Information and Notices

Similar documents
C 319/6 Official Journal of the European Union

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2015/C 335/02)

(Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2016/C 126/02)

Official Journal of the European Union

(Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION

C 183/10 Official Journal of the European Union

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2018/C 092/02)

(Notices) EUROPEAN COMMISSION

(Notices) EUROPEAN COMMISSION

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2015/C 014/04)

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2017/C 389/02)

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2016/C 173/02)

Official Journal of the European Union

(Information) COMMISSION

OFFICIAL JOURNAL OF ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVE (90/385/EEC)

Information and Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

EUROPEAN C O M M I S S I O N

Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

(Text with EEA relevance) First publication OJ EN 12322:1999/A1: Note 3 Date expired ( ) 19.8.

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2015/C 226/03)

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2017/C 389/04)

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

OFFICIAL JOURNAL OF IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVE (98/79/EC)

Commission communication in the framework of the implementation of the Council Directive 93/ 42/EEC of 14 June 1993 concerning medical devices

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2016/C 054/02)

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2018/C 209/02)

Commission communication in the framework of the implementation of the Council Directive 93/ 42/EEC of 14 June 1993 concerning medical devices

Commission communication in the framework of the implementation of the Council Directive 93/ 42/EEC concerning medical devices

Commission communication in the framework of the implementation of the Council Directive 93/ 42/EEC of 14 June 1993 concerning medical devices

Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

European Standards moved from the Low Voltage Directive to the Machine Directive

Official Journal of the European Union C 97/11

(Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION

(Text with EEA relevance) Reference and title of the harmonised standard (and reference document) EN 26:1997/A1:2000 Note 3 Date expired (18.7.

(Notices) EUROPEAN COMMISSION

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

(Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION

(Publication of titles and references of European standards under the directive) (Text with EEA relevance) (2017/C 267/03) First publication OJ

EN Official Journal of the European Union C 14/29

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2016/C 173/05)

EN Official Journal of the European Union C 359/47

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2016/C 293/03)

Do you manufacture equipment or protective systems for use in potentially explosive atmospheres? Do you process, trade or import them?

(Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION

ISO INTERNATIONAL STANDARD

C 271/32 Official Journal of the European Union

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Flexible Schedule of Accreditation. SIRA CERTIFICATION SERVICE Unit 6, Hawarden Industrial Park, Hawarden, CH5 3US.

Flexible Schedule of Accreditation. SIRA CERTIFICATION SERVICE Unit 6, Hawarden Industrial Park, Hawarden, CH5 3US.

NATIONAL RULES FOR ELECTRICAL INSTALLATIONS IN POTENTIALLY EXPLOSIVE ATMOSPHERES. ET 105:2001 (Second Edition)

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

HARMONISATION STATUS OF SELECTED ELECTRICAL AND NON-ELECTRICAL Ex STANDARDS MARCH 2018

CPX RIGID PENDANT INSTALLATION, OPERATIONS & MAINTENANCE MANUAL

INTERNATIONAL STANDARD

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2017/C 435/04)

Test procedure/ method name. method identification. Testing of industrial and explosion isolation valves and tank lining

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2014/C 110/03)

Single Market : regulatory environment, standardisation and New Approach Pressure equipment, medical devices, metrology M/327

ATEX GUIDE. A short introduction to ATEX Terminology. Equipment for use in flammable atmospheres. Directive 94/9/EC

C 435/6 EN Official Journal of the European Union

ISO INTERNATIONAL STANDARD

(Publication of titles and references of harmonised standards under Union harmonisation legislation) (Text with EEA relevance) (2017/C 118/03)

Tracheostomy tubes - Part 2: Paediatric tubes. Anestesi- och ventilationsutrustning - Trakeostomituber - Del 2: Tuber avsedda för barn

An overview of sterilizer equipment standards current and planned. Richard Bancroft Science & Technical Director STERIS

BUSINESS PLAN CEN/TC 305 POTENTIALLY EXPLOSIVE ATMOSPHERES EXPLOSION PREVENTION AND PROTECTION EXECUTIVE SUMMARY

AS/NZS :2009 Explosive atmospheres - Part 14: Electrical installations design, selection and erection

(Notices) EUROPEAN COMMISSION

INTERNATIONAL STANDARD

(Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES COMMISSION

WHAT WHITE PAPER IS POTENTIALLY EXPLOSIVE ATMOSPHERE CERTIFICATION AND WHY YOU. June 2010

This document is a preview generated by EVS

HAZARDOUS AREA CLASSIFICATION AND SELECTION OF EQUIPMENT FOR SAFE USE THEREIN FROM AN ELECTRICAL VIEWPOINT

Gas meters - Conversion devices - Part 1: Volume conversion

Not to be reproduced without the permission of Last date for receipt of BIS or used as a STANDARD comments is: 15 July 2012

