SR EN ISO 11737-2:2010

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)

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.

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General information

Status : Withdrawn
Approval date : 4/30/2010
Publish date : 5/2/2010
Withdrawal date : 6/30/2020
Number of pages : 26
ICS : 07.100.10 Medical microbiology,11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 11737-2:2002
Normative reference SR EN ISO 13485:2004
Normative reference SR EN ISO/CEI 17025:2005
Normative reference SR EN ISO 13485:2004/AC:2010
Normative reference SR EN ISO 11737-1:2006/AC:2009
Normative reference SR EN ISO/CEI 17025:2005/AC:2007
Normative reference SR EN ISO 11737-1:2006
Normative reference SR EN ISO 10012:2004
Replaced by SR EN ISO 11737-2:2020