Development on Technical Communication in Europe R émi Orth, SESEC project assistant

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Development on Technical Communication in Europe

Rémi Orth, SESEC project assistant

IFAN conference “application and development of standards for instructions for use of products”

9th -10th June 2011,Huangshan

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Standards in EU and China -a different context for a different ecosystem

The teaching examples of pictograms in Europe

-> road signs, instructions etc…

EU: 23 official languages!!!

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Content

1. Standardization in the EU

2. Technical Communication in the EU

3. Examples of EU technical communication in specific sectors

4. Cooperation with China

5. Conclusion

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1 – Standardization in the EU: European Standardization Organizations

– CENEuropean Committee for Standardization

• Horizontal mandate

– CENELECEuropean Committee for Electro-Technical Standardization

• Covers mainly the electro-technical sector

– ETSI European Telecommunications Standards Institute

• Covers mainly telecommunication and electronic communication networks and services

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European Standards EN

• CEN & CENELEC• → 27 EU Members• → 3 EFTA Countries • → 1 Neighbourhood• Total: 31 Members•

• ETSI• → 40+ Countries• → Over 700 Members

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CEN/CENELEC deliverables are vehicles for technical communication

- Standards:

European Standard – EN

- Pre-Standards:

Technical Specification – TS

- Informative:

Technical Report - TR

CEN/CENELEC Guide

- Workshop Agreement:

CEN/CENELEC Workshop Agreement (CWA)

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European Standardization Organizations

– 1 European standard:

... Replaces 31 different

national standards

in Europe

Creates access

to a market of

500 million

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Documents including EN have been developed specifically to provide information

– Maintenance instructions

– Instructions for use

– Operating instructions

– Requirements for marking of products

– Assembly instructions

– Installation instructions

– Warnings

– Requirements for the format of product declarations

– Guidelines for the preparation of instructions

– Labelling requirements

– Instructions for drafting standards

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2 - Technical Communication in the EU

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Essential Requirements relating to provision of information in European law - 1

Toys Directive (2009/48/EC) Manufacturers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned

Machinery directive (2006/42/EC) Manufacturers shall provide information and warnings on the machinery, Information and information devices and instructions

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Construction Products Regulation CPR (Regulation EU 305/2011) When making a construction product available on the market, manufacturers shall ensure that the product is accompanied by instructions and safety information in a language determined by the Member State concerned which can be easily understood by users.

PPE Directive 89/686 EEC Information shall be supplied by the manufacturer - on storage, use, cleaning, maintenance, servicing and disinfection of the product.

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Essential Requirements relating to provision of information in European law - 2

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• In general standard give info on Safety, interoperability…

• Communication to industrial technical uses:

-helpdesk

-Case studies

-PED guidelines

-Annex Z

-Directive Guidelines

• Communication to users: how to use a sophisticated device

• Communication to define a category of product or specific pictogram

• Finally, standards may give information on how to design

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Examples of European standardization deliverables providing technical communicationprCEN ISO/TS Guidance on the labelling of manufactured nano-objects and

products containing manufactured nano-objects

EN ISO 21148 Cosmetics - Microbiology - General instructions for microbiological examination

CEN/TR 15775 Child use and care articles - National translations of warnings and instructions for use in child use and care articles standards

prEN 16256-4 Pyrotechnic articles - Theatrical pyrotechnic articles - Part 4: Minimum labelling requirements and Instructions for use

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Examples of EU technical communication in specific sectors

• Machinery Sector

• PPE Sector

• Construction

• Toys

• Nano - objects

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Machinery sector (1)

1. No normative document (standard) for instruction for use

2. But in machinery directive 2006/42/EC, there are some paragraphs related to information for use:

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directive 2006/42/EC, Article 5:– Before placing machinery on the market and/or putting it into service, the manufacturer or

his authorised representative shall:

• (a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;

• (b) ensure that the technical file referred to in Annex VII, part A is available;

• (c) provide, in particular, the necessary information, such as instructions;

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directive 2006/42/EC, Article 5:

• (d) carry out the appropriate procedures for assessing conformity in accordance with Article 12;

• (e) draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;

• (f) affix the CE marking in accordance with Article 16.

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• directive 2006/42/EC, Annex 1:• 1.7.4. Instructions

• All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.

• The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.

