CSA序言这是CAN/CSA-C22的合并版2.2。2第60601-2-43号，医用电气设备-第2-43部分:介入手术用X射线设备基本安全和基本性能的特殊要求，采用相同名称的IEC（国际电工委员会）标准60601-2-43（版本2:2010，合并修订件1:2017和修订件2:2019），但有加拿大的偏差。它取代了2003年作为CAN/CSA-C22出版的第一版。2编号60601-2-43（采用IEC 60601-2-43:2000）。它是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，包括修改件1:2012，但有加拿大偏差）.如果本合并版与出版版及其修订版之间存在差异，则以这些文件为准。本标准适用于本标准规定范围内的合格评定。本标准的制定符合加拿大标准委员会对加拿大国家标准的要求。CSA集团已将其作为国家标准发布。 范围和目的通用标准1）第1条适用，但以下情况除外:201.1.1*范围更换:本国际标准适用于制造商宣布适用于放射引导介入手术的固定和移动X射线设备（以下简称介入X射线设备）的基本安全和基本性能。其范围尤其不包括:放射治疗设备计算机断层摄影设备；-拟引入患者体内的附件；-乳房X光设备牙科X射线设备。注1:放射镜引导下的介入手术示例，其中使用介入X- 建议使用符合本标准的射线设备，见附录AA。注2:本特殊标准未考虑磁导航设备和手术室环境下使用介入性X射线设备的具体要求；因此，没有针对这些设备或用途制定具体要求。在任何情况下，此类装置或用途仍符合通用条款要求。注3:当用于锥束CT模式时，介入X射线设备受本标准而非IEC 60601-2-44[2]2的保护。本标准未确定锥束CT模式下操作的额外要求（另见203.6.4.5中的注释4）。介入X- 制造商声明适用于放射镜引导的介入手术的射线设备（不包括作为系统一部分的患者支持）不受本标准患者支持条款的约束。如果某一条款或子条款专门适用于介入性X射线设备，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。如果不是这样，本条款或子条款适用于介入X射线设备和医用电气系统（视情况而定）。注4:另见通用标准的4.2。本标准的子条款取代IEC 60601-2-54子条款。IEC 60601-2-54仅适用于所引用的子条款； IEC 60601-2-54中未引用的子条款不适用。201.1.2物体更换:本特殊标准的目的是:-为设计和制造用于放射引导介入手术的X射线设备，制定特殊的基本安全和基本性能要求，如201.3.203所定义。-明确此类介入X射线设备应提供的信息，以协助责任机构和运营商管理这些程序可能影响患者或员工的辐射风险和设备故障风险。

CSA PrefaceThis is consolidated edition 2.2 of CAN/CSA-C22.2 No. 60601-2-43, Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-43 (edition 2:2010 consolidated with Amendment 1:2017 and Amendment 2:2019). It supersedes the first edition, published in 2003 as CAN/CSA-C22.2 No. 60601-2-43 (adopted IEC 60601-2-43:2000). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as "CAN/CSA-C22.2 No. 60601-2-43" 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, including Amendment 1:2012, with Canadian deviations). Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence.This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard by CSA Group.Scope and objectClause 1 of the general standard1) applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:- equipment for RADIOTHERAPY;- equipment for COMPUTED TOMOGRAPHY;- ACCESSORIES intended to be introduced into the PATIENT;- mammographic X-RAY EQUIPMENT;- dental X-RAY EQUIPMENT.NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA.NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements.NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5). INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard. If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY 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 INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.NOTE 4 See also 4.2 of the general standard. The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply. 201.1.2 Object Replacement: The object of this particular standard is:- to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the design and manufacture of X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, as defined in 201.3.203.- to specify information which is to be provided with such INTERVENTIONAL X-RAY EQUIPMENT for the assistance of the RESPONSIBLE ORGANIZATION and OPERATOR in managing the RADIATION RISK and equipment failure RISK arising from these procedures which could affect PATIENTS or staff.