Sterilization of health care products -- Dry heat -- 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 ISO 20857
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:

specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.
It also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

Project need:

Supports sterilization processes not othewise covered. New SMC leadership identified this as important to adopt

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