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.[]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.

Medizinische elektrische Geräte - Teil 1-10: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen

Appareils électromédicaux - Partie 1-10: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour le développement des régulateurs physiologiques en boucle fermée

Spécifie les exigences pour le développement (analyse, conception, vérification et validation) d'un régulateur physiologique en boucle fermée (RPBF) en tant que partie d'un système physiologique de commande en boucle fermée (SPCBF) dans les appareils em et les systèmes em pour la commande d'une variable physiologique.[]La présente norme collatérale s'applique aux différents types de RPBF, par exemple linéaire et non-linéaire, adaptatifs, fuzzy, réseaux de neurones.[]La présente norme collatérale s'applique à un régulateur en boucle fermée qui règle la variable de sortie du régulateur afin d'ajuster (c'est-à-dire, changer ou maintenir) la variable physiologique mesurée en effectuant une comparaison avec la variable de référence.

Medicinska električna oprema - 1-10 del: Splošne zahteve za osnovne varnostne in bistvene lastnosti - Spremljevalni standard: Zahteve za razvoj fizioloških krmilnikov s sklenjeno zanko (IEC 60601-1-10:2007)

General Information

• Status: Published
• Publication Date: 23-Apr-2008
• Withdrawal Date: 28-Feb-2011
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Parallel Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-Apr-2008
• Completion Date: 24-Apr-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST 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

Relations

• Amended By: EN 60601-1-10:2008/A1:2015 - 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
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-1-10:2008/A2:2021 - 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
• Effective Date: 29-Aug-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-10:2008
01-julij-2008
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ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DUD]YRMIL]LRORãNLK
NUPLOQLNRYVVNOHQMHQR]DQNR,(&
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 (IEC 60601-1-10:2007)
Medizinische elektrische Geräte - Teil 1-10: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an die Entwicklung von physiologischen geschlossenen Regelkreisen (IEC 60601-1-
10:2007)
Appareils électromédicaux -- Partie 1-10: Exigences générales pour la sécurité de base
et les performances essentielles - Norme collatérale: Exigences pour le développement
des régulateurs physiologiques en boucle fermée (CEI 60601-1-10:2007)
Ta slovenski standard je istoveten z: EN 60601-1-10:2008
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-10:2008 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN 60601-1-10

NORME EUROPÉENNE
April 2008
EUROPÄISCHE NORM

ICS 11.040


English version


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
(IEC 60601-1-10:2007)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-10: Exigences générales Teil 1-10: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Exigences Ergänzungsnorm: Anforderungen
pour le développement des régulateurs an die Entwicklung von physiologischen
physiologiques en boucle fermée geschlossenen Regelkreisen
(CEI 60601-1-10:2007) (IEC 60601-1-10:2007)



This European Standard was approved by CENELEC on 2008-03-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-10:2008 E

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EN 60601-1-10:2008 - 2 -

Foreword
The text of document 62A/576/FDIS, future edition 1 of IEC 60601-1-10, prepared by SC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical
practice, and ISO SC 1, Breathing attachments and anaesthetic machines, and SC 3, Lung ventilators
and related devices, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-10 on 2008-03-01
The following dates were fixed:

– latest date by which the EN has to be implemented

at national level by publication of an identical
(dop) 2008-12-01
national standard or by endorsement

– latest date by which the national standards conflicting
(dow) 2011-03-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
In the 60601 series of publications, collateral standards
...