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AAMI/ISO 11737-2:2009/(R)2014

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 11/10/2009

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Full Description

AAMI/ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
 

Product Details

Published:
11/10/2009
ISBN(s):
1570203725
Number of Pages:
31
File Size:
1 file , 220 KB
Part of:
AAMI STBK10-3
Same As:
ISO 11737-2:2009
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 11737-2: 2019


    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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  2. AAMI/ISO 11737-2:2009/(R)2014

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    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

    • Historical Version

  3. AAMI 11737-2


    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

    • Historical Version

  4. AAMI TIR 8-91


    Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices

    • Historical Version