Historical
ANSI/AAMI/ISO 11137:1994 and ANSI/AAMI/ISO 11137:1
Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization with Amendment 1
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.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]