IEC 60601-2-62:2013

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.

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.

General Information

• Status: Published
• Publication Date: 08-Jul-2013
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 17.140.50 - Electroacoustics
• ICS: 19.040 - Environmental testing
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 18 - TC 62/SC 62D/MT 18
• Current Stage: PPUB - Publication issued
• Start Date: 15-Jul-2013
• Completion Date: 09-Jul-2013

Standards Content (Sample)

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)

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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 depicted by the
dark ellipse . 56
Figure FF.1 – Representing the patient or operator impedance. . 58
Figure FF.2 – Possible setup for artificial hand for HITU equipment. . 59
Figure FF.3 – Showing copper band in saline. . 60

Table 201.101 – List of symbols & abbreviations. 21
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements . 22
Table CC.1 – Hazards related to image to focus misalignment . 41
Table CC.2 – Hazards related to use of HITU device by unskilled or untrained
personnel or reasonably foreseeable misuse . 41
Table CC.3 – Hazards arising from improper acoustic energy . 42
Table CC.4 – Lack of, or inadequate, specification for maintenance including
inadequate specification of post-maintenance functional checks . 43
Table CC.5 – Miscellaneous hazards . 43
Table CC.6 – Data transfer errors . 43
Table CC.7 – HITU transducer failure . 44
Table CC.8 – Generator failure . 44
Table CC.9 – Cooling system failure . 44
Table CC.10 – Software gets stuck in endless loop . 44
Table CC.11 – Wrong calculations by computer . 45

– 4 – 60601-2-62 © IEC:2013
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of o
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