前言:这是CAN/CSA-C22的第一版。2编号60601-2-64，医用电气设备-第2-64部分:光离子束医用电气设备基本安全和基本性能的特殊要求，采用了标题相同的IEC（国际电工委员会）标准60601-2-64（第一版，2014-09），但有加拿大的偏差。这是CSA集团根据《加拿大电气规范》第二部分发布的一系列标准之一。为简洁起见，本标准将被称为“CAN/CSA”- C22。本标准旨在与CAN/CSA-C22.2第60601-1:14号《医用电气设备第1部分:基本安全和基本性能的一般要求》结合使用（采用IEC 60601-1:2005+A1:2012，有加拿大偏差）.201.1.1范围:本国际标准适用于用于治疗患者的光离子束医用电气设备（以下简称医用电气设备）的基本安全和基本性能。如果某一条款或子条款明确规定仅适用于医用电气设备，或仅适用于医用电气系统，则该条款或子条款的标题和内容应如此说明。 如果情况并非如此，则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，分别适用于人类医疗实践中用于放射治疗的光离子束医用设备的制造和某些安装方面，包括可编程电子子系统（PES）自动控制操作参数的选择和显示的标准，在正常使用中，发射每核子能量在10 MeV/n至500 MeV/n范围内的光离子辐射束，并预期正常使用，由具有特定医疗应用所需技能的操作员在适当许可或合格人员的授权下操作，按照使用说明中给出的建议维护特定的临床用途； 由合格人员定期进行质量保证性能和校准检查。注1:在本特定标准中，所有有关安装的参考均指责任机构中的安装？这是我的房子。注2:在本特定标准中，所有提及的吸收剂量均指水中的吸收剂量。注3:IEC 60601-2-68（正在开发）中提供了有关x射线图像引导的信息。注4:IEC 61217给出了医用电气设备运动的指定、刻度的标记、零位和运动方向的指南（见201）。 7.4.101）.201.1.2目的:本特定标准的目的是为10 MeV/n至500 MeV/n范围内的光离子束医用电气设备制定特定的基本安全和基本性能要求，并规定检查是否符合这些要求的试验。注:采用本标准有助于确保医用电气设备在医用电气设备移动和供电干线故障期间保持患者安全；提供预先选择的辐射类型、每个核子的能量、轻离子种类和吸收剂量； 通过使用光离子束修改设备等，向患者提供预先选择的光离子束，而不会对患者、操作员、其他人员或环境造成不必要的风险。

Preface:This is the first edition of CAN/CSA-C22.2 No. 60601-2-64,Medical electrical equipment — Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-64 (first edition, 2014-09). It is one in a series of Standards issued by CSA Group under Part II of theCanadian Electrical Code.For brevity, this Standard will be referred to as "CAN/CSA-C22.2 No. 60601-2-64" throughout.This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14,Medical electrical equipment — Part 1: General requirements for basic safety and essential performance(adopted IEC 60601-1:2005+A1:2012, with Canadian deviations).201.1.1 Scope:This International Standard 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 be for 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.NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION?S premises.NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development).NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their zero positions and the direction of movement with increasing value (see 201.7.4.101).201.1.2 Object:The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for LIGHT ION BEAM ME EQUIPMENT in the range 10 MeV/n to 500 MeV/n and to SPECIFY tests to check compliance to those requirements.NOTE The adoption of this standard helps to ensure that the ME EQUIPMENTmaintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS;delivers the pre-selected RADIATION TYPE, ENERGY PER NUCLEON, LIGHT ION species, and ABSORBED DOSE;delivers pre-selected LIGHT ION BEAMS to the PATIENT, by utilizing LIGHT ION BEAM modifying devices, etc., without causing unnecessary risk to the PATIENT, the OPERATOR, other persons or the environment.