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现行 IEC 60976:2007
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Medical electrical equipment - Medical electron accelerators - Functional performance characteristics 医疗电子设备 - 医疗电子加速器 - 功能性能特征
发布日期: 2007-10-16
适用于医疗电子加速器,用于治疗目的,用于人类医疗实践。 本标准适用于医用电子加速器,该加速器在距离辐射源1m处,最大吸收剂量率在0001 Gy s-1和1 Gy s-1之间,在距离辐射源50 cm和200 cm之间的正常治疗距离下,以1 MeV至50 MeV的标称能量发射X射线或电子辐射束。 本标准描述了制造商在医用电子加速器设计和施工阶段进行的测量和试验程序,但未规定在买方现场安装后进行的验收试验。然而,随附的IEC 60977报告确实表明,许多试验程序适用于验收试验。 本标准中描述的测量条件与之前使用的测量条件不同。这尤其适用于测量的模型位置和距离等中心的测量。这些新条件应被取代,而不是添加到以前的方法中。 本标准规定了用于确定和披露功能性能特性的试验程序,认为正确应用和使用医用电子加速器需要了解这些特性,并在随附文件中声明这些特性,以及在正常使用的特定条件下预期的最大偏差或变化。功能性能值的表示格式见附录A。 人们认识到,在评估性能时,必须考虑测试方法中的不精确性。 然而,不建议将误差合并为整体性能公差,而是将它们分开,以期发展出更准确的测试方法。 本标准无意以任何方式阻止新设计设备的未来发展,这些设备可能具有不同于本文所述的操作模式和参数,前提是此类设备在治疗患者方面达到同等水平的性能。 除非另有说明,本标准假定医用电子加速器具有等中心机架。如果设备为非等中心设备,则可能需要对性能描述和试验方法进行适当调整。 第二版取消并取代1989年出版的第一版。 这是一项技术性修订。 第二版增加了与以下新技术相关的性能标准和测试方法: -动态束流传输技术,如移动束放射治疗、调强放射治疗(IMRT)、图像引导放射治疗(IGRT)和可编程楔形场; -立体定向放射治疗(SRT)/立体定向放射外科(SRS); -使用电子成像设备。 本标准以及IEC TR 60977应与IEC 60601-2-1一起阅读。
Applies to medical electron accelerators when used, for therapy purposes, in human medical practice. This standard applies to medical electron accelerators which deliver a radiation beam of either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source. The present standard describes measurements and test procedures to be performed by the manufacturer at the design and construction stage of a medical electron accelerator but does not specify acceptance tests to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for acceptance tests. The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the phantom position for measurements and the measurement of distances from the isocentre. These new conditions should be substituted for and not be added to previous methods. This standard specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical electron accelerator and which are to be declared in the accompanying documents together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of functional performance values is given in Annex A. It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved. It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment of patients. Except where otherwise stated this standard assumes that the medical electron accelerators have an isocentric gantry. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted. This second edition cancels and replaces the first edition published in 1989. It constitutes a technical revision. This second edition includes the addition of performance standards and test methods relating to the following new technologies: - dynamic beam delivery techniques, such as moving beam radiotherapy, intensity-modulated radiation therapy (IMRT), image-guided radiotherapy (IGRT) and programmable wedge fields; - stereotactic radiotherapy (SRT) / stereotactic radiosurgery (SRS); - use of electronic imaging devices. This standard, together with IEC TR 60977, should be read in conjunction with IEC 60601-2-1.
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归口单位: TC 62/SC 62C
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