EN 60601-2-49:2015

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

IEC 60601-2-49:2011 applies to the basic safety and essential performance requirements of multifunction patient monitoring equipment. It applies to medical electrical equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Medical electrical equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to me equipment for those environments of use. The scope of this standard is restricted to medical electrical equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an applied part. This second edition cancels and replaces the first edition of IEC 60601-2-49, published in 2001. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005 (third edition).

Medizinische elektrische Geräte - Teil 2-49: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von multifunktionalen Patientenüberwachungsgeräten

Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance multifonction des patients

La CEI 60601-2-49:2011 s'applique aux exigences pour la sécurité de base et les performances essentielles des appareils de surveillance multifonction des patients. Elle s'applique aux appareils électromédicaux utilisés dans un environnement hospitalier ainsi qu'à ceux utilisés hors de l'environnement hospitalier, par exemple dans les ambulances et dans le transport aérien. Les appareils électromédicaux destinés à être utilisés dans des conditions d'environnement extrêmes ou non contrôlées hors de l'environnement hospitalier, par exemple dans les ambulances et dans le transport aérien, doivent être conformes à la présente norme particulière. Des normes complémentaires peuvent s'appliquer aux appareils em utilisés dans ces environnements. Le domaine d'application de la présente norme est restreint aux appareils électromédicaux destinés à la connexion à un patient unique qui comportent soit deux ou plusieurs parties appliquées, soit des fonctions multiples sur une partie appliquée. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-49 publiée en 2001. Cette édition constitue une révision technique par rapport à la nouvelle structure de la CEI 60601-1:2005 (troisième édition).

Medicinska električna oprema - 2-49. del: Posebne zahteve za osnovno varnost in bistvene lastnosti večfunkcijske opreme za nadzor pacientov

Ta standard se uporablja za zahteve glede OSNOVNE VARNOSTI in BISTVENIH LASTNOSTI VEČFUNKCIJSKE OPREME ZA NADZOR PACIENTOV, kot je določeno v točki 201.3.63 (v nadaljevanju »ELEKTROMEDICINSKA OPREMA«). Področje uporabe tega standarda je omejeno na ELEKTROMEDICINSKO OPREMO z najmanj dvema UPORABLJENIMA DELOMA ali POSAMEZNIMA FUNKCIJAMA za UPORABLJENI DEL, ki je namenjen za povezavo s posameznim PACIENTOM. Ta standard ne določa zahtev za posamezne nadzorne funkcije.

General Information

• Status: Withdrawn
• Publication Date: 22-Oct-2015
• Withdrawal Date: 14-Sep-2018
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 07-Aug-2022
• Completion Date: 07-Aug-2022
• 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 60601-2-49:2015 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

Relations

• Replaces: EN 60601-2-49:2001 - Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 80601-2-49:2019 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-49:2015
01-december-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLYHþIXQNFLMVNHRSUHPH]DQDG]RUSDFLHQWRY
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitoring equipment
Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de surveillance multifonction des patients
Ta slovenski standard je istoveten z: EN 60601-2-49:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-49:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-49:2015

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SIST EN 60601-2-49:2015


EUROPEAN STANDARD EN 60601-2-49

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2015
ICS 11.040.55 Supersedes EN 60601-2-49:2001
English Version
Medical electrical equipment - Part 2-49: Particular requirements
for the basic safety and essential performance of multifunction
patient monitoring equipment
(IEC 60601-2-49:2011)
Appareils électromédicaux - Partie 2-49: Exigences Medizinische elektrische Geräte - Teil 2-49: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance multifonction des wesentlichen Leistungsmerkmale von multifunktionalen
patients Patientenüberwachungsgeräten
(IEC 60601-2-49:2011) (IEC 60601-2-49:2011)
This European Standard was approved by CENELEC on 2015-09-15. 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 60601-2-49:2015 E

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SIST EN 60601-2-49:2015
EN 60601-2-49:2015
European foreword
The text of document 62D/886/FDIS, future edition 2 of IEC 60601-2-49, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-49:2015.
The following dates are fixed:
(dop) 2016-06-15
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-49:2001.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-49:2011 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 80601-2-56 NOTE Harmonized as EN 80601-2-56.
IEC 62366 NOTE Harmonized as EN 62366.
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SIST EN 60601-2-49
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