Standard IEC 60601-1-10-ed.1.0 21.11.2007 preview

IEC 60601-1-10-ed.1.0

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



STANDARD published on 21.11.2007


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The information about the standard:

Designation standards: IEC 60601-1-10-ed.1.0
Publication date standards: 21.11.2007
SKU: NS-410665
The number of pages: 79
Approximate weight : 237 g (0.52 lbs)
Country: International technical standard
Category: Technical standards IEC

The category - similar standards:

Medical equipment in general

Annotation of standard text IEC 60601-1-10-ed.1.0 :

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. Specifie les exigences pour le developpement (analyse, conception, verification et validation) dun regulateur physiologique en boucle fermee (RPBF) en tant que partie dun systeme physiologique de commande en boucle fermee (SPCBF) dans les appareils em et les systemes em pour la commande dune variable physiologique. La presente norme collaterale sapplique aux differents types de RPBF, par exemple lineaire et non-lineaire, adaptatifs, fuzzy, reseaux de neurones. La presente norme collaterale sapplique a un regulateur en boucle fermee qui regle la variable de sortie du regulateur afin dajuster (cest-a-dire, changer ou maintenir) la variable physiologique mesuree en effectuant une comparaison avec la variable de reference.

These changes apply to this standard:

IEC 60601-1-10-ed.1.0/Amd.1 Change

Amendment 1 - 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
(Amendement 1 - Appareils electromedicaux - Partie 1-10: Exigences generales pour la securite de base et les performances essentielles - Norme collaterale: Exigences pour le developpement des regulateurs physiologiques en boucle fermee)

Change published on 27.11.2013

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IEC 60601-1-10-ed.1.0/Amd.2 Change

Amendment 2 - 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
(Amendement 2 - Appareils electromedicaux - Partie 1-10 : Exigences generales pour la securite de base et les performances essentielles - Norme collaterale : Exigences pour le developpement des regulateurs physiologiques en boucle fermee)

Change published on 22.7.2020

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