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)

Standard No.

EN ISO 11137-1:2015/A2:2019

Release Date

2019

Published By

European Committee for Standardization (CEN)

Status

Withdraw 2020-05

Latest

EN ISO 11137-1:2015/A2:2019

Replace By

prEN ISO 11137-1

EN ISO 11137-1:2015/A2:2019 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for development, validation and routine control of a sterilization process for medical devices ISO 11137-1:2006;:1994 [Superseded: CEN EN 552]