IEC 60601-1: 3판이 적용된 진단용 X선장치 관련 개별규격의 동향 및 특징
Features and Trends of IEC Particular Standards for Medical Equipment Related to Diagnostic X-ray Based on IEC 60601-1:2005 Ed. 3.0
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초록
IEC 규격은 유럽, 일본 등 해외 여러 나라에서 자국의 규격으로서 이용되고 있으며, 우리나라에서는 현재 산업표준인 KS 형태와 더불어 강제성을 갖는 식품의약품안전청 고시로서도 발행되고 있다. 전자의료기기에 관한 IEC 규격인 IEC 60601 시리즈의 공통규격(IEC 60601-1:2005)이 3판으로 개정됨에 따라, 보조규격과 개별규격 또한 그에 맞추어 제․개정이 필요하다. IEC 규격의 변화 동향을 파악하는 것은 국내 의료기기 제조․수입업체 및 시험검사기관에서 매우 중요하다. 따라서 본 연구에서는, 진단용X선기기와 관련한 3개 규격 IEC 60601-2-44(CT의 기본안전과 필수성능에 관한 규격), IEC 60601-2-45(유방촬영용X선장치의 기본안전과 필수성능에 관한 규격), IEC 60601-2-54(진단용 X선장치의 기본안전과 필수성능에 관한 개별규격)에 대하여 IEC 60601-1의 3판에 맞추어 제·개정된 최신판의 동향 및 특징을 살펴보고자 하였다. 또한 현행 식품의약품안전청 고시가 IEC 60601-1의 2판이 적용된 개별규격을 참고로 하고 있어, 현행 식품의약품안전청 고시와 대비하여 그 특징을 살펴보았다. IEC 60601-1의 3판이 적용된 진단용X선장치 외 2개의 IEC 개별규격의 특징은 다음과 같다. 1) 기계적 위해요인, 특히 움직이는 부분에 대한 내용이 강화되었다. 2) 환자 선량을 표시 및 기록하도록 명시하고 있다. 3) 잠재적인 위험요소에 대해 체계적으로 관리가 가능한 위험관리 프로세스를 도입하고 있다. 4) 과거 Film-Screen System과 더불어 DR system(digital radiography system)에 대해서도 적용하고 있다. 현재 IEC 60601-1의 3판이 적용된 개별규격이 식품의약품안전청 고시로 개정될 예정이므로, 국내 시험 검사기관 및 의료기기 제조·수입업체 등에 유용한 자료가 되기를 기대한다.
Abstract
IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as industrial standards (KS) and notifications of Korea Food and Drug Administration (KFDA) in Korea. As the general standard of IEC 60601 series for medical electric (ME) equipment was revised as 3rd edition in 2005, additional and particular standards have been revised or established newly. Under these circumstances, it is importance for manufacturing and assembling companies or authorized testing companies to understand the trend for revisions of IEC publications. Therefore in this study, the latest version of 3 IEC standards related to medical X-ray equipment : IEC 60601-2-44 for X-ray equipment for computed tomography (CT), IEC 60601-2-45 for mammographic X-ray equipment and IEC 60601-2-54 for X-ray equipment for radiography or radioscopy were covered and analyzed for trends and features accompanied by revision based on IEC 60601-1 3rd Ed. As KFDA notifications in force have referred to the particular standards based on 2nd edition of IEC 60601-1, those revised version of 3 particular standards were compared to KFDA notifications in force. The features of the latest standards applying IEC 60601-1 3rd Ed were shown as following: 1) Requirements for mechanical hazards, especially (motorized) moving parts were emphasized. 2) Indication and recording of patient dose were required. 3) Risk management process was introduced and enabled to monitor potential risks systematically. 4) DR system (digital radiography system) as well as analogue system (film-screen system) was included in the scope. Presently, KFDA will revise the notifications applying the particular standards based on IEC 60601-1 3rd Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 3rd Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.
참고문헌 (9)
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- "식품의약품안전청 고시 제 2012-91호, 의료기기의 전기·기계적 안전에 관한 공통기준규격", ~ (2012)
- "식품의약품안전청 고시 제 2011-8호, 전자의료기기 기준규격", ~ (2011)
- "IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3rd Ed", ~ (2005)
- "IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests 3rd Ed", ~ (2007)
- "IEC 60601-1-3 General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment 2nd Ed", ~ (2008)
- "IEC 60601-2-44 Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography 3rd Ed", ~ (2009)
- "IEC 60601-2-45 Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic device 3rd Ed", ~ (2011)
- "IEC 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 1st Ed", ~ (2009)