医用电气设备.医用电子加速器.功能特性

[中文适用范围]： 本国际标准适用于在人类医疗实践中用于治疗目的的医用电子加速器。本标准适用于医用电子加速器，其可提供 X 射线或电子辐射的辐射束，标称能量在 1 MeV 至 50 MeV 范围内，最大吸收剂量率在 1 时为 0.001 Gy s–1 至 1 Gy s–1 之间。距辐射源 50 厘米至 200 厘米的正常治疗距离。本标准描述了制造商在医用电子加速器的设计和制造阶段要执行的测量和测试程序，但没有指定在购买者现场安装后要执行的验收测试。然而，随附的报告 IEC 60977 确实表明许多测试程序适用于验收测试。本标准中描述的测量条件与以前使用的不同。这尤其适用于用于测量的 PHANTOM 位置以及距 ISOCENTRE 的距离测量。这些新条件应该取代而不是添加到以前的方法中。本标准规定了确定和披露功能性能特征的测试程序，这些知识被认为是正确应用和使用医用电子加速器所必需的，并且应在随附文件中声明，并连同最大偏差或变化一起声明。在正常使用的特定条件下预期。附录 A 中给出了功能性能值的表示格式。人们认识到，在评估性能时必须允许测试方法中的不准确性。然而，人们认为将这些错误合并到整体性能容差中并不可取，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抑制设备新设计的未来开发，这些设备可能具有与本文所述不同的操作模式和参数，只要此类设备在患者治疗方面达到同等的性能水平。除非另有说明，本标准假定医用电子加速器具有等中心龙门架。如果设备是非等中心的，则可能需要适当调整性能和测试方法的描述。注：符合本标准的声明并不一定意味着这些测试将或已经作为型式测试或单独测试应用。 [外文原描述]： 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.