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Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
| 분야 | TC 62/SC 62B : Medical imaging equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-43:2010+A1:2017+A2:2019 establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration. This consolidated version consists of the second edition (2010), its amendment 1 (2017) and its amendment 2 (2019). Therefore, no need to order amendment in addition to this publication. |
| 국제분류(ICS)코드 | 11.040.50 : 방사선 및 기타 진단 기기 |
| 페이지수 | 264 |
| Edition | 2.2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-43:2022 | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | 2022-12-05 | 표준 |
| 2 | IEC 60601-2-43:2022 RLV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | 2022-12-05 | 표준 |
| 3 | IEC 60601-2-43:2010/AMD2:2019 | Amendment 2 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | 2019-10-16 | 구판 |
| 4 | IEC 60601-2-43:2010+AMD1:2017+AMD2:2019 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | 2019-10-16 | 구판 |
| 5 | IEC 60601-2-43:2010+AMD1:2017 CSV | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | 2017-05-31 | 구판 |
| 6 | IEC 60601-2-43:2010/AMD1:2017 | Amendment 1 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | 2017-05-31 | 구판 |
| 7 | IEC 60601-2-43:2010 | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | 2010-03-25 | 구판 |
| 8 | IEC 60601-2-43:2000 | Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures | 2000-06-30 | 구판 |
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