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Medical electrical equipment - Diagnostics X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration
| 분야 | TC 62/SC 62B : Medical imaging equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60522-1:2020 applies to X-RAY TUBE ASSEMBLIES and to FILTERING MATERIAL, in medical diagnostic applications up to a HIGH VOLTAGE of 150 kV. For HIGH VOLTAGES greater than 50 kV, this document applies to X-RAY TUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only. IEC 60522-1:2021 defines the concept of PERMANENT FILTRATION of X-RAY TUBE ASSEMBLIES, and it defines the term FILTERING MATERIAL. Methods are given to determine the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY and for determining the QUALITY EQUIVALENT FILTRATION of FILTERING MATERIALS. It contains requirements for statements of compliance of X-RAY TUBE ASSEMBLIES in ACCOMPANYING DOCUMENTS and for markings on X-RAY TUBE ASSEMBLIES, and for indications and statements of compliance of FILTERING MATERIAL. IEC 60522-1:2020 cancels and replaces the second edition of IEC 60522 published in 1999. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the IEC 60522:1999: The scope of the IEC 60522-1 has been changed with respect to second edition of the IEC 60522 as follows: a) As radiotherapy standards do not reference IEC 60522, radiotherapy is no longer in the scope. Consequently, the HIGH VOLTAGE is limited to 150 kV, and copper is no longer used as reference material. b) While IEC 60522:1999 covers only PERMANENT FILTRATION, IEC 60522-1 also covers quite generally “material filtering the X-RAY BEAM incident on the PATIENT”. This concerns materials like ADDED FILTERS, table-tops, a breast COMPRESSION DEVICE, and materials in the BEAM LIMITING DEVICE. For these materials the defined term FILTERING MATERIAL has been introduced. c) In order to provide technical and scientific background and rationale on the content of IEC 60522-1, IEC TR 60522-2 was introduced. |
| 국제분류(ICS)코드 | 11.040.50 : 방사선 및 기타 진단 기기 |
| 페이지수 | 37 |
| Edition | 1.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60522-1:2020 | Medical electrical equipment - Diagnostics X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration | 2020-12-04 | 표준 |
IEC TR 60522-2:2020 - Medical electrical equipment - Diagnostics X-rays - Part 2: Guidance and rationale on quality equivalent filtration and permanent filtration 상세보기
IEC 82304-1:2016 - Health software - Part 1: General requirements for product safety 상세보기
IEC 60601-2-44:2009/AMD2:2016 - Amendment 2 - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography 상세보기
IEC 62220-1-1:2015 - Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging 상세보기
IEC 60613:2010 - Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis 상세보기
IEC TR 80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software 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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