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BS EN 60601-2-36-1997

医疗电气设备.体外诱导碎石设备的安全特殊要求

Medizinische elektrische Geraete. Besondere Festlegungen fuer die Sicherheit von Geraeten zur extrakorporal induzierten Lithotripsie Medical Electrical Equipment Part 2:Particular Requirements for Safety-Specification for Equipment for Extra-Corporeally Induced Lithotripsy Appareils electromedicaux. Regles particulieres de securite des appareils pour lithotritie creee de facon extra-corporelle Also Known as BS 5724-2-36:1997;IEC 60601-2-36:1997

适用范围:Addition: This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101. The applicability of this Particular Standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this Standard, because they are treated in other applicable IEC standards. While this Particular Standard has been developed for EQUIPMENT intended for use in LITHOTRIPSY, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal PRESSURE PULSE equipment, this Standard may be used as a guideline.

实施日期: 1997-08-15

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