BS EN 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.

BS EN ISO 11737-2:2009 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].



Cross References:
ISO 10012
ISO 11737-1:2006
ISO 13485:2003
ISO/IEC 17025:2005
ISO 11135-1
ISO/TS 11135-2
ISO 11137-1
ISO 11137-2
ISO 11138-2
ISO/TS 11139:2006
ISO 14160
ISO 14161
ISO 14644-1
ISO 14644-4
ISO 14644-7
ISO 14937
ISO 17665-1
ISO 20857
ISO 9000:2005
ISO 9001:2008
ISO 90003
90/385/EEC
93/42/EEC
98/79/EC


All current amendments available at time of purchase are included with the purchase of this document.