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ANSI/AAMI/IEC 60601-2-16:2008

Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment

Applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEMODIALYSIS, HEMODIAFILTRATION and HEMOFILTRATION EQUIPMENT, hereafter referred to as HEMODIALYSIS EQUIPMENT.


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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.

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