CE技术文档清单
1. 2. 2.1 2.2 2.3 2.4 2.5 Table of content Contents 目录 内容 General Information Manufacturer European Representative Short general description of the product Location of – design, -manufacturing facilities In case of contract design / manufacturing/sterilization 一般信息 厂商 欧洲代表 产品的简短描述 设计、生产场地 设计/生产/消毒的分承包方 产品描述 产品组描述 附件 预期用途 分类 符合性评审路径 公告机构 适用的标准 符合性声明 质量体系证书，批准等等 产品 符合基本需求 风险分析 生产过程 包装规格 产品确认 稳定性研究 性能评估研究 自我测试器械 参考材料，校准和对照材料 安全测试 软件验证 QC/QA 过程 标签和使用说明书 标签 使用说明书 文献，出版物 技术文件的修订记录 3 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 Product description Product family description Accessories Intended use Categorization Conformity assessment route Notified body Applicable standards Declaration of conformity Quality system certificate, approvals etc. 4 4.1 Product 4.1 4.2 Compliance with essential requirements 4.2 4.3 Risk Analysis 4.3 Manufacturing Process 4.4 Packaging specifications 5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 6 6.1 6.2 7 1 8 PRODUCT VERIFICATION Stability studies Performance evaluation studies For self testing devices Reference material, calibration and control materials Safety testing Software validation QC / QA processes LABELING AND INSTRUCTION FOR USE Labels Instruction for use LITERATURE, PUBLICATIONS REVISION HISTORY OF THE TECHNICAL FILE
CE技术文档清单
