
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)
出版:National Standards Authority of Ireland

专家解读视频
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
EN ISO 11137-1:2015/A2:2019 - Identical
EN ISO 11137-1 : 2015 - Identical
ISO 11137-1:2006(R2016) - Identical