DSF/EN ISO 11137-1/FprA1
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/FDAM 1:2013)
pending
| Organization: | DS |
| Status: | pending |
| Page Count: | 16 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
| ICS Code (Other standards related to sterilization and disinfection): | 11.080.99 |
scope:
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This part of ISO 11137 covers radiation processes employing irradiators using, a) the radionuclide 60Co or 137Cs, b) a beam from an electron generator or c) a beam from an X-ray generator.
Document History
November 25, 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)
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited...
July 6, 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)
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited...
August 29, 2013
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO...
August 14, 2006
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO...
Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE – Although the scope of this document is...
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/FDAM 2:2018)
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited...
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.1:2012)
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO...
DSF/EN ISO 11137-1/FprA1
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/FDAM 1:2013)
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO...