SS-EN ISO 13004:2023
Current
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
Hardcopy
English
07-04-2023
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.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
68
|
| PublisherName |
Standardiserings-Kommissionen I Sverige
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 13004:2023 | Identical |
| ISO 13004:2022 | Identical |
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