Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

Medizinische elektrische Geräte – Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale – Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme für die medizinische Versorgung in häuslicher Umgebung

Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile

La CEI 60601-1-11:2010 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux destinés par leur fabricant à être utilisés dans l'environnement des soins À domicile sans distinguer si l'appareil électromédical ou le système électromédical est prévu pour être utilisé par un opérateur non spécialiste ou par du personnel de santé qualifié. La CEI 60601-1-11:2010 est destinée à spécifier des exigences générales qui viennent s'ajouter à celles de la norme générale CEI 60601-1:2005 et à servir de base pour les normes particulières. Le comité recommande que le contenu de la présente publication soit adopté pour mise en oeuvre au niveau national au plus tôt 3 ans après la date de publication.

Medicinska električna oprema - 1-11. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za medicinsko električno opremo in medicinske električne sisteme, ki se uporabljajo v okolju domače zdravstvene oskrbe (IEC 60601-1-11:2010)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV, v nadaljevanju ME OPREMA in ME SISTEMI, ki so namenjeni uporabi s strani neusposobljenega upravljalca ali usposobljenega zdravstvenega osebja. Ta mednarodni standard ne velja za ME opremo in ME SISTEME, ki se uporabljajo izključno pri nujnih zdravstvenih storitvah ali izključno v strokovnih zdravstvenih ustanovah.

General Information

Status
Withdrawn
Publication Date
03-Jun-2010
Withdrawal Date
31-May-2013
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
31-Dec-2018
Completion Date
31-Dec-2018

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme für die medizinische Versorgung in häuslicher Umgebung (IEC 60601-1-11:2010)Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile (CEI 60601-1-11:2010)Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010)11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 60601-1-11:2010SIST EN 60601-1-11:2010en01-september-2010SIST EN 60601-1-11:2010SLOVENSKI
STANDARD



SIST EN 60601-1-11:2010



EUROPEAN STANDARD EN 60601-1-11 NORME EUROPÉENNE
EUROPÄISCHE NORM June 2010
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2010 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-11:2010 E
ICS 11.040
English version
Medical electrical equipment -
Part 1-11: General requirements for basic safety and essential performance -
Collateral standard: Requirements for medical electrical equipment
and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010)
Appareils électromédicaux -
Partie 1-11: Exigences générales
pour la sécurité de base et les performances essentielles -
Norme collatérale: Exigences
pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile(CEI 60601-1-11:2010)
Medizinische elektrische Geräte -
Teil 1-11: Besondere Festlegungen
für die Sicherheit einschließlich
der wesentlichen Leistungsmerkmale -
Ergänzungsnorm: Anforderungen
an medizinische elektrische Geräte
und medizinische elektrische Systeme
für die medizinische Versorgung
in häuslicher Umgebung (IEC 60601-1-11:2010)
This European Standard was approved by CENELEC on 2010-06-01. 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, Croatia, 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. SIST EN 60601-1-11:2010



EN 60601-1-11:2010 - 2 - Foreword The text of document 62A/693/FDIS, future edition 1 of IEC 60601-1-11, prepared by SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-11 on 2010-06-01. This EN 60601-1-11:2010 constitutes a collateral standard to EN 60601-1:2006, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following dates were fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop)
2011-03-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2013-06-01 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to: – a subgroup of MEDICAL ELECTRICAL
...

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