BAS EN ISO 11737-2:2011
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
General Information
Status: Withdrawn
No. of pages: 22
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 12.05.2011
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
...
Abstract
ISO 11737-2:2009 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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 11737-2:2009, identical
- ISO 11737-2:2009, identical