CE技术文档清单

Telefax Page 3 of 3TV Rheinland (Shanghai) Co., Ltd.5/6F, Azia Center, No. 1233, Lujiazui Ring Road, Pudong District, Shanghai, P.R. ChinaTel.:+86 21 6108 1188Fax: +86 21 6108 1199 Mail: Web: 莱茵技术（上海）有限公司上海市浦东新区陆家嘴环路1233号汇亚大厦5、6层邮编： 电话:+86 21 6108 1188传真: +86 21 6108 1199 电邮: 网站: CE技术文档须知Contents of Technical FileContents NotesPart A1Name, Postal Address of Manufacturer /EU Representive2A listing of all manufacturing sites covered by the quality system3Product description3.1Product name, classification of the device and accessories3.2List of accessories (if applicable)3.3Specification, model and article numbers3.4Chosen conformity assessment path3.5Intended use3.6Integral parts of the sales unit3.7A brief product history (including existing regulatory approvals)4List of harmonized standardsSatisfy the Annex I5Essential Requirements checklistthe solutions adopted to satisfy the Essential Requirements(template, English version)6Overall manufacturing and inspection plan of the product7Risk analysisEN ISO 14971:2007(template, English version)8Clinical reportDetailed see in Part B9Labelling, inl. Product labels and package labels(English version)10Instruction for use, patient information, advertising material(English version)11Declaration of conformity(template, English version)Part B12Information concerning the quality system specific to the product13Detailed descriptions of the product13.1Design drawings and product specifications13.2Packaging and specification(English version)13.3Description of the manufacturing processesDrawings, qualification, Labeling control, Traceability,Product and environmental bioburden particles, Pyrogene testing, Preventive monitoring of processes (i.e. SPC), Viral- Prion Desactivation steps etc.13.4Raw materials and suppliers14Test, verification and evaluation report14.1Sterile method and validationIQ/OQ/PQ14.2Packaging verification (if applicable)Incl. package expired date14.3Chemical, physical and biology test, verification and evaluation report15Clinical datasThe critical report must be in Part A of the Technical File. The publications quoted in the report must be available in Part B of the Technical File as original documents, reprints or copies.15.1Preclinical Evaluation, Expert Opinions15.2Clinical plan15.3Clinical datas15.4Clinical Summary, Expert Opinions15.5Clinical report15.6Relevant Literature技 术 文 档 的 内 容内 容 备 注Part A1制造商和 欧洲代表的名字、地址2质量体系所涉及的全部制造场所清单3产品描述3.1产品名字、器械及附件的分类3.2产品附件清单（适用时）3.3规格、型号及货号3.4符合性评价路径3.5预期用途描述3.6主要的销售单元（适用时）3.7简要的产品历史（包括现有的管理审批）4适用的标准清单符合医疗器械指令附录I5基本要求检查表符合医疗器械指令附录I的方案(有固定模板，需提交英文文件)6产品的总体生产或质量控制方案7风险分析EN ISO 14971:2007有固定模板，需提交英文文件8临床报告详细的临床数据见Part B9标签，包括产品标签、包装标签(需提交英文文件)10使用说明、患者信息、广告材料(需提交英文文件)11符合性声明(有固定模板，需提交英文文件)Part B12与产品有关的质量体系的信息13详细的产品描述13.1设计图及产品技术规范13.2包装条件及规格(需提交英文文件)13.3生产过程描述包括流程图、资格确认、标签控制、追溯性、产品及生产环境控制、过程的预防监控、消毒或防护过程等13.4原材料和供方14试验、验证及评估报告14.1灭菌方法和验证的概述，灭菌证书（适用时）IQ/OQ/PQ14.2包装验证（适用时）包