CEI EN 60601-2-65

ENGLISH

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

The scope of this standard is restricted to X-RAY EQUIPMENT
where the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER
ASSEMBLY.

DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of
this standard

NOTE 1 The X-RAY GENERATOR in DENTAL INTRA-ORAL X-RAY EQUIPMENT
always comprises an X-RAY MONOBLOCK ASSEMBLY. Therefore in this
particular standard the concept of X-RAY TUBE ASSEMBLY is replaced
by that of X-RAY MONOBLOCK ASSEMBLY.

NOTE 2 Main components may be for instance the X-RAY MONOBLOCK
ASSEMBLY and an ELECTRONIC X-RAY IMAGE RECEPTOR.

NOTE 3 Photostimulated phosphor plates and their readers
(hardware and software) are excluded from the scope of this
particular standard, since they have no electrical APPLIED PARTS in
the PATIENT ENVIRONMENT, and are not ME EQUIPMENT.

ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC
60601-2-44, IEC 60601-2-54, IEC 60601-2-45 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 4 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
in 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 INTRA-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.