Standard

NEK EN 60601-1-10:2008

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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 NEK
  • Published:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 11.040
  • National Committee NEK/NK62

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EU law: 93/42/EEC

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