This International Standard specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. It 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.
Annexes are also included to provide supplementary information.
Facility design, licensing, operator training and factors related to radiation safety are outside the scope of this International Standard. It does not cover the assessment of the suitability of the product for its intended use. The use of biological indicators for validation or process monitoring, or the use of sterility testing for product release, are also not covered, as they are not recommended practices for sterilization.
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Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization (Adopted ISO 11137:1995, first edition)
Stérilisation des dispositifs médicaux - Prescriptions pour la validation et le contrôle de routine - Stérilisation par irradiation (norme ISO 11137:1995 adoptée, première édition)