Report on the activities of the ATEX consultant. Xavier Lefebvre. Contract : CENELEC/NA Consultant/2013-1

Annex to the Accreditation Certificate D-PL according to DIN EN ISO/IEC 17025:2005

Institute of Decontamination Sciences Blackburn House, Redhouse Road, Seafield, Bathgate, West Lothian EH47 7AQ

Australian/New Zealand Standard

ISO INTERNATIONAL STANDARD. Hydrogen generators using fuel processing technologies Part 1: Safety

The R. STAHL Technology Group Worldwide Success with Competence and Customer Support

INTERNATIONAL STANDARD

Notification of a Body in the framework of a technical harmonization directive

Zakres notyfikacji UE dla IMQ. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Via Quintiliano, MILANO Country : Italy

INTRODUCTION TO DUSTS AND THEIR EXPLOSIVE PROPERTIES

INTERNATIONAL STANDARD

ISO 7010 INTERNATIONAL STANDARD. Graphical symbols Safety colours and safety signs Registered safety signs

Safety Standards for Electronic Products

CE Marking and Technical Standardisation

Hazardous Areas - EXPLOSIONPROOF SOLENOIDS

NZQA registered unit standard version 1 Page 1 of 5. Install fixed gas detection apparatus in hazardous areas

Numerical Standards Listing

AS/NZS :2008

Part 2-55: Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors

OPTIBAR DP 7060 Supplementary Instructions

EUROPEAN DIRECTIVES Explosive atmospheres ATEX 2014/34/EU

Transcription:

Official Journal of the European Union ISSN 1725-2423 C 183 English edition Information and Notices Volume 53 7 July 2010 Notice No Contents Page IV Notices NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGCIES European Commission 2010/C 183/01 Commission communication in the framework of the implementation of the Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres ( 1 ) (Publication of titles and references of harmonised s under the directive)............ 1 2010/C 183/02 Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 1 ) (Publication of titles and references of harmonised s under the directive)............................................................................................ 10 2010/C 183/03 Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 1 ) (Publication of titles and references of harmonised s under the directive).............................................................. 15 2010/C 183/04 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 1 ) (Publication of titles and references of harmonised s under the directive)........................... 45 Price: EUR 4 ( 1 ) Text with EEA relevance

7.7.2010 Official Journal of the European Union C 183/1 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGCIES EUROPEAN COMMISSION Commission communication in the framework of the implementation of the Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (Text with EEA relevance) (Publication of titles and references of harmonised s under the directive) (2010/C 183/01) superseded C 809:1998+A1:2009 Pumps and pump units for liquids - Common safety requirements 16.4.2010 C 1010-1:2004 Safety of machinery - Safety requirements for the design and construction of printing and paper converting machines - Part 1: Common requirements C 1010-2:2006 Safety of machinery - Safety requirements for the design and construction of printing and paper converting machines - Part 2: Printing and varnishing machines including pre-press machinery C 1127-1:2007 Explosive atmospheres - Explosion prevention and protection - Part 1: Basic concepts and methodology 30.11.2005 20.7.2006 11.4.2008 1127-1:1997 (28.12.2009) C 1127-2:2002+A1:2008 Explosive atmospheres - Explosion prevention and protection - Part 2: Basic concepts and methodology for mining 20.8.2008 1127-2:2002 (28.12.2009) C 1710:2005+A1:2008 Equipment and components intended for use in potentially explosive atmospheres in underground mines 20.8.2008 1710:2005 (28.12.2009) C 1755:2000+A1:2009 Safety of industrial trucks - Operation in potentially explosive atmospheres - Use in flammable gas, vapour, mist and dust 16.4.2010 1755:2000 (16.4.2010)

C 183/2 Official Journal of the European Union 7.7.2010 superseded C 1834-1:2000 Reciprocating internal combustion engines - Safety requirements for design and construction of engines for use in potentially explosive atmospheres - Part 1: Group II engines for use in flammable gas and vapour atmospheres C 1834-2:2000 Reciprocating internal combustion engines - Safety requirements for design and construction of engines for use in potentially explosive atmospheres - Part 2: Group I engines for use in underground workings susceptible to firedamp and/or combustible dust C 1834-3:2000 Reciprocating internal combustion engines - Safety requirements for design and construction of engines for use in potentially explosive atmospheres - Part 3: Group II engines for use in flammable dust atmospheres C 1839:2003 Determination of explosion limits of gases and vapours C 12581:2005 Coating plants - Machinery for dip coating and electrodeposition of organic liquid coating material - Safety requirements C 12621:2006 Machinery for the supply and circulation of coating materials under pressure - Safety requirements C 12757-1:2005 Mixing machinery for coating materials - Safety requirements - Part 1: Mixing machinery for use in vehicle refinishing C 12874:2001 Flame arresters - Performance requirements, test methods and limits for use C 13012:2001 Petrol filling stations - Construction and performance of automatic nozzles for use on fuel dispensers C 13160-1:2003 Leak detection systems - Part 1: General principles C 13237:2003 Potentially explosive atmospheres - Terms and definitions for equipment and protective systems intended for use in potentially explosive atmospheres C 13463-1:2009 Non-electrical equipment for use in potentially explosive atmospheres - Part 1: Basic method and requirements C 13463-2:2004 Non-electrical equipment for use in potentially explosive atmospheres - Part 2: Protection by flow restricting enclosure fr 21.7.2001 21.7.2001 21.7.2001 12.8.2004 9.3.2006 20.7.2006 9.3.2006 7.9.2002 22.1.2002 14.8.2003 14.8.2003 16.4.2010 13463-1:2001 30.11.2005 (16.4.2010)

