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ISO 11137-2:2006Withdrawn

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

Stérilisation des produits de santé — Irradiation — Partie 2: Établissement de la dose stérilisante

Abstract / 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

Amendments & corrigenda

ISO 11137-2:2006/Cor 1:2009WithdrawnSterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Technical Corrigendum 1International Standard · Published 10 Feb 2009 · ISO/TC 198

Replaces

ISO 11137:1995WithdrawnSterilization of health care products — Requirements for validation and routine control — Radiation sterilizationInternational Standard · Published 9 Mar 1995 · ISO/TC 198ISO 11137:1995/Cor 1:1997WithdrawnSterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Technical Corrigendum 1International Standard · Published 22 May 1997 · ISO/TC 198ISO 11137:1995/Amd 1:2001WithdrawnSterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Amendment 1: Selection of items for dose settingInternational Standard · Published 13 Dec 2001 · ISO/TC 198

Replaced by

ISO 11137-2:2012WithdrawnSterilization of health care products — Radiation — Part 2: Establishing the sterilization doseInternational Standard · Published 15 Mar 2012 · ISO/TC 198