ANSI AAMI ISO 11137-1-2006 (R2019)

Category: Technical


Posted on 2020-09-14, by banz.

Description

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

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.

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