醫(yī)療器械指令技術(shù)文件的內(nèi)容
發(fā)布時間：2025-07-25 點擊：15
醫(yī)療器械指令技術(shù)文件的內(nèi)容
醫(yī)療器械指令技術(shù)文件的內(nèi)容Content of Technical Files for Medical Devices(93/42/EEC指令) (Directive 93/42/EEC)1/ 認(rèn)證資料IDENTIFICATON DATA制造商名稱和地址Name and address of Manufacturer公告機構(gòu)名稱和地址Name and address of Notify Body證書形式Certificate Form器械分類Device Classification合格評定途徑Conformity assessment route2/ 產(chǎn)品一般描述GENERAL DEscriptION OF THE PRODUCT介紹Introduction使用目的Intended use化驗或測試或功能原理Principle of the assay or test or function產(chǎn)品/ 設(shè)備 / 成套工具內(nèi)容Content of products / devices / kits成套工具 /產(chǎn)品 /設(shè)備保存期限Shelf-life of the kit / product / device產(chǎn)品 / 材料 / 試劑的儲存和穩(wěn)定性Storage and stability of the products / materials / reagents化驗 / 測試程序Assay / Testing procedure測試結(jié)果合格的標(biāo)準(zhǔn)Criteria of acceptability of the test results結(jié)果的計算和解釋Calculation and interpretation of results化驗 / 測試性能 – 靈敏性, 特異性,再現(xiàn)性, 穩(wěn)定性Assay / Test performances – sensitivity, specificity, reproducibility, stability限制和副作用Limits and side effects3/ 協(xié)調(diào)標(biāo)準(zhǔn)REGULATORY STANDARDS APPLIED應(yīng)用規(guī)范/標(biāo)準(zhǔn)清單List of the applied norms / standards關(guān)于指令附錄I的核對清單Check list with respect to Annex I of Directive4/ 危險分析RISK ANALYSIS根據(jù)EN ISO 14971醫(yī)療器械的風(fēng)險管理的應(yīng)用Application of the risk management to medical devices according to EN ISO 149715/ 臨床評估CLINICAL evalUATION6/ 文件清單document LIST標(biāo)簽圖Labeling plan包裝及包裝內(nèi)使用物Package insert產(chǎn)品技術(shù)表Technical sheet of product材料安全性數(shù)據(jù)表Material Safety data sheet7/ 項目說明PROJECT DEscriptION產(chǎn)品歷史History of the product顧客投訴Complaints from customers8/ 詳細(xì)原料清單DETAILED RAW MATERIAL LIST基本的原材料 / 試劑Strategic raw material / reagents人體組織材料Material of human origin材質(zhì)信息和危險性材料Information on substances and dangerous materials 9/ 產(chǎn)品說明書SPECIFICATIONS OD THE PRODUCT10/ 與其它MDD指令的兼容性COMPATIBILITY WITH OTHER MDD11/ 評估結(jié)果evalUATION RESULTS電氣安全, EMC, 生物化學(xué)性能, 毒性研究,生物適應(yīng)性, 等等Electric safety, EMC, biochemical performances, toxicity studies, bio-compatibility, etc12/ 穩(wěn)定性數(shù)據(jù)STABILITY DATA13/ 生產(chǎn)文件PRODUCTION documentS制造方法和程序標(biāo)準(zhǔn)Method of manufacture and procedures standards生產(chǎn)過程確認(rèn)Validation of the productive process設(shè)備清單List of the equipments程序維護和控制Program of maintenance and controls 14/質(zhì)量體系文件QUALITY SYSTEM documentS生產(chǎn)控制Control of production設(shè)備Equipments產(chǎn)品維護Maintenance of the product環(huán)境特征Characteristic of the environment抽樣文件documentation and lot samples15/ 符合聲明DECLARATION OF CONFORMITY制造商起草聲明Draft prepared by manufacturer16/ 公告機構(gòu)同意宣告DECLARATIOM OF AGREEMENT WITH NOTIFY BODY今天通過對《醫(yī)療器械指令技術(shù)文件的內(nèi)容》的學(xué)習(xí)，相信你對認(rèn)證有更好的認(rèn)識。如果要辦理相關(guān)認(rèn)證，請聯(lián)系我們吧。
