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SRPS ISO 11137:1998

Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization

Mar 17, 1998
Mar 17, 1998

General information

60.60    

ISS

Z076

International Standard

11.080.01  

Serbian  

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Published

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Scope

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.

Life cycle

NOW

PUBLISHED
SRPS ISO 11137:1998
60.60 Standard published

Related project

Adopted from ISO 11137:1995