ISO 11137:1995Withdrawn

Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization

Stérilisation des dispositifs médicaux — Prescriptions pour la validation et le contrôle de routine — Stérilisation par irradiation

Abstract / scope

Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.

Life cycle

Amendments & corrigenda

ISO 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 198 ISO 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/WD 11137Deleted (project abandoned)Sterilization of health care products — Requirements for validation and routine control — Radiation sterilizationInternational Standard · ISO/TC 198 ISO 11137-1:2006WithdrawnSterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesInternational Standard · Published 19 Apr 2006 · ISO/TC 198 ISO 11137-2:2006WithdrawnSterilization of health care products — Radiation — Part 2: Establishing the sterilization doseInternational Standard · Published 19 Apr 2006 · ISO/TC 198 ISO 11137-3:2006WithdrawnSterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspectsInternational Standard · Published 19 Apr 2006 · ISO/TC 198