|
ESO
|
Reference and title of the harmonised standard
(and reference document) |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard
|
|
CEN |
EN 556-1:2001
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
EN 556:1994 + A1:1998 |
Date expired
(30.04.2002) |
|
|
EN 556-1:2001/AC: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 |
— |
|
|
CEN |
EN 980:2008
Symbols for use in the labelling of medical devices |
EN 980:2003 |
31.05.2010 |
|
CEN |
EN 1041:2008
Information supplied by the manufacturer of medical devices |
EN 1041:1998 |
31.08.2011 |
|
CEN |
EN ISO 10993-1:2003
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003) |
— |
|
|
CEN |
EN ISO 10993-4:2002
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) |
EN 30993-4:1993 |
Date expired
(30.04.2003) |
|
|
EN ISO 10993-4:2002/A1:2006 |
Note 3 |
Date expired
(31.01.2007) |
|
CEN |
EN ISO 10993-5:1999
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) |
EN 30993-5:1994 |
Date expired
(30.11.1999) |
|
CEN |
EN ISO 10993-6:2007
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
EN 30993-6:1994 |
Date expired
(31.10.2007) |
|
CEN |
EN ISO 10993-9:1999
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) |
— |
|
|
CEN |
EN ISO 10993-10:2002
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) |
EN ISO 10993-10:1995 |
Date expired
(31.03.2003) |
|
|
EN ISO 10993-10:2002/A1:2006 |
Note 3 |
Date expired
(31.01.2007) |
|
CEN |
EN ISO 10993-11:2006
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
EN ISO 10993-11:1995 |
Date expired
(28.02.2007) |
|
CEN |
EN ISO 10993-12:2007
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) |
EN ISO 10993-12:2004 |
Date expired
(31.05.2008) |
|
CEN |
EN ISO 10993-13:1998
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) |
— |
|
|
CEN |
EN ISO 10993-16:1997
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) |
— |
|
|
CEN |
EN ISO 10993-17:2002
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
— |
|
|
CEN |
EN ISO 10993-18:2005
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
— |
|
|
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) |
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) |
EN 552:1994 |
30.04.2009 |
|
CEN |
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) |
— |
|
|
CEN |
EN ISO 11138-2:2006
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
— |
|
|
CEN |
EN ISO 11138-3:2006
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
— |
|
|
CEN |
EN ISO 11140-1:2005
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) |
— |
|
|
CEN |
EN ISO 11607-1:2006
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
EN 868-1:1997 |
Date expired
(30.04.2007) |
|
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) |
EN 1174-1:1996
EN 1174-2:1996
EN 1174-3:1996 |
Date expired
(31.10.2006) |
|
CEN |
EN ISO 13485:2003
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) |
EN ISO 13485:2000
EN ISO 13488:2000 |
31.07.2009 |
|
|
EN ISO 13485:2003/AC:2007 |
|
|
|
CEN |
EN 13824:2004
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements |
— |
|
|
CEN |
EN ISO 14155-1:2003
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
EN 540:1993 |
Date expired
(31.08.2003) |
|
CEN |
EN ISO 14155-2:2003
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
— |
|
|
CEN |
EN ISO 14937:2000
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 14937:2000) |
— |
|
|
CEN |
EN ISO 14971:2007
Medical devices - Application of risk management to medical devices (ISO 14971:2007) |
EN ISO 14971:2000 |
31.03.2010 |
|
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) |
EN 554:1994 |
31.08.2009 |
|
CEN/CENELEC |
EN 45502-1:1997
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
— |
|
|
CEN/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) |
— |
|
|
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) |
— |
|
| CENELEC |
EN 60601-1:1990
Medical electrical equipment -- Part 1: General requirements for safety
(IEC 60601-1:1988) |
_ |
_ |
| |
Amendment A1:1993 to EN 60601-1:1990
(IEC 60601-1:1988/A1:1991) |
Note 3 |
_ |
| |
Amendment A2:1995 to EN 60601-1:1990
(IEC 60601-1:1988/A2:1995) |
Note 3 |
_ |
| CENELEC |
EN 60601-1:2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
(IEC 60601-1:2005) |
EN 60601-1:1990
and its amendments
Note 2.1 |
_ |
| CENELEC |
EN 62304:2006
Medical device software - Software life-cycle processes
(IEC 62304:2006) |
_ |
_ |