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PPE Sector (1)

• CEN/TR 14560:2003”Guidance for selection, use, care and maintenance of protective clothing against heat and flame” – however not general to all PPE

• PPE Directive 89/686 EEC, applies to manufacturing of protective clothing, defines the “essential” requirements and technical communication as set in the following articles:

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PPE Sector (2)

• Article 1.4 of the directive 89/686 :The manufacturer must provide all relevant information on:

• (a) storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on PPE or users when applied in accordance with the relevant instructions;

• (b) performance as recorded during technical tests to check the levels or classes of protection provided by the PPE in question;

• (c) suitable PPE accessories and the characteristics of appropriate spare parts;

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PPE Sector (3)• (d) the classes of protection appropriate to different levels of risk and the corresponding limits of use;

• (e) the obsolescence deadline or period of obsolescence of PPE or certain of its components;

• (f) the type of packaging suitable for transport;

• (g) the significance of any markings (see 2.12).

• (h) where appropriate, the references of the Directives applied in accordance with Article 5 (6) (b);

• (i) the name, address and identification number of the notified body involved in the design stage of the PPE.

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Construction sector (1)• EPBD Directive 2010/31/EU states:

- The prospective buyer and tenant of a building or building unit should, in the energy performance certificate, be given correct information about the energy performance of the building and practical advice on improving such performance (...)The energy performance certificate should also provide information about the actual impact of heating and cooling on the energy needs of the building, on its primary energy consumption and on its carbon dioxide emissions

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Construction sector (2)• EPBD Directive 2010/31/EU

- Buildings occupied by public authorities and buildings frequently visited by the public should set an example by showing that environmental and energy considerations are being taken into account and therefore those buildings should be subject to energy certification on a regular basis. The dissemination to the public of information on energy performance should be enhanced by clearly displaying these energy performance certificates,

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Construction sector (3)in the CPR (Regulation EU 305/2011) - CHAPTER III – Obligations of Economic Operators - art.

11 – Obligation of manufacturers

Par. 1 - Manufacturers shall draw up a declaration of performance

Par. 4 - Manufacturers shall ensure that their construction products bear a type, batch or serial number or any other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the construction product.

Par. 6 - When making a construction product available on the market, manufacturers shall ensure that the product is accompanied by instructions and safety information in a language determined by the Member State concerned which can be easily understood by users.

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Construction sector (4)

• TC 350 developed FprEN 15804 Sustainability of construction works - Environmental product declarations - Core rules for the product category of construction products.

• This European standard provides core product category rules (PCR) for Type III environmental declarations for any construction product and construction service.

• The core PCR: - defines the parameters to be declared and the way in which they are collated and reported,

• describes which stages of a product’s life cycle are considered in the EPD and which processes are to be included in the life cycle stages,

• defines rules for the development of scenarios, 25

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Construction sector (5)

FprEN 15804 (continued)

• includes the rules for calculating the Life Cycle Inventory and the Life Cycle Impact Assessment underlying the EPD, including the specification of the data quality to be applied,

• includes the rules for reporting predetermined, environmental and health information where necessary,

• defines the conditions under which construction products can be compared based on the information provided by EPD.

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Toys Sector (1)

Toys Directive (2009/48/EC)

art.4 Obligations of manufacturers:

Manufacturers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned;

Art.6 obligations of importer

Importers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.

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Toys Sector (2)

Toys Directive (2009/48/EC) (continued)

Art. 11 warnings: • Warnings which determine the decision to purchase the

toy, such as those specifying the minimum and maximum ages for users and the other applicable warnings set out in Annex V, shall appear on the consumer packaging or be otherwise clearly visible to the consumer before the purchase, including in cases where the purchase is made on-line.

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Nano – objects

• CEN/TC 352 is currently developing in parallel with ISO (CEN lead) a TS on Guidance on the labelling of manufactured nano-objects and products containing manufactured nano-objects (pr TS 13830:2011)

• It provides guidance on the format and content of voluntary labelling for manufactured nano-objects (MNOs) and products, preparations and mixtures containing MNOs. It also provides guidance on the use of the term “nano” in product labelling.

