Standard

IEC 60601-1-10:2007 ED1

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Note: This standard has a new edition: IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 CSV

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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. 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.

Document information

  • Standard from IEC
  • Published:
  • Edition: 1
  • Version: 1
  • Document type: IS
  • ICS 11.040.01
  • ISO TC TC 62/SC 62A

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