DS/EN ISO 13004
Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
active, Most Current
| Organization: | DS |
| Publication Date: | 3 July 2023 |
| Status: | active |
| Page Count: | 68 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
Adoption of ISO 13004:2022 - This is currently in FDIS and will be publishing in October 2022. This document describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. NOTE - Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1.
Document History
DS/EN ISO 13004
July 3, 2023
Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022. This document describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5,...