CAN/CSA C22.2 NO. 60601-2-43:11+A1:19+A2:21(R2021) Historical

CSA Preface 

This 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 object 

Clause 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.