7.7.2010 Official Journal of the European Union C 183/3 superseded C 13463-3:2005 Non-electrical equipment for use in potentially explosive atmospheres - Part 3: Protection by flameproof enclosure d C 13463-5:2003 Non-electrical equipment intended for use in potentially explosive atmospheres - Part 5: Protection by constructional safety c C 13463-6:2005 Non-electrical equipment for use in potentially explosive atmospheres - Part 6: Protection by control of ignition source b C 13463-8:2003 Non-electrical equipment for potentially explosive atmospheres - Part 8: Protection by liquid immersion k C 13616:2004 Overfill prevention devices for static tanks for liquid petroleum fuels 30.11.2005 12.8.2004 30.11.2005 12.8.2004 9.3.2006 13616:2004/AC:2006 C 13617-1:2004+A1:2009 Petrol filling stations - Part 1: Safety requirements for construction and performance of metering pumps, dispensers and remote pumping units 13617-1:2004 The date of this C 13617-2:2004 Petrol filling stations - Part 2: Safety requirements for construction and performance of safe breaks for use on metering pumps and dispensers C 13617-3:2004 Petrol filling stations - Part 3: Safety requirements for construction and performance of shear valves C 13673-1:2003 Determination of the maximum explosion pressure and the maximum rate of pressure rise of gases and vapours - Part 1: Determination of the maximum explosion pressure C 13673-2:2005 Determination of maximum explosion pressure and the maximum rate of pressure rise of gases and vapours - Part 2: Determination of the maximum rate of explosion pressure rise C 13760:2003 Automotive LPG filling system for light and heavy duty vehicles - Nozzle, test requirements and dimensions C 13821:2002 Potentially explosive atmospheres - Explosion prevention and protection - Determination of minimum ignition energy of dust/air mixtures 30.11.2005 30.11.2005 14.8.2003 30.11.2005 24.1.2004 20.5.2003

C 183/4 Official Journal of the European Union 7.7.2010 superseded C 13980:2002 Potentially explosive atmospheres - Application of quality systems C 14034-1:2004 Determination of explosion characteristics of dust clouds - Part 1: Determination of the maximum explosion pressure pmax of dust clouds C 14034-2:2006 Determination of explosion characteristics of dust clouds - Part 2: Determination of the maximum rate of explosion pressure rise (dp/dt)max of dust clouds C 14034-3:2006 Determination of explosion characteristics of dust clouds - Part 3: Determination of the lower explosion limit LEL of dust clouds C 14034-4:2004 Determination of explosion characteristics of dust clouds - Part 4: Determination of the limiting oxygen concentration LOC of dust clouds C 14373:2005 Explosion suppression systems C 14460:2006 Explosion resistant equipment C 14491:2006 Dust explosion venting protective systems 20.5.2003 30.11.2005 15.12.2006 15.12.2006 30.11.2005 9.3.2006 15.12.2006 20.7.2006 14491:2006/AC:2008 C 14492-1:2006+A1:2009 Cranes - Power driven winches and hoists - Part 1: Power driven winches 16.4.2010 14492-1:2006 (30.4.2010) 14492-1:2006+A1:2009/AC:2010 C 14492-2:2006+A1:2009 Cranes - Power driven winches and hoists - Part 2: Power driven hoists 16.4.2010 14492-2:2006 (31.3.2010) 14492-2:2006+A1:2009/AC:2010 C 14522:2005 Determination of the auto ignition temperature of gases and vapours C 14591-1:2004 Explosion prevention and protection in underground mines - Protective systems - Part 1: 2-bar explosion proof ventilation structure 30.11.2005 9.3.2006 14591-1:2004/AC:2006

