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ÖNORM EN ISO 13004:2023 11 01

Current

Current

The latest, up-to-date edition.

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmax SD (ISO 13004:2022

Available format(s)

Hardcopy

Language(s)

German - English

Published date

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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