Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

Designation Number:
CAN/CSA-ISO 11140-5
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 requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.

Additionally, ISO 11140-5:2007 includes test methods and equipment used to meet these performance requirements

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).

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

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.