7.7.2010 Official Journal of the European Union C 183/5 superseded C 14591-2:2007 Explosion prevention and protection in underground mines - Protective systems - Part 2: Passive water trough barriers 12.12.2007 14591-2:2007/AC:2008 C 14591-4:2007 Explosion prevention and protection in underground mines - Protective systems - Part 4: Automatic extinguishing systems for road headers 12.12.2007 14591-4:2007/AC:2008 C 14677:2008 Safety of machinery - Secondary steelmaking - Machinery and equipment for treatment of liquid steel 20.8.2008 C 14678-1:2006+A1:2009 LPG equipment and accessories - Construction and performance of LPG equipment for automotive filling stations - Part 1: Dispensers 16.4.2010 14678-1:2006 (16.4.2010) C 14681:2006 Safety of machinery - Safety requirements for machinery and equipment for production of steel by electric arc furnaces C 14756:2006 Determination of the limiting oxygen concentration (LOC) for flammable gases and vapours C 14797:2006 Explosion venting devices 15.12.2006 12.12.2007 12.12.2007 C 14973:2006+A1:2008 Conveyor belts for use in underground installations - Electrical and flammability safety requirements 14973:2006 The date of this C 14983:2007 Explosion prevention and protection in underground mines - Equipment and protective systems for firedamp drainage C 14986:2007 Design of fans working in potentially explosive atmospheres C 14994:2007 Gas explosion venting protective systems C 15089:2009 Explosion isolation systems C 15188:2007 Determination of the spontaneous ignition behaviour of dust accumulations 12.12.2007 12.12.2007 12.12.2007 16.4.2010 12.12.2007

C 183/6 Official Journal of the European Union 7.7.2010 superseded C 15198:2007 Methodology for the risk assessment of non-electrical equipment and components for intended use in potentially explosive atmospheres C 15233:2007 Methodology for functional safety assessment of protective systems for potentially explosive atmospheres C 15268:2008 Petrol filling stations - Safety requirements for the construction of submersible pump assemblies C 15794:2009 Determination of explosion points of flammable liquids Cenelec 50050:2006 Electrical apparatus for potentially explosive atmospheres - Electrostatic hand-held spraying equipment Cenelec 50104:2002 Electrical apparatus for the detection and measurement of oxygen - Performance requirements and test methods 12.12.2007 12.12.2007 27.1.2009 16.4.2010 20.8.2008 12.8.2004 50104:1998 (1.2.2005) 50104:2002/A1:2004 12.8.2004 Note 3 (1.8.2004) Cenelec 50176:2009 Stationary electrostatic application equipment for ignitable liquid coating material - Safety requirements Cenelec 50177:2009 Stationary electrostatic application equipment for ignitable coating powders - Safety requirements Cenelec 50241-1:1999 Specification for open path apparatus for the detection of combustible or toxic gases and vapours Part 1: General requirements and test methods 16.4.2010 16.4.2010 6.11.1999 50241-1:1999/A1:2004 12.8.2004 Note 3 (1.8.2004) Cenelec 50241-2:1999 Specification for open path apparatus for the detection of combustible or toxic gases and vapours Part 2: Performance requirements for apparatus for the detection of combustible gases Cenelec 50281-2-1:1998 Electrical apparatus for use in the presence of combustible dust Part 2-1: Test methods - Methods for determining the minimum ignition temperatures of dust Cenelec 50303:2000 Group I, Category M1 equipment intended to remain functional in atmospheres endangered by firedamp and/ or coal dust 6.11.1999 6.11.1999 16.2.2001

7.7.2010 Official Journal of the European Union C 183/7 superseded Cenelec 50381:2004 Transportable ventilated rooms with or without an internal source of release 9.3.2006 50381:2004/AC:2005 Cenelec 60079-0:2009 Explosive atmospheres Part 0: Equipment - General requirements IEC 60079-0:2007 Cenelec 60079-1:2007 Explosive atmospheres - Part 1: Equipment protection by flameproof enclosures d IEC 60079-1:2007 Cenelec 60079-2:2007 Explosive atmospheres Part 2: Equipment protection by pressurized enclosure p IEC 60079-2:2007 Cenelec 60079-5:2007 Explosive atmospheres Part 5: Equipment protection by powder filling q IEC 60079-5:2007 Cenelec 60079-6:2007 Explosive atmospheres Part 6: Equipment protection by oil immersion o IEC 60079-6:2007 Cenelec 60079-7:2007 Explosive atmospheres Part 7: Equipment protection by increased safety e IEC 60079-7:2006 Cenelec 60079-11:2007 Explosive atmospheres Part 11: Equipment protection by intrinsic safety i IEC 60079-11:2006 Cenelec 60079-15:2005 Electrical apparatus for explosive gas atmospheres Part 15: Construction, test and marking of type of protection n electrical apparatus IEC 60079-15:2005 16.4.2010 60079-0:2006 + 61241-0:2006 20.8.2008 60079-1:2004 20.8.2008 60079-2:2004 20.8.2008 50017:1998 20.8.2008 50015:1998 11.4.2008 60079-7:2003 11.4.2008 50020:2002 20.7.2006 60079-15:2003 1.6.2012 (1.7.2010) 1.11.2010 1.11.2010 (1.5.2010) (1.10.2009) (1.10.2009) (1.6.2008) Cenelec 60079-18:2009 Explosive atmospheres Part 18: Equipment protection by encapsulation m 60079-18:2004 + 61241-18:2004 1.10.2012 IEC 60079-18:2009 Cenelec 60079-25:2004 20.8.2008 Electrical apparatus for explosive gas atmospheres Part 25: Intrinsically safe systems IEC 60079-25:2003

