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医疗器械指令技术文件的内容Content of Technical Files for Medical Devices(93/42/EEC指令) (Directive 93/42/EEC) 1、认证资料IDENTIFICATON DATA 制造商名称和地址Name and address of Manufacturer 公告机构名称和地址Name and address of Notify Body 证书形式Certificate Form 器械分类Device Classification 合格评定途径Conformity assessment route 2、产品一般描述GENERAL DESCRIPTION OF THE PRODUCT 介绍Introduction 使用目的Intended use 化验或测试或功能原理Principle of the assay or test or function 产品/设备/成套工具内容Content of products / devices / kits 成套工具/产品/设备保存期限Shelf-life of the kit / product / device 产品/材料/试剂的储存和稳定性Storage and stability of the products / materials / reagents 化验/测试程序Assay / Testing procedure 测试结果合格的标准Criteria of acceptability of the test results 结果的计算和解释Calculation and interpretation of results 化验/测试性能 – 灵敏性,特异性,再现性,稳定性Assay / Test performances–sensitivity, specificity, reproducibility, stability 限制和副作用Limits and side effects 3、协调标准REGULATORY STANDARDS APPLIED 应用规范/标准清单List of the applied norms / standards 关于指令附录I的核对清单Check list with respect to Annex I of Directive 4、危险分析RISK ANALYSIS 根据EN ISO 14971医疗器械的风险管理的应用Application of the risk management to medical devices according to EN ISO 14971 5、临床评估CLINICAL EVALUATION 6/文件清 |
