IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 CSV
Consolidated version
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Abstract
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.
- 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.
Additional information
Publication type | International Standard |
---|---|
Publication date | 2021-05-12 |
Edition | 1.2 |
Available language(s) | English, English/French |
TC/SC | TC 62/SC 62B - Medical imaging equipment, software, and systemsrss |
ICS | 11.040.50 - Radiographic equipment |
Stability date | 2024 |
Pages | 193 |
File size | 2528 KB |
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