IEC 60601-2-1:2009 医疗电气设备 - 第2-1部分:电子加速器的基本安全性和基本性能的特殊要求范围1 Mev至50 Mev

标准编号：IEC 60601-2-1:2009

中文名称：医疗电气设备 - 第2-1部分:电子加速器的基本安全性和基本性能的特殊要求范围1 Mev至50 Mev

英文名称：Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

发布日期：2009-10-13

标准范围

IEC 60601-2-1:20 09适用于1 MeV至50 MeV范围内用于治疗患者的电子加速器的基本安全和基本性能。该特定标准规定了制造商在设计和建造用于放射治疗的电子加速器时应遵守的要求；它没有试图定义它们的最佳性能要求。其目的是确定目前被认为对此类医疗电气设备的安全操作至关重要的那些设计特征。它对医疗电气设备性能的退化施加了限制，超过该限制，可以假定存在故障条件，并且互锁随后操作以防止me设备的继续操作。这第三版取消并取代了1998年出版的第二版及其修正案1（2002）。它构成技术修订。第三版解决了以前版本中未涉及的以下问题:-与新的相关抵押品标准保持一致；-放射治疗新技术，包括立体定向放射外科（SRS）和立体定向放射治疗（SRT）、调强放射治疗（IMRT）、电子成像设备（如EPID）和移动射束放射治疗（动态治疗）。

IEC 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions:
- alignment with the new relevant collateral standards;
- new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).

标准预览图