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GB 18280-2000
Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization (TEXT OF DOCUMENT IS IN CHINESE)
This standard specifies various requirements for validation, process control and routine monitoring during radiation sterilization for health care products. This standard applies to continuous and batch type ? irradiators using radioactive nuclein cobalt-60 and caesium-137, and those using electron beams or X-rays generators.
The appendix in this standard also provides complementary reference materials.
The design of device, certification acquirement, operator training and various factors related to radiation safety are not covered in this standard. This standard does not cover the evaluation of the suitability of pre-established applications of products. Biological indicators used for validation or process monitoring, or sterility testing used for product qualification is not covered in this standard, because these methods are not recommended in radiation sterilization.
CHINESE GB Standards [spc]