BS EN 60601-2-63:2015+A1:2019

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT.

Clause1 of the general standard 1 applies, except as follows: 201.1.1 Scope Replacement: 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. NOTE1 This includes panoramic equipment, cephalometric equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below. NOTE2 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. NOTE3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment). NOTE4 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. NOTE5 dental intra-oral X-ray equipment is excluded from the scope of this standard. NOTE6 Focal spot to image receptor distance and focal spot to object distance are preset in the design of dental extra-oral x-ray equipment. NOTE7 For dental X-ray equipment not in the scope of this document because of the restriction above, applicable clauses of IEC60601‑2‑54 may be used with this document. Me equipment and me systems in the scope of IEC60601‑2‑44, IEC60601‑2‑54, IEC60601‑2‑45, IEC60601‑2‑65 or IEC60601‑2‑43 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 IEC60601‑2‑7, Medical electrical equipment– Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC60601‑2‑32, Medical electrical equipment– Particular requirements for the safety of associated equipment of X-ray equipment. NOTE8 Requirements for X-ray generators and for associated equipment, which were previously specified in IEC60601‑2‑7 and IEC60601‑2‑32, have been included in either IEC60601‑1:2005 (Ed3) or this particular standard. Therefore IEC60601‑2‑7 and IEC60601‑2‑32 are not part of the IEC60601‑1 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 IEC60601‑2‑28 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. NOTE9 Requirements particular to dental x-ray-equipment which were included in previous editions of the collateral standard IEC60601‑1‑3 or the particular standard IEC60601‑2‑28 have been extracted and moved into this particular standard. NOTE10 For x-ray equipment in the scope of this particular standard X-ray tube assemblies are x-ray monoblock assemblies. 201.1.2 Object Replacement: The object of this particular standard is to establish particular basic safety and essential performance requirements for me equipment for extra-oral dental radiography. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause2 of the general standard and Clause201.2 of this particular standard. IEC60601‑1‑2 and IEC60601‑1‑3 apply as modified in Clause202 and 203 respectively. IEC60601‑1‑8, IEC60601‑1‑102), IEC60601‑1‑113) and IEC60601‑1‑124) do not apply. All other published collateral standards in the IEC60601‑1 series apply as published. NOTE operators of dental extra-oral X-ray equipment are used to audible signals as required in this particular standard rather than to the concepts of IEC60601‑1‑8. Therefore IEC60601‑1‑8 does not apply. 201.1.4 Particular standards Replacement: In the IEC60601 series, particular standards may modify, replace or delete requirements contained in the general standard or collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC60601‑1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC60601‑1‑2, 203 for IEC60601‑1‑3, etc. The term “this standard” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.