BS EN 60601-2-68:2015适用于X射线的基本安全和基本性能 基于图像引导的放射治疗设备，用于外束设备（EBE）。本特殊标准涵盖千伏（kV）和兆伏（MV）X射线的安全方面 与EBE具有已知几何关系的成像设备，用于IGRT。信息技术 涵盖外部光束设备之间的通信和关系 和X射线成像设备，连接或不直接连接，但处于同一辐射中 屏蔽区，仅用于外部光束设备。本特殊标准涉及实时X-IGRT、在线X-IGRT和离线X-IGRT设备 X-IGRT。它涵盖了减少过度依赖X的风险的程序- IGRT外束 系统（X-IGRT EBS）。例如，制造商将为 用户与系统建议的更正进行交互。如果条款或子条款特别适用于X-IGRT EBE系统 该条款或子条款的内容会这样说。如果情况并非如此，则该条款或子条款 仅适用于X-IGRT设备。本特殊标准（包括型式试验和现场试验）分别适用 向制造商和X-IGRT EBE系统的某些安装方面说明，该系统在正常使用之前，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，例如 特定的临床目的，例如。 g、 固定放射治疗还是移动放射治疗 放射治疗，按照使用说明中给出的建议进行维护，并由合格人员定期进行质量保证性能和校准检查 人参考参考:IEC 60601-1 1-1 1-3:参考参考:IEC 60601-1-1-1-3:3参考参考参考:IEC 60601-1:2010/AMD1:1:2012年3 IEC 60601-1:1 1:2005/AMD1:1:1:2005年1:1:1:1:1:1:1:1:1:1:1:1.6参考参考参考参考参考参考参考参考:IEC 60601 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007 2007年6 6 6 6 6 6 6.1:1:1:1:1:1:1.6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6.1:1:10 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 10 10:1:1:1:1:1:1-3:2008+corr.三月:2010年60601-1-6:2010EN 60601-1-6:2010+A1:2015EN 60601-1:2006EN 60601-1:2006+corr.三月:2010EN 60601-1:2006+A1:2013EN 60601-1:2006+A1/AC:2014EN 60601- 2009年10月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 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 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 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 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 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 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 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 1039:1985ICRU报告51:1993EN 60336:2005HD 60364-7-710:2012EN 60522:1999EN 62220-1:2004购买本文件时可获得的所有现行修订均包含在购买本文件中。

BS EN 60601-2-68:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE).This particular standard covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT.This particular standard deals with equipment for REAL-TIME X-IGRT, ONLINE X-IGRT and OFFLINE X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EXTERNAL BEAM SYSTEM (X-IGRT EBS). For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS the content of that clause or subclause will say so. If that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended 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, e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,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 60601-1-3:2008IEC 60601-1-6:2010IEC 60601-1-6:2010/AMD1:2013IEC 60601-1:2005IEC 60601-1:2005/AMD1:2012IEC 60601-2-1:2009IEC 60601-2-4:2010IEC 60601-2-44:2012IEC 60731:2011IEC/TR 60788:2004IEC 60976:2007IEC 61217:2011IEC 61223-3-5:2004IEC 61262-7:1995IEC 62083:2009IEC 62274:2005IEC 62366:2007IEC 62396-1:2012IEC 62563-1:2009EN 60601-1-3:2008EN 60601-1-3:2008+corr. March:2010EN 60601-1-6:2010EN 60601-1-6:2010+A1:2015EN 60601-1:2006EN 60601-1:2006+corr. March:2010EN 60601-1:2006+A1:2013EN 60601-1:2006+A1/AC:2014EN 60601-1:2006+A12:2014EN 60601-2-4:2011EN 60601-2-44:2009EN 60601-2-44:2009+A11:2011EN 60601-2-44:2009+A1:2012EN 60731:2012EN 60976:2007EN 61217:2012EN 61223-3-5:2004EN 61262-7:1995EN 62083:2009EN 62274:2005EN 62563-1:201093/42/EECIEC 60336:2005IEC 60364-7-710:2002IEC 60522:1999IEC TR 60977IEC 62220-1:2003ISO 9334:2012ICRP Publication 33:1982ICRP Publication 60:1991ICRU Report 35:1984ICRU Report 39:1985ICRU Report 51:1993EN 60336:2005HD 60364-7-710:2012EN 60522:1999EN 62220-1:2004All current amendments available at time of purchase are included with the purchase of this document.