Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Current hospital guidelines in

Germany and in Switzerland
DIN 1946-4: Ventilation and air conditioning;
Ventilation in hospitals
SWKI 99-3: Heating, ventilation and air-conditioning
in hospitals

DIN 1946-4 Folie 2 / 81

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The new German

standard DIN 1946-4:
Ventilation in hospitals

Arnold Brunner, dipl. Ing. SIA

DIN 1946-4 Folie 3 / 81

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DIN 1946-
1946-4: Ventilation in hospitals

History and Basics

DIN 1946-4 Folie 4 / 81

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Juliusspital Wü
Würzburg 1805

Carl Caspar von Siebold (1769–1807)

During Siebolds aegis occurred the reconfiguration of the Theatrum
anatomicum (1788) and an extension of the capacity of the Juliusspital
(1799) in which 1805 the first modern operating room of the world was set
up.
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DIN 1946-
1946-4 Ventilation in hospitals

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Inspiration through Sir J. Charnley 1968

Greenhouse ® room-in-room construction

Anaesthesia separated

Improved air filter

Body exhaust system

Self-instrumentation

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Realization by Weber/Meierhans 1970

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Swiss Guideline for construction, operation and

monitoring of ventilation systems in hospitals

Swiss Guideline SKI Bulletin 4 published in 1975

This guideline is based on the German standard
DIN 1946, Part 4 (Ventilation in hospitals) 1963

Three hygiene-room classes
 Class I 10 CFU/m3
 Class II 200 CFU/m3
 Class III 500 CFU/m3

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RLT-
RLT-Richtlinie von 1975

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Swiss Ventilation Guideline 1975

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DIN 1946-4 Folie 12 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
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Lidwell-
Lidwell-Study 1982

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Swiss Guideline for the design, construction,

operation and monitoring of ventilation
and airconditioning systems in hospitals

Swiss-Guideline SKI-Band 35 (1987)

Three hygiene room-classes

Class I 10 CFU/m3

Class II 200 CFU/m3 Class IIb 50 CFU/m3

Class III 500 CFU/m3

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Low turbulence
Swiss Ventilation Guideline 1987 displacement
air flow

Low turbulence
displacement
air flow with zone
segregation

Dilution air
flow, no zone
segregation

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Development of the standard OP-

OP-Room:
"small" ULF with 2000 - 3000 m3/h

ULF: Unilateral flow (Laminar air flow)

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OP Cl.1: ULF with 8'000 - 10'000 m3/h

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1989: Überarbeitung der DIN 1946-

1946-4
Im Wesentlichen zwei Raumklassen (Luftreinheit):

Raumklasse I (Operationsräume)
Hohe bzw. besonders hohe Anforderungen an
die Keimarmut

Raumklasse II (übrige Räume im Krankenhaus)
Übliche Anforderungen an die Keimarmut

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1989: Revision of DIN 1946-

1946-4
Essentially two room classes (air cleanliness):

Room class I (operating rooms)
High and highest requirements with respect to
low germ concentrations

Room class II (remaining rooms in the hospital)
General requirements with respect to low germ
concentrations

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1990: Development DIN 4799

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1990: Development DIN 4799

Supply air 1‘600 m3/h

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Revision of the Swiss hospital guideline

Start January 22nd, 1997

Target: End in 1998

essential Hospital-organisations participate
 Hospital hygiene
 Technical and maintenance service
 Building services engineering

1st draft with official consultation January 2001

final draft December 2002 (2nd official consultation)

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Inquiries (publications,
publications, companys)
companys)

Bild Admeco

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Kostenvergleich: Ergebnisse (1)

TFH Berlin
Energiebedarfsunterschiede
Einfluß des Grundkonzeptes auf den Jahresenergiebedarf
30000
198 %

Wärme
Jahresenergiebedarf [kWh/a]

