CE认证所需技术文档

Medical Devices

Technical File

Medical Device Documentation Form Sheet (G:\\GF6.1 System\\MDD\\Project\\2009\\CA\\大慧乳胶\\技术文档\\技术文档目录-客户.DOC) Rev.2

Table of Contents

1. Manufacturer Information (Name, Address, Telephone…)制造商信息 (公司名称、地址、联系方

式……)

2. *MDD Agreement (EU representative) MDD协议 (欧盟代表) 3. *EC Declaration of Conformity 欧盟符合性声明

4. Certificate of ISO 9001/2, EN 46001/2, 93/42/EEC MDD approvel ISO 9001/2, EN 46001/2, 93/42/EEC MDD 认证证书

5. Product Description (including Product group/ planned variations/photo) 产品描述 (产品系列、预计的型号、图片)

6. *Classification (according 93/42/EEC MDD Annex 9)(这个不用提供文件,在CE 声明上写清楚就 行了)

分类 (MDD 附录9) 7. Product Specification 产品技术规格

8. Technical Documents (drawings, production plans, component lists, labeling, Users manual / Instruction for Use, Sterile condition and method used, packaging materail evaluation, production environmental control program, biocompatibility evaluation, sterilization validation report)

技术文件 (图纸、生产计划、结构部件清单、标识(英文)、用户手册(英文)、使用说明书(英文)、

灭菌条件和方法、包装材料评估、生产环境控制程序、生物相容性评估、灭菌确认报告) 9. Certificate of Conformity (prodcut /material) 符合性证书 (产品/材料)

10. Test Reports (testing laboratories, reports) 测试报告 (实验室、报告)

11. *Essential Requirements (93/42/EEC MDD Annex 1) 基本要求 (93/42/EEC MDD 附录 1) 12. Risk Analysis 风险分析

13. The results of the design calculations and of the inspections carried out 设计计算和检查结果

14. Applicable standards (harmonized standards, international standards, partly applicable standards)

适用标准 (协调标准、国际标准、部分适用标准) 15. Literary study (Journal, Books, Internet, Magazines) 文献 (杂志, 书籍, 因特网, 期刊)

16. Clinical Evaluation: Literary review or Clinical Investigation (93/42/EEC MDD Annex 10)

临床评估: 文献评估或临床研究 (MDD附录10)

17. Vigilance System 警戒系统

注：带* 的项目莱茵公司可提供模板，其他项目可采用贵公司内部文件格式