Approved Work Item
IEC/AWI 60601-1-10
Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers
Reference number
IEC/AWI 60601-1-10
Edition 2
© ISO 2026
Approved Work Item
Under development
A working group has prepared a draft.
Will replace IEC 60601-1-10:2007

Abstract

Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 121/SC 3
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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