IEC 60601-2-1:2020 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 60601-2-1:2020

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：2020-10-28

标准范围

IEC 60601-2-1:20 20适用于用于治疗患者的1 MeV至50 MeV范围内的电子加速器（以下简称ME设备）的基本安全和基本性能。注1:虽然用于治疗患者的电子加速器始终是ME设备，但在本文件中有时将其称为外部束设备（EBE）。EBE的使用并不消除对ME设备的要求，而是旨在澄清所讨论的ME设备是EBE，而不是可能是系统配置一部分的其他ME设备。本特定标准包括型式试验和现场试验，适用于电子加速器及其配套设备的制造和某些安装方面，这些设备用于提高治疗输送的精密度、准确度和体积靶向性-用于医疗实践中的放射治疗，包括治疗参数的选择和显示可由可编程电子子系统(PESS)自动控制的那些，-在正常条件和正常使用中，递送X射线或电子射线的辐射束，所述X射线或电子射线具有？标称能量在1MeV至50MeV范围内，？来自辐射源的ERP处的最大吸收剂量率在0,001 Gy x s-1和1 Gy x s-1之间，以及？距辐射源0.5米至2米之间的参考治疗距离；和-拟为？正常使用，在负责组织的授权下由获得适当执照或具有特定医疗应用所需技能的合格人员操作，用于特定指定的临床目的，？按照使用说明中给出的建议进行维护，以及？由合格人员定期进行质量保证性能和校准检查。IEC 60601-2-1:20 20取消并取代2009年发布的第三版和修正案1:20 14。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)与新的相关抵押品标准保持一致；b)增加计算机接口和控制；c)在放射治疗中增加新技术，包括？射束选通，以及？适应性放疗。

IEC 60601-2-1:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS.
NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery
– intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having
？ NOMINAL ENERGY in the range 1 MeV to 50 MeV,
？ maximum ABSORBED DOSE RATES between 0,001 Gy x s–1 and 1 Gy x s–1 at the ERP from the RADIATION SOURCE, and
？ REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE;
and
– intended to be
？ for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes,
？ maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
？ subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-1:2020 cancels and replaces the third edition published in 2009 and Amendment 1:2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new relevant collateral standards;
b) addition of computer interface and control;
c) addition of new technologies in RADIOTHERAPY, including
？ BEAM GATING, and
？ ADAPTIVE RADIOTHERAPY.

标准预览图