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Requirements for Instruction Manuals in the European Market Introduction with Samples. The International Symposium o n Technical Communication and Product Marketing 25-27 May 2013, Guiyang City, Guizhou Province, China Dr. Konstantin Angnostopoulos ISE Europe GmbH, Switzerland.

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Requirements for Instruction Manuals in the European Market Introduction with Samples

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Requirements for Instruction Manualsin the European MarketIntroduction with Samples

  • The International Symposium

  • on Technical Communication andProduct Marketing

  • 25-27 May 2013, Guiyang City, Guizhou Province, China

  • Dr. Konstantin Angnostopoulos

  • ISE Europe GmbH,

  • Switzerland


Part 1 - European Directivesand Standards

Harmonizationof Laws and Standards in Europe

EU-Directives and EN Standards for instruction manuals


SafetyandUsabilityaspects in instructionmanuals

Part 2-Introductionofsamples

Risk Assessment - definitionofsafetyinstructions

ProductSpecificStandards -specificsafetyinstructions

Country Deviations-countryspecificsafetyinstructions

Usabilityandconsumertest - improvements on instructionmanualergonomics

Part 3 - ISE EuropeGmbH, alliancenetworkandservices

Part 1 Harmonizationof Laws and Standards in Europe

EU-DirectivesEU/EFTA assigns CEN thecreationof European Standards

New Approach

Consistent Laws Consistent, Harmonized


EU-Directives and EN Standardsimportant for design of instruction manuals

  • EU Directives:

  • 2006/42/EC Safety of Machinery

  • 2006/95/ECSafety of Low Voltage Equipment

  • 2001/95/EC General Product Safety Directive

  • 2004/108/EC EMC Directive

  • 93/42/EECMedical Equipment Directive

  • EN Standards:

  • IEC 82079-1:2012 Preparation of instructions for use

  • EN 12100:2010 Safety of machinery - risk assessment and reduction

  • EN 9241:2006 Ergonomics of human-system interaction

  • EN 9241-11:2006 Usability Requirements

  • ISO DIN 20282-1Ease of operation of everyday products

  • EN 60601-1-6:2010Safety and Usability for electrical Medical Products

  • EN 15038:2006Quality of translations

EN Standards (product/ instructionmanualrelated)

PRODUCT - related



Risk Assessment - RiskReductionEN ISO 12100:2011

PreparationofinstructionsforuseIEC 82079-1:2012

  • Annex B (Conformity)

  • Annex C (Communication Effectiveness)




Productspecific EN-Standards

  • SafetyInstructionsdefined

  • DeclarationofConfornity CE

  • Certification / Safety-Requirements





Country Deviations

Optimizationbased on usabilitytestevaluationswithusers


  • Usability - Ergonomics

    EN ISO 9241:11 Usabilityrequirements

    + productspecific C standards

Production Process of Instruction Manuals

  • Requirements

  • - System & product analysis

  • - User and application analysis

  • - User requirements, user cases ..

  • Basic concept (IEC 82079-1)

  • - Structure / content, styling

  • - Simple manual prototyping

  • Evaluation 1: (EN 12100)

  • - Usability expertise

  • - Review of Standards, Risk analysis

  • - OptimizationFirst Draft (IEC 82079-1), Annex B+C important!

    • - Design concept with full contents

    • Evaluation 2: (EN ISO 9241, Prod. Safety Standards)

    • Usabilty test with users, optimization

    • Special safety instructionsFinal Draft (IEC 82079-1) Complete User Manuals

    • Printing Translations(EN 15038)

Conformity of instrustion manuals with the Law

  • Is it possible to produce Manuals in conformity with the Law based on the Machinery Directive?

  • Unfortunately not!

  • The legal requirements incorporate only basic demands

  • Is it possible to produce Manuals in conformity with the Law by following the requirements of the Standards?

  • Very difficult!

