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Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment
| 분야 | TC 62/SC 62B : Medical imaging equipment, software, and systems |
|---|---|
| 적용범위 | IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016. IEC 60601-2-44 and this document • defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3, • defines the methods of testing the essential parameters, and • evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS. The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER. This document does not apply to • aspects of mechanical and electrical safety, and • aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning. IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6: 1) modification of the RADIATION protection and control; 2) modification of the acceptance testing; 3) introduction of constancy testing. The contents of the corrigendum of June 2022 have been included in this copy. |
| 국제분류(ICS)코드 | 11.040.50 : 방사선 및 기타 진단 기기 |
| 페이지수 | 126 |
| Edition | 2.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 61223-3-5:2019/COR1:2022 | Corrigendum 1 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment | 2022-06-08 | 표준 |
| 2 | IEC 61223-3-5:2019 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment | 2019-09-16 | 표준 |
| 3 | IEC 61223-3-5:2004/COR1:2006 | Corrigendum 1 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment | 2006-03-24 | 구판 |
| 4 | IEC 61223-3-5:2004 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment | 2004-08-23 | 구판 |
IEC TS 61223-1:1993 - Evaluation and routine testing in medical imaging departments - Part 1: General aspects 상세보기
IEC TS 61223-2-1:1993 - Evaluation and routing testing in medical imaging departments - Part 2-1: Constancy tests - Film processors 상세보기
IEC TS 61223-2-2:1993 - Evaluation and routine testing in medical imaging departments - Part 2-2: Constancy tests - Radiographic cassettes and film changers - Film-screen contact and relative sensitivity of the screen-cassette assembly 상세보기
IEC TS 61223-2-3:1993 - Evaluation and routine testing in medical imaging departments - Part 2-3: Constancy tests - Darkroom safelight conditions 상세보기
IEC 61223-2-4:1994 - Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras 상세보기
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
IEC 61223-3-4:2000 - Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment 상세보기
IEC 62304:2006 - Medical device software - Software life cycle processes 상세보기
IEC 60601-2-18:2009 - Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment 상세보기
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 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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