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现行 IEC 60601-2-62:2013
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Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment 医疗电气设备第2-62部分:高强度治疗超声(hitu)设备的基本安全和基本性能的特殊要求
发布日期: 2013-07-09
IEC 60601-2-62:2013适用于高强度治疗超声设备的基本安全性和基本性能。本国际标准增加或取代了IEC 60601-1中列出的专门用于高强度治疗超声设备的条款。如果某一条款或子条款特别旨在仅适用于此类设备,或仅适用于相关系统,则该条款或子条款的标题和内容将如此说明。如果不是这种情况,则该条款或子条款适用于相关的单个设备和系统。本标准范围内的设备或系统预期生理功能中固有的危害,除通用标准的7.2.13和8.4.1外,本标准中的具体要求未涵盖。 本标准也可适用于 -用于通过暴露于高强度治疗性超声来溶栓的治疗设备; -用于通过暴露于高强度聚焦超声来治疗闭塞的供血血管的治疗设备; -以及旨在用于缓解由于骨转移引起的癌症疼痛的设备。 本特定标准不适用于 -拟用于理疗的超声设备(使用IEC 60601-2-5和IEC 61689); -拟用于碎石术的超声设备(使用IEC 60601-2-36); -打算用于专用热疗设备的超声设备;和 -拟用于超声乳化术的超声设备。
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.
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归口单位: TC 62/SC 62D
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