EN ISO 11137-1:2006/A1:2013
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/Amd 1:2013)

Standard No.
EN ISO 11137-1:2006/A1:2013
Release Date
2013
Published By
European Committee for Standardization (CEN)
Status
Replace By
EN ISO 11137-1:2015
Latest
EN ISO 11137-1:2015/A2:2019
Replace
EN ISO 11137-1/FprA1:2013

EN ISO 11137-1:2006/A1:2013 Referenced Document

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

EN ISO 11137-1:2006/A1:2013 history

  • 2019 EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
  • 2015 EN ISO 11137-1:2015 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, including Amd 1:2013)
  • 2013 EN ISO 11137-1:2006/A1:2013 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/Amd 1:2013)
  • 2006 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for development, validation and routine control of a sterilization process for medical devices ISO 11137-1:2006;:1994 [Superseded: CEN EN 552]



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