Sterilization of health care products — Radiation — Part 4: Guidance on process control

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
ISO 11137-4
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:

ISO 11137-4 provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.

Project need:

To align Canadian requirements with those of international standards, namely ISO 11137 series of standards, including adoption of new standard ISO 11137-4 on Sterilization of health care products and radiation guidance on process control.

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