Contents

內(nèi)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(chǎn)品的簡短描述

設(shè)計(jì)、生產(chǎn)場地

設(shè)計(jì)/生產(chǎn)/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(chǎn)品描述

產(chǎn)品組描述

附件

預(yù)期用途

分類

符合性評審路徑

公告機(jī)構(gòu)

適用的標(biāo)準(zhǔn)

符合性聲明

質(zhì)量體系證書，批準(zhǔn)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(chǎn)品

符合基本需求

風(fēng)險(xiǎn)分析

生產(chǎn)過程

包裝規(guī)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(chǎn)品確認(rèn)

穩(wěn)定性研究

性能評估研究

自我測試器械

參考材料，校準(zhǔn)和對照材料

安全測試

軟件驗(yàn)證

QC/QA 過程

6

6.1

6.2

LABELING AND INSTRUCTION FOR USE

Labels

Instruction for use

標(biāo)簽和使用說明書

標(biāo)簽

使用說明書

7

LITERATURE, PUBLICATIONS

文獻(xiàn)，出版物

5.1        8

REVISION HISTORY OF THE TECHNICAL FILE

技術(shù)文件的修訂記錄