EN IEC 80601-2-49:2019
(Main)Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
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.
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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 as EN ISO 80601-2-13
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56
ISO 80601-2-72 NOTE Harmonized as EN ISO 80601-2-72
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
The Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
General requirements for basic safety and
essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
+EN 60601-1-2010
8:2007/corrigendum
Mar. 2010
+A11 2017
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
+EN 1993
60529:1991/corrige
ndum May 1993
Publication Year Title EN/HD Year
Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
IEC 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
IEC 60601-1-12 2014 Medical electrical equipment - Part 1-12: - -
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for medical
electrical equipment and medical electrical
systems intended for use in the emergency
medical services environment
IEC 60601-2-2 2017 Medical electrical equipment - Part 2-2: EN IEC 60601-2-2 2018
Particular requirements for the basic safety
and essential performance of high
frequency surgical equipment and high
frequency surgical accessories
IEC 60601-2-27 2011 Medical electrical equipment - Part 2-27: EN 60601-2-27 2014
Particular requirements for the basic safety
and essential performance of
electrocardiographic monitoring equipment
IEC 60601-2-34 2011 Medical electrical equipment - Part 2-34: EN 60601-2-34 2014
Particular requirements for the basic safety
and essential performance of invasive
blood pressure monitoring equipment
IEC 80601-2-49
Edition 1.0 2018-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitors
Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des moniteurs multifonctions des patients
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-5359-5
– 2 – IEC 80601-2-49:2018 © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 19
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19
202 Electromagnetic disturbances – Requirements and tests . 19
206 USABILITY . 24
208 General requirements, tests and guidance for ALARM SYSTEMS IN MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 25
Annexes . 28
Annex AA (informative) Particular guidance and rationale . 29
Bibliography . 38
Index of defined terms used in this particular standard . 39
Figure 201.101 – MULTIFUNCTION PATIENT MONITOR with single PATIENT circuit (6) with
multiple PHYSIOLOGICAL MONITORING UNITS and multiple PATIENT circuits (7) each with a
single PHYSIOLOGICAL MONITORING UNIT . 15
Figure 202.101 – Test layout for conducted and radiated EMISSIONS and IMMUNITY test . 20
Figure 202.102 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with PATIENT CONNECTIONS . 22
Figure 202.103 – Test setup for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 . 23
Figure 202.104 – Test circuit for HF SURGICAL EQUIPMENT protection measurement
according to 202.8.102 with non-conductive APPLIED PART . 24
Figure AA.1 – Example of a pre-configured MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.2 – Example of a modular MULTIFUNCTION PATIENT MONITOR . 30
Figure AA.3 – Example of a MULTIFUNCTION PATIENT MONITOR connected to a central
station . 30
IEC 80601-2-49:2018 © IEC 2018 – 3 –
Figure AA.4 – Example of a MULTIFUNCTION PATIENT MONITOR integrated into a ventilator . 31
Figure AA.5 – Single PATIENT circuit with multiple PHYSIOLOGICAL MONITORING UNITS and
PATIENT cables . 33
Table 201.101 – ESSENTIAL PERFORMANCE requirements. 12
SIST EN IEC 60601-2-49:20
...
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