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IEC 60601-1-10

IEC 60601-1-10:2007
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. 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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Technical committee

TC 62/SC 62A Common aspects of medical equipment, software, and systems

Category

Safety
Publication typeInternational Standard
Publication date2007-11-21
Edition1.0
ICS

11.040.01

Stability date2026
ISBN number2831894484
Pages79
File size1.35 MB
EditionDatePublicationEditionStatus
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