• Title/Summary/Keyword: IEC 60601-2-54 X-ray equipment for radiography or radioscopy

Search Result 2, Processing Time 0.015 seconds

The Tendency of Medical Electrical Equipment - IEC 60601-2-54: Particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy (촬영 및 투시용 X선 장치의 기본안전과 필수 성능에 관한 개별 기준규격의 동향)

  • Roh, Young Hoon;Kim, Jung Min
    • Journal of radiological science and technology
    • /
    • v.38 no.4
    • /
    • pp.331-336
    • /
    • 2015
  • Medical electrical equipment - Part 1: General requirement for basic safety and essential performance of MFDS was revised as 3th edition and Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment will be expected to be announced as notification. Therefore this technical report was written to introduce provision of the particular requirements, replacement, addition, amendment. The purpose of this particular requirements is to secure requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy. X-ray high voltage generator, mechanical protective device, protection against radiation is included in this particular requirements. Medical electrical equipment - Part 1, Part 1-2, Part 1-3 is applied to this particular requirements. If the requirements is announced as notification, It is expected to widen understanding for basic safety and essential performance of X-ray equipment for radiography and radioscopy and play a part to internationalize of medical equipments.

Features and Trends of IEC Particular Standards for Medical Equipment Related to Diagnostic X-ray Based on IEC 60601-1:2005 Ed. 3.0 (IEC 60601-1: 3판이 적용된 진단용 X선장치 관련 개별규격의 동향 및 특징)

  • Kim, Hyun-Ji;Kim, Jung-Min;Choi, In-Seok;Yoon, Yong-Su;Seo, Deok-Nam;Kim, Jung-Su;Kim, Dae-Young;Park, Sung-Yong
    • Journal of radiological science and technology
    • /
    • v.36 no.1
    • /
    • pp.1-10
    • /
    • 2013
  • IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as in dustrial 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 $3^{rd}$ 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 $3^{rd}$ 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 $3^{rd}$ 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 $3^{rd}$ Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.