25000
Strom
20000
122 %
108 % 108 %
15000 100 %
88 %
78 %
10000

5000

0
CH 1 CH 2 DIN 1 DIN 2 DGKH 1 DGKH 2 DGKH-OPT

Merkmale CH 1 CH 2 DIN 1 DIN 2 DGKH 1 DGKH 2 DGKH-OPT Einheit

V AU (OP + EIN/AUS) 800 1200 2800 1600 1000 1000 1000 m³/h
V ZU (OP-LAF) 4000 4000 2400 2800 4000 8000 8000 m³/h
Überströmung mit mit ohne mit mit mit mit

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Kostenvergleich: Ergebnisse (2)

TFH Berlin
Gesamtkostenunterschiede
Einfluß des Grundkonzeptes auf die Jahreskosten

50.000 147 %
Energiekosten
Jahreskosten [D M/a]

45.000
40.000
88 % 100 % 104 % 97 % 96 % Betriebskosten
35.000
30.000
83% Kapitalk. (20 a)
25.000
20.000 Strompreis:
15.000
10.000
0,20 DM/kW h
5.000 W ärmepreis:
0 0,08 DM /kW h
CH 1 CH 2 DIN 1 DIN 2 DGKH 1 DGKH 2 DGKH-OPT

Merkmale CH 1 CH 2 DIN 1 DIN 2 DGKH 1 DGKH 2 DGKH-OPT Einheit

V AU (OP + EIN/AUS) 800 1200 2800 1600 1000 1000 1000 m³/h
V ZU (OP-LAF) 4000 4000 2400 2800 4000 8000 8000 m³/h
Überströmung mit mit ohne mit mit mit mit

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Comparison of costs,
costs, findings
 By decreasing the outdoor air flow to 1000 m³/h and by
increasing the circulating air flow to 3.000 m³/h (OR-supply
air flow: 4000 m³/h) energy costs are virtually unaltered.
 Electricity costs are even lower at a circulating air flow of 7000 m³/h
than in the case of DIN with an outdoor air flow of 2800 m³/h.
 Electricity costs only amount for approx. 5 – 8 % of the annual
costs for the air-conditioning of operating rooms.
 With optimisation of the ULF/circulating air concepts, annual costs
may even be further reduced compared to the DIN cases (see
DGKH-OPT-case).

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DIN 1946-4 Folie 28 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
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Mai 2003

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The revision of the DIN 1946-

1946-4

Revision of the guideline
DIN 1946-4 "Ventilation and air conditioning.
Part 4: Ventilation in hospitals" of 1999
was classified as unsatisfactory

Alternatives are published

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DIN 1946-4 Folie 31 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
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RKI requirements for surgery

Unidirectional airflow ventilation is essential for
aseptic interventions with high risk of infection.

The size of the ceiling panel has to conform to
the type of surgical intervention.
As a rule, the operating table and the instrument
tables shall be protected.

A room class I (DIN1946-4) shall be installed only
in the operating room.

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Hygiene und Medizin 2002

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Conventions of the German Society for

Hospital Hygiene (et all.)

Protection range with a size of 2.8 x 2.8 m
required (containing OP and instrument tables)

unidirectional airflow

Total size: 3.2 x 3.2 m with aprons 5 - 50 cm

Filter class H 14

degree of primary turbulence < 5%

corridors for sterile goods supply shall be
operated with positive pressure at all times

DIN 1946-4 Folie 34 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
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DIN 1946-4 Folie 35 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
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DIN 1946-4 Folie 36 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
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The new ventilation standard

DIN 1946-
1946-4

Date of publication:
publication:
November 2008

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Publication in November 2008

DIN 1946-4 Folie 39 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Table of contents

Foreword
1 Scope
2 Normative references
3 Terms, definitions, and abbreviations
4 General requirements
5 Classification of rooms used for medical pur-
poses (room classes) and ventilation concepts

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Table of contents

6 Requirements for ventilation and

air-conditioning components
7 System qualification and Acceptance tests
8 Periodic tests
9 Requirements for the technical documentation

