前言:这是CAN/CSA-C22的合并版1.1。2第60601-2-63号，医用电气设备-第2-63部分:口腔外X射线设备基本安全和基本性能的特殊要求，采用了相同名称的IEC（国际电工委员会）标准60601-2-63（第1:2012版合并修订件1:2017），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。本标准拟与CAN/CSA-C22结合使用。2 No.60601-1:14，医用电气设备-第1部分:基本安全和基本性能的一般要求（采用IEC 60601-1:2005，包括修改件1:2012，带有加拿大偏差）。 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:201.1.1范围:本国际标准适用于口腔外X射线设备（以下简称ME设备）的基本安全和基本性能。范围包括包含此类医用电气设备的医用电气系统。注1:这包括以下201.3.203中定义的全景设备、头影测量设备和牙科容积重建设备（以下简称DVR）。注2:DVR包括牙科CBCT（锥束计算机断层扫描），在世界某些地区也与其他名称一起使用，例如:。 g、 数字体层摄影术；DVR还包括tomosynthesis。注3:这可能包括牙齿治疗（如正畸治疗）所需的其他解剖部位（如手）的成像。注4:这可能包括耳鼻喉科专家感兴趣的解剖对象。本标准的范围仅限于X射线设备，其中:-X射线管组件包含高压变压器组件和 -X射线源、在患者体内成像的解剖对象和X射线图像接收器之间的几何关系在设计中是预先设定的，操作员在预期使用期间不能随意更改。注5:口腔内X射线设备不在本标准范围内。注6:焦点到图像接收器的距离和焦点到物体的距离在牙科治疗仪的设计中预设- 口腔X光设备。注7:对于因上述限制而不在本文件范围内的牙科X射线设备，IEC 60601-2-54的适用条款可与本文件一起使用。IEC 60601-2-44、IEC 60601-2-54、IEC 60601-2-45、IEC 60601-2-65或IEC 60601-2-43范围内的医用电气设备和医用电气系统不在本特定标准的范围内。本国际标准的范围也不包括用于骨或组织吸收密度测定的放疗模拟器和设备。不包括用于牙科放射检查的医用电气设备。在其特定范围内，本特殊标准的条款取代并取代IEC 60601-2-7《医用电气设备-高压电缆安全的特殊要求》- 诊断X射线发生器的电压发生器和IEC 60601-2-32《医用电气设备——X射线设备相关设备安全的特殊要求》。注8:先前在IEC 60601-2-7和IEC 60601-2-32中规定的X射线发生器和相关设备的要求已包含在IEC 60601-1:2005（Ed3）或本特定标准中。因此，IEC-6067-01和IEC-6062-01第3版不是口腔设备IEC-6062的额外版本。本标准涵盖了集成X射线管组件的所有要求。因此，IEC 60601-2-28不适用于本国际标准范围内的医用电气设备，但现场可更换的X射线管组件除外。 注9:附带标准IEC 60601-1-3或特定标准IEC 60601-2-28之前版本中包含的牙科X射线设备的特定要求已被提取并移至本特定标准中。注10:对于本特定标准范围内的X射线设备，X射线管组件为X射线整体组件。201.1.2目的:本特定标准的目的是为口腔外牙科X射线照相用医用电气设备制定特定的基本安全和基本性能要求。

Preface:This is consolidated edition 1.1 of CAN/CSA-C22.2 No. 60601-2-63,Medical electrical equipment — Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-63 (edition 1:2012 consolidated with Amendment 1:2017). It is one in a series of Standards issued by CSA Group under Part II of theCanadian Electrical Code.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 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 object:201.1.1 Scope:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT.NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below.NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis.NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment).NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist.The scope of this standard is restricted to X-RAY EQUIPMENT where:- the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and - the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be arbitrarily altered by the OPERATOR during INTENDED USE.NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard.NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT.NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above, applicable clauses of IEC 60601-2-54 may be used with this document.ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY.Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7,Medical electrical equipment — Particular requirements for the safety of high-voltage generators of diagnostic X-ray generatorsand of IEC 60601-2-32,Medical electrical equipment — Particular requirements for the safety of associated equipment of X-ray equipment.NOTE 8 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT.All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field.NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into this particular standard.NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY MONOBLOCK ASSEMBLIES.201.1.2 Object:The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ME EQUIPMENT for EXTRA-ORAL DENTAL RADIOGRAPHY.