EN 60601-2-37:2008
(Main)Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005.
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
S'applique à la sécurité de base et aux performances essentielles des appareils de diagnostic à ultrasons. L'approche et la philosophie utilisées en rédigeant cette norme particulière de sécurité pour les appareils de diagnostic à ultrasons sont cohérentes avec celles des normes actuellement en vigueur de la série des CEI 60601-2-xx, qui s'appliquent à d'autres modalités de diagnostic, telles que les appareils à rayonnement X et les systèmes à résonance magnétique. Dans chacun des cas, la norme de sécurité est prévue pour prescrire une sophistication croissante de l'affichage des indicateurs de sortie et/ou des commandes, en fonction de l'augmentation des niveaux d'énergie dans le champ d'interrogation/d'exploration soumis au diagnostic. Ainsi, pour toutes ces modalités de diagnostic, il est de la responsabilité de l'opérateur d'appréhender le risque relatif à l'énergie de sortie de l'appareil de diagnostic à ultrasons et d'agir convenablement afin d'obtenir les informations de diagnostic requises, avec le risque minimum pour le patient. Cette deuxième édition annule et remplace la première édition publiée en 2001 et ses Amendement 1 (2004) et Amendement 2 (2005). La présente édition regroupe l'édition précédente et ses deux amendements dans un format compatible avec la CEI 60601-1:2005.
Medicinska električna oprema - 2-37.del: Posebne varnostne zahteve za ultrazvočno medicinsko diagnostično in nadzorovalno opremo (IEC 60601-2-37:2007)
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ULTRAZVOČNE DIAGNOSTIČNE OPREME, kot je določeno v 201.3.217, v nadaljevanju ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 tega standarda.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons (CEI 60601-2-37:2007)Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung (IEC 60601-2-37:2007)Ta slovenski standard je istoveten z:EN 60601-2-37:2008SIST EN 60601-2-37:2008en,fr17.140.5011.040.55ICS:SIST EN 60601-2-37:2002/A1:2005SIST EN 60601-2-37:20021DGRPHãþDSLOVENSKI
STANDARDSIST EN 60601-2-37:200801-april-2008
EUROPEAN STANDARD EN 60601-2-37 NORME EUROPÉENNE
EUROPÄISCHE NORM January 2008
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2008 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-37:2008 E
ICS 11.040.55; 17.140.50 Supersedes EN 60601-2-37:2001 + A1:2005 + A2:2005
English version
Medical electrical equipment -
Part 2-37: Particular requirements for the basic safety
and essential performance of ultrasonic medical diagnostic
and monitoring equipment (IEC 60601-2-37:2007)
Appareils électromédicaux -
Partie 2-37: Exigences particulières
pour la sécurité de base
et les performances essentielles
des appareils de diagnostic
et de surveillance médicaux à ultrasons (CEI 60601-2-37:2007)
Medizinische elektrische Geräte -
Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung (IEC 60601-2-37:2007)
This European Standard was approved by CENELEC on 2007-10-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
EN 60601-2-37:2008
- 2 - Foreword The text of document 62B/624/CDV, future edition 2 of IEC 60601-2-37, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved by CENELEC as EN 60601-2-37 on 2007-10-01. This European Standard supersedes EN 60601-2-37:2001 + A1:2005 + A2:2005. EN 60601-2-37:2008 combines EN 60601-2-37:2001 + A1:2005 + A2:2005 into a form compatible with the parent EN 60601-1:2006. The following dates were fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop) 2008-08-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow) 2010-10-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. In this standard, the following print types are used:
requirements and definitions: in roman type;
test specifications: in 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: IN 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 7.1, 7.2, etc.); –
“subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subcl
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