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 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 to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
| SDO | ISO: International Organization for Standardization |
| Document Number | ISO 11137 |
| Publication Date | Not Available |
| Language | en - English |
| Page Count | |
| Revision Level | |
| Supercedes | |
| Committee | ISO/TC 198 |