Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

Designation Number:
CAN/CSA-ISO 11137-2:16
Standard Type:
National Standard of Canada - Domestic
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:

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified 
requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization 
dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of 
sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
This part of ISO 11137 defines product families for sterilization dose establishment and sterilization 
dose audit.

Project need:

To review the Standard within the required 5 year period

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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.