Adopts ISO 11137-1:2006 to specify requirements for the development, validation and routine control of a radiation sterilization process employing irradiations.RECONFIRMATION NOTICETechnical Committee HE-023 has reviewed the content of this publication and in accordance with Standards Australia procedures for reconfirmation, it has been determined that the publication is still valid and does not require change.Certain documents referenced in the publication may have been amended since the original date of publication. Users are advised to ensure that they are using the latest versions of such documents as appropriate, unless advised otherwise in this Reconfirmation Notice.Approved for reconfirmation in accordance with Standards Australia procedures for reconfirmation on 06 December 2016.Approved for reconfirmation in New Zealand on behalf of the Standards Council of New Zealand on 10 August 2017.The following are represented on Technical Committee HE-023:Australasian College for Infection Prevention and ControlAustralian Chamber of Commerce and IndustryAustralian College of Perioperative NursesAustralian Dental AssociationAustralian Dental Industry AssociationAustralian Industry GroupAustralian Institute of PackagingAustralian Nursing and Midwifery FederationDay Hospitals AustraliaDepartment of Health (WA)Department of Health and Human Services (VIC)Federal Sterilizing Research and Advisory Council of AustraliaGastroenterological Nurses College of AustraliaInstitute of Hospital Engineering AustraliaMedical Technology Association of AustraliaNew Zealand Nurses OrganisationNew Zealand Sterile Services AssociationNSW HealthQueensland HealthRoyal Australian College of General PractitionersRoyal College of Pathologists of AustralasiaSA HealthTherapeutic Goods Administration

Reconfirmed 15/09/2017.
This standard has been reconfirmed in Australia in 2017 and remains current in New Zealand.

DR 06397

AS ISO 11137-2002

ISO 11137-1:2006 - Identical