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IVDD指令协调标准清单

ESO?(1)

Reference and title of the standard?
(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard?
Note 1

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

31/07/2002

EN 556:1994 + A1:1998

Note 2.1

Date expired
(30/04/2002)

EN 556-1:2001/AC:2006

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

EN 980:2008

Symbols for use in the labelling of medical devices

23/07/2008

EN 980:2003

Note 2.1

Date expired
(31/05/2010)

CEN

EN ISO 11137-2:2013

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

16/01/2015

EN ISO 11137-2:2012

Note 2.1

Date expired
(30/11/2014)

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 12322:1999

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

09/10/1999

 

 

EN 12322:1999/A1:2001

31/07/2002

Note 3

Date expired
(30/04/2002)

CEN

EN ISO 13408-1:2011

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)

19/08/2011

 

 

EN ISO 13408-1:2011/A1:2013

16/01/2015

Note 3

Date expired
(30/11/2014)

CEN

EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

19/08/2011

 

 

CEN

EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

19/08/2011

 

 

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

 

 

CEN

EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

19/08/2011

 

 

CEN

EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

19/08/2011

 

 

CEN

EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

30/08/2012

EN ISO 13485:2003

Note 2.1

Date expired
(31/08/2012)

EN ISO 13485:2012/AC:2012

30/08/2012

 

 

CEN

EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

17/12/2002

 

 

CEN

EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

17/12/2002

 

 

EN 13612:2002/AC:2002

02/12/2009

 

 

CEN

EN 13640:2002

Stability testing of in vitro diagnostic reagents

17/12/2002

 

 

CEN

EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

17/12/2002

 

 

CEN

EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

21/11/2003

 

 

CEN

EN 14136:2004

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

15/11/2006

 

 

CEN

EN 14254:2004

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

28/04/2005

 

 

CEN

EN 14820:2004

Single-use containers for human venous blood specimen collection

28/04/2005

 

 

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

Note 2.1

Date expired
(30/04/2010)

CEN

EN ISO 14971:2012

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

30/08/2012

EN ISO 14971:2009

Note 2.1

Date expired
(30/08/2012)

CEN

EN ISO 15193:2009

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

07/07/2010

 

 

CEN

EN ISO 15194:2009

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

07/07/2010

 

 

CEN

EN ISO 15197:2003

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

28/04/2005

 

 

EN ISO 15197:2003/AC:2005

02/12/2009

 

 

CEN

EN ISO 17511:2003

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

28/04/2005

 

 

 

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