Medical electrical equipment – Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral x-ray equipment

Clause 1 of the general standard applies, except as follows:

201.1.1 Scope

Replacement:

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.

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 DENTAL INTRA-ORAL RADIOGRAPHY