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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)
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1.1 This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent 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. 1.2 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) performing a test for sterility (see 3.12); NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or ISO 17665-1. c) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 14161[8].
To find similar documents by classification:
07.100.10 (Medical microbiology Laboratory medicine, see 11.100)
11.080 (Sterilization and disinfection)
Active implantable medical devices. Medical devices. In vitro diagnostic medical devices
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Designation Name
SS-EN ISO 11737-2:2009
Revision Level
2009 EDITION
Status
Superseded
Publication Date
Nov. 30, 2009
Language(s)
English
Page Count
32
International Equivalent
EN ISO 11737-2:2009(IDT); ISO 11737-2:2009(IDT)