ISO 20607: 2019

Just another standard that tells you how to do your job?

Margaretha Hopman
▪ Technidoc, since 1991
▪ Training ‘How to write a CE-compliant user
manual’
▪ Workshops ‘Tech writing for engineers’
▪ MadCap Flare addict
▪ I hate standards. Usually.

https://www.linkedin.com/in/margarethahopman/
www.technidoc.nl

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 Session overview
▪ Recap machinery directive
▪ CE and the machinery directive
▪ Requirements for instructions for use

▪ Introduction ISO 20607:2019

▪ New terminology
▪ Structure
▪ What’s new

▪ How to use the new standard

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CE and the Machinery
Directive
 Overall objectives of
the Machinery
▪ Free movement of machinery Directive
within the single market
▪ High level of protection for EU
workers and citizens.

2006/42/EC
The MD is in need of revision

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 3 Phases in product safety

Residual
Safeguards risks:
Inherently
1st safe design 2nd in the
machine
3rd warnings in
user
information

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 Steps in CE – product within the scope of MD
Step 1
Do additional directives apply?

Step 2
Do specific standards apply?

Step 3
Do a risk assessment

Step 4
Write instructions for use & Compile technical file

Step 5
Write EU declaration of conformity + CE mark on machine

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 Requirements – Instructions for use (1)
▪ ‘Instruction for use’ = essential health and safety requirement
▪ Manufacturer/authorized representative is responsible for supplying the
instructions for use
▪ In the case of machinery intended for use by non-professional operators, the
wording and layout of the instructions for use must take into account the level of
general education and acumen that can reasonably be expected from such
operators
▪ Information on residual risks
▪ Instructions must cover not only the intended use of the machinery but also any
reasonably foreseeable misuse.

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 Requirements – Instructions for use (2)
▪ Instructions must be in a form that is unambiguous and easily understood. It
must not be excessive to the extent of overloading the operator.
▪ Instructions must be available in one or more official Community languages. The
words ‘Original instructions’ must appear on the language version(s) verified by
the manufacturer/his authorized representative
▪ Exception: instructions for specialized personnel (e.g. maintenance instructions)
may be supplied in one Community language that specialized personnel
understand
▪ Instructions should contain all information that is required for safe use of
machinery

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 Contents of the instructions

MD section 1.7.4.2

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ISO 20607:2019
Safety of machinery – Instruction handbook – General drafting principles
 Why created / purpose
▪ To provide guidance to machine manufacturers on how to provide an
instruction handbook
▪ To improve the safety specifications and readability / ease of use of
the instruction handbook of the machine
▪ To specify requirements for the machine manufacturer for preparation
of the safety relevant parts of an instruction handbook (more specific
than IEC/IEEE 82079-1).

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 ISO 20607 is a Type-B standard

▪ Generic safety
▪ The requirements of ISO 20607 can be supplemented or modified
by a type-C standard

Reference: ISO 12100:2010 “Safety of machinery – General principles for design – Risk
assessment and risk reduction”

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 Relationship with Directive 2006/42/EC
Compliance with the normative clauses of ISO 20607 confers a presumption of
conformity with the corresponding essential requirements of Directive 2006/42/EC
▪ Stick to what the standard tells you to do on the subject of instructions for use/
instruction handbook
▪ Check the official list regularly (https://eur-lex.europa.eu/oj/direct-access.html;
accessed September 2019)
▪ ISO 20607 is not on the list yet

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 New terminology
Instruction handbook Part of the information for use provided by a machine
manufacturer to the machine user that contains instructions and
advice concerning the use of the machinery during all phases
of its life cycle.

Purpose of the instruction handbook is to provide the user with

information that enables him/her to effectively and safely use
the machine during the life cycle of the machine, also
considering reasonably foreseeable misuse.

