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Norm
ÖNORM EN ISO 11737-2
Issue date: 2000 07 01
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998)
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 ...
Withdrawn: 2010 04 01
Publisher:
Austrian Standards International
Format:
Digital | 19 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
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:
a) sterility testing for routine release of product that has been subjected to a sterilization process;
b) performance of a pharmacopoeial test for sterility; or
NOTE 1 The performance of a) or b) above is not a requirement of ISO 11134, 11135 or 11137.
c) culturing of biological indicators, including inoculated products.
NOTE 2 Methods of culturing biological indicators are described in ISO 11138.
ÖNORM EN ISO 11737-2
2020 06 15
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility perform...
Norm
ÖNORM EN ISO 11737-2
2010 04 01
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in...
Norm
ÖNORM EN ISO 11737-2
2000 07 01
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in...
Norm
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Issue date :
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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 (ISO 11737-2:2009)
Norm
Issue date :
1998 07 09
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process
