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Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
| 분야 | TC 62/SC 62B : Medical imaging equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-54:2009+A1:2015+A2:2018 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 1 (March 2010) and 2 (June 2011) have been included in this copy. This consolidated version consists of the first edition (2009), its amendment 1 (2015) and its amendement 2 (june 2018). Therefore, no need to order amendment in addition to this publication. |
| 국제분류(ICS)코드 | 11.040.50 : 방사선 및 기타 진단 기기 |
| 페이지수 | 321 |
| Edition | 1.2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 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
IEC 60601-2-28:2017 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis 상세보기
IEC 60601-2-45:2011+AMD1:2015 CSV - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 상세보기
IEC 62366-1:2015+AMD1:2020 CSV - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
ISO/TR 24971:2020 - Medical devices — Guidance on the application of ISO 14971 상세보기
ASTM D4332-14 REDLINE - Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing 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
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KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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