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ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 (Consolidated Text)
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
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Summary
This document specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products. It applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or X-ray generator. Annex 2
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2006 |
| Confirmation Date | 01/01/2015 |
| Page Count | 0 |
| Themes | Sterilization—Industrial |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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