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DANSK DS/EN ISO 11137-2/A1 [ Active ]

Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

Amendment by Dansk Standard , 04/24/2023

This document is an amendment. View the base document.

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Full Description

SAME AS ISO 11137-2

This part of ISO 11137 specifies methods of 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. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.

 

Product Details

Edition:
15#
Published:
04/24/2023
Number of Pages:
18
File Size:
1 file , 1.2 MB
Product Code(s):
DS-017, DS-017