Contents

內容

1.

Table of content

目錄

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

廠商

歐洲代表

產品的簡短描述

設計、生產場地

設計/生產/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.

產品描述

產品組描述

附件

預期用途

分類

符合性評審路徑

公告機構

適用的標準

符合性聲明

質量體系證書，批準等等

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

產品

符合基本需求

風險分析

生產過程

包裝規格

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

產品確認

穩定性研究

性能評估研究

自我測試器械

參考材料，校準和對照材料

安全測試

軟件驗證

QC/QA 過程

6

6.1

6.2

LABELING AND INSTRUCTION FOR USE

Labels

Instruction for use

標簽和使用說明書

標簽

使用說明書

7

LITERATURE, PUBLICATIONS

文獻，出版物

5.1        8

REVISION HISTORY OF THE TECHNICAL FILE

技術文件的修訂記錄