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(jī)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 route
2/ 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 effects
3/ 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 Directive
4/ 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 14971
5/ 臨床評估CLINICAL EVALUATION
6/ 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 sheet
7/ 項目說明PROJECT DESCRIPTION
產(chǎn)品歷史History of the product
顧客投訴Complaints from customers
8/ 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 PRODUCT
10/ 與其他 MDD 指令的兼容性COMPATIBILITY WITH OTHER MDD
11/ 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, etc
12/ 穩(wěn)定性數(shù)據(jù)STABILITY DATA
13/ 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(hù)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(hù)Maintenance of the product
環(huán)境特征Characteristic of the environment
抽樣文件Documentation and lot samples
15/ 符合聲明DECLARATION OF CONFORMITY
制造商起草聲明Draft prepared by manufacturer
16/ 公告機(jī)構(gòu)同意宣告 DECLARATIOM OF AGREEMENT WITH NOTIFY BODY
