BS EN 60601-2-36-1997 医用电气设备.体外诱导碎石设备安全性规范
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标准号:BS EN 60601-2-36-1997
中文标准名称:医用电气设备.体外诱导碎石设备安全性规范
英文标准名称:Medical electrical equipment. Particular requirements for safety. Specification for equipment for extra-corporeally induced lithotripsy
标准类型:C37
发布日期:1997/8/15 12:00:00
实施日期:1997/8/15 12:00:00
中国标准分类号:C37
国际标准分类号:11.040.60
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.
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