Standard: AAMI 11737-2

STERILIZATION OF MEDICAL DEVICES – MICROBIOLOGICAL METHODS – PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS

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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].

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 11737-2
Publish Date: 2009-01-01
Page Count: 31
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
AAMI 11737-2 Change Type: STCH Update Date: 2009-01-01 Revision: 09 Status: ACTV

Standards That Reference This Standard

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