  • IEC 82079:2012 andProduct-Specific Standards containmanysingle

  • requirements,whichrequire expert knowledgefromtechnicalwritersin

  • ordertobeimplemented


  • GPSG §2 - Conceptdefinitions

    (5) IntendedUseis:

    1. theuseforwhich a Productissuitable, accordingtothestatementsand


    2. theusualusewhichresultsfromthe design andimplementationoftheproduct

  • 2006/42/EC Annex I 1.1.1

    h) "intendeduse"meanstheuseofmachineryin accordancewiththeinformation

    provided in theinstructionsmanual

  • 2006/42/EC Annex I

    Each instructions manual must contain, where applicable, at least the

    following information:

    g) a description of the intended use of the machinery

Sample for risk assessmentEN ISO 12100:2010

Part 2

Risk assessment structure

Hazard identificationHazard assessment

 Operation anduse 6 weighingcategories

 Disturbances 4 probabilitiesofoccurrence

 Environmental factors

 Dangerousproperties

Risk assessment and risk reduction


Prepare the Hazard Catalogue with Risk Assessment

Risk assessment and risk reduction


Work out the Risk Profile for the particular product

Risk assessment and risk reduction


Measures and Safety

Instructions that need

to be implemented

Compliance to Product Safety Standards

Compliance to Country Deviations

Compliance to other European Directives


and others like: EMC, etc.

Usability Evaluation - Consumer testISO EN 9241-11ISO DIN 20282-1and the respective product specific C-Standards

Part 2

Usability Evaluation

Usability Laboratory

Evaluation von

echten Benutzern

Usability Testing in the Lab: pragmaticoptimization

Evaluation von

echten Benutzern

Productand Manual testingwithusersfromvariousculturalbackgrounds



Notes: 1 – „very good“; 2 – „good“; 3 – „satisfactory“;

4 – „sufficient“; 5 – „unsatisfactory"


Notes: 1 – „very good“; 2 – „good“; 3 – „satisfactory“;

4 – „sufficient“; 5 – „unsatisfactory"


Notes: 1 – „very good“; 2 – „good“; 3 – „satisfactory“;

4 – „sufficient“; 5 – „unsatisfactory"

Consumer assessment of a washing machine manual

Summary of individual comments and suggestions from the users:

What do I like in the Manual:

  • Clear recognizable pictures

  • Short and good explanations

  • Better understanding compared to the purely textual manuals

  • The manual is easy to handle and overview

  • Attractive Design

  • Good overview, the information can be found fast and easy

    What I do not like in the Manual:

  • The graphics in Troubleshooting are not good recognizable

  • Some texts are not good readable especially under bad lighting

  • The information ”how long the door stays locked after finishing the washing” is found under ”Troubleshooting“. It should be found in the central graphic of the washing process

  • Letters are too small in some parts of the manual

  • Red text in grey background is difficult to read (safety instructions)

  • Reference to standards is not understandable by the users

  • Some difficulty when choosing the programs

Consumer assessment of a washing machine manual

Consumer remarks during the tests:

  • Point 3 of the manual “Requirements for installation site” mentions a length of the cable to the plug of 1.5m. Point 6 shows a cable length of 1m.These specifications are inconsistent and confuse the users. Under ”Preparation“: Points 1-4 are shown as recurrent actions. These actions, however, take place only once after the assembly of the machine. This should be made also clear.

  • It would be better if the transport safety parts were preserved at the machine.

  • Buttons ”OPTION“:One should be enough.

  • User manual: In the washing programs information for 95C0 is missing.

STIWA - Evaluation of Instructions Manuals

STIWA - Evaluation of Instructions manuals

Part 3: ISE Europe GmbH, alliance network

Part 3: ISE Europe GmbH, alliance services

Risk Analysis - Standards

・Coordination servicesDepending upon the product’s features and points of destination, coordinate with prestigious certification institutions and translation service companies

・One-stop servicesProvide required product certifications and document productions for target markets in Europe

・Risk AnalysisRisk analysis of products. Safety instructions. Product Safety Standards. Technical Expertise

ISE Europe GmbH

Translation Services


・Provides services near customersExpansion of 10 base offices in Europe and Asia

・Multilanguage translation servicesProvides high-quality translation services for more than 200 languages

・LocalizationsLocalizations for website translations and software applications

・Terminology managementTerminology management that is supported by experience in multilanguage translation services

・DTPExperience in online data and Multilanguage printing

・Product testingConduct professional product testing at usability laboratories, and optimize usability via observations

・User-centered designingSupport design processes centered upon users, and sublimate product ideas to final products which provide user-friendliness

・User experiencesBirth loyal customers and the acceptance of products in markets via clearer user experiences

・Visalyser testingTools for measuring the visual impacts that pamphlets and websites bring about

Part 3: ISE EuropeGmbH, partner companies in Asia

  •  ISE (Beijing) Inc.  ISE Inc., Tokyo, Japan

  • Mr. Yang YongxunMr. Satoshi Kuroda

  • Telephone: +86 10-6463-8124Telephone: +81 3 3368 4687

  • E-mail: ise-china@ise.jpE-mail:

  • Thankyouforyourattention謝 謝

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