO 2016 – All rights reserved 95

ISO 17966:2016(E)

Bibliography

transmitted vibration — Part 2: Practical guidance for measurement at the workplace

ISO 7176-8,
fatigue strengths

responses to contact with surfaces — Part 1: Hot surfaces

Building construction — Accessibility and usability of the built environment
2),
and persons with disabilities

Castors and wheels — Castors and wheels for manually propelled institutional applications

http://www.npuap.org/resources/educational-and-clinical-resources/prevention-and-
treatment-of-pressure-ulcers-clinical-practice-guideline/
https://www.oeko-tex.com

2) Replaces IO/IEC Guide 71:2001.

96 © ISO 2016 – All rights reserved

ISO 17966:2016(E)

Price based on 9 pages

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