Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

IEC 60601-2-62:2013 applies to the basic safety and essential performance of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. If a clause or subclause is specifically intended to be applicable to such equipment only, or to related systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to individual equipment and to systems, as relevant. Hazards inherent in the intended physiological function of the equipment or systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This standard can also be applied to - therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound; - therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound; - and equipment intended to be used for relieving cancer pain due to bone metastases. This particular standard does not apply to - Ultrasound Equipment intended to be used for physiotherapy (use IEC 60601-2-5 and IEC 61689); - Ultrasound Equipment intended to be used for lithotripsy (use IEC 60601-2-36); - Ultrasound Equipment intended to be used for dedicated hyperthermia devices; and - Ultrasound Equipment intended to be used for phacoemulsification.

Medizinische elektrische Geräte - Teil 2-62: Besondere Anforderungen an die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von hochintensiven therapeutischen Ultraschallsystemen (HITU-Systemen)

Appareils électromédicaux - Partie 2-62: Exigences particulières pour la sécurité de base et les performances essentielles des appareils ultrasonores thérapeutiques de haute intensité (HITU)

La CEI 60601-2-62:2013 s'applique à la sécurité de base et aux performances essentielles des APPAREILS ULTRASONORES THÉRAPEUTIQUES DE HAUTE INTENSITÉ. La présente Norme internationale complète ou remplace les articles énumérés dans la CEI 60601-1 qui sont spécifiques aux APPAREILS ULTRASONORES THÉRAPEUTIQUES DE HAUTE INTENSITÉ. Si un article ou un paragraphe est spécifiquement destiné à s'appliquer uniquement aux appareils individuels, ou uniquement aux systèmes, le titre et le contenu dudit article ou paragraphe devra alors le préciser. Dans le cas contraire, l'article ou le paragraphe s'applique aux appareils individuels et aux systèmes, selon le cas. Les dangers inhérents à la fonction physiologique prévue des appareils individuels ou des systèmes dans le cadre de la présente norme ne sont pas couverts par les exigences spécifiques de la présente norme, excepté en 7.2.13 et en 8.4.1 de la norme générale. La présente norme peut également être appliquée - à des appareils thérapeutiques pour thrombolyse par exposition à des ultrasons thérapeutiques de haute intensité; - à des appareils thérapeutiques pour le traitement de l'occlusion de vaisseaux nourriciers par exposition à des ultrasons focalisés de haute Intensité; - et aux appareils destinés à être utilisés pour atténuer la douleur liée au cancer et due aux métastases osseuses. La présente norme particulière ne s'applique pas - aux appareils à ultrasons destinés à être utilisés pour la physiothérapie (utilisation: CEI 60601-2-5 et CEI 61689); - aux appareils à ultrasons destinés à être utilisés pour la lithotritie (utilisation: CEI 60601-2-36); - aux appareils à ultrasons destinés à être utilisés pour des dispositifs dédiés à l'hyperthermie; - et aux appareils à ultrasons destinés à être utilisés pour la phacoémulsification.

Medicinska električna oprema - 2-62. del: Posebne zahteve za osnovno varnost in bistvene lastnosti visokointenzivnih terapevtskih ultrazvočnih (HITU) naprav

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI VISOKOINTENZIVNIH
TERAPEVTSKIH ULTRAZVOČNIH NAPRAV, kot so opredeljene v točki 201.3.218 (v nadaljevanju ELEKTROMEDICINSKA OPREMA).
Ta mednarodni standard dodaja ali zamenja klavzule, navedene v standardu IEC 60601-1, ki se nanašajo na VISOKOINTENZIVNE TERAPEVTSKE ULTRAZVOČNE NAPRAVE.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
OPOMBA 1: Glej tudi točko 4.2 splošnega standarda.
OPOMBA 2: Ker se na področju HITU pričakuje, da je akustično valovanje močno popačeno zaradi nelinearnih učinkov širjenja zvoka, je potrebno ultrazvočne meritve opraviti v navidezno linearnih pogojih in jih nato ekstrapolirati s postopki, podanimi v standardu IEC/TS 62556. Glejte tudi IEC/TS 61949
Ta standard je mogoče uporabiti tudi za:
– terapevtsko opremo za trombolizo prek obsevanja z visokointenzivnim terapevtskim ultrazvokom;
– terapevtsko opremo za zdravljenje zamašenih dovodnic z obsevanjem z visokointenzivnim osredotočenim ultrazvokom;
– opremo, namenjeno lajšanju bolečin raka, ki so posledica kostnih metastaz.
Ta standard se ne uporablja za:
• ULTRAZVOČNO OPREMO, namenjeno fizioterapiji (uporabite standarda IEC 60601-2-5 [1]2) in IEC 61689);
• ULTRAZVOČNO OPREMO, namenjeno litotripsiji (uporabite standard IEC 60601-2-36 [2]);
• ULTRAZVOČNO OPREMO, namenjeno uporabi za namenske hipertermične naprave;
• ULTRAZVOČNO OPREMO, namenjeno fakoemulzifikaciji.

General Information

Status
Published
Publication Date
21-May-2015
Withdrawal Date
13-Apr-2018
Current Stage
6060 - Document made available - Publishing
Start Date
22-May-2015
Completion Date
22-May-2015

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-62:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLYLVRNRLQWHQ]LYQLKWHUDSHYWVNLKXOWUD]YRþQLK +,78 QDSUDY
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and
essential performance of high intensity therapeutic ultrasound (HITU) equipment
Medizinische elektrische Geräte - Teil 2-62: Besondere Anforderungen an die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von hochintensiven therapeutischen
Ultraschallsystemen (HITU-Systemen)
Appareils électromédicaux - Partie 2-62: Exigences particulières pour la sécurité de base
et les performances essentielles des systèmes à ultrasons thérapeutiques de haute
intensité (HITU)
Ta slovenski standard je istoveten z: EN 60601-2-62:2015
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-62:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-62:2015

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SIST EN 60601-2-62:2015


EUROPEAN STANDARD EN 60601-2-62

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040.01; 17.140.50

English Version
Medical electrical equipment - Part 2-62: Particular requirements
for the basic safety and essential performance of high intensity
therapeutic ultrasound (HITU) equipment
(IEC 60601-2-62:2013)
Appareils électromédicaux - Partie 2-62: Exigences Medizinische elektrische Geräte - Teil 2-62: Besondere
particulières pour la sécurité de base et les performances Anforderungen an die Sicherheit einschließlich der
essentielles des appareils ultrasonores thérapeutiques de wesentlichen Leistungsmerkmale von hochintensiven
haute intensité (HITU) therapeutischen Ultraschallsystemen (HITU-Systemen)
(IEC 60601-2-62:2013) (IEC 60601-2-62:2013)
This European Standard was approved by CENELEC on 2015-04-14. 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 60601-2-62:2015 E

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SIST EN 60601-2-62:2015
EN 60601-2-62:2015
Foreword
The text of document 62D/1069/FDIS, future IEC 60601-2-62, 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 60601-2-62:2015.

The following dates are fixed:
(dop) 2016-01-14
• 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) 2018-04-14
standards conflicting with the
document have to be withdrawn

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.

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 60601-2-62:2013 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added f
...

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