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4 – Cooperation with China (1)

• Europe and China are Working Together

– Regulatory Dialogue between European Commission and AQSIQ: 12+ Working Groups, incl. Standardization

– CEN, CENELEC, ETSI and SAC (Standardization Administration of China) signed a MoU in 2008 CEN,CENELEC,ETSI

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• Europe and China are Working Together

• SESEC (since 2006): – Raises awareness on the European system

and values

– Informs about development in China and in Europe

– Helps sector and industry 31

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• China – Europe Standards Information Platform (CESIP) – Website: www.eu-china-standards.eu-> Electrical Equipment, Medical devices, Machinery, Environmental protection

• Bilateral activities between member states / European national standardization bodies and Chinese side

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Conclusion

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• Different realities but tangible need for common global language

-> harmonized standards for market

-> global leveling of essential health and safety concerns

For further information on European standards

please contact Mr. Rémi Orth at :

[email protected], tel:(10)6462 2066-87

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00350013 FprEN 15942 Sustainability of construction works - Environmental product declarations - Communication format business-to-business Active Not Published Dispatch of FV draft to CMC45.99.0979 00350014 Sustainability of construction works - Environmental product declarations communication format – Business to Consumer Waiting Not Published Completion of Proposal/Preliminary stage00.60.0000

Annex: non exhaustive list of European standards providing guidance on technical communication

EN 13015:2001 Maintenance for lifts and escalators - Rules for maintenance instructions Closed Withdrawn Withdrawal effective99.60.0000

00010069 EN 13015:2001/prA1 Maintenance for lifts and escalators - Rules for maintenance instructions Closed Not Published Closure of Vote50.60.0000

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00010080 EN 13015:2001+A1:2008 Maintenance for lifts and escalators - Rules for maintenance instructions Active Published Definitive text made available (DAV)60.60.0000

00052035 CEN/TR 15071:2005 Safety of toys - National translations of warnings and instructions for use in EN 71 Active Published Definitive text made available (DAV)60.60.0000


00054024 CEN/TS 764-6:2004 Pressure equipment - Part 6: Structure and content of operating instructions Active Published Decision on results of review/2YR ENQ - revise90.92.0000

00054088 prCEN/TR 764-6 Pressure equipment - Part 6: Structure and content of operating instructions Abandoned Not Published End of interruption of work - abandoned30.98.0009

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00054119 prCEN/TR 764-6 Pressure equipment - Part 6: Structure and content of operating instructions Active Not Published Decision on WI proposal - Accept10.99.0000

00055217 prEN ISO 21532 Dentistry - Reprocessing instructions for resterilizable instruments Abandoned Not Published Decision on WI proposal - Accept10.99.0000


00052035 CEN/TR 15071:2005 Safety of toys - National translations of warnings and instructions for use in EN 71 Active Published Definitive text made available (DAV)60.60.0000

00054024 CEN/TS 764-6:2004 Pressure equipment - Part 6: Structure and content of operating instructions Active Published Decision on results of review/2YR ENQ - revise90.92.0000

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00054088 prCEN/TR 764-6 Pressure equipment - Part 6: Structure and content of operating instructions Abandoned Not Published End of interruption of work - abandoned30.98.0009

00054119 prCEN/TR 764-6 Pressure equipment - Part 6: Structure and content of operating instructions Active Not Published Decision on WI proposal - Accept10.99.0000


00055217 prEN ISO 21532 Dentistry - Reprocessing instructions for resterilizable instruments Abandoned Not Published Decision on WI proposal - Accept10.99.0000

00055262 EN ISO 24234:2004/FprA1 Dentistry - Mercury and alloys for dental amalgam - Amendment 1: Requirements for marking and manufacturer's instructions concerning mercury (ISO 24234:2004/FDAM 1:2011) Active Not Published Dispatch of FV draft to CMC45.99.0979

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00088201 EN 15715:2009 Thermal insulation products - Instructions for mounting and fixing for reaction to fire testing - Factory made products Active Published Definitive text made available (DAV)60.60.0000

00088262 Thermal insulation products for building applications - Instructions for mounting and fixing for determination of the reaction to fire testing of external thermal Insulation composite systems (ETICS) (Analogue to EN 15715) Waiting Not Published Completion of Proposal/Preliminary stage00.60.0000


00093006 EN 131-3:2007 Ladders - Part 3: User Instructions Active Published Decision on results of review/2YR ENQ - revise90.92.0000

00093178

prEN 131-3 rev Ladders - Part 3: User Instructions Information Active Not Published Closure of enquiry40.60.0000

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00110005 ENV 307:1990 Heat exchangers - Guidelines to prepare installation, operating and maintenance instructions required to maintain the performance of each type of heat exchanger Closed Withdrawn Withdrawal effective99.60.0000

