IEC 60601-1-10:2020
Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers CONSOLIDATED EDITION

Standard No.

IEC 60601-1-10:2020

Release Date

2020

Published By

SCC

Status

Be replaced

Replace By

IEC 60601-1-10:2007/AMD2:2020

Latest

IEC 60601-1-10:2007/AMD2:2020

Scope

  Full Description IEC 60601-1-10:2007+A1:2013+A2:2020 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. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard applies to a closed-loop controller that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable. This consolidated version consists of the first edition (2007), amendment 1 (2013) and amendment 2 (2020). Therefore, no need to order amendment in addition to this publication.

IEC 60601-1-10:2020 history

• 2020 IEC 60601-1-10:2007/AMD2:2020 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
• 2020 IEC 60601-1-10:2020 Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers CONSOLIDATED EDITION
• 2013 IEC 60601-1-10:2007/AMD1:2013 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; Amendment 1
• 2013 IEC 60601-1-10:2013 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
• 2007 IEC 60601-1-10:2007 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