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Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
| 분야 | TC 62/SC 62B : Medical imaging equipment, software, and systems |
|---|---|
| 적용범위 | This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the risk management process. This collateral standard considers radiation protection aspects related to X-radiation only. Requirements for the control of the electrical energy used to generate X-radiation, which is also an important aspect of radiation protection, are included in IEC 60601-1 and in particular standards for the safety and essential performance of the equipment concerned. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C. |
| 국제분류(ICS)코드 |
13.280 : 방사능 보호
11.040.50 : 방사선 및 기타 진단 기기 |
| 페이지수 | 99 |
| Edition | 2.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-1-3:2008/AMD2:2021 | Amendment 2 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | 2021-01-26 | 표준 |
| 2 | IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 CSV | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | 2021-01-26 | 표준 |
| 3 | IEC 60601-1-3:2008/AMD1:2013 | Amendment 1 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | 2013-04-19 | 표준 |
| 4 | IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | 2013-04-19 | 표준 |
| 5 | IEC 60601-1-3:2008 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | 2008-01-22 | 표준 |
| 6 | IEC 60601-1-3:1994 | Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment | 1994-07-14 | 구판 |
IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs 상세보기
IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators 상세보기
IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment 상세보기
IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment 상세보기
IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems 상세보기
IEC 60601-2-65:2012+AMD1:2017+AMD2:2021 CSV - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment 상세보기
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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