IEC 60601-2-62-ed.1.0

Detail information

Designation: IEC 60601-2-62-ed.1.0

Publication date: 09/07/2013

Pages: 131

Country: International technical standard

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Anotation

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. La CEI 60601-2-62:2013 sapplique a la securite de base et aux performances essentielles des APPAREILS ULTRASONORES THERAPEUTIQUES DE HAUTE INTENSITE. La presente Norme internationale complete ou remplace les articles enumeres dans la CEI 60601-1 qui sont specifiques aux APPAREILS ULTRASONORES THERAPEUTIQUES DE HAUTE INTENSITE. Si un article ou un paragraphe est specifiquement destine a sappliquer uniquement aux appareils individuels, ou uniquement aux systemes, le titre et le contenu dudit article ou paragraphe devra alors le preciser. Dans le cas contraire, larticle ou le paragraphe sapplique aux appareils individuels et aux systemes, selon le cas. Les dangers inherents a la fonction physiologique prevue des appareils individuels ou des systemes dans le cadre de la presente norme ne sont pas couverts par les exigences specifiques de la presente norme, excepte en 7.2.13 et en 8.4.1 de la norme generale. La presente norme peut egalement etre appliquee - a des appareils therapeutiques pour thrombolyse par exposition a des ultrasons therapeutiques de haute intensite; - a des appareils therapeutiques pour le traitement de locclusion de vaisseaux nourriciers par exposition a des ultrasons focalises de haute Intensite; - et aux appareils destines a etre utilises pour attenuer la douleur liee au cancer et due aux metastases osseuses. La presente norme particuliere ne sapplique pas - aux appareils a ultrasons destines a etre utilises pour la physiotherapie (utilisation: CEI 60601-2-5 et CEI 61689); - aux appareils a ultrasons destines a etre utilises pour la lithotritie (utilisation: CEI 60601-2-36); - aux appareils a ultrasons destines a etre utilises pour des dispositifs dedies a lhyperthermie; - et aux appareils a ultrasons destines a etre utilises pour la phacoemulsification.