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ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package establishes the risk management process associated with the biological evaluation of medical devices. It also provides test methods for in vitro cytotoxicity, irritation and skin sensitization involving medical devices. ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package includes:
ISO 10993-1:2018
ISO 10993-5:2009
ISO 10993-10:2010

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package includes:

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International Organization for Standardization [ISO]


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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.

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