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AAMI/ISO 11137-1:2006/(R)2015 & A1:2003 & 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, Includes A1:2013 & A2:2019

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 12/30/2013

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Full Description

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.
 

Product Details

Published:
12/30/2013
ISBN(s):
9781570202532
ANSI:
ANSI Approved
Number of Pages:
54
File Size:
1 file , 450 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 11137-1:2006/(R)2015 & A1:2003 & A2:2019 (Consolidated Text)

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    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019

    • Most Recent

  2. AAMI/ISO 11137-1:2006/(R)2010


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

    • Historical Version

  3. AAMI/ISO 11137:1994 + Amendment 1


    Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization, 3ed.

    • Historical Version

  4. AAMI TIR 15843


    Sterilization of health care products-Radiation sterilization-Product families, sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits

    • Historical Version

  5. AAMI ST1137-94


    Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. 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