Sterilization of health care products - Radiation - Part 1: Requirements for 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:
CAN/CSA Z11137-1
Standard Type:
National Standard of Canada - Domestic
Standard Development Activity:
Amendment Revision
ICS code(s):
11.080.01
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

ISO 11137-1 describes the requirements for ensuring that the activities associated with the process of radiation sterilization are performed properly.

Amendment 2 to included revisions to 4.3.4 and 11.2.

Project need:

To maintain alignment with international requirements (new ISO standard adoption) on Sterilization of health care products and radiation guidance on process control. ISO 11137-1 is the first edition of the standard, part of the ISO 11137 series, released on 2006-04-15 and the first edition of CAN/CSA 11137-1 that was adopted without Canadian deviations.

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