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CEN - EN ISO 11737-2

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

active, Most Current
Organization: CEN
Publication Date: 1 November 2009
Status: active
Page Count: 28
ICS Code (Medical microbiology): 07.100.10
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

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.

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].

Document History

EN ISO 11737-2
November 1, 2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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...
February 1, 2000
Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process
A description is not available for this item.

References

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