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

IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment. The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units. For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient. This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply. This document does not apply to implantable parts of multifunction patient monitors. This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.

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

L’IEC 80601-2-49:2018 s'applique aux exigences pour la sécurité de base et les performances essentielles des moniteurs multifonctions des patients, désignés ci-après par appareils EM ou systèmes électromédicaux. La présente norme particulière s'applique aux moniteurs multifonctions des patients destinés à être utilisés dans les établissements professionnels de santé ainsi que dans l'environnement des services medicaux d'urgence ou dans l'environnement des soins à domicile. Le domaine d'application du présent document est limité aux appareils EM ou aux systèmes électromédicaux destinés à la connexion à un patient unique qui comportent au minimum deux unités de surveillance physiologique. Le présent document ne spécifie pas d'exigences pour les unités de surveillance physiologique individuelles telles que l'ECG, la pression prélevée directement et l'oxymétrie de pouls. Les normes particulières relatives à ces unités de surveillance physiologique spécifient des exigences dans la perspective d'appareils EM autonomes. La présente norme particulière aborde les exigences supplémentaires relatives aux moniteurs multifonctions des patients. Les moniteurs multifonctions des patients peuvent être intégrés dans d'autres appareils EM ou systèmes électromédicaux. Lorsque c'est le cas, d'autres normes s'appliquent également. Le présent document ne s'applique pas aux parties implantables des moniteurs multifonctions des patients. Cette première édition annule et remplace la deuxième édition de l'IEC 60601-2-49 parue en 2011. Cette édition constitue une révision technique et permet un alignement avec l'édition actuelle de l'IEC 60601-1 et son Amendement, ainsi qu'avec les nouvelles versions des normes collatérales et de leurs amendements. Les modifications majeures concernent l'Article 208, car une grande partie des exigences précédentes sont désormais traitées dans l'IEC 60601-1-8.

Medicinska električna oprema - 2-49. del: Posebne zahteve za osnovno varnost in bistvene lastnosti večfunkcijske opreme za nadzor pacientov (IEC 80601-2-49:2018)

Ta del mednarodnega standarda 80601 se uporablja za zahteve glede OSNOVNE VARNOSTI in BISTVENIH LASTNOSTI VEČFUNKCIJSKIH MONITORJEV PACIENTE, kot je določeno v točki 201.3.201 (v nadaljevanju »ELEKTROMEDICINSKA OPREMA« ali »ELEKTROMEDICINSKI SISTEMI«). Ta standard se uporablja za VEČFUNKCIJSKE MONITORJE ZA NADZOR PACIENTOV, namenjene uporabi v strokovnih zdravstvenih ustanovah in v OKOLJU NUJNIH ZDRAVSTVENIH STORITEV ali v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE. Področje uporabe tega dokumenta je omejeno na ELEKTROMEDICINSKO OPREMO ali ELEKTROMEDICINSKE SISTEME, ki so namenjeni za povezavo s posameznim PACIENTOM, ki ima dve ali več ENOT ZA NADZOROVANJE FIZIOLOŠKIH FUNKCIJ. OPOMBA: V tem dokumentu se nosečnica in njen plod/plodovi štejejo za enega PACIENTA. Ta dokument ne določa zahtev za posamezne ENOTE ZA NADZOROVANJE FIZIOLOŠKIH FUNKCIJ, kot so EKG, naprave za invazivno nadzorovanje krvnega tlaka in pulzni oksimetri. Standardi v zvezi s temi ENOTAMI ZA NADZOROVANJE FIZIOLOŠKIH FUNKCIJ določajo zahteve z vidika samostojne ELEKTROMEDICINSKE OPREME. Ta standard obravnava dodatne zahteve glede VEČFUNKCIJSKIH MONITORJEV ZA NADZOR PACIENTOV. VEČFUNKCIJSKE MONITORJE ZA NADZOR PACIENTOV je mogoče vgraditi v drugo ELEKTROMEDICINSKO OPREMO ALI ELEKTROMEDICINSKE SISTEME. V tem primeru se uporabljajo tudi drugi ustrezni standardi. PRIMER 1: VEČFUNKCIJSKI MONITOR ZA NADZOR PACIENTOV, ki je vgrajen v respirator za intenzivno nego in za katerega se uporablja tudi standard ISO 80601-2-12. PRIMER 2: VEČFUNKCIJSKI MONITOR ZA NADZOR PACIENTOV, ki je vgrajen v respirator za oskrbo od aparata odvisnih pacientov na domu in za katerega se uporablja tudi standard ISO 80601-2-72. PRIMER 3: VEČFUNKCIJSKI MONITOR ZA NADZOR PACIENTOV, ki je vgrajen v delovno postajo za anestezijo in za katerega se uporablja tudi standard ISO 80601-2-13. PRIMER 4: VEČFUNKCIJSKI MONITOR ZA NADZOR PACIENTOV, ki je vgrajen v opremo za hemodializo in za katerega se uporablja tudi standard ISO 60601-2-16. Ta dokument se ne uporablja za dele VEČFUNKCIJSKIH MONITORJEV ZA NADZOR PACIENTOV, ki so namenjeni vsaditvi.

General Information

Status
Published
Publication Date
10-Oct-2019
Withdrawal Date
06-Aug-2022
Current Stage
6060 - Document made available - Publishing
Start Date
11-Oct-2019
Completion Date
11-Oct-2019

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-49:2019
01-december-2019
Nadomešča:
SIST EN 60601-2-49:2015
Medicinska električna oprema - 2-49. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti večfunkcijske opreme za nadzor pacientov (IEC 80601-2-
49:2018)
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitoring equipment (IEC 80601-2-
49:2018)
Medizinische elektrische Geräte - Teil 2-49: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von multifunktionalen
Patientenüberwachungsgeräten (IEC 80601-2-49:2018)
Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de surveillance multifonction des patients
(IEC 80601-2-49:2018)
Ta slovenski standard je istoveten z: EN IEC 80601-2-49:2019
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 60601-2-49:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-49:2019

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SIST EN IEC 60601-2-49:2019


EUROPEAN STANDARD EN IEC 80601-2-49

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2019
ICS 11.040.55 Supersedes EN 60601-2-49:2015 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-49: Particular requirements
for the basic safety and essential performance of multifunction
patient monitoring equipment
(IEC 80601-2-49:2018)
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 80601-2-49:2018) (IEC 80601-2-49:2018)
This European Standard was approved by CENELEC on 2019-08-07. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 80601-2-49:2019 E

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SIST EN IEC 60601-2-49:2019
EN IEC 80601-2-49:2019 (E)
European foreword
The text of document 62D/1547/FDIS, future edition 1.0 of IEC 80601-2-49, 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 IEC 80601-2-49:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-05-07
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-08-07
document have to be withdrawn

This document supersedes EN 60601-2-49:2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 80601-2-49:2018 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 60601-2-16 NOTE Harmonized as EN IEC 60601-2-16
ISO 80601-2-13 NOTE Harmonized
...

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