CSA C22.2 NO. 60601-2-63:15 + A1:19 (CONSOLIDATED) (R2020)

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 the Canadian 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 generators and 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.