EN 60601-1-11:2015

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

NEW! IEC 60601-1-11:2015 is available as IEC Standards+ 60601-1-11:2015 which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-1-11:201 5 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies 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 home healthcare environment includes: - the dwelling place in which a patient lives; - other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - correction of test method for relative humidity control at temperatures above 35 °C; - redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and - harmonizing with the changes to the amendments to the general standard and other collateral standards.

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

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

NEW! IEC 60601-1-11:2015 est disponible sous forme de IEC Standards+ 60601-1-11:2015 qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente. L'IEC 60601-1-11:2015 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, destinés à être utilisés dans l'environnement des soins à domicile. Elle s'applique 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. L'environnement des soins à domicile comprend:
- l'habitation dans laquelle un patient vit; - d'autres environnements où des patients sont présents à l'intérieur comme à l'extérieur, à l'exclusion des environnements des établissements de soins où des opérateurs ayant une formation médicale sont disponibles de façon continue lorsque des patients sont présents. Cette deuxième édition annule et remplace la première édition de l'IEC 60601-1-11, parue en 2010. Cette édition constitue une révision technique. Les modifications majeures par rapport à l'édition précédente sont les suivantes: - correction de la méthode d'essai pour le contrôle de l'humidité relative à des températures supérieures à 35 °C; - reformulation des paragraphes qui modifient plus qu'ils ne complètent la norme générale ou d'autres normes collatérales; et - harmonisation avec les modifications apportées aux amendements de la norme générale et aux autres normes collatérales.

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

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV za uporabo v OKOLJU
DOMAČE ZDRAVSTVENE OSKRBE, kot je določeno v poglavju 3.1 in kot je navedel PROIZVAJALEC v navodilih za uporabo. Ta mednarodni standard velja ne glede na to, ali je ELEKTROMEDICINSKA OPREMA ali ELEKTROMEDICINSKI SISTEM namenjen uporabi nestrokovnjakov ali usposobljenega osebja za zdravstveno oskrbo.
OKOLJE DOMAČE ZDRAVSTVENE OSKRBE vključuje:
– stanovanje, v katerem PACIENT prebiva;
– drugi zunanji in notranji prostori, kjer so PACIENTI prisotni, razen okolja strokovnih zdravstvenih ustanov, kjer so IZVAJALCI z medicinskim znanjem neprestano na voljo, ko so PACIENTI prisotni.
Ta mednarodni standard se ne uporablja za ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME, namenjene izključno za uporabo v OKOLJU NUJNE MEDICINSKE POMOČI, ki so zajeti v standardu IEC 60601-1-12, ali namenjene izključno za uporabo v strokovnih zdravstvenih ustanovah, ki so zajeti v standardu IEC 60601-1 brez dodatkov standarda IEC 60601-1-12 ali tega spremljevalnega standarda. Kljub temu so ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICISNKI SISTEMI lahko namenjeni uporabi v različnih okoljih in so tako v področju uporabe tega standarda tudi, če so med drugim namenjeni za uporabo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE. PRIMER: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI namenjeni tako za uporabo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE in okolju strokovnih zdravstvenih ustanov.
OPOMBA: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI, namenjeni uporabi v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE, se lahko pogosto uporabljajo na mestih z nezanesljivimi električnimi viri in slabo ozemljitvijo.

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 30-Dec-2018
• ICS: 11.020.10 - Health care services in general
• ICS: 11.040 - Medical equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-1-11:2015 - 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

Relations

• Replaces: EN 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
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-1-11:2015/A1:2021 - 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
• Effective Date: 29-Aug-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-11:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-1-11:2010
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DPHGLFLQVNRHOHNWULþQR
RSUHPRLQPHGLFLQVNHHOHNWULþQHVLVWHPHNLVHXSRUDEOMDMRYRNROMXGRPDþH
]GUDYVWYHQHRVNUEH
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
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
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
Ta slovenski standard je istoveten z: EN 60601-1-11:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-11:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1-11:2015

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SIST EN 60601-1-11:2015


EUROPEAN STANDARD EN 60601-1-11

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040 Supersedes EN 60601-1-11:2010
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 60601-1-11:2015)
Appareils électromédicaux - Partie 1-11: Exigences Medizinische elektrische Geräte - Teil 1-11: Besondere
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme Collatérale: Exigences pour les wesentlichen Leistungsmerkmale - Ergänzungsnorm:
appareils électromédicaux et les systèmes électromédicaux Anforderungen an medizinische elektrische Geräte und
utilisés dans l'environnement des soins à domicile medizinische elektrische Systeme für die medizinische
(IEC 60601-1-11:2015) Versorgung in häuslicher Umgebung
(IEC 60601-1-11:2015)
This European Standard was approved by CENELEC on 2015-04-14. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1-11:2015 E

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SIST EN 60601-1-11:2015
EN 60601-1-11:2015
Foreword
The text of document 62A/959/FDIS, future edition 2 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 approved by
CENELEC as EN 60601-1-11:2015.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-01-14
national level by publication of an identical national
standard or by endorsement
(dow) 2018-12-31
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-1-11:2010.
Attention is dr
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