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Table of contents
Annex A Project phases and objectives
Annex B Flow visualisation for room class 1a
Annex C Acceptance test by determining the
protective effect for room class 1a
Annex D Acceptance test following the procedure
for measuring the turbulence intensity
Annex E System test / Pre-qualification (class 1a)
Annex F Microbiological tests
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Scope of DIN 1946-

1946-4
- hospitals buildings
- day hospitals
- physician’s practices with intervention rooms
- outpatient surgery centres / facilities / ambulatories
- dialysis centres
- facilities for internal and external (service) units for
the processing of medical devices / sterilization
areas

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Guide for planning,

planning, construction and operation
1. Analysis To determine the current situation, establish the basics,
and declare the aims
2. Project aims Performance specifications, to conclude the phase of
establishing the objectives
3. Planning To implement the performance specifications in the
planning department, to conclude the planning phase
4. Implementation To apply the performance specifications, system
qualification, documentation, to conclude the
implementation phase
5. Operation Personnel training, to supplement and complete the
system documentation, maintenance management,
disposal of consumables, short microbiological tests
6. Re-qualification Operation optimisation of existing operating systems

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Project performance specifications II

Prepared by the orderer / customer
in cooperation with experts

The target definition phase will be concluded
when the performance specification of the
project is approved by all parties involved in
target definition.

This serves as a basis for planning.

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Project performance specifications

Project definition, Intended use description

Project organisation and quality management
(QM-Masterplan)

Testing concept (system qualification)

Energy control and measurement concept

Fire protection concept (fire compartments,
escape routes, smoke extraction, evacuation)

Time schedule, cost estimate
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Project performance specifications

Room definitions (room data sheet) listing at least:

 hygiene classification
 protective-overpressure concept
 electrical safety classification
 room-climate requirements
(temperature, humidity, sound pressure level)
 materials to be used (walls, floor, ceilings, etc.)
 operational facilities, equipments (internal loads)

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parties involved in the project

Investor (authorities, hospital management, etc.)

Users (surgeons, anaesthetists, nursing service, etc.)

Hospital hygiene (hospital-hygiene experts, cleaning pers.)

Purchase departement (OP equipment, medium supply
system, IT equipment etc.)

Maintenance staff (technical service, external maintenance
service, energy suppliers, etc.)

Planner (architects, building services engineering, ...)

Consultant (organizational and financial consultants, ...)

Further parties involved in the project
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Responsibilities

Technical acceptance:
 Planner, manufacturer and supplier

Hygienic acceptance:
 The measuring technician collect the readings
 the hospital-hygiene expert in charge makes the
hygienic interpretation and determines the
protective measures or use restrictions

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Air hygiene in operating

operating rooms
Operating rooms are distinguished into:

Operating rooms with ventilation systems of
unilateral flow (ULF) for attaining a protected area
in which the operation takes place and where the
instruments tables are positioned (room
room class 1A);
1A

Operating rooms with ventilation systems of mixed
or turbulent displacement flow (room
room class 1B).
1B

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Basic requirements on ventilation and air–

air–
conditioning in operating rooms class 1B

Sound pressure level at a nominal air flow rate of
max. 48 dB(A)

Supply air temperature 19-26°C (adjustable)

Measurement of comfort (though not defined)

Testing of the recovery time (recovery test)
according to DIN EN ISO 14644-3
 Reduction of the particle concentration
by 99 % within 25 minutes
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New operating room class 1A

vertical displacement flow

minimum size of the ULF diffuser 9,0 m2

terminal, manufacturer inspected, high efficiency
particulate air (HEPA) filters H13

surrounding airflow aprons down to the height of the
doors (approx. 2,1 m above foor level)

supply air volume flow > 8‘000 m3/h

outdoor air supply (800 –) 1200 m3/h
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Basic requirements on ULF air diffusers

in operating rooms class 1A

supply air velocity = 0,23 to 0,25 m/s

minimum local supply air velocity = 0,15 m/s

sound pressure level at a nominal air flow rate
of max. 48 dB(A)

supply air temperature 19 - 26°C (adjustable)

local deviation from Tmean: 0,3 K

measurement of comfort (though not defined)
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Integral OP acceptance tests (qualification)

