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AAMI CR500:2019

Basic Introduction to the IEC 60601 Series

This document provides information regarding concepts and principles that underlie the IEC 60601 series of standards. (The IEC 60601 series is defined in the Introduction.) This document is intended to clarify and to point out the importance of the series as well as to provide guidance to understanding and to implementing the series.

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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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