BS EN ISO 11737-2:2009

BS EN ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that havebeen exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routinesterilization processing. These tests are intended to be performed when defining, validating or maintaining asterilization 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 orISO 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.



Keywords: Sterile equipment; Sterilization (hygiene); Medical equipment; Microbiological analysis; Process control; Approval testing; Biological analysis and testing; Microbiology; Assessed reliability; Test equipment ; Samples; Specimen preparation

Product Code(s): 30157770,30157770

This product references:ISO 11737-1:2006 - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 9001:2008 - Quality management systems -- Requirements
ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories
ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
This product replaces:BS EN ISO 11737-2:2000 - Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the validation of a sterilization process
This product same asISO 11737-2:2009 - Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process