Vulnerable user User at greater risk of harm from products or systems, due to
age, level of literacy, physical or mental condition or limitations,
or inability to access product safety information

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 What is in the standard
▪ Scope, normative reference, terms ▪ Annexes
and definitions (the usual content)
▪ Correspondence between ISO
12100:2010, 6.4, and ISO 20607
▪ Principles and general information
▪ Presentation and formatting
▪ Content and structure of the
instruction handbook (example) ▪ Recommendations for writing
instructions
▪ Language and formulation/style
▪ Bibliography
guide
▪ Forms of publication

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 Section 4 Principles and general information
• Identify target groups/persons who ▪ Create a single document or multiple
interact directly with the machine documents
• Identify tasks that target groups shall ▪ Warnings, hazards etc must stand
perform / Information needs per out
target group
▪ Describe residual risks
▪ Use comprehensible and consistent
language (short and simple ▪ Create a clear structure
sentences, chronological, logical and
sequential writing, active voice, …) ▪ Provide info concerning IT security
vulnerabilities
▪ Write easily translatable text

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 Target groups
▪ Target group = any group that
interacts with the machine
▪ Describe/specify the target group in
the instruction handbook

Take into account:

• specific needs
• knowledge
• technical vocabulary

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 What is in the standard
▪ Scope, normative reference, terms ▪ Annexes
and definitions (the usual content)
▪ Correspondence between ISO
12100:2010, 6.4, and ISO 20607
▪ Principles and general information
▪ Presentation and formatting
▪ Content and structure of the
instruction handbook (example) ▪ Recommendations for writing
instructions
▪ Language and formulation/style
▪ Bibliography
guide
▪ Forms of publication

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 Section 5 Content and structure of the
instruction handbook
▪ Title page, TOC, Introduction / ▪ Operation
purpose of this instruction handbook
▪ Product or capacity changeover
▪ Safety
▪ Inspection, testing and maintenance
▪ Machine overview
▪ Cleaning and sanitizing
▪ Transportation, handling and storage
▪ Fault finding / troubleshooting and
▪ Assembly, installation and repair
commissioning
▪ Dismantling, disabling and scrapping
▪ Original equipment manufacturer
settings ▪ Index, glossary, annex(es)

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 What does it
look like?

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 Section 6 …more advice
▪ Language and formulation / style Warning:
guide • A signal word
• Describe the nature or type of
▪ Provide the instruction handbook hazard
in the language(s) agreed with • Identify possible injury or
the customer damage
▪ Again: Formulation guidance for • How such injury or damage
instructions can be avoided

▪ How to ...Simple wording for

instructions
▪ How to … for Warnings

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 Section 7
Provide in one or more of the following
Forms of publication ways:
▪ paper publication
▪ Provide in the form(s) agreed
with the customer. ▪ electronic storage medium made
available with the machine
▪ Provide in the language(s)
agreed with the customer. ▪ external server, website or storage
location with info how to access,
▪ Manufacturer must be aware available with the machine
of applicable legal ▪ internal server or storage location
requirements of the country in
which the machine is placed ▪ visual and/or auditory forms (HMI,
on the market and/or put into video, internet-based, audio
recording …).
service the first time.

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 Annexes

▪ Annex A Correspondence between ISO 12100:2010 (section 6.4)

and this document
▪ Annex B Presentation and formatting (cf. IEC/IEEE 82079-1:2019)
▪ Annex C Recommendations for writing instructions - again, with lots
of examples (cf. NEN 5509)

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 What’s new
▪ Emphasizes the complete life cycle ▪ Explains how to handle info from
of a machine component or subsystem suppliers
▪ Statement on IT security ▪ The standard helps you/
vulnerabilities* manufacturers decide what type of
information should go where
▪ Enormous list of aspects you should
consider, with many examples ▪ Digital is allowed - just not by the
MD (yet)
▪ Suggests that it is good practice to
create a different instruction
handbook for each target group

*ISO/TR 22100-4:2018, 10.4

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ISO 20607 workflow
Workflow based on checklist
 Is it time to update your workflow?
Use section 5 of ISO 20607,
or use the checklist.

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 Suggested workflow
1. Define purpose(s)
2. Define target group(s) / user analysis
3. Do a task analysis per target group • Create an instruction handbook
for each target group
4. Use the checklist to help determine • Give each instruction handbook
content an appropriate title
5. Design a logical structure for your
content
6. Apply navigational aids

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 References
CE
▪ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006L0042-
20091215
▪ https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en
▪ https://ec.europa.eu/docsroom/documents/24722 (Guide to application of the
Machinery Directive 2006/42/EC)
ISO 20607:2019
▪ https://www.iso.org/standard/68519.html
▪ https://www.evs.ee/products/evs-en-iso-20607-2019

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 doc

Would you like to receive a copy

of the checklist?
[email protected]

• Checklist
• ISO 20607
• IEC 82079-1
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