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ANSI/AAMI/ISO 14160:2011 (R2016)

Sterilization of health care products - liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices

Specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part, materials of animal origin.


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Association for the Advancement of Medical Instrumentation [aami]


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