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IEC 60601-1-4 Ed. 1.1 b:2000

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk. This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.

Content Provider
International Electrotechnical Commission [IEC]

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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.