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PDF Price. Not a Member? This standard is not included in any packages. Request Free Trial. Language: English. Full Description BS EN ISO specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this part of ISO is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.
Moist heat sterilization processes covered by this part of ISO include but are not limited to: a saturated steam venting systems; b saturated steam active air removal systems; c air steam mixtures; d water spray; e water immersion. BS EN ISO does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
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