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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 device

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.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.