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ISO 11137

1st Edition, March 1, 1995

Complete Document

Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization

Includes all amendments and changes through Amendment 1, December 15, 2001


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Superseded By: ISO 11137-1

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Additional Comments:
W/D S/S BY ISO 11137-1, ISO 11137-2, ISO 11137-3
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Referenced Items:

ISO 11737-1
ISO 9001
ISO 9002

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Description / Abstract:

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 radiation sterilization.

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