Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments 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 for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ('Holter') monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes.

Medizinische elektrische Geräte - Teil 2-27: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographie-Überwachungsgeräten

Appareils électromédicaux - Partie 2-27: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance d'électrocardiographie

La CEI 60601-2-27:2011 s'applique aux appareils de surveillance électrocardiographique utilisés dans un environnement hospitalier, ainsi qu'en dehors de cet environnement, tels que dans les ambulances et les moyens de transport aérien. La présente norme particulière s'applique également aux systèmes de télémétrie ECG utilisés dans un environnement hospitalier. Les appareils de surveillance électrocardiographique conçus pour être utilisés dans des conditions extrêmes ou dans des conditions d'environnement non contrôlées à l'extérieur de l'environnement hospitalier, tels que dans les ambulances ou les moyens de transport aérien, doivent être conformes à la présente norme particulière. Des normes supplémentaires peuvent s'appliquer pour ces environnements d'utilisation. La présente norme ne s'applique pas aux moniteurs d'électrocardiographie pour une utilisation à domicile. Il convient cependant que les fabricants envisagent d'utiliser les articles correspondants de la présente Norme, en fonction de leur application à l'utilisation prévue. Les moniteurs ambulatoires (dits 'Holter'), la surveillance de la fréquence cardiaque foetale, les dispositifs pléthysmographiques de pouls et les autres appareils d'enregistrement d'ECG n'entrent pas dans le domaine d'application de la présente norme particulière. L'objet de la présente troisième édition est de mettre à jour la présente norme particulière en prenant en compte la troisième édition de la norme générale par un reformatage et des modifications techniques.

Medicinska električna oprema - 2-27. del: Posebne varnostne zahteve, vključno z bistvenimi lastnostmi za elektrokardiografsko nadzorno opremo (IEC 60601-2-27:2011)

Ta standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTROKARDIOGRAFSKE (ECG) NADZORNE OPREME, kot je določeno v 201.3.63 (v nadaljevanju tudi: MEDICINSKA ELEKTRIČNA OPREMA). Ta standard se uporablja za MEDICINSKO ELEKTRIČNO OPREMO, ki se uporablja v bolnišnicah in zunaj njih, npr. v reševalnih vozilih in zračnem prometu. Ta standard se uporablja tudi za ELEKTROKARDIOGRAFSKE telemetrične sisteme, ki se uporabljajo v bolnišnicah. MEDICINSKA ELEKTRIČNA OPREMA, ki je namenjena za uporabo v izrednih ali nenadzorovanih vremenskih razmerah zunaj bolnišnic, npr. v reševalnih vozilih ali zračnem prometu, mora biti v skladu s tem standardom. Za MEDICINSKO ELEKTRIČNO OPREMO v tovrstnih okoljih se lahko uporabljajo dodatni standardi. Ta standard se ne uporablja za elektrokardiografsko nadzorno opremo, namenjeno za domačo uporabo. Vendar PROIZVAJALCI morajo upoštevati ustrezna določila tega standarda glede na PREDVIDENO UPORABO. Nadzorna oprema v reševalnih vozilih (»Holter«), nadzorna oprema srčnega utripa zarodka, pletizmografske naprave za merjenje pulza in druga elektrokardiografska oprema za beleženje niso zajete v tem standardu.

General Information

Status
Published
Publication Date
21-Aug-2014
Withdrawal Date
21-Aug-2017
Current Stage
6060 - Document made available - Publishing
Start Date
22-Aug-2014
Completion Date
22-Aug-2014

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-27:2016
01-julij-2016
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYHYNOMXþQR]
ELVWYHQLPLODVWQRVWPL]DHOHNWURNDUGLRJUDIVNRQDG]RUQRRSUHPR ,(&

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and
essential performance of electrocardiographic monitoring equipment (IEC 60601-2-
27:2011)
Medizinische elektrische Geräte - Teil 2-27: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographie-
Überwachungsgeräten
Appareils électromédicaux - Partie 2-27 : Exigences particulières pour la sécurité de
base et les performances essentielles des appareils de surveillance
d'électrocardiographie
Ta slovenski standard je istoveten z: EN 60601-2-27:2014
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-27:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-27:2016

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SIST EN 60601-2-27:2016


EUROPEAN STANDARD EN 60601-2-27

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2014
ICS 11.040.50 Supersedes EN 60601-2-27:2006
English Version
Medical electrical equipment - Part 2-27: Particular requirements
for the basic safety and essential performance of
electrocardiographic monitoring equipment
(IEC 60601-2-27:2011 + corrigendum May 2012)
Appareils électromédicaux - Partie 2-27: Exigences Medizinische elektrische Geräte - Teil 2-27: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance wesentlichen Leistungsmerkmale von Elektrokardiographie-
d'électrocardiographie Überwachungsgeräten
(CEI 60601-2-27:2011 + corrigendum Mai 2012) (IEC 60601-2-27:2011 + Berichtigung Mai 2012)
This European Standard was approved by CENELEC on 2011-05-04. 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
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-27:2014 E

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SIST EN 60601-2-27:2016
EN 60601-2-27:2014 - 2 -
Foreword
The text of document 62D/900/FDIS, future edition 3 of IEC 60601-2-27, 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 60601-2-27:2014.
The following dates are fixed:
(dop) 2015-02-22
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2017-08-22
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-27:2006.

In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses
...

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