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ANSI/AAMI/IEC 60601-1-12:2016

Medical electrical equipment -Part 1-12: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Applies to basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended for use by their manufacturers for use in the EMS environment. Does not apply to equipment and systems intended for use solely in home healthcare environment or professional healthcare facilities


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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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