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ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package

     

ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2 and ANSI/AAMI/ISO 11137-3

The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices. The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package includes:


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