Name:
DANSK DS/EN ISO 13004 PDF
Published Date:
07/03/2023
Status:
[ Active ]
Publisher:
Dansk Standard
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.
| Edition : | 23# |
| File Size : | 1 file , 1.7 MB |
| Number of Pages : | 68 |
| Product Code(s) : | DS-061, DS-061 |
| Published : | 07/03/2023 |
