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ÖNORM EN ISO 11137-2:2023 10 01

Current

Current

The latest, up-to-date edition.

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Available format(s)

Hardcopy

Language(s)

German - English

Published date

10-01-2023

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10^(-6).

Committee
ISO/TC 198
DevelopmentNote
New child “AMD 1 2023” is now added
DocumentType
Standard
Pages
102
ProductNote
New child “AMD 1 2023” is now added
PublisherName
Osterreichisches Normungsinstitut/Austrian Standards
Status
Current
Supersedes

Standards Relationship
ISO 11137-2:2013 Identical
EN ISO 11137-2:2015 Identical

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