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醫(yī)療器械指令技術(shù)文件的內(nèi)容Content of Technical Files for Medical Devices(93/42/EEC指令) (Directive 93/42/EEC)1/ 認(rèn)證資料IDENTIFICATON DATA制造商名稱和地址Name and address of Manufacturer公告機構(gòu)名稱和地址Name and address of Notify Body證書形式Certificate Form器械分類Device Classification合格評定途徑Conformity assessment route2/ 產(chǎn)品一般描述GENERAL DEscriptION OF THE PRODUCT介紹Introduction使用目的Intended use化驗或測試或功能原理Principle of the assay or test or function產(chǎn)品/ 設(shè)備 / 成套工具內(nèi)容Content of products / devices / kits成套工具 /產(chǎn)品 /設(shè)備保存期限Shelf-life of the kit / product / device產(chǎn)品 / 材料 / 試劑的儲存和穩(wěn)定性Storage and stability of the products / materials / reagents化驗 / 測試程序Assay / Testing procedure測試結(jié)果合格的標(biāo)準(zhǔn)Criteria of acceptability of the test results結(jié)果的計算和解釋Calculation and interpretation of results化驗 / 測試性能 – 靈敏性, 特異性,再現(xiàn)性, 穩(wěn)定性Assay / Test performances – sensitivity, specificity, reproducibility, stability限制和副作用Limits and side effects3/ 協(xié)調(diào)標(biāo)準(zhǔn)REGULATORY STANDARDS APPLIED應(yīng)用規(guī)范/標(biāo)準(zhǔn)清單List of the applied norms / standards關(guān)于指令附錄I的核對清單Check list with respect to Annex I of Directive4/ 危險分析RISK ANALYSIS根據(jù)EN ISO 14971醫(yī)療器械的風(fēng)險管理的應(yīng)用Application of the risk management to medical devices according to EN ISO 149715/ 臨床評估CLINICAL evalUATION6/ 文件清單document LIST標(biāo)簽圖Labeling plan包裝及包裝內(nèi)使用物Package insert產(chǎn)品技術(shù)表Technical sheet of product材料安全性數(shù)據(jù)表Material Safety data sheet7/ 項目說明PROJECT DEscriptION產(chǎn)品歷史History of the product顧客投訴Complaints from customers8/ 詳細(xì)原料清單DETAILED RAW MATERIAL LIST基本的原材料 / 試劑Strategic raw material / reagents人體組織材料Material of human origin材質(zhì)信息和危險性材料Information on substances and dangerous materials 9/ 產(chǎn)品說明書SPECIFICATIONS OD THE PRODUCT10/ 與其它MDD指令的兼容性COMPATIBILITY WITH OTHER MDD11/ 評估結(jié)果evalUATION RESULTS電氣安全, EMC, 生物化學(xué)性能, 毒性研究,生物適應(yīng)性, 等等Electric safety, EMC, biochemical performances, toxicity studies, bio-compatibility, etc12/ 穩(wěn)定性數(shù)據(jù)STABILITY DATA13/ 生產(chǎn)文件PRODUCTION documentS制造方法和程序標(biāo)準(zhǔn)Method of manufacture and procedures standards生產(chǎn)過程確認(rèn)Validation of the productive process設(shè)備清單List of the equipments程序維護和控制Program of maintenance and controls 14/質(zhì)量體系文件QUALITY SYSTEM documentS生產(chǎn)控制Control of production設(shè)備Equipments產(chǎn)品維護Maintenance of the product環(huán)境特征Characteristic of the environment抽樣文件documentation and lot samples15/ 符合聲明DECLARATION OF CONFORMITY制造商起草聲明Draft prepared by manufacturer16/ 公告機構(gòu)同意宣告DECLARATIOM OF AGREEMENT WITH NOTIFY BODY今天通過對《醫(yī)療器械指令技術(shù)文件的內(nèi)容》的學(xué)習(xí)，相信你對認(rèn)證有更好的認(rèn)識。如果要辦理相關(guān)認(rèn)證，請聯(lián)系我們吧。
六西格瑪——它并沒有你想象中那么復(fù)雜可怕
如何代辦ISO三體系認(rèn)證要什么條件
畜禽養(yǎng)殖有機食品文件
如何辦理AAA級信用企業(yè)等級證書低費用多少
綠色食品認(rèn)證申請人需要什么資質(zhì)
簽署商標(biāo)轉(zhuǎn)讓協(xié)議的注意事項有什么？
清潔服務(wù)認(rèn)證證書是屬于未列明證書嗎
集團公司推動知識產(chǎn)權(quán)貫標(biāo)工作之建議