C 183/8 Official Journal of the European Union 7.7.2010 superseded Cenelec 60079-26:2007 Explosive atmospheres Part 26: Equipment with equipment protection level (EPL) Ga IEC 60079-26:2006 Cenelec 60079-27:2008 Explosive atmospheres Part 27: Fieldbus intrinsically safe concept (FISCO) IEC 60079-27:2008 Cenelec 60079-28:2007 Explosive atmospheres Part 28: Protection of equipment and transmission systems using optical radiation IEC 60079-28:2006 Cenelec 60079-29-1:2007 Explosive atmospheres Part 29-1: Gas detectors - Performance requirements of detectors for flammable gases IEC 60079-29-1:2007 (Modified) Cenelec 60079-30-1:2007 Explosive atmospheres Part 30-1: Electrical resistance trace heating - General and testing requirements IEC 60079-30-1:2007 20.8.2008 16.4.2010 60079-27:2006 11.4.2008 20.8.2008 61779-1:2000 and its amendment + 61779-2:2000 + 61779-3:2000 + 61779-4:2000 + 61779-5:2000 20.8.2008 1.4.2011 1.11.2010 Cenelec 60079-31:2009 Explosive atmospheres Part 31: Equipment dust ignition protection by enclosure t 61241-1:2004 1.10.2012 IEC 60079-31:2008 Cenelec 61241-4:2006 20.8.2008 Electrical apparatus for use in the presence of combustible dust Part 4: Type of protection pd IEC 61241-4:2001 Cenelec 61241-11:2006 11.4.2008 Electrical apparatus for use in the presence of combustible dust Part 11: Protection by intrinsic safety id IEC 61241-11:2005 Cenelec 62013-1:2006 Caplights for use in mines susceptible to firedamp Part 1: General requirements - Construction and testing in relation to the risk of explosion IEC 62013-1:2005 20.8.2008 62013-1:2002 (1.2.2009) ( 1 ) ESO: European Standards Organisation: C: Avenue Marnix 17, 1000 Brussels, BELGIUM, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu) CELEC: Avenue Marnix 17, 1000 Brussels, BELGIUM, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu) ETSI: 650, route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

7.7.2010 Official Journal of the European Union C 183/9 : Generally the date of cessation of conformity will be the date of withdrawal ( dow ), set by the European Standardisation Organisation, but attention of users of these s is drawn to the fact that in certain exceptional cases this can be otherwise. : The new (or amended) has the same scope as the superseded. On the date stated, the superseded ceases to give conformity with the essential requirements of the directive. Note 2.2: The new has a broader scope than the superseded. On the date stated the superseded ceases to give conformity with the essential requirements of the directive. Note 2.3: The new has a narrower scope than the superseded. On the date stated the (partially) superseded ceases to give conformity with the essential requirements of the directive for those products that fall within the scope of the new. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded, but that do not fall within the scope of the new, is unaffected. Note 3: In case of amendments, the referenced is CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded (column 3) therefore consists of CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded ceases to give conformity with the essential requirements of the directive. NOTE: Any information concerning the availability of the s can be obtained either from the European Standardisation Organisations or from the national isation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council ( 1 ) amended by the Directive 98/48/EC ( 2 ). Harmonised s are adopted by the European Standardisation Organisations in English (C and CELEC also publish in French and German). Subsequently, the titles of the harmonised s are translated into all other required official languages of the European Union by the National Standards Bodies. The European Commission is not responsible for the correctness of the titles which have been presented for in the Official Journal. Publication of the references in the Official Journal of the European Union does not imply that the s are available in all the Community languages. This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. More information about harmonised s on the Internet at http://ec.europa.eu/enterprise/policies/european-s/harmonised-s/index_en.htm ( 1 ) OJ L 204, 21.7.1998, p. 37. ( 2 ) OJ L 217, 5.8.1998, p. 18.

