Sterilization of health care products — Biological indicators — Part 7: 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:
ISO 11138-7:2019
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Standard
ICS code(s):
11.080.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

The ISO 11138 series provides manufacturers and others with the requirements for production, labeling, test methods and performance requirements of biological indicators used to develop, validate and monitor sterilization processes.  They are a vital part of insuring that sterile medical devices and products are used in health care settings.

 

ISO 11138-7:2019 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.

Project need:

To maintain alignment with international requirements (new ISO standard adoption) on the selection, use and interpretation of results of biological indicators used to develop, validate and monitor sterilization processes. ISO 11138-7:19 edition of the ISO 23500 series was released in March 2019 and it supersedes the previously adopted CAN/CSA-Z14161-11. This will be the first edition of CAN/CSA 11138-7 that will be adopted with Canadian deviations.

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.