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.
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.
Required fields are indicated with *
