SESEC - Seconded European Standardization Expert in China 1 Development on Technical Communication in Europe Rémi Orth, SESEC project assistant IFAN conference “application and development of standards for instructions for use of products” 9 th -10 th June 2011,Huangshan 1

SESEC - Seconded European Standardization Expert in China 2 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!!! 2

SESEC - Seconded European Standardization Expert in China 3 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 3

SESEC - Seconded European Standardization Expert in China 4 1 – Standardization in the EU: European Standardization Organizations –CEN European Committee for Standardization Horizontal mandate –CENELEC European 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 4

SESEC - Seconded European Standardization Expert in China 5 European Standards EN CEN & CENELEC → 27 EU Members → 3 EFTA Countries → 1 Neighbourhood Total: 31 Members ETSI → 40+ Countries → Over 700 Members 5

SESEC - Seconded European Standardization Expert in China 6 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) 6

SESEC - Seconded European Standardization Expert in China 7 European Standardization Organizations –1 European standard:... Replaces 31 different national standards in Europe Creates access to a market of 500 million 7

SESEC - Seconded European Standardization Expert in China 88

9 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 Technical Communication in the EU

SESEC - Seconded European Standardization Expert in China 10 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 10

SESEC - Seconded European Standardization Expert in China 11 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. 11 Essential Requirements relating to provision of information in European law - 2

SESEC - Seconded European Standardization Expert in China 12 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 12

SESEC - Seconded European Standardization Expert in China 13 Examples of European standardization deliverables providing technical communication prCEN ISO/TS Guidance on the labelling of manufactured nano-objects and products containing manufactured nano-objects EN ISO Cosmetics - Microbiology - General instructions for microbiological examination CEN/TR Child use and care articles - National translations of warnings and instructions for use in child use and care articles standards prEN Pyrotechnic articles - Theatrical pyrotechnic articles - Part 4: Minimum labelling requirements and Instructions for use 13

SESEC - Seconded European Standardization Expert in China 14 Examples of EU technical communication in specific sectors Machinery Sector PPE Sector Construction Toys Nano - objects 14

SESEC - Seconded European Standardization Expert in China 15 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: 15

SESEC - Seconded European Standardization Expert in China 16 Machinery sector (2) 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; 16

SESEC - Seconded European Standardization Expert in China 17 Machinery sector (3) 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

SESEC - Seconded European Standardization Expert in China 18 Machinery sector (4) directive 2006/42/EC, Annex 1: 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. 18

SESEC - Seconded European Standardization Expert in China 19 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: 19

SESEC - Seconded European Standardization Expert in China 20 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; 20

SESEC - Seconded European Standardization Expert in China 21 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. 21

SESEC - Seconded European Standardization Expert in China 22 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 22

SESEC - Seconded European Standardization Expert in China 23 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, 23

SESEC - Seconded European Standardization Expert in China 24 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. 24

SESEC - Seconded European Standardization Expert in China 25 Construction sector (4) TC 350 developed FprEN 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

SESEC - Seconded European Standardization Expert in China 26 Construction sector (5) FprEN (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. 26

SESEC - Seconded European Standardization Expert in China 27 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. 27

SESEC - Seconded European Standardization Expert in China 28 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. 28

SESEC - Seconded European Standardization Expert in China 29 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. 29

SESEC - Seconded European Standardization Expert in China 30 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 30

SESEC - Seconded European Standardization Expert in China 31 4 – Cooperation with China (2) 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

SESEC - Seconded European Standardization Expert in China 32 4 – Cooperation with China (3) China – Europe Standards Information Platform (CESIP) – Website: -> Electrical Equipment, Medical devices, Machinery, Environmental protection Bilateral activities between member states / European national standardization bodies and Chinese side 32

SESEC - Seconded European Standardization Expert in China 33 Conclusion 33 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 : tel:(10)

SESEC - Seconded European Standardization Expert in China FprEN Sustainability of construction works - Environmental product declarations - Communication format business-to-business Active Not Published Dispatch of FV draft to CMC Sustainability of construction works - Environmental product declarations communication format – Business to Consumer Waiting Not Published Completion of Proposal/Preliminary stage 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 effective EN 13015:2001/prA1 Maintenance for lifts and escalators - Rules for maintenance instructions Closed Not Published Closure of Vote

SESEC - Seconded European Standardization Expert in China EN 13015:2001+A1:2008 Maintenance for lifts and escalators - Rules for maintenance instructions Active Published Definitive text made available (DAV) 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) Annex: non exhaustive list of European standards providing guidance on technical communication CEN/TS 764-6:2004 Pressure equipment - Part 6: Structure and content of operating instructions Active Published Decision on results of review/2YR ENQ - revise prCEN/TR Pressure equipment - Part 6: Structure and content of operating instructions Abandoned Not Published End of interruption of work - abandoned

