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IEC 60601-1-10:2007 ED1

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

Publication date:   Nov 21, 2007

General information

60.60 Standard published   Nov 21, 2007

IEC

TC 62/SC 62A

International Standard

11.040.01   Medical equipment in general

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Scope

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.

Life cycle

NOW

PUBLISHED
IEC 60601-1-10:2007 ED1
60.60 Standard published
Nov 21, 2007

CORRIGENDA / AMENDMENTS

PUBLISHED
IEC 60601-1-10:2007/AMD1:2013 ED1

PUBLISHED
IEC 60601-1-10:2007/AMD2:2020 ED1