医疗器械指令技术文件的内容
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/ 文件清单document LIST
标签图Labeling plan
包装及包装内使用物Package insert
产品技术表Technical sheet of product
材料安全性数据表Material Safety data sheet
7/ 项目说明PROJECT DEscriptION
产品历史History of the product
顾客投诉Complaints from customers
8/ 详细原料清单DETAILED RAW MATERIAL LIST
基本的原材料 / 试剂Strategic raw material / reagents
人体组织材料Material of human origin
材质信息和危险性材料Information on substances and dangerous materials
9/ 产品说明书SPECIFICATIONS OD THE PRODUCT
10/ 与其它MDD指令的兼容性COMPATIBILITY WITH OTHER MDD
11/ 评估结果evalUATION RESULTS
电气安全, EMC, 生物化学性能, 毒性研究,生物适应性, 等等Electric safety, EMC, biochemical performances, toxicity studies, bio-compatibility, etc
12/ 稳定性数据STABILITY DATA
13/ 生产文件PRODUCTION documentS
制造方法和程序标准Method of manufacture and procedures standards
生产过程确认Validation of the productive process
设备清单List of the equipments
程序维护和控制Program of maintenance and controls
14/质量体系文件QUALITY SYSTEM documentS
生产控制Control of production
设备Equipments
产品维护Maintenance of the product
环境特征Characteristic of the environment
抽样文件documentation and lot samples
15/ 符合声明DECLARATION OF CONFORMITY
制造商起草声明Draft prepared by manufacturer
16/ 公告机构同意宣告DECLARATIOM OF AGREEMENT WITH NOTIFY BODY
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