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ISO 11137-2:2006

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

Publication date:   Apr 19, 2006

95.99 Withdrawal of Standard   Mar 15, 2012

General information

95.99 Withdrawal of Standard   Mar 15, 2012

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

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Scope

ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11137:1995

WITHDRAWN
ISO 11137:1995/Cor 1:1997

WITHDRAWN
ISO 11137:1995/Amd 1:2001

NOW

WITHDRAWN
ISO 11137-2:2006
95.99 Withdrawal of Standard
Mar 15, 2012

CORRIGENDA / AMENDMENTS

ABANDON
ISO 11137-2:2006/PWI Amd 1

WITHDRAWN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

REVISED BY

WITHDRAWN
ISO 11137-2:2012