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.
WITHDRAWN
ISO 11137:1995
95.99
Withdrawal of Standard
Apr 19, 2006
ABANDON
ISO/WD 11137
PUBLISHED
ISO 11137-1:2006
WITHDRAWN
ISO 11137-2:2006
WITHDRAWN
ISO 11137-3:2006
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