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관심표준 등록 : 표준업데이트 시 알림서비스

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    IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 CSV

    Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    • 발행일 : 2021-05-12
    • 발행기관 : IEC
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분야 TC 62/SC 62B : Medical imaging equipment, software, and systems
적용범위 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.
국제분류(ICS)코드 11.040.50 : 방사선 및 기타 진단 기기
페이지수 193
Edition 1.2

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

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