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분야 | TC 62/SC 62B : Medical imaging equipment, software, and systems |
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적용범위 | IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. The contents of the corrigenda of March 2010 and June 2011 have been included in this copy. |
국제분류(ICS)코드 | 11.040.50 : 방사선 및 기타 진단 기기 |
페이지수 | 141 |
Edition | 1.0 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | IEC 60601-2-54:2022 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2022-09-26 | 표준 |
2 | IEC 60601-2-54:2022 RLV | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2022-09-26 | 표준 |
3 | IEC 60601-2-54:2009+AMD1:2015+AMD2:2018 CSV | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2018-06-29 | 구판 |
4 | IEC 60601-2-54:2009/AMD2:2018 | Amendment 2 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2018-06-29 | 구판 |
5 | IEC 60601-2-54:2009/AMD1:2015 | Amendment 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2015-04-17 | 구판 |
6 | IEC 60601-2-54:2009+AMD1:2015 CSV | Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy | 2015-04-17 | 구판 |
7 | IEC 60601-2-54:2009/COR2:2011 | Corrigendum 2 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2011-06-10 | 구판 |
8 | IEC 60601-2-54:2009/COR1:2010 | Corrigendum 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2010-03-10 | 구판 |
9 | IEC 60601-2-54:2009 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 2009-06-29 | 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
KS C IEC 60601-2-65 - 의료용 전기기기 — 제2-65부: 치과용 구강내 엑스선 장치의 기본 안전과 필수 성능에 관한 개별 요구사항 상세보기
KS P IEC 62366-1 - 의료기기 — 제1부:의료기기에 대한 사용성 공학 적용 상세보기
KS C IEC 60601-2-54 - 의료용 전기기기 — 제2-54부: 촬영 및 투시용 X선 장치의 기본안전과 필수성능에 관한 개별 요구사항 상세보기
KS C IEC 61223-3-1 - 의료 영상 진단실의 평가 및 일상 시험-제3-1부:인수 시험-촬영용 및 투시용 X선 장치의 영상 성능 상세보기
IEC 60601-2-40:2016 - Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment 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