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Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
| 분야 | TC 62/SC 62C : Equipment for radiotherapy, nuclear medicine and radiation dosimetry |
|---|---|
| 적용범위 | The use of afterloading equipment for brachytherapy purposes may expose patients to danger if the equipment fails to deliver the required dose to the patient, or if the equipment design does not satisfy standards of electrical and mechanical safety. The equipment may also cause danger to persons in the vicinity if the equipment itself fails to contain the radioactive source(s) adequately within the storage container(s) and/or if there are inadequacies in the design of the treatment room. This Particular Standard establishes requirements to be complied with by manufacturers in the design and construction of afterloading equipment for use in temporary brachytherapy procedures. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to return the radioactive source(s) to the storage container(s) and afterwards to prevent continued operation of the equipment. |
| 국제분류(ICS)코드 |
19.100 : 비파괴 시험 및 기구
11.040.60 : 치료장비 |
| 페이지수 | 69 |
| Edition | 2.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-17:2013 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment | 2013-11-27 | 표준 |
| 2 | IEC 60601-2-17:2004 | Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment | 2004-01-29 | 구판 |
| 3 | IEC 60601-2-17:1989/AMD1:1996 | Amendment 1 - Medical electrical equipment. Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray afterloading equipment | 1996-03-07 | 구판 |
| 4 | IEC 60601-2-17:1989 | Medical electrical equipment. Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray afterloading equipment | 1989-09-30 | 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
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