Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CSA Z17665-1:09 (R2019)
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
ICS code(s):
11.080.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

1.1 Inclusions

1.1.1

This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.

1.1.2

Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to:

a) saturated steam venting systems;

b) saturated steam active air removal systems;

c) air steam mixtures;

d) water spray;

e) water immersion.

Project need:

To review the Standard within the required 5 year period.

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.