Sterilization of health care products - Vocabulary

Designation Number:
CAN/CSA-ISO/TS 11139
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 gives definitions of terms in the field of sterilization technology.

This Standard does not provide requirements for the validation and routine control of a sterilization process, but is intended to contribute fundamentally towards mutual understanding amongst those preparing and using International Standards in the field of sterilization technology

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.