Two acceptance tests:

tests:
Technical acceptance test
performance parameter of the
HVAC system
Hygienic acceptance test
sufficient protective effect against
load entry from outside
sufficient protective effect against
load entry from inside

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OP-
OP-Room acceptance test (outer load entry)

M3

OP-Lampe

M11 M12 M13

M2

M01 M02 M03

OP-Tisch
200x60 OP-Tisch
M1

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OP-
OP-Room acceptance test (inner load entry)

M3

OP-Lampe

M11 M12 M13

M2

M01 M02 M03

OP-Tisch
200x60 OP-Tisch
M1

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Test structure I

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Test structure II

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Reference load

reference particle concentration CRef = 106 P/ft3

(room background, ULF field surroundings)

Protection degree 10-5 is correctly traceable
cx / cRef = 10 / 106 = 10-5

aerosol flow is emitted at the specified locations,
the emission having low momentum and being
isothermal

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Local protection class SGx

measured values: particle concentration cx at a
hygienically relevant measuring point X in the
area to be protected

 cX 

definition SGX = −log   cRef : 106 P/ft³
 cRef 

example: cx = 950 P/ft³: SGX = 3,0

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Result: Protection effect of the OP-

OP-Room

The smallest numerical value of the local
protection classes is used to characterise the
actual protective effect of the operating room

Usual range of values: SG = 1 ... 5

The result integrates all influences of the clean air
diffuser (ULF), medical devices and anaesthetic
equipment, i.e. heat-load, convection, turbulences,
...
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Interpretation of the protection classes

Degree of mean particle concen- Classification

protection SG tration at measuring
point X [P/ft3]
5 10 excellent
4 100 outstanding
3 1’000 Good
2 10’000 sufficient
1 100’000 insufficient
0 1’000’000 poor

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hospital-
hospital-hygiene conclusion

State-
State-of-
of-the-
the-art operating rooms
Minimum requirement:
For the entire protected area a protective effect
> 4 (without operating lamps) or
> 2 (with operating lamps)
respectively, shall be demonstrated.

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Acceptance test (turbulence intensity)

These examinations shall
be carried out in the
form of averaged
double determinations
above the test positions
(n = 17 in accordance
with Figure D.2 projected
onto the floor below the
LTF outlet ) marked by
black, orange and white
self-adhesive dots.

Figure D.2: 17 test positions in the measuring grid

projected onto the floor below the ULF outlet

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Microbiological tests in the operating room

The decision on the need for microbiological /
hygienic checks during operation is made by the
hospital-hygiene expert in charge.

Requirements (Example sedimentation plates):
room class Ia: mean value of the specific colony
forming units: ≤ 1 CFU / (50 cm2 • 60 min);

room class Ib: mean value of the specific colony
forming units : ≤ 5 CFU / (50 cm2 • 60 min).

Airborne-germ counts in the empty operating room
are not required in any case.
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Hygiene requirements on HVAC-

HVAC-Plants

In addition to hospital-specific requirements,

the HVAC systems must also fulfil the
“common” requirements.

Furthermore, observe VDI 6022 „Hygienic
standards for ventilation and air-conditioning
systems – Offices and assembly rooms” and its
requirements.

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next generation guideline

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Summary and look-

look-out

The new hospital guidelines contains for the
first time details on the technical and hygienic
qualification of operating rooms

The results of predefined test methods lead to
clear quality characteristics which can be used
to deduce specific design elements.

