IEC-60601-1-10 › Historical Revision Information
Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
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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.
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11.040.01 (Medical equipment in general)
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Document Number
IEC-60601-1-10
Revision Level
FOR ED. 1.0 AMENDMENT 1
Status
Superseded
Publication Date
Nov. 1, 2013
Committee Number
62A