C 183/10 Official Journal of the European Union 7.7.2010 Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Text with EEA relevance) (Publication of titles and references of harmonised s under the directive) (2010/C 183/02) superseded C 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices 31.7.2002 556:1994 + A1:1998 (30.4.2002) 556-1:2001/AC:2006 15.11.2006 C 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices 9.8.2007 C 980:2008 Symbols for use in the labelling of medical devices 23.7.2008 980:2003 (31.5.2010) C 1041:2008 Information supplied by the manufacturer of medical devices 19.2.2009 1041:1998 31.8.2011 C ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) 2.12.2009 ISO 10993-1:2009 C ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) 2.12.2009 ISO 10993-4:2002 C ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) 2.12.2009 ISO 10993-5:1999 (31.12.2009) C ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) 2.12.2009 ISO 10993-6:2007 C ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) ISO 10993-7:2008/AC:2009

7.7.2010 Official Journal of the European Union C 183/11 superseded C ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) C ISO 10993-10:2009 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006) C ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) C ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) C ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) 2.12.2009 ISO 10993-9:2009 2.12.2009 ISO 10993-10:2002 2.12.2009 ISO 10993-11:2006 2.12.2009 ISO 10993-12:2007 2.12.2009 ISO 10993-13:1998 C ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) ISO 10993-16:2009 31.8.2010 C ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) C ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) C ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) C ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) C ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01) 2.12.2009 ISO 10993-17:2002 2.12.2009 ISO 10993-18:2005 9.8.2007 550:1994 7.9.2006 552:1994 9.8.2007 (31.5.2010) (30.4.2009) ISO 11137-2:2007/AC:2009 2.12.2009

C 183/12 Official Journal of the European Union 7.7.2010 superseded C ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) C ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) C ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) C ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) C ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) 2.12.2009 ISO 11138-2:2006 2.12.2009 ISO 11138-3:2006 2.12.2009 ISO 11140-1:2005 2.12.2009 ISO 11607-1:2006 7.9.2006 1174-2:1996 1174-1:1996 1174-3:1996 (31.10.2006) ISO 11737-1:2006/AC:2009 2.12.2009 C ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) C ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) ISO 13485:2003/AC:2009 C 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements 2.4.2004 ISO 13488:2000 ISO 13485:2000 24.6.2005 (31.7.2009) C ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) ISO 14155-1:2003 C ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) ISO 14155-2:2003 C ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) ISO 14937:2000

7.7.2010 Official Journal of the European Union C 183/13 superseded C ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) ISO 14971:2007 C ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) C 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer C 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) C 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems Cenelec 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer (*) Cenelec 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) (*) Cenelec 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) (*) Cenelec 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety IEC 60601-1:1988 15.11.2006 554:1994 27.8.1998 24.6.2005 27.8.1998 8.7.2004 27.11.2008 23.8.1996 (31.8.2009) 60601-1:1990/A1:1993 IEC 60601-1:1988/A1:1991 60601-1:1990/A2:1995 IEC 60601-1:1988/A2:1995 (*) 23.8.1996 Note 3 The date of this 23.8.1996 Note 3 The date of this Cenelec 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 (*) 27.11.2008 60601-1:1990 and its amendments 1.6.2012

C 183/14 Official Journal of the European Union 7.7.2010 superseded Cenelec 62304:2006 Medical device software - Software life-cycle processes IEC 62304:2006 (*) 27.11.2008 ( 1 ) ESO: European Standards Organisation: C: Avenue Marnix 17, 1000, Brussels, BELGIUM, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu) CELEC: Avenue Marnix 17, 1000, Brussels, BELGIUM, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu) ETSI: 650, route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu) (*) This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. : Generally the date of cessation of conformity will be the date of withdrawal ( dow ), set by the European Standardisation Organisation, but attention of users of these s is drawn to the fact that in certain exceptional cases this can be otherwise. : The new (or amended) has the same scope as the superseded. On the date stated, the superseded ceases to give conformity with the essential requirements of the directive. Note 2.2: The new has a broader scope than the superseded. On the date stated the superseded ceases to give conformity with the essential requirements of the directive. Note 2.3: The new has a narrower scope than the superseded. On the date stated the (partially) superseded ceases to give conformity with the essential requirements of the directive for those products that fall within the scope of the new. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded, but that do not fall within the scope of the new, is unaffected. Note 3: In case of amendments, the referenced is CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded (column 3) therefore consists of CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded ceases to give conformity with the essential requirements of the directive. NOTE: Any information concerning the availability of the s can be obtained either from the European Standardisation Organisations or from the national isation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council ( 1 ) amended by the Directive 98/48/EC ( 2 ). Harmonised s are adopted by the European Standardisation Organisations in English (C and CELEC also publish in French and German). Subsequently, the titles of the harmonised s are translated into all other required official languages of the European Union by the National Standards Bodies. The European Commission is not responsible for the correctness of the titles which have been presented for in the Official Journal. Publication of the references in the Official Journal of the European Union does not imply that the s are available in all the Community languages. This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. More information about harmonised s on the Internet at http://ec.europa.eu/enterprise/policies/european-s/harmonised-s/index_en.htm ( 1 ) OJ L 204, 21.7.1998, p. 37 ( 2 ) OJ L 217, 5.8.1998, p. 18

