| Publication CODE |
Title |
| IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 CSV (2021-05) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
408.00 €
|
95. |
Description
IEC 60601-2-63:2012+A1:2017+A2:2021 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. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental extra-oral x-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. 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.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Status |
IEC PUBLICATION |
| Situation |
Currently active
|
|
| Committee |
TC 62/SC 62B
DIAGNOSTIC IMAGING EQUIPMENT
|
| BEC Approval |
2021-05-12 |
| ICS-Code (International Standards Classification) |
11.040.50
|
| NBN Status |
New |
|
| IEC publication date |
2021-05-12 |
| IEC stability date |
2024-12-31 |
| IEC file modification date |
2021-05-12 |
| IEC last modification date |
2021-05-12 |
|
