Consolidated

NEK IEC 60601-1-4:1996+A1:1999 CSV

Withdrawn

Corrigendums and amendments are bought separately.

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Abstract

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. This consolidated version consists of the first edition (1996) and its amendment 1 (1999). Therefore, no need to order amendment in addition to this publication.

Document information

  • Consolidated from NEK
  • Published:
  • Withdrawn:
  • Edition: 1.1
  • Version: 1
  • Document type: NAT
  • ICS 11.040.01
  • National Committee NEK/NK62

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