7.7.2010 Official Journal of the European Union C 183/15 Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Text with EEA relevance) (Publication of titles and references of harmonised s under the directive) (2010/C 183/03) superseded C 285:2006+A2:2009 Sterilization - Steam sterilizers - Large sterilizers 2.12.2009 285:2006+A1:2008 C 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes 30.9.2005 455-1:1993 (30.4.2001) C 455-2:2009 Medical gloves for single use - Part 2: Requirements and testing for physical properties 455-2:2000 (31.5.2010) C 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation 9.8.2007 455-3:1999 (30.6.2007) C 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination C 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices 31.7.2002 556:1994 + A1:1998 (30.4.2002) 556-1:2001/AC:2006 15.11.2006 C 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices 9.8.2007 C 794-1:1997+A2:2009 Lung ventilators - Part 1: Particular requirements for critical care ventilators 2.12.2009 794-1:1997 C 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators 794-3:1998 C 980:2008 Symbols for use in the labelling of medical devices 23.7.2008 980:2003 (31.5.2010) C 1041:2008 Information supplied by the manufacturer of medical devices 19.2.2009 1041:1998 31.8.2011

C 183/16 Official Journal of the European Union 7.7.2010 superseded C 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: General requirements C 1060-2:1995+A1:2009 Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers 1060-2:1995 (31.5.2010) C 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems 1060-3:1997 (31.5.2010) C 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers C 1089-3:2004 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding 30.9.2005 30.9.2005 1089-3:1997 (31.10.2004) C 1282-2:2005+A1:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) 1282-2:2005 C 1422:1997+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods 2.12.2009 1422:1997 C 1618:1997 9.5.1998 Catheters other than intravascular catheters - Test methods for common properties C 1639:2009 Dentistry - Medical devices for dentistry - Instruments 1639:2004 (30.4.2010) C 1640:2009 Dentistry - Medical devices for dentistry Equipment 1640:2004 (30.4.2010) C 1641:2009 Dentistry - Medical devices for dentistry - Materials 1641:2004 (30.4.2010) C 1642:2009 Dentistry - Medical devices for dentistry - Dental implants 1642:2004 (30.4.2010) C 1707:1996 17.5.1997 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings C 1782:1998+A1:2009 Tracheal tubes and connectors 1782:1998

7.7.2010 Official Journal of the European Union C 183/17 superseded C 1789:2007 Medical vehicles and their equipment - Road ambulances 23.7.2008 1789:1999 (30.11.2007) This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. C 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified) 1820:2005 C 1865:1999 Specifications for stretchers and other patient handling equipment used in road ambulances C 1970:2000 Adjustable beds for disabled persons - Requirements and test methods 14.10.2000 14.11.2001 1970:2000/A1:2005 30.9.2005 Note 3 (30.9.2005) C 1985:1998 Walking aids - General requirements and test methods 10.8.1999 This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. C ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) C ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006) C ISO 4074:2002 Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) 19.2.2009 27.2.2008 31.7.2002 600:1996 (31.8.2005) ISO 4074:2002/AC:2008 2.12.2009 C ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) C ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004) C ISO 5356-2:2007 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006) 31.7.2002 ISO 4135:1996 30.9.2005 1281-1:1997 9.11.2007 1281-2:1995 (28.2.2002) (30.11.2004) (29.2.2008)

C 183/18 Official Journal of the European Union 7.7.2010 superseded C ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) 23.7.2008 739:1998 (30.6.2010) C ISO 5360:2009 Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006) 2.12.2009 ISO 5360:2007 C ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) 2.12.2009 ISO 5366-1:2004 C ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) 2.12.2009 ISO 5840:2005 C ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) 2.12.2009 ISO 7197:2006 C ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) 2.12.2009 ISO 7376:2009 C ISO 7396-1:2007 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) 9.8.2007 737-3:1998 (30.4.2009) ISO 7396-1:2007/A1:2010 Note 3 31.7.2010 ISO 7396-1:2007/A2:2010 Note 3 31.8.2010 C ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) 9.8.2007 737-2:1998 (30.4.2009) C ISO 7439:2009 Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002) 2.12.2009 ISO 7439:2002 C ISO 7886-3:2009 Sterile hypodermic syringes for single use - Part 3: Autodisable syringes for fixed-dose immunization (ISO 7886-3:2005) ISO 7886-3:2005 C ISO 7886-4:2009 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006) ISO 7886-4:2006

