It is currently not possible to order printed and bound versions of standards. This is due to challenges related to our printing supplier. We are working to resolve the situation and apologize for any inconvenience this may cause. For other options, contact salg@standard.no.
Standard

NEK EN 60601-1-10:2008

Published
Preview

Corrigenda and amendments are bought separately.

Language
Services

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

Legal references

EU law: 93/42/EEC

Product Relations