ÖNORM EN ISO 13004:2023 11 01
Current
The latest, up-to-date edition.
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmax SD (ISO 13004:2022
Hardcopy
German - English
01-11-2023
This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy 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 |
72
|
PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
Status |
Current
|
Supersedes |
Standards | Relationship |
EN ISO 13004:2023 | Identical |
ISO 13004:2022 | Identical |
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