European Standards Organisation (1) Reference and title of the harmonised standard (and reference document) First publication in the Official Journal Reference of superseded standard Date of cessation of presumption of conformity of superseded standard Note 1

CEN EN 556-1:2001 Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilised medical devices 31.7.2002 EN 556:1994 + A1:1998 Note 2.1 Date expired (30.4.2002)

EN 556-1:2001/AC:2006 15.11.2006

CEN EN 556-2:2003 Sterilisation of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices 9.8.2007

CEN EN 980:2008 Symbols for use in the labelling of medical devices 23.7.2008 EN 980:2003 Note 2.1 31.5.2010

CEN EN 1041:2008 Information supplied by the manufacturer of medical devices 19.2.2009 EN 1041:1998 Note 2.1 31.8.2011

CEN EN ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) This is the first publication EN ISO 10993-1:2003 Note 2.1 21.3.2010

CEN EN 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) This is the first publication EN ISO 10993-4:2002 Note 2.1 21.3.2010

CEN EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) This is the first publication EN ISO 10993-5:1999 Note 2.1 31.12.2009

CEN EN ISO 10993-6:2009 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:2007) This is the first publication EN ISO 10993-6:2007 Note 2.1 21.3.2010

CEN EN ISO 10993-9:2009 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) This is the first publication EN ISO 10993-9:1999 Note 2.1 21.3.2010

CEN EN 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) This is the first publication EN ISO 10993-10:2002 Note 2.1 21.3.2010

CEN EN ISO 10993-11:2009 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006) This is the first publication EN ISO 10993-11:2006 Note 2.1 21.3.2010

CEN EN ISO 10993-12:2009 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2007) This is the first publication EN ISO 10993-12:2007 Note 2.1 21.3.2010

CEN EN 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) This is the first publication EN ISO 10993-13:1998 Note 2.1 21.3.2010

CEN EN ISO 10993-16:2009 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) This is the first publication EN ISO 10993-16:1997 Note 2.1 21.3.2010

CEN EN ISO 10993-17:2009 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) This is the first publication EN ISO 10993-17:2002 Note 2.1 21.3.2010

CEN EN ISO 10993-18:2009 Biological evaluation of medical devices — Part 18: Chemical characterisation of materials (ISO 10993-18:2005) This is the first publication EN ISO 10993-18:2005 Note 2.1 21.3.2010

CEN EN ISO 11135-1:2007 Sterilisation of healthcare products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11135-1:2007) 9.8.2007 EN 550:1994 Note 2.1 31.5.2010

CEN EN ISO 11137-1:2006 Sterilisation of healthcare products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006) 7.9.2006 EN 552:1994 Note 2.1 Date expired (30.4.2009)

CEN EN ISO 11137-2:2007 Sterilisation of healthcare products — Radiation — Part 2: Establishing the sterilisation dose (ISO 11137-2:2006, corrected version 2006-08-01) 9.8.2007

EN ISO 11137-2:2007/AC:2009 This is the first publication

CEN EN ISO 11138-2:2009 Sterilisation of healthcare products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilisation processes (ISO 11138-2:2006) This is the first publication EN ISO 11138-2:2006 Note 2.1 21.3.2010

CEN EN ISO 11138-3:2009 Sterilisation of healthcare products — Biological indicators — Part 3: Biological indicators for moist heat sterilisation processes (ISO 11138-3:2006) This is the first publication EN ISO 11138-3:2006 Note 2.1 21.3.2010

CEN EN ISO 11140-1:2009 Sterilisation of healthcare products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005) This is the first publication EN ISO 11140-1:2005 Note 2.1 21.3.2010

CEN EN ISO 11607-1:2009 Packaging for terminally sterilised medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) This is the first publication EN ISO 11607-1:2006 Note 2.1 21.3.2010

CEN EN ISO 11737-1:2006 Sterilisation of medical devices — Microbiological methods — Part 1: Determination of a population of micro-organisms on products (ISO 11737-1:2006) 7.9.2006 EN 1174-2:1996 EN 1174-1:1996 EN 1174-3:1996 Note 2.1 Date expired (31.10.2006)

EN ISO 11737-1:2006/AC:2009 This is the first publication

CEN EN ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) 2.4.2004 EN ISO 13488:2000 EN ISO 13485:2000 Note 2.1 Date expired (31.7.2009)

EN ISO 13485:2003/AC:2007 9.8.2007

CEN EN 13824:2004 Sterilisation of medical devices — Aseptic processing of liquid medical devices — Requirements 24.6.2005

CEN EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) 11.11.2003 EN 540:1993 Note 2.1 Date expired (31.8.2003)

CEN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) 11.11.2003

CEN EN ISO 14937:2000 Sterilisation of healthcare products — General requirements for characterisation of a sterilising agent and the development, validation and routine control of a sterilisation process for medical devices (ISO 14937:2000) 31.7.2002

EN ISO 14937:2000/AC:2005 This is the first publication

CEN EN ISO 14971:2007 Medical devices — Application of risk management to medical devices (ISO 14971:2007) 9.8.2007 EN ISO 14971:2000 Note 2.1 31.3.2010

CEN EN ISO 17665-1:2006 Sterilisation of healthcare products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilisation process for medical devices (ISO 17665-1:2006) 15.11.2006 EN 554:1994 Note 2.1 Date expired (31.8.2009)

CEN EN 45502-1:1997 Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer 27.8.1998

CEN EN 45502-2-1:2004 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) 24.6.2005

Cenelec EN 45502-1:1997 Active implantable medical devices — Part 1: General requirements for safety, marking and information to be provided by the manufacturer 27.8.1998

Cenelec EN 45502-2-1:2003 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) 8.7.2004

Cenelec EN 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) 27.11.2008

Cenelec EN 60601-1:1990 Medical electrical equipment — Part 1: General requirements for safety IEC 60601-1:1988 23.8.1996

EN 60601-1:1990/A1:1993 IEC 60601-1:1988/A1:1991 23.8.1996 Note 3

EN 60601-1:1990/A2:1995 IEC 60601-1:1988/A2:1995 23.8.1996 Note 3

Cenelec EN 60601-1:2006 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 27.11.2008 EN 60601-1:1990 and its amendments Note 2.1