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嘉峪检测网 2015-04-04 23:46
有源植入性医疗器械指令协调标准约60多项(官网链接)，详见下表：
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标准组织 |
协调性标准 |
发布时间 |
被替代标准 |
被替代标准终止日期 |
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CEN
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EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
31/07/2002
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EN 556:1994 + A1:1998 |
30/04/2002 |
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CEN
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EN 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
09/08/2007
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CEN |
EN 1041:2008 Information supplied by the manufacturer of medical devices
|
19/02/2009
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EN 1041:1998 |
31/08/2011 |
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CEN |
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
|
02/12/2009
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EN ISO 10993-1:2009 |
21/03/2010 |
|
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)
|
02/12/2009
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EN ISO 10993-4:2002 |
21/03/2010 |
|
CEN |
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
|
02/12/2009
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EN ISO 10993-5:1999 |
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)
|
02/12/2009
|
EN ISO 10993-6:2007 |
21/03/2010 |
|
CEN |
EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
|
07/07/2010
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|
CEN |
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
|
02/12/2009
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EN ISO 10993-9:2009 |
21/03/2010 |
|
CEN |
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
|
02/12/2009
|
EN ISO 10993-11:2006 |
21/03/2010 |
|
CEN |
EN ISO 10993-12:2012 (new) Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
|
|
EN ISO 10993-12:2009 |
31/01/2013
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|
CEN |
EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
|
18/01/2011
|
EN ISO 10993-13:2009 |
31/12/2010 |
|
CEN |
EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
|
07/07/2010
|
EN ISO 10993-16:2009 |
31/08/2010 |
|
CEN |
EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
|
02/12/2009
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EN ISO 10993-17:2002 |
Date expired
|
|
CEN |
EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
|
02/12/2009
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EN ISO 10993-18:2005 |
21/03/2010 |
|
CEN |
EN 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)
|
09/08/2007
|
EN 550:1994 |
31/05/2010 |
|
CEN |
EN 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)
|
07/09/2006
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EN 552:1994 |
30/04/2009 |
|
CEN |
EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
|
30/08/2012
|
EN ISO 11137-2:2007 |
30/09/2012 |
|
CEN |
EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
|
02/12/2009
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EN ISO 11138-2:2006 |
21/03/2010 |
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CEN |
EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
|
02/12/2009
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EN ISO 11138-3:2006 |
21/03/2010 |
|
CEN |
EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
|
02/12/2009
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EN ISO 11140-1:2005 |
21/03/2010 |
|
CEN |
EN 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)
|
02/12/2009
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EN ISO 11607-1:2006 |
21/03/2010 |
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CEN
|
EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
|
07/09/2006
|
EN 1174-2:1996 |
31/10/2006 |
|
CEN
|
EN 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)
|
07/07/2010
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|
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|
CEN
|
EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
|
19/08/2011 |
EN 13824:2004 |
31/12/2011 |
|
CEN
|
EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
|
19/08/2011
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EN 13824:2004 |
31/12/2011 |
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CEN
|
EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
|
19/08/2011
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EN 13824:2004 |
31/12/2011 |
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CEN
|
EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
|
19/08/2011
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EN 13824:2004 |
31/12/2011 |
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CEN
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EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
|
19/08/2011
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EN 13824:2004 |
31/12/2011 |
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CEN
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EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
|
19/08/2011
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EN 13824:2004 |
31/12/2011 |
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CEN
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EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
|
30/08/2012
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EN ISO 13485:2003 |
30/08/2012 |
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CEN
|
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
|
27/04/2012
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EN ISO 14155:2011 |
30/04/2012 |
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CEN
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EN 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)
|
07/07/2010
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EN ISO 14937:2000 |
21/03/2010 |
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CEN
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EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
|
30/08/2012
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EN ISO 14971:2009 |
30/08/2012 |
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CEN
|
EN 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)
|
15/11/2006
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EN 554:1994 |
31/08/2009 |
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CEN
|
EN 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
|
27/08/1998
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CEN
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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)
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24/06/2005
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CEN
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EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
|
07/07/2010
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Cenelec
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EN 45502-1:1997 Active implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer
|
27/08/1998 |
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