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欧盟有源植入医疗器械指令AIMDD90/385/EEC相关标准
 

欧盟有源植入医疗器械指令AIMDD90/385/EEC相关标准

The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union.
Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.

ESO

Reference and title of the harmonised standard
皇冠篮球比分网(and reference document)

First publication OJ

皇冠篮球比分网Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

CEN

皇冠篮球比分网EN 556-1:2001

皇冠篮球比分网Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

皇冠篮球比分网31/07/2002

EN 556:1994 + A1:1998

Date expired
皇冠篮球比分网(30/04/2002)

EN 556-1:2001/AC:2006

皇冠篮球比分网15/11/2006

CEN

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

CEN

皇冠篮球比分网EN 980:2008

皇冠篮球比分网Symbols for use in the labelling of medical devices

23/07/2008

EN 980:2003

Date expired
(31/05/2010)

CEN

EN 1041:2008

Information supplied by the manufacturer of medical devices

19/02/2009

EN 1041:1998

31/08/2011

CEN

皇冠篮球比分网EN ISO 10993-1:2009

皇冠篮球比分网Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

02/12/2009

EN ISO 10993-1:2009

Date expired
皇冠篮球比分网(21/03/2010)

EN ISO 10993-1:2009/AC:2010 (new)

CEN

皇冠篮球比分网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)

皇冠篮球比分网02/12/2009

EN ISO 10993-4:2002

Date expired
(21/03/2010)

CEN

皇冠篮球比分网EN ISO 10993-5:2009

皇冠篮球比分网Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

02/12/2009

EN ISO 10993-5:1999

Date expired
(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

Date expired
(21/03/2010)

CEN

EN ISO 10993-7:2008

皇冠篮球比分网Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

07/07/2010

EN ISO 10993-7:2008/AC:2009

皇冠篮球比分网07/07/2010

CEN

皇冠篮球比分网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

EN ISO 10993-9:2009

Date expired
皇冠篮球比分网(21/03/2010)

CEN

EN ISO 10993-11:2009

皇冠篮球比分网Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

皇冠篮球比分网02/12/2009

EN ISO 10993-11:2006

Date expired
(21/03/2010)

CEN

皇冠篮球比分网EN ISO 10993-12:2009

皇冠篮球比分网Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

皇冠篮球比分网02/12/2009

EN ISO 10993-12:2007

Date expired
(21/03/2010)

CEN

EN ISO 10993-13:2010 (new)

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

EN ISO 10993-13:2009

皇冠篮球比分网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

Date expired
皇冠篮球比分网(31/08/2010)

CEN

EN ISO 10993-17:2009

皇冠篮球比分网Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

02/12/2009

EN ISO 10993-17:2002

Date expired
(21/03/2010)

CEN

EN ISO 10993-18:2009

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

02/12/2009

EN ISO 10993-18:2005

Date expired
皇冠篮球比分网(21/03/2010)

CEN

皇冠篮球比分网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)

皇冠篮球比分网09/08/2007

EN 550:1994

Date expired
(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)

皇冠篮球比分网07/09/2006

EN 552:1994

Date expired
(30/04/2009)

CEN

皇冠篮球比分网EN 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)

皇冠篮球比分网09/08/2007

EN ISO 11137-2:2007/AC:2009

02/12/2009

CEN

EN ISO 11138-2:2009

皇冠篮球比分网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

Date expired
(21/03/2010)

CEN

皇冠篮球比分网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

EN ISO 11138-3:2006

Date expired
皇冠篮球比分网(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

Date expired
(21/03/2010)

CEN

EN ISO 11607-1:2009

皇冠篮球比分网Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

02/12/2009

EN ISO 11607-1:2006

Date expired
(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)

皇冠篮球比分网07/09/2006

EN 1174-2:1996
EN 1174-1:1996
EN 1174-3:1996


Date expired
皇冠篮球比分网(31/10/2006)

皇冠篮球比分网EN ISO 11737-1:2006/AC:2009

02/12/2009

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

CEN

EN ISO 13485:2003

皇冠篮球比分网Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

02/04/2004

EN ISO 13488:2000
EN ISO 13485:2000


Date expired
(31/07/2009)

皇冠篮球比分网EN ISO 13485:2003/AC:2009

皇冠篮球比分网07/07/2010

CEN

EN 13824:2004

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

24/06/2005

CEN

皇冠篮球比分网EN ISO 14155-1:2009

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

07/07/2010

EN ISO 14155-1:2003

Date expired
(21/03/2010)

CEN

EN ISO 14155-2:2009

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

皇冠篮球比分网07/07/2010

EN ISO 14155-2:2003

Date expired
(21/03/2010)

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)

07/07/2010

EN ISO 14937:2000

Date expired
(21/03/2010)

CEN

EN ISO 14971:2009

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

07/07/2010

EN ISO 14971:2007

Date expired
皇冠篮球比分网(21/03/2010)

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

EN 554:1994

Date expired
(31/08/2009)

CEN

皇冠篮球比分网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

皇冠篮球比分网EN 45502-2-1:2004

皇冠篮球比分网Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

24/06/2005

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

皇冠篮球比分网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

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 45502-2-1:2003

皇冠篮球比分网Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

08/07/2004

皇冠篮球比分网(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

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

EN 45502-2-2:2008/AC:2009 (new)

皇冠篮球比分网(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 45502-2-3:2010 (new)

Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

皇冠篮球比分网(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1:1990

Medical electrical equipment -- Part 1: General requirements for safety
IEC 60601-1:1988

23/08/1996

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

23/08/1996

The date of this publication
()

EN 60601-1:1990/A2:1995
皇冠篮球比分网IEC 60601-1:1988/A2:1995

23/08/1996

The date of this publication
()

EN 60601-1:1990/AC:1994 (new)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1:2006

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
皇冠篮球比分网IEC 60601-1:2005

皇冠篮球比分网27/11/2008

EN 60601-1:1990
and its amendments

皇冠篮球比分网01/06/2012

EN 60601-1:2006/AC:2010 (new)

(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 60601-1-6:2010 (new)

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
皇冠篮球比分网IEC 60601-1-6:2010

皇冠篮球比分网(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Cenelec

EN 62304:2006

Medical device software - Software life-cycle processes
皇冠篮球比分网IEC 62304:2006

皇冠篮球比分网27/11/2008

EN 62304:2006/AC:2008 (new)

皇冠篮球比分网(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

(1) ESO皇冠篮球比分网: European Standardisation Organisation:

CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

皇冠篮球比分网CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.org)

皇冠篮球比分网ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

Note 2.1:皇冠篮球比分网 The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

Note 3:皇冠篮球比分网 In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

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