设为首页
您现在的位置: 首页 / 行业动态 / 行业资讯
  行业动态
 
 
行业资讯

 

AIMD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Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard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 1041:2008

Information supplied by the manufacturer of medical devices

19/02/2009

EN 1041:1998

Note 2.1

Date expired
(31/08/2011)

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

EN ISO 10993-1:2009

Note 2.1

Date expired
(21/03/2010)

EN ISO 10993-1:2009/AC:2010

18/01/2011

 

 

CEN

EN ISO 10993-3:2014?(new)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

This is the first publication

 

 

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

EN ISO 10993-4:2002

Note 2.1

Date expired
(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

EN ISO 10993-5:1999

Note 2.1

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

Note 2.1

Date expired
(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

 

 

EN ISO 10993-7:2008/AC:2009

07/07/2010

 

 

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

EN ISO 10993-9:2009

Note 2.1

Date expired
(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

Note 2.1

Date expired
(21/03/2010)

CEN

EN ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

24/01/2013

EN ISO 10993-12:2009

Note 2.1

Date expired
(31/01/2013)

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

Note 2.1

Date expired
(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

Note 2.1

Date expired
(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

EN ISO 10993-17:2002

Note 2.1

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

Note 2.1

Date expired
(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

Note 2.1

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)

07/09/2006

EN 552:1994

Note 2.1

Date expired
(30/04/2009)

EN ISO 11137-1:2006/A1:2013

16/01/2015

Note 3

Date expired
(31/01/2014)

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
(31/12/2013)

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

Note 2.1

Date expired
(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)

02/12/2009

EN ISO 11138-3:2006

Note 2.1

Date expired
(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

Note 2.1

Date expired
(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

EN ISO 11607-1:2006

Note 2.1

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)

07/09/2006

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


Note 2.1

Date expired
(31/10/2006)

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

 

 

 

首 页  1 2 尾 页  第1页  共2页


首页关于我们认证注册培训辅导管理优化行业动态成功案例联系我们
电话:0755-86069197 邮箱:info@cefda.com
版权所有 深圳市卓远天成咨询有限公司 粤ICP备10081024号-2