北京生物醫(yī)學(xué)工程

基于行動(dòng)者網(wǎng)絡(luò)理論的中國(guó)醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)研究

Standardization development of medical devices in China based on the actor network theory

作者：杜然然歐陽(yáng)昭連郭柯磊池慧

單位：中國(guó)醫(yī)學(xué)科學(xué)院北京協(xié)和醫(yī)學(xué)院醫(yī)學(xué)信息研究所（北京 100020）

關(guān)鍵詞：醫(yī)療器械；標(biāo)準(zhǔn)化；行動(dòng)者網(wǎng)絡(luò)理論

分類(lèi)號(hào)：

出版年·卷·期（頁(yè)碼）：2012·31·2（208-212）

摘要：

目的對(duì)中國(guó)醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)進(jìn)行概念性梳理和動(dòng)力機(jī)制揭示，探討中國(guó)醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)中應(yīng)注意的問(wèn)題。方法以行動(dòng)者網(wǎng)絡(luò)理論(actor network theory，ANT)為視角，通過(guò)對(duì)中國(guó)醫(yī)療器械領(lǐng)域戰(zhàn)略性新興產(chǎn)業(yè)的標(biāo)準(zhǔn)化進(jìn)程進(jìn)行分析，構(gòu)建出標(biāo)準(zhǔn)化建設(shè)中的行動(dòng)者網(wǎng)絡(luò)框架，梳理醫(yī)療器械標(biāo)準(zhǔn)化進(jìn)程中的主要行動(dòng)者。結(jié)果理順了行動(dòng)者之間的普遍關(guān)系，歸納出當(dāng)前標(biāo)準(zhǔn)化建設(shè)中應(yīng)注意的重要問(wèn)題。結(jié)論基于ANT的中國(guó)醫(yī)療器械標(biāo)準(zhǔn)化建設(shè)研究為醫(yī)療器械標(biāo)準(zhǔn)化管理工作提供理論支持。

Objective The important issues in the process of standardization development of medical devices in China were discussed through the conceptual carding and the analysis of dynamic mechanism.Methods In the view of the actor network theory (ANT)，firstly，the standardization process of the strategic new industry in Chinese medical devices was discussed.Then the standardization framework of the actor network was constructed，the main actors in the standardization process of medical devices were organized.Results The general relationship of the main actors was recognized，and the important issues in the current standardization process were summarized.Conclusions The theoretical support for the standardization management of the medical devices was provided through the standardization development of medical devices in China based on the ANT.

參考文獻(xiàn)：

［1］張流波,全逸先.填補(bǔ)國(guó)際空白我國(guó)將出臺(tái)首個(gè)醫(yī)用清洗劑國(guó)家標(biāo)準(zhǔn)——訪《醫(yī)用清洗劑衛(wèi)生標(biāo)準(zhǔn)》主要起草人張流波［J］.中國(guó)衛(wèi)生標(biāo)準(zhǔn)管理,2010,1(3):45-46.
［2］母瑞紅,肖憶梅.我國(guó)醫(yī)療器械標(biāo)準(zhǔn)現(xiàn)狀分析與建議［J］.中國(guó)藥事,2011,25(7):657-658.
Mu RH,Xiao YM.Analysis on the current situations of medical device standards［J］.ChinesePharmaceuticalAffairs,2011,25(7):657-658.
［3］Callon M.Some elements of a sociology of transition：domestication of the scallops and fishermen of St.Brieuc Bay［C］,1986.
［4］Latour B.Science in Action：How to Follow Scientists and Engineers Through Society，Milton Keynes［M］.Freedom,Milton Keynes:Open University Press,1987.
［5］Latour BP.Action and Belief:A New Sociology of Knowledge［C］.London:Routledge and KeganPaul,1986:264-279.
［6］洪進(jìn),余文濤,汪凱.基于“行動(dòng)者網(wǎng)絡(luò)理論”的中國(guó)生物制藥產(chǎn)業(yè)技術(shù)的演化和治理研究［J］.中國(guó)科技論壇,2010,11(11):55-61.
［7］中國(guó)醫(yī)療器械行業(yè)協(xié)會(huì).協(xié)會(huì)簡(jiǎn)介［EB/OL］.（2011-09-20）.http://www.camdi.org.
［8］徐家新,趙女畫(huà).標(biāo)準(zhǔn)戰(zhàn)略研究［J］.蘭州學(xué)刊,2006（6）:125-126,181.
Xu JX,Zhao H.Research on standard strategy［J］.Lanzhou Academic Journal,2006（6）:125-126,181.
［9］Lyytinen K,King JL.Around the cradle of the wi reless revolution：the emergence and evolution of cellar telephony［J］.Telecommunications Policy,2002,26(3-4):97-100.
［10］龔艷萍,康瑛.行動(dòng)者網(wǎng)絡(luò)理論視角下的區(qū)域物流網(wǎng)絡(luò)研究［J］.價(jià)值工程，2011,30(13):29.
Gong YP,KANG Y.Research on regional logistics network from the perspective of actor network theory［J］.Value Engineering，2011,30(13):29.
［11］AAMI.AAMI簡(jiǎn)介［EB/OL］.（2011-09-15）.http://www.aami.org.
［12］梁曉婷.歐洲、美國(guó)、日本醫(yī)療器械標(biāo)準(zhǔn)管理及對(duì)我國(guó)的啟示［J］.中國(guó)醫(yī)療器械信息,2008(8):51-52.
Liang XT.Enlightenment for medical device standards administration in China from experiences of the EU,the USA and Japan［J］.China Medical Device Information,2008（8）:51-52.
［13］國(guó)家標(biāo)準(zhǔn)化管理委員會(huì)．國(guó)際標(biāo)準(zhǔn)化教程［M］．北京：中國(guó)標(biāo)準(zhǔn)出版社,2004：22-23.
Standardization Administration fo the People’s Republic of China.Guoji Biaozhun hua Jiaocheng［M］.Beijing：China Standard Publishing House,2004：22-23.

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