EN 60601-2-62:2015

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
• ICS: 11.040.01 - Medical equipment in general
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-62:2015 - Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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 for the standards indicated:

IEC 60601-2-5 NOTE Harmonized as EN 60601-2-5.
IEC 60601-2-36 NOTE Harmonized as EN 60601-2-36.
IEC 60529 NOTE Harmonized as EN 60529.
IEC 61161 NOTE Harmonized as EN 61161.
IEC 61828 NOTE Harmonized as EN 61828.
IEC 62464-1 NOTE Harmonized as EN 62464-1.
IEC 62555 NOTE Harmonized as EN 62555.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When 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
Annex ZA of EN 60601-1:2006 applies except as follows:

Publication Year Title EN/HD Year
Replacement:
1)
IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
1)
(mod) Part 1-2: General requirements for basic + corr. March 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
Addition:
IEC 61689 2013 Ultrasonics - Physiotherapy systems - EN 61689 2013
Field specifications and methods of
measurement in the frequency range
0,5 MHz to 5 MHz
IEC/TS 61949 -  Ultrasonics - Field characterization - CLC/TS 61949 -
In situ exposure estimation in finite-
amplitude ultrasonic beams
IEC 62127-1 -  Ultrasonics - Hydrophones - EN 62127-1 -
Part 1: Measurement and characterization
of medical ultrasonic fields up to 40 MHz
IEC 62127-2 -  Ultrasonics - Hydrophones - EN 62127-2 -
Part 2: Calibration for ultrasonic fields
up to 40 MHz
IEC 62359 -  Ultrasonics - Field characterization - Test EN 62359 -
methods for the determination of thermal
and mechanical indices related to medical
diagnostic ultrasonic fields
IEC 62555 -  Ultrasonics - Power measurement - High EN 62555 -
intensity therapeutic ultrasound (HITU)
transducers and systems
IEC/TS 62556 -  Ultrasonics - Field characterization - - -
Specification and measurement of field
parameters for high intensity therapeutic
ultrasound (HITU) transducers and
systems
1)
Superseded by EN 60601-1-2:2014 (IEC 60601-1-2:2014): DOW = 2018-12-31.
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-62 ®
Edition 1.0 2013-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-62: Particular requirements for the basic safety and essential performance

of high intensity therapeutic ultrasound (HITU) equipment

Appareils électromédicaux –
Partie 2-62: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils ultrasonores thérapeutiques de haute intensité (HITU)

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.01; 17.140.50 ISBN 978-2-8322-0865-6

– 2 – 60601-2-62 © IEC:2013
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards. 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 21
201.5 General requirements for testing of ME EQUIPMENT . 22
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 23
201.7 ME EQUIPMENT identification, marking and documents . 23
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 25
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 25
201.10 Protection against unwanted and excessive radiation HAZARDS . 25
201.11 Protection against excessive temperatures and other HAZARDS . 28
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 28
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 30
201.14 Programmable ELECTRICAL MEDICAL SYSTEMS (PEMS). 30
201.15 Construction of ME EQUIPMENT . 30
201.16 ME systems . 30
201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30
202 Electromagnetic compatibility – Requirements and tests . 30
Annexes . 33
Annex AA (informative) Particular guidance and rationale . 34
Annex BB (informative) Targeting . 38
Annex CC (informative) HITU – specific risks . 41
Annex DD (informative) Determining regions of HITU fields for measurement . 46
Annex EE (informative) Guidance in classification according to CISPR 11 . 57
Annex FF (informative) Notes on using a saline or water bath for EMI testing . 58
Bibliography . 61

Figure 201.101 – Schematic diagram showing the relationship between the various
defined surfaces and distances for an ULTRASONIC TRANSDUCER with water stand-off
distance when applied to a PATIENT. [IEC 61157 Ed2] . 20
Figure 201.102 – Parameters for describing a focusing transducer of a known
geometry . 20
Figure 201.103 – Example set-up for the measurement of the unwanted ultrasound
radiation on the side-wall (the handle) of the transducer . 27
Figure DD.1 – Illustration of target, intermediate (shaded or yellow) region and safe
regions defined by boundaries 1 and 2. . 46
Figure DD.2 – Exposure time vs temperature increase above 37 °C for three different
bioffects threshold exposures shown as solid curves. . 47
Figure DD.3 – Two-layer model with target . 51
Figure DD.4 – TEMPORAL-AVERAGE INTENSITY (in dB) corrected for absorption vs
transverse dimension in the focal plane . 54

60601-2-62 © IEC:2013 – 3 –
Figure DD.5 – TEMPORAL-AVERAGE INTENSITY (in dB) vs axial distance z (mm) for a
beam from a spherical focusing transducer with a radius of 20 mm and a geometric
focal length of 40 mm at 1 MHz . 55
Figure DD.6 – Overlapping multiple exposure regions in a target region depic
...