BS EN 60601-2-64:2015适用于灯的基本安全和基本性能 离子束医用电气设备，以下简称医用电气设备，用于治疗患者。如果某条款或子条款专门适用于医用电气设备，或 仅适用于ME系统，该条款或子条款的标题和内容将说明这一点。如果不是这样的话 在这种情况下，本条款或子条款适用于医用电气设备和医用电气系统（视情况而定）。本特殊标准（包括型式试验和现场试验）分别适用 用于人类医疗实践中放射治疗的光离子束医用电气设备的制造和某些安装方面，包括 操作参数的选择和显示可通过以下方式自动控制: 可编程电子子系统（PES），在正常使用情况下，提供一束光离子的辐射束，每个核子的能量在 10 MeV/n至500 MeV/n的范围，在正常使用前，在适当许可或合格的授权下运行 具有特定医疗应用所需技能的操作员， 为了特定的临床目的，按照 使用说明中给出的建议，须经合格人员定期进行质量保证性能和校准检查 人参考参考参考:IEC 60601-1-1 1-1 1:2:2012年1 1 1:2007 2007 2007年1:1 1:2005/1:2012 2年2 1:2012年10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1:2007 2007 2007 2007年1 1:2007 2007 2007年1 1 1:1 1:1参考参考参考参考参考参考:IEC 60601-1-1-1:1 1:2012年10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10:1-1-1-1-1:1 1:1:1:1:1-1-1-1:2006年10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10-1-1-1-1-1-1-1-1-1-1-1-1-1-1:2006 2006 2006 2006 2006 2006年1:1-1-1 1 1 EECICRU报告33:1980ICRU报告85a:2011购买本文件时，所有当前可用的修订均包含在购买本文件中。

BS EN 60601-2-64:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENTintended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n,andintended to befor NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS 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,subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.Cross References:IEC 60601-1-2:2014EN 60601-1-2:2014IEC 60601-1:2005IEC 60601-1:2005/A1:2012EN 60601-1:2006EN 60601-1:2006/Corrigendum 1:2010EN 60601-1:2006/A1:2013EN 60601-1:2006/A1:2013/Corrigendum 1:2014EN 60601-1:2006/A12:2014IEC 60601-2-1:2009IEC 60601-2-11:2013EN 60601-2-11:2015IEC/TR 60788:2004IEC 61217:2011EN 61217:2012ISO/IEC 14165-321:2009IEC 60601-2-68EN 60601-2-6893/42/EECICRU Report 33:1980ICRU Report 85a:2011All current amendments available at time of purchase are included with the purchase of this document.