EN 60601-1-10:2008

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:   Sep 5, 2008

General information

60.60 Standard published   Apr 24, 2008

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040   Medical equipment

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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.[<BR>]This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.[<BR>]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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

PUBLISHED
EN 60601-1-10:2008
60.60 Standard published
Apr 24, 2008

CORRIGENDA / AMENDMENTS

PUBLISHED
EN 60601-1-10:2008/A1:2015

PUBLISHED
EN 60601-1-10:2008/A2:2021