Sterilization of health care products – Radiation – Part 2: establishing the sterilization dose

Designation Number:

ISO 11137-2

Standard Type:

National Standard of Canada - Adoption of International Standard

Standard Development Activity:

New Standard

Status:

Proceeding to development

SDO Comment Period Start Date:

2016-01-26

SDO Comment Period End Date:

2016-02-16

Posted On:

2016-01-20

Scope:

This Standard 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. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

Project need:

n/a

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

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.