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Norm
ÖNORM EN ISO 11737-2
Issue date: 2020 06 15
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been red...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 38 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process,
b) performing a test for sterility,
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
d) culturing of biological indicators or inoculated products.
ÖNORM EN ISO 11737-2
2020 06 15
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility perform...
Norm
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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
Norm
ISO 11737-2:2019
Issue date :
2019 12 02
Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process