7.7.2010 Official Journal of the European Union C 183/19 superseded C ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) 2.12.2009 ISO 8185:2007 C ISO 8359:2009 Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996) 2.12.2009 ISO 8359:1996 C ISO 8536-4:2007 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007) 9.8.2007 C ISO 8835-2:2009 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) 2.12.2009 ISO 8835-2:2007 C ISO 8835-3:2009 Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) 2.12.2009 ISO 8835-3:2007 C ISO 8835-4:2009 Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) 2.12.2009 ISO 8835-4:2004 C ISO 8835-5:2009 Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) 2.12.2009 ISO 8835-5:2004 C ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) 19.2.2009 737-1:1998 31.7.2010 C ISO 9170-2:2008 Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) 19.2.2009 737-4:1998 31.7.2010 C ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) 2.12.2009 ISO 9360-1:2000 C ISO 9360-2:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) 2.12.2009 ISO 9360-2:2002

C 183/20 Official Journal of the European Union 7.7.2010 superseded C ISO 9713:2009 Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) C ISO 9919:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) C ISO 10079-1:2009 Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999) C ISO 10079-2:2009 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) C ISO 10079-3:2009 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) C ISO 10328:2006 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006) 2.12.2009 ISO 9713:2004 2.12.2009 ISO 9919:2005 2.12.2009 ISO 10079-1:1999 2.12.2009 ISO 10079-2:1999 2.12.2009 ISO 10079-3:1999 9.8.2007 This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. C ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flowmetering devices (ISO 10524-1:2006) C ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) C ISO 10524-3:2006 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) C ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) C ISO 10535:2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) 2.6.2006 738-1:1997 7.6.2009 738-2:1998 7.9.2006 738-3:1998 23.7.2008 738-4:1998 9.8.2007 ISO 10535:1998 (31.10.2008) (31.10.2008) (31.10.2008) (30.6.2010) (30.6.2007) This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.

7.7.2010 Official Journal of the European Union C 183/21 superseded C ISO 10555-1:2009 Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004) 2.12.2009 ISO 10555-1:1996 C ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) 2.12.2009 ISO 10651-2:2004 C ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) 2.12.2009 ISO 10651-4:2002 C ISO 10651-6:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) 2.12.2009 ISO 10651-6:2004 C ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) 2.12.2009 ISO 10993-1:2009 C ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) 2.12.2009 ISO 10993-3:2003 C ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) 2.12.2009 ISO 10993-4:2002 C ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) 2.12.2009 ISO 10993-5:1999 (31.12.2009) C ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) 2.12.2009 ISO 10993-6:2007 C ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) 19.2.2009 ISO 10993-7:2008/AC:2009 C ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) 2.12.2009 ISO 10993-9:2009

C 183/22 Official Journal of the European Union 7.7.2010 superseded C ISO 10993-10:2009 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006) 2.12.2009 ISO 10993-10:2002 C ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) 2.12.2009 ISO 10993-11:2006 C ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) 2.12.2009 ISO 10993-12:2007 C ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) 2.12.2009 ISO 10993-13:1998 C ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) 2.12.2009 ISO 10993-14:2001 C ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) 2.12.2009 ISO 10993-15:2000 C ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) ISO 10993-16:2009 31.8.2010 C ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) 2.12.2009 ISO 10993-17:2002 C ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) 2.12.2009 ISO 10993-18:2005 C ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) 9.8.2007 550:1994 (31.5.2010) C ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) 7.9.2006 552:1994 (30.4.2009)

7.7.2010 Official Journal of the European Union C 183/23 superseded C ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01) 9.8.2007 ISO 11137-2:2007/AC:2009 2.12.2009 C ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) 2.12.2009 ISO 11138-2:2006 C ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) 2.12.2009 ISO 11138-3:2006 C ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) 2.12.2009 ISO 11140-1:2005 C ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) 2.12.2009 ISO 11140-3:2007 C ISO 11197:2009 Medical supply units (ISO 11197:2004) 2.12.2009 ISO 11197:2004 C ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) 2.12.2009 ISO 11607-1:2006 C ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) 7.9.2006 C ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) 7.9.2006 1174-2:1996 1174-1:1996 1174-3:1996 (31.10.2006) ISO 11737-1:2006/AC:2009 2.12.2009 C ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

C 183/24 Official Journal of the European Union 7.7.2010 superseded C ISO 11810-1:2009 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005) C ISO 11810-2:2009 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007) C ISO 11979-8:2009 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006) C ISO 11990:2003 Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) 2.12.2009 2.12.2009 ISO 11810-2:2007 2.12.2009 ISO 11979-8:2006 7.11.2003 ISO 11990:1999 (31.10.2003) C 12006-2:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits 2.12.2009 12006-2:1998 C 12006-3:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices 2.12.2009 12006-3:1998 C 12182:1999 Technical aids for disabled persons - General requirements and test methods 14.10.2000 This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. C 12183:2009 Manual wheelchairs - Requirements and test methods C 12184:2009 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods C 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators 12342:1998 C 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device 2.12.2009 12470-1:2000 C 12470-2:2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers 2.12.2009 12470-2:2000

2024 © homedocbox.com Privacy Policy | Terms of Service | Feedback