UNI EN ISO 13004:2023
Current
Current
The latest, up-to-date edition.
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
Published date
27-07-2023
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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 |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 13004:2023 | Identical |
| ISO 13004:2022 | Identical |
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