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

5.1        8

REVISION HISTORY OF THE TECHNICAL FILE

技术文件的修订记录