13.10.2025: The site is under construction - ERRORS AND OMISSIONS RESERVED
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10.10.2025: The site is under construction - ERRORS AND OMISSIONS RESERVED
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TWO RECOMMENDED STANDARDS:
❶ DS/EN IEC/IEEE 82079-1:2020 – for ALL instructions for use
❷ DS/EN ISO 20607:2019 – for instructions for use with MACHINERY SAFETY
Guidelines (by standards) - part of the product cycle
5.4 Standards and process for product development
The preparation of the guide is thus part of the process of developing, designing, producing and documenting a product - in accordance with EU directives. Here is the overall process:
- Define the product's function, target group and use.
- Identify the EU directives and national regulations that the product is covered by.
- Determine the harmonized standards that will form the basis for design and documentation.
- Construct the product in accordance with the selected standards.
- Carry out a risk assessment (e.g. according to EN ISO 12100).
- Use the results to determine technical protection measures and user information requirements.
- Plan and prepare the User Manual in parallel with product development.
- Use DS/EN IEC/IEEE 82079-1:2020 as the basis for structure, content, language and usability.
- If the product is a machine: Also use DS/EN ISO 20607:2019 to ensure correct safety information and integration with the CE marking.
- Test the product technically.
- Verify the Instructions for Use through user testing.
- Check the Documentation to ensure that the product can be used safely and correctly.
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Comparison: They both overlap and complement each other:
| Punkt | ❶ DS/EN IEC/IEEE 82079-1:2020 | ❷ DS/EN ISO 20607:2019 |
|---|---|---|
| Title | Preparation of user manuals – Principles and general requirements | Safety of machinery – Instructions for use – General requirements |
| Area of application | All types products and systems (mechanical, electrical, software, etc.) | Only machines covered by the Machinery Directive |
| Purpose | Determines general principles for good user manual | Indicates safety-related requirements for machine operating instructions |
| Directive relation | No direct link to one directive, but relevant for all CE products | Supports the requirements of Annex I, point 1.7.4 of the Machinery Directive |
| Content type | Structure, terminology, information level, life cycle and user profile | Safety information, warnings, residual risks, maintenance |
| Audience | Anyone who prepares user manuals | Producers of machines and machine parts |
| Standard type | Type B (generic) | Type B (safety-related) |
| Supplements | Can be combined with ISO/IEC 82079-2 and -3, EN 82079-1 previous edition | Complements 82079-1 for the machinery area |
| Status in the CE context | Gives best practice but not “presumption of conformity” | Harmonized standard → gives presumption of conformity |
Buy the two COMPLETE standards from Dansk Standard – here only the ESSENCE :
❶
DS/EN IEC/IEEE 82079-1:2020:
Preparation of user manuals (instructions for use) for products – Part 1: Principles and general requirements
They are a headline
WARNING!
This description is only a abstract.
The full conformity: Kopen it complete standard, and translate the requirements into practice.
1. Contents
1.1 Purpose and target group clearly specified?
1.2 Completeness: Does the text cover all necessary functions, processes and prerequisites?
1.3 Precision: Are all data, measurements, tolerances, units of measurement and references correct and consistent?
1.4 Update: Version, revision date and change history indicated?
1.5 Security & Compliance: Safety instructions, warnings, standards (e.g. ISO/EN) correct?
2. Structure and navigation
2.1 Textured: Logical chapters: Use, operation, maintenance...?
2.2 Table of contents: Auto-generated TOC – with H1, H2, H3?
2.3 Cross-references: Are internal links correct and clickable (PDF/HTML)?
2.4 Numbering – paragraphs, figures: Consistent and machine-readable?
2.5 Modular division: The information is divided into reusable “topics” – absolutely central to Single-Source Publishing)?
3. Illustrations and graphic elements
3.1 Relevance: Does each illustration support the text and add value?
3.2 Quality: High resolution, correct color profile, no pixelation?
3.3 Clarity: Labels easy to read, scalable (SVG/Vector, if possible)?
3.4 Consistency: Uniform style (line thickness, colors, fonts)?
3.5 Location: Figures close to associated text and with captions?
3.6 Accessibility: All text (for web/PDF) and contrast requirements met?
4. Language and terminology
4.1 Clarity: Short, precise sentences, active language?
4.2 Terminology: Uniform use of technical terms, with a glossary/glossary?
4.3 Language standard: Correct grammar and punctuation, style guide (e.g. British English)?
4.4 Translation-friendly: No idioms, long sentences, variables/constants correct?
4.5 Tone: Neutral, instructive and without marketing jargon?
5. Layout and publishing
5.1 Template: Does the document follow the organization's official layout (logo, colors, typography)?
5.2 Responsiveness/printing: Works on screen, tablet and print?
5.3 Metadata/SEO: Title, author, keywords, descriptions correctly filled in (relevant for web)?
5.4 Version control: File name, version number and possibly Git/PLM link registered?
6. Quality assurance
6.1 Peer review: Has another professional performed a technical and linguistic review?
6.2 User testing: Have the instructions been tested by a representative user group?
6.3 Error handling: Is there a plan for maintenance and updates after release.
You can read more here.
