SR 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

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.

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General information

Status : Valid
Approval date : 9/15/2008
Publish date : 9/17/2008
Number of pages : 87
ICS : 11.040.01 Medical equipmet in general
Technical Committee : 22 - Electrical equipment in medical practice

Relations with other standards:

Amended by SR EN 60601-1-10:2008/A1:2015
Amended by SR EN 60601-1-10:2008/A2:2021