SESEC - Seconded European Standardization Expert in China prCEN/TR Pressure equipment - Part 6: Structure and content of operating instructions Active Not Published Decision on WI proposal - Accept prEN ISO Dentistry - Reprocessing instructions for resterilizable instruments Abandoned Not Published Decision on WI proposal - Accept Annex: non exhaustive list of European standards providing guidance on technical communication 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) CEN/TS 764-6:2004 Pressure equipment - Part 6: Structure and content of operating instructions Active Published Decision on results of review/2YR ENQ - revise

SESEC - Seconded European Standardization Expert in China prCEN/TR Pressure equipment - Part 6: Structure and content of operating instructions Abandoned Not Published End of interruption of work - abandoned prCEN/TR Pressure equipment - Part 6: Structure and content of operating instructions Active Not Published Decision on WI proposal - Accept Annex: non exhaustive list of European standards providing guidance on technical communication prEN ISO Dentistry - Reprocessing instructions for resterilizable instruments Abandoned Not Published Decision on WI proposal - Accept 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 CMC

SESEC - Seconded European Standardization Expert in China 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) 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 stage Annex: non exhaustive list of European standards providing guidance on technical communication EN 131-3:2007 Ladders - Part 3: User Instructions Active Published Decision on results of review/2YR ENQ - revise prEN rev Ladders - Part 3: User Instructions Information Active Not Published Closure of enquiry

SESEC - Seconded European Standardization Expert in China 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 effective 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) Annex: non exhaustive list of European standards providing guidance on technical communication EN :1996 Water slides over 2 m height - Part 2: Instructions Closed Withdrawn Withdrawal effective EN :1999 Water slides over 2 m height and more - Part 2: Instructions Closed Withdrawn Withdrawal effective

SESEC - Seconded European Standardization Expert in China Swimming pools - Part xx: Operational instructions Split Not Published Decision on WI proposal - Accept EN Waterslides - Part 2: Instructions Abandoned Not Published End of interruption of work - abandoned Annex: non exhaustive list of European standards providing guidance on technical communication EN :2010 Water slides - Part 2: Instructions Active Published Definitive text made available (DAV) EN 591:2001 Instructions for use for in vitro diagnostic instruments for professional use Closed Withdrawn Withdrawal effective

SESEC - Seconded European Standardization Expert in China EN 592:2002 Instructions for use for in vitro diagnostic instruments for self-testing Closed Withdrawn Withdrawal effective EN :2001 Cranes - Information for use and testing - Part 1: Instructions Closed Withdrawn Withdrawal effective Annex: non exhaustive list of European standards providing guidance on technical communication EN :2001/prA1 Cranes - Information for use and testing - Part 1: Instructions Closed Not Published Closure of Vote EN :2001+A1:2008 Cranes - Information for use and testing - Part 1: Instructions Active Published Decision on results of review/2YR ENQ - confirm

SESEC - Seconded European Standardization Expert in China EN 365:1992 Personal protective equipment against falls from a height - General requirements for instructions for use and for marking Closed Withdrawn Withdrawal effective 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 - confirm Annex: non exhaustive list of European standards providing guidance on technical communication 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) EN :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 - confirm

SESEC - Seconded European Standardization Expert in China Refrigerating systems and heat pumps - Labelling, marking and instructions Waiting Not Published Completion of Proposal/Preliminary stage prEN Pyrotechnic articles - Theatrical pyrotechnic articles - Part 4: Minimum labelling requirements and Instructions for use Active Not Published Submission to enquiry Start date: End date: Annex: non exhaustive list of European standards providing guidance on technical communication 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) prEN Shell boilers - Part 13: Operating instructions Abandoned Not Published Dispatch of FV draft to CMC

SESEC - Seconded European Standardization Expert in China prEN Water-tube boilers and auxiliary installations - Part 18: Operating instructions Active Not Published Dispatch of ENQ draft to CMC prEN Shell boilers - Part 13: Operating instructions Active Not Published Closure of enquiry Annex: non exhaustive list of European standards providing guidance on technical communication 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) FprCEN/TR Postal Services - Address databases - Part 2: Element mapping conventions, template design considerations, address templates and rendition instructions Active Not Published Closure of Vote

SESEC - Seconded European Standardization Expert in China EN ISO 21148:2009 Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005) Active Published Definitive text made available (DAV) prEN Instructions for the drafting and use of metallic material standards - Part 1: General requirements Abandoned Not Published Decision on WI proposal - Accept Annex: non exhaustive list of European standards providing guidance on technical communication CSH99028 EN ISO 21148:2005/prAC Cosmetics - Microbiology - General instructions for microbiological examination Abandoned Not Published Decision on WI proposal - Accept