Std

AAMI TIR 8-91

Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices

standard by Association for the Advancement of Medical Instrumentation , 07/01/1991

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Full Description

This document outlines proper microbiological methods for obtaining data necessary to control the manufacture and sterilization of medical devices. Subjects addressed in this document include the sampling of devices, the concept of sample item portion (SIP), media preparation, bioburden methods, sterility test methods for validation, validation of bioburden and sterility test methods, and environmental control and monitoring.
 

Product Details

Published:
07/01/1991
ISBN(s):
0910275602
Number of Pages:
21
File Size:
1 file , 1.2 MB
Note:
This product is unavailable in Russia, Ukraine, 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

    • Most Recent

  2. 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

    • 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

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    Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices

    • Historical Version