Verifiability of each design element allows to
achieve constant & reproducible quality levels

DIN 1946-4 Folie 68 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

DIN 1946-4 Folie 69 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Summary and look-

look-out II

The target is a European guideline

The first steps for the CEN guideline are made:
RESOLUTION taken by CEN/TC 156 Ventilation for
buildings, agrees to create the following Working
Group:
CEN/TC 156; WG 13 – Ventilation in Hospitals

Research and development in the laboratory

operating room at the HTA School of
Engineering + Architecture in Lucerne

DIN 1946-4 Folie 70 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Conclusion on hospital hygiene

Applies to all operating theatres:

Without a catalogue of flanking measures

and the application of due operational
discipline the best clean air technology
can only be seen as an 'alibi exercise'.

DIN 1946-4 Folie 71 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Thank you for

your attention

DIN 1946-4 Folie 72 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

more information

www.bht.ch
DIN 1946-4 Folie 73 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Swiss Guideline SWKI 99-

99-3

Some additional information

DIN 1946-4 Folie 74 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Centralised sterilisation

Centralised sterilisation must be subdivided into:
cleaning room, packing room and sterile goods
storeroom

Decontamination- and (additional) cleaning machines
between cleaning area and packing area

Pass-through autoclaves between packing area and
sterile goods storeroom

Outgassing is required for material sterilised by gas-
eous media. These materials must be stored separately.

DIN 1946-4 Folie 75 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Hygiene Classification of rooms

based on the risk of infection

General consideration

Operating rooms and other rooms for surgical
interventions

Other rooms with increased hygienic-requirements

Other hygienically relevant rooms

DIN 1946-4 Folie 76 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Operating rooms and other rooms for

surgical interventions

Outdoorair flow volume of 800 to 1000 m3/h

for outdoorair three-stage filtering is required

work checked terminal H13-filters

ULF supply-air diffuser (unilateral-flow diffuser )

Minimum size for the ULF diffuser 9.0 m2

surrounding apron down to the height of the
doors (up to approx. 2,1m above floor level)
DIN 1946-4 Folie 77 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Other hygienically relevant rooms

Patient’s room

Emergency ward

Recovery, observation room

Delivery, Labour room,
Room for caesarean sections

Waiting rooms

DIN 1946-4 Folie 78 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Waiting rooms

The danger of transmitting unidentified
pathogen makes it necessary to provide
efficiently ventilated waiting rooms (exhaust-air
rate in excess of 75 m3/(h·P).

Separate waiting rooms must be available for
patients undergoing immunological suppression

DIN 1946-4 Folie 79 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Basic requirements for rooms with

increased hygienic demands

Requires increased outdoor-air flow rate
> 100 m3 / (h ·P)

Terminal filter F9

Non-unilateral flow may be accepted
(turbulent ventilation)

DIN 1946-4 Folie 80 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Rooms with increased hyg.

hyg.-requirements

Sterile-goods storage / sterile corridor

Angiographie, heart catheter laboratory, surgical
Angiographie where minor interventions serve to
implant foreign material

minor surgery, dermatology, wound care

Rooms for transplant recipients after surgery

Intensive care unit including neonatology

Endoscopic diagnosis
DIN 1946-4 Folie 81 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Isolating room

Closed space

Supply-air rate per room of 500 m3/h or

Air-exchange rate of 12 vol/h

Maintained at negative pressure

Exhaust air shall be HEPA-filtered before entering
the exhaust-air network (terminal high-efficiency
particulate air filter, class H13)

DIN 1946-4 Folie 82 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir
 Brunner Haustechnik AG, CH-8304 Wallisellen-Zürich

Isolating room
gemeinsame Zuluft gemeinsame Abluft

Joint supply air Joint exhaust

LW = 12-fach
ev. flexibel
AC = 12/h flexible ev.

50 m3/h 150 m3/h

F9 H13
100 m3/h

Korridor (bei Normalzimmer) Patientenzimmer Dusche / WC / Ausguss

Schleuse (bei ordentlichem Isolierzimmer)
Corridor (in case of normal room) Patient's room Shower / WC / Sink
Airlock (in case of normal isolation room)

DIN 1946-4 Folie 83 / 73 TESKON 2009 - TMMOB Makina Mühendisleri Odası Đzmir