ANSI/AAMI/ISO 11137:1994 + Amendment 1


Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization, 3ed. Edition: 3
Association for the Advancement of Medical Instrumentation/International Org. for Standardization / 01-Jan-2002 / 67 pages

This International Standard specifies requirements for validation, process control and routine monitoring inthe radiation sterilization of health care products. It applies to continuous and batch type gamma irradiatorsusing the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-raygenerator.
Annexes are also included to provide supplementary information.

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