You buy the COMPLETE standard
They are a headline
WARNING!
This description is only a abstract.
The full conformity: Kopen it complete standard, and translate the requirements into practice.
❷
DS/EN ISO 20607:2019
Safety of machinery – Instructions for use – General requirements
They are a headline
WARNING!
This description is only a abstract.
The full conformity: Kopen it complete standard, and translate the requirements into practice.
They are a headline
This standard is a RECOMMENDATION if you need to CE mark according to machinery directive.
1. Scope
1.1 Purpose: Requirements for safety-related parts of the user manual
1.2 Extension of ISO 12100:2010, clause 6.4.5
1.3 Covers the entire machine life cycle
2. Normative references
2.1 ISO 12100:2010 – Safety of machinery
3. Terms and definitions
3.1 “Instruction handbook” – safety-related user guide
3.2 “Integrator” – responsible for overall security strategy
3.3 “Risk reduction measure” – measure to reduce risks
3.4 “Vulnerable user” – user with special risk factors
4. Principles and general information
4.1 Purpose: ensure safe use including reasonably foreseeable misuse
4.2 Target group: operator, service, cleaning, etc.
4.3 Language and expression: consistency, active form, clear units
4.4 Presentation: one or more documents, divided by life cycle
4.5 Information from component/system suppliers
4.6 Legibility: Text and symbols must be clear
4.7 Warnings and danger symbols: clear signal words and consequences
4.8 Structuring: Quick access to hazard information
4.9 Description of safety guards and signaling systems
4.10 IT security aspects, where relevant
5. Content and structure
5.1 Table of contents
5.2 Operating instructions: start, stop, emergencies, error messages
5.3 Maintenance and inspection
5.4 Drawings and spare parts lists
5.5 Warnings and precautions
6. Warnings
6.1 Signal words: DANGER, WARNING, CAUTION
6.2 Wording: clear text, no ambiguity
7. Forms of publication
7.1 Delivery as agreed (paper, digital, etc.)
7.2 Multilingual versions as needed
You can read more here.
You buy the COMPLETE standard
e is a headline
WARNING!
This description is only a abstract.
The full compliance: Kopen it complete standard, and translate the requirements into practice.
The 5 basic steps to obtain CE marking:
1. Read the Machinery Directive / Machinery Regulation
a) Clarify: Is the machine covered by: Machinery Directive 2006/42/EC (until 19 Jan 2027) OR by the NEW Machinery Regulation (EU) 2023/1230.
b) Map other relevant directives:
EMC, low voltage, ATEX).
c) Select harmonized standards as proof of conformity.
2. Conduct Risk Assessment
a) Apply EN ISO 12100.
b) Determine the machine's limits.
c) Identify Hazards.
d) Assess and Reduce Risks.
e) Document remaining Risks and Warnings,
The result is the basis for: Safety design, Instructions for use and CE documentation.
3. Perform Construction with implemented risk reduction
a) Apply Inherently Secure design solutions.
b) Provide the structure with: Technical protective equipment; Shielding, Emergency stop, Interlocks.
c) As described in EN ISO 12100 and DS/EN ISO 20607: Provide the machine with User Information and Warnings:
d) As described in EN ISO 13849-1/-2 (PL) or IEC 62061 (SIL): Verify and validate according to relevant standards.
4. Prepare Instructions for Use
a) Apply DS/EN ISO 20607:2019
b) On the machine's marketing language:
Prepare SECTION: Purpose, Target group, Safety information (residual risks, emergency procedures), Installation, Commissioning, Operation, Maintenance/Service, Troubleshooting and Disposal.
NB! The instructions for use must be included in the technical dossier and be completed before CE marking.
5. CE marking
a) Elaborate EU Declaration of Conformity with reference to the Machinery Directive/Regulation and the standards used.
b) Collect technical dossier: Risk assessment, Drawings, Calculations, Test protocols and Instructions for use.
c) Apply CE marked.
d) Store the dossier for at least 10 years after the last unit produced.