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. DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard Excluded from the scope of this standard is X-RAY EQUIPMENT where ACCESSIBLE PARTS may bear HIGH VOLTAGE in NORMAL USE. NOTE 101 As a consequence of the exclusion above, the X-RAY GENERATOR in DENTAL INTRA-ORAL X-RAY EQUIPMENT always comprises an X-RAY TUBE HEAD. Therefore in this particular standard the concepts of X-RAY SOURCE ASSEMBLY and of X-RAY TUBE ASSEMBLY are replaced by that of X-RAY TUBE HEAD and X-RAY MONOBLOCK ASSEMBLY. NOTE 102 Main components may be for instance the X-ray monoblock assembly and a electronic x-ray image receptor. NOTE 103 Photostimulated Phosphor Plates (CR) 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 no X-RAY EQUIPMENT. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC 60601-2-44, IEC 60601-159 2-54, IEC 60601-2-45 or IEC 60601-2-43 are excluded from the scope of this particular 160 standard. NOTE 104 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 163 edition scheme for DENTAL INTRA-ORAL X-RAY EQUIPMENT.