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

Designation Number:
CAN/CSA-Z17665-1-09, Proposed Reaffirmation
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:

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:

N/A

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