CE技术文档清单
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CE技术文档清单
Contents 内容
1. Table of content 目录
2.
2.1
2.2
2.3
2.4
2.5 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
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. 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
4
4.1
4.2
4.3
4.4
4.1 Product
4.2 Compliance with essential requirements
4.3 Risk Analysis
Manufacturing Process
Packaging specifications
产品
符合基本需求
风险分析
生产过程
包装规格
5
5.1
5.2
5.3
5.4
5.5
5.6
5.7
PRODUCT VERIFICATION
Stability studies
Performance evaluation studies
For self testing devices
Reference material, calibration and control materials
Safety testing
Software validation
QC / QA processes
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
6
6.1
6.2 LABELING AND INSTRUCTION FOR USE
Labels
Instruction for use 标签和使用说明书
标签
使用说明书
7 LITERATURE, PUBLICATIONS 文献,出版物
1 8 REVISION HISTORY OF THE TECHNICAL FILE 技术文件的修订记录