Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

Designation Number:
CAN/CSA-ISO 11140-4
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Standard
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This Standard specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads).

An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration.

This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure

Project need:

The following proposed ISO TC 198 Canadian adoptions are being developed as part of an overall program of health care standardization and are intended to complement the Canadian-developed medical device reprocessing standards. ISO/TC 198 is responsible for specifying requirements for sterilization processes, sterilizing equipment, washer-disinfectors and ancillary products used in ensuring satisfactory sterilization of health care products. Health care products encompass medical devices, including in vitro diagnostic medical devices, and medicinal products (pharmaceuticals including biopharmaceuticals).

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Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.