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IEC 60601-2-63:2012+AMD1:2017 CSV
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment- 발행일 : 2017-07-07
- 발행기관 : IEC
상세정보
| 분야 | TC 62/SC 62B : Medical imaging equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-63:2012+A1:2017 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. This consolidated version consists of the first edition (2012) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication. |
| 국제분류(ICS)코드 | 11.040.50 : 방사선 및 기타 진단 기기 |
| 페이지수 | 184 |
| Edition | 1.1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-63:2012/AMD2:2021상세보기 | Amendment 2 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | 2021-05-12 | 표준 |
| 2 | IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 CSV상세보기 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | 2021-05-12 | 표준 |
| 3 | IEC 60601-2-63:2012/AMD1:2017상세보기 | Amendment 1 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | 2017-07-07 | 표준 |
| 4 | IEC 60601-2-63:2012+AMD1:2017 CSV상세보기 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | 2017-07-07 | 표준 |
| 5 | IEC 60601-2-63:2012상세보기 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | 2012-09-19 | 표준 |
관련상품
- IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
- IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment
- IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
- IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems
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