2077373

AAMI/ISO 11137-1:2006/(R)2015 A2:2019

A2:2019 to Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

Amendment by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 05/01/2019

This document is an amendment. View the base document.

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4.3.4 Add the following sentence to the end of the clause: Detailed guidance on dosimetry and associated measurement uncertainty is given in ISO 11137-3. 11.2 Replace the second sentence with the following: The procedure(s) shall define the requirements (see 9.4.3 or 9.4.4 as appropriate) for designating a sterilization process as conforming.
 

Product Details

Published:
05/01/2019
ISBN(s):
9781570207174
ANSI:
ANSI Approved
Number of Pages:
11
File Size:
1 file , 260 KB
Note:
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