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现行 IEC 60601-2-11:2013
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Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment 医疗电气设备 - 第2-11部分:伽马射线治疗设备的基本安全和基本性能的特殊要求
发布日期: 2013-01-16
IEC 60601-2-11:2013适用于伽马射线治疗设备的基本安全和基本性能,包括多源立体定向放射治疗设备。60601系列的本特殊标准规定了制造商在设计和制造伽马射线治疗设备时应遵守的要求。它规定了公差限值,超过该限值,联锁装置必须防止、中断或终止辐射,以避免出现不安全情况。制造商进行的型式试验或不一定由制造商进行的现场试验均针对每项要求进行了规定。它并不试图定义用于放射治疗的伽马射线治疗设备的最佳性能要求。 其目的是确定目前认为对此类设备的安全运行至关重要的设计特征。它限制了设备性能的退化,在这种情况下,可以假定存在故障条件,例如部件故障,然后联锁装置运行以防止继续运行。本第三版取消并取代1997年发布的IEC 60601-2-11第二版及其修订版1:2004。本版本构成技术修订版,使本标准符合IEC 60601-1第三版及其附属标准。
IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
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归口单位: TC 62/SC 62C
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