00110031 EN 307:1998 Heat exchangers - Guidelines to prepare installation, operating and maintenance instructions required to maintain the performance of each type of heat exchangers Active Published Definitive text made available (DAV)60.60.0000


00136082 EN 1069-2:1996 Water slides over 2 m height - Part 2: Instructions Closed Withdrawn Withdrawal effective99.60.0000

00136121 EN 1069-2:1999 Water slides over 2 m height and more - Part 2: Instructions Closed Withdrawn Withdrawal effective99.60.0000

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00136160 Swimming pools - Part xx: Operational instructions Split Not Published Decision on WI proposal - Accept10.99.0000

00136193 EN 1069-2 Waterslides - Part 2: Instructions Abandoned Not Published End of interruption of work - abandoned30.98.0009


00136223 EN 1069-2:2010 Water slides - Part 2: Instructions Active Published Definitive text made available (DAV)60.60.0000

00140034 EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use Closed Withdrawn Withdrawal effective99.60.0000

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00140035 EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing Closed Withdrawn Withdrawal effective99.60.0000

00147021 EN 12644-1:2001 Cranes - Information for use and testing - Part 1: Instructions Closed Withdrawn Withdrawal effective99.60.0000


00147083 EN 12644-1:2001/prA1 Cranes - Information for use and testing - Part 1: Instructions Closed Not Published Closure of Vote50.60.0000

00147094 EN 12644-1:2001+A1:2008 Cranes - Information for use and testing - Part 1: Instructions Active Published Decision on results of review/2YR ENQ - confirm90.93.0000

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00160015 EN 365:1992 Personal protective equipment against falls from a height - General requirements for instructions for use and for marking Closed Withdrawn Withdrawal effective99.60.0000

00160041 EN 365:2004 Personal protective equipment against falls from a height - General requirements for instructions for use, maintenance, periodic examination, repair, marking and packaging Active Published Decision on results of review/2YR ENQ - confirm90.93.0000


00160C02 EN 365:2004/AC:2006 Personal protective equipment against falls from a height - General requirements for instructions for use, maintenance, periodic examination, repair, marking and packaging Active Published Definitive text made available (DAV)60.60.0000 00165067 EN 12056-5:2000 Gravity drainage systems inside buildings - Part 5: Installation and testing, instructions for operation, maintenance and use Active Published Decision on results of review/2YR ENQ - confirm90.93.0000

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00182045 Refrigerating systems and heat pumps - Labelling, marking and instructions Waiting Not Published Completion of Proposal/Preliminary stage00.60.0000

00212081 prEN 16256-4 Pyrotechnic articles - Theatrical pyrotechnic articles - Part 4: Minimum labelling requirements and Instructions for use Active Not Published Submission to enquiry40.20.0000 Start date:2011-03-17End date:2011-08-17


00252057 CEN/TR 15775:2008 Child use and care articles - National translations of warnings and instructions for use in child use and care articles standards Active Published Definitive text made available (DAV)60.60.0000

00269034 prEN 12953-13 Shell boilers - Part 13: Operating instructions Abandoned Not Published Dispatch of FV draft to CMC45.99.0979

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00269061 prEN 12952-18 Water-tube boilers and auxiliary installations - Part 18: Operating instructions Active Not Published Dispatch of ENQ draft to CMC30.99.0979

00269062 prEN 12953-13 Shell boilers - Part 13: Operating instructions Active Not Published Closure of enquiry40.60.0000


00300018 EN ISO 19019:2005 Sea-going vessels and marine technology - Instructions for planning, carrying out and reporting sea trials (ISO 19019:2005) Active Published Definitive text made available (DAV)60.60.0000

00331092 FprCEN/TR 14142-2 Postal Services - Address databases - Part 2: Element mapping conventions, template design considerations, address templates and rendition instructions Active Not Published Closure of Vote50.60.0000

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00392002 EN ISO 21148:2009 Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005) Active Published Definitive text made available (DAV)60.60.0000

04000967 prEN 2500-1 Instructions for the drafting and use of metallic material standards - Part 1: General requirements Abandoned Not Published Decision on WI proposal - Accept10.99.0000


CSH99028 EN ISO 21148:2005/prAC Cosmetics - Microbiology - General instructions for microbiological examination Abandoned Not Published Decision on WI proposal - Accept10.99.0000