Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CAN/CSA-Z14161-11
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. This International Standard applies to biological indicators for which International Standards exist.

NOTE 1 See, for example, the ISO 11138 series.

NOTE 2 The general information provided in this International Standard can have useful application for processes and
biological indicators not currently addressed by existing International Standards, e.g., new and developing sterilization
processes.

This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration.

This International Standard is not intended to apply to combination processes using, for example, washer disinfectors or flushing and steaming of pipelines.

This International Standard is not intended to apply to liquid sterilization processes.

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.