ANSI/AAMI/ISO 11137-3:2017/(R)2023
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ANSI/AAMI/ISO 11137-3:2017/(R)2023

Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control

Summary

Guidance on dosimetry for radiation sterilization of health care products. Requirements in regard to dosimetry are given in ISO 11137-1 and ISO 11137-2 and ISO/TS 13004. This document gives guidance to these requirements. The guidance given is not normative and is not provided as a checklist for auditors. The guidance provides explanations and methods that are regarded as being suitable means for complying with the requirements. Methods other than those given in the guidance may be used, if they are effective in achieving compliance with the requirements of ISO 11137-1, ISO 11137-2 and ISO/TS 13004. Annex 2

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2017
Confirmation Date 01/01/2023
Page Count 0
Themes Sterilization—Industrial
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ISBN ---
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