北京生物醫(yī)學(xué)工程

醫(yī)用電氣設(shè)備漏電流風(fēng)險(xiǎn)管理

Risk Management of Medical Electrical Equipment Leakage Current

作者：彭安民胡兆燕

單位：上海醫(yī)療器械高等專(zhuān)科學(xué)校精密醫(yī)療器械系(上海 200093)

關(guān)鍵詞：漏電流；IEC60601-1；ISO14971；風(fēng)險(xiǎn)管理

分類(lèi)號(hào)：

出版年·卷·期（頁(yè)碼）：2011·30·6（638-642）

摘要：

目的根據(jù)IEC60601-1第3版的要求討論醫(yī)用電氣設(shè)備的漏電流危害及漏電流風(fēng)險(xiǎn)管理，為應(yīng)用醫(yī)用電氣設(shè)備的漏電流風(fēng)險(xiǎn)管理提供參考。方法首先闡述了醫(yī)用電氣設(shè)備的漏電流通用要求并分析了漏電流的危害，然后依據(jù)ISO 14971:2007和 IEC60601-1第3版等標(biāo)準(zhǔn)講述了醫(yī)用電氣設(shè)備的漏電流風(fēng)險(xiǎn)管理過(guò)程。結(jié)果醫(yī)用電氣設(shè)備的漏電流風(fēng)險(xiǎn)管理是醫(yī)用電氣設(shè)備風(fēng)險(xiǎn)管理的一個(gè)重要方面，應(yīng)用系統(tǒng)化的醫(yī)用電氣設(shè)備漏電流風(fēng)險(xiǎn)管理可以降低風(fēng)險(xiǎn)。結(jié)論醫(yī)用電氣設(shè)備符合IEC60601-1第3版要求即意味制造商有符合ISO14971規(guī)定的風(fēng)險(xiǎn)管理過(guò)程。在醫(yī)用電氣設(shè)備安全通用要求標(biāo)準(zhǔn)上，我國(guó)落后發(fā)達(dá)國(guó)家10年,等同采用IEC60601-1第3版作為強(qiáng)制性國(guó)家標(biāo)準(zhǔn)是當(dāng)務(wù)之急。

Objective The leakage current hazard and leakage current risk management of medical electrical equipment are discussed according to the requirements of the 3rd edition of IEC60601-1 for the application of medical electrical equipment leakage current risk management process for reference. Methods Firstly, general requirements for leakage current of medical electrical equipment are described and the leakage current hazards are analyzed, then medical electrical equipment leakage current risk management process is illustrated according to ISO14971:2007, IEC60601-1 3rd edition and other standards. Results Medical electrical equipment leakage current risk management is an important aspect of medical electrical equipment risk management. The systematic application of leakage current risk management process to medical electrical equipment can reduce the risk. Conclusions Medical electrical equipment meeting IEC60601-1 3rd edition requirements means that the manufacturers have applied the risk management process according with ISO14971 requirements. The general requirements for safety standard of medical electrical equipment in China are 10 years behind those in the developed countries.It is an urgent matter to make the IEC60601-1 3rd edition as a mandatory national standard.

參考文獻(xiàn)：

［1］國(guó)家食品藥品監(jiān)督管理局. YY/T 0316-2008/ISO14971:2007 醫(yī)療器械風(fēng)險(xiǎn)管理對(duì)醫(yī)療器械的應(yīng)用［S］.北京: 中國(guó)標(biāo)準(zhǔn)出版社, 2008:Ⅰ-Ⅱ.
［2］董放. 醫(yī)療器械風(fēng)險(xiǎn)管理及法規(guī)要求［J］. 中國(guó)藥物警戒, 2010, 7(5): 290-292.
［3］張素敏, 張亮. 國(guó)內(nèi)外醫(yī)療器械風(fēng)險(xiǎn)管理現(xiàn)狀分析［J］. 中國(guó)醫(yī)療器械雜志, 2010, 34(6): 442-444, 447.
［4］呂大雷, 李非, 魏晶, 等. 醫(yī)療器械生產(chǎn)企業(yè)對(duì)風(fēng)險(xiǎn)管理認(rèn)知程度的調(diào)查［J］. 中國(guó)執(zhí)業(yè)藥師, 2009，6 (7): 26-28.
［5］呂大雷, 楊?lèi)? 風(fēng)險(xiǎn)管理在我國(guó)醫(yī)療器械領(lǐng)域的應(yīng)用［D］．沈陽(yáng)：沈陽(yáng)藥科大學(xué)，2009: 3-12.

［6］International Electrotechnical Commission. IEC 60601-1:2005 Medical electrical equipment-part 1: General requirements for basic safety and essential performance［S］. Geneva: IEC Central Office, 2005: 21-28,79-81.
［7］中華人民共和國(guó)國(guó)家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局，中國(guó)國(guó)家標(biāo)準(zhǔn)化管理委員會(huì). GB9706.1-2007/IEC60601-1:1988醫(yī)用電氣設(shè)備第1部分: 安全通用要求［S］.北京: 中國(guó)標(biāo)準(zhǔn)出版社, 2008:25-40.
［8］鄒任玲,胡秀枋.醫(yī)用電氣安全工程［M］.南京：東南大學(xué)出版社, 2008: 40-46.
［9］國(guó)家食品藥品監(jiān)督管理局. 醫(yī)療器械警戒快訊2008, 8: ［EB/OL］. ［2003-03-12］.http://www.sda.gov.cn/WS01/CL0493/32758.html.
［10］國(guó)家食品藥品監(jiān)督管理局. 醫(yī)療器械警戒快訊2008，17：［EB/OL］［2011-04-11］. http://www.sda.gov.cn/WS01/CL0493/35051.html.

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