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About This Item


Full Description

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.

Document History

  1. 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 CONSOLIDATED EDITION

    • Most Recent
  2. IEC 60601-1-4 Ed. 1.0 b:1996

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

    • Historical Version