Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
ISO 11737-2-2019
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
07.100.10 & 11.080.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

The ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been 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.

Project need:

To maintain alignment with international requirements (new ISO standard adoption) on sterilization of health care products and biological indicators, guidance for selection, use and interpretation of results. ISO 11737-2 is the third edition, part of the ISO 11737 series, released in 2019. This will be the first edition of CAN/CSA 11737-2 that will be adopted without Canadian deviations.

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