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ISO 11137-2:2012

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

Mar 15, 2012
95.99 Withdrawal of Standard   May 21, 2013

General information

95.99     May 21, 2013

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

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Scope

ISO 11137-2:2011 specifies methods of 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 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11137-2:2006

WITHDRAWN
ISO 11137-2:2006/Cor 1:2009

NOW

WITHDRAWN
ISO 11137-2:2012
95.99 Withdrawal of Standard
May 21, 2013

REVISED BY

PUBLISHED
ISO 11137-2:2013