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ISO 11737-2:1998

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

Pages: 13
Publication date: 1998-07-01
Price: Contact

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This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which 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 validating a sterilization process.This part of ISO 11737 is not applicable to:sterility testing for routine release of product that has been subjected to a sterilization process;performance of a pharmacopoeial test for sterility; orculturing of biological indicators, including inoculated products.
Document identifier
ISO 11737-2:1998
Title
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process
ISO Category
TC 198/WG 8: Microbiological methods
Publication date
1998-07-01
Status
Ineffective
International Relationship
Cross references
Latest version
ISO 11737-2:2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Document identifier ISO 11737-2:2009
Publication date 2009-11-15
Classification 07.100.10. Medical microbiology
11.080.01. Sterilization and disinfection in general
Status Effective
*
History of version
ISO 11737-2:2009*ISO 11737-2:1998 * ISO 11737-2:2009 * ISO 11737-2:1998
Keywords
Classification
07.100.10. Medical microbiology
11.080.01. Sterilization and disinfection in general
Pages
13
Price Contact

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