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標(biāo)準(zhǔn)組織
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協(xié)調(diào)性標(biāo)準(zhǔn)
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發(fā)布時間
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被替代標(biāo)準(zhǔn)
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被替代標(biāo)準(zhǔn)終止日期
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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
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31/07/2002
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EN 556:1994 + A1:1998
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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
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09/08/2007
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|
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CEN
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EN 1041:2008
Information supplied by the manufacturer of medical devices
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19/02/2009
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EN 1041:1998
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31/08/2011
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CEN
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EN ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
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02/12/2009
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EN ISO 10993-1:2009
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21/03/2010
|
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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)
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02/12/2009
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EN ISO 10993-4:2002
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21/03/2010
|
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CEN
|
EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
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02/12/2009
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EN ISO 10993-5:1999
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31/12/2009
|
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CEN
|
EN ISO 10993-6:2009
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
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02/12/2009
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EN ISO 10993-6:2007
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21/03/2010
|
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CEN
|
EN ISO 10993-7:2008
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
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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)
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02/12/2009
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EN ISO 10993-9:2009
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21/03/2010
|
|
CEN
|
EN ISO 10993-11:2009
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
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02/12/2009
|
EN ISO 10993-11:2006
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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)
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EN ISO 10993-12:2009
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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
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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)
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02/12/2009
|
EN ISO 10993-17:2002
|
Date expired
(21/03/2010)
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CEN
|
EN ISO 10993-18:2009
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
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02/12/2009
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EN ISO 10993-18:2005
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21/03/2010
|
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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)
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09/08/2007
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EN 550:1994
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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)
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07/09/2006
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EN 552:1994
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30/04/2009
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CEN
|
EN ISO 11137-2:2012
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
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30/08/2012
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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
|
EN ISO 11138-2:2006
|
21/03/2010
|
|
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)
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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
|
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)
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02/12/2009
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EN ISO 11607-1:2006
|
21/03/2010
|
|
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)
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07/09/2006
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EN 1174-2:1996
EN 1174-1:1996
EN 1174-3:1996
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31/10/2006
|
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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)
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07/07/2010
|
|
|
|
CEN
|
EN ISO 13408-1:2011
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
|
19/08/2011
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EN 13824:2004
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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
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31/12/2011
|
|
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
|
|
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
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31/12/2011
|
|
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
|
|
CEN
|
EN ISO 13408-6:2011
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
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19/08/2011
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EN 13824:2004
|
31/12/2011
|
|
CEN
|
EN ISO 13485:2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
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30/08/2012
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EN ISO 13485:2003
|
30/08/2012
|
|
CEN
|
EN ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
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27/04/2012
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EN ISO 14155:2011
|
30/04/2012
|
|
CEN
|
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)
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07/07/2010
|
EN ISO 14937:2000
|
21/03/2010
|
|
CEN
|
EN ISO 14971:2012
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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30/08/2012
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EN ISO 14971:2009
|
30/08/2012
|
|
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)
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15/11/2006
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EN 554:1994
|
31/08/2009
|
|
CEN
|
EN 45502-1:1997
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
|
27/08/1998
|
|
|
|
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)
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24/06/2005
|
|
|
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CEN
|
EN 45502-2-3:2010
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
|
07/07/2010
|
|
|
|
Cenelec
|
EN 45502-1:1997
Active implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer
|
27/08/1998
|
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