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CE技术文档清单(中英文)
 

Contents of Technical File

Contents

 Notes

Part A

1

Name, Postal Address of Manufacturer /EU Representive

2

A listing of all manufacturing sites covered by the quality system

3

皇冠篮球比分网Product description

3.1

Product name, classification of the device and accessories

3.2

皇冠篮球比分网List of accessories (if applicable)

3.3

Specification, model and article numbers

3.4

Chosen conformity assessment path

3.5

Intended use

3.6

皇冠篮球比分网Integral parts of the sales unit

3.7

A brief product history (including existing regulatory approvals)

4

皇冠篮球比分网List of harmonized standards

Satisfy the Annex I

5

Essential Requirements checklist

皇冠篮球比分网the solutions adopted to satisfy the Essential Requirements

皇冠篮球比分网(template, English version)

6

Overall manufacturing and inspection plan of the product

7

Risk analysis

EN ISO 14971:2007

(template, English version)

8

Clinical report

皇冠篮球比分网Detailed  see in Part B

9

Labelling, inl. Product labels and package labels

皇冠篮球比分网(English version)

10

Instruction for use, patient information, advertising material

(English version)

11

Declaration of conformity

皇冠篮球比分网(template, English version)

Part B

12

Information concerning the quality system specific to the product

13

Detailed descriptions of the product

13.1

皇冠篮球比分网Design drawings and product specifications

13.2

皇冠篮球比分网Packaging and specification

(English version)

13.3

Description of the manufacturing processes

Drawings, qualification, Labeling control, Traceability,Product and environmental bioburden particles, Pyrogene testing, Preventive monitoring of processes (i.e. SPC), Viral- Prion Desactivation steps etc.

13.4

皇冠篮球比分网Raw materials and suppliers

14

Test, verification and evaluation report

14.1

Sterile method and validation

IQ/OQ/PQ

14.2

皇冠篮球比分网Packaging verification (if applicable)

皇冠篮球比分网Incl. package expired date

14.3

皇冠篮球比分网Chemical, physical and biology test, verification and evaluation report

15

Clinical datas

皇冠篮球比分网The critical report must be in Part A of the Technical File.  The publications quoted in the report must be available in Part B of the Technical File as original documents, reprints or copies.

15.1

皇冠篮球比分网Preclinical Evaluation, Expert Opinions

15.2

Clinical plan

15.3

Clinical datas

15.4

Clinical Summary, Expert Opinions

15.5

Clinical report

15.6

Relevant Literature


皇冠篮球比分网技 术 文 档 的 内 容

NEI     RONG

 BEI     ZHU

Part A

1

ZHIZAOSHANGHE OUZHOUDAIBIAODEMINGZI、DIZHI

2

皇冠篮球比分网ZHILIANGTIXISUOSHEJIDEQUANBUZHIZAOCHANGSUOQINGDAN

3

CHANPINMIAOSHU

3.1

CHANPINMINGZI、QIXIEJIFUJIANDEFENLEI

3.2

CHANPINFUJIANQINGDAN(SHIYONGSHI)

3.3

GUIGE、XINGHAOJIHUOHAO

3.4

FUHEXINGPINGJIALUJING

3.5

YUQIYONGTUMIAOSHU

3.6

ZHUYAODEXIAOSHOUDANYUAN(SHIYONGSHI)

3.7

皇冠篮球比分网JIANYAODECHANPINLISHI(BAOKUOXIANYOUDEGUANLISHENPI)

4

SHIYONGDEBIAOZHUNQINGDAN

符合医疗器械指令附录I

5

JIBENYAOQIUJIANCHABIAO

符合医疗器械指令附录I的方案

(有固定模板,需提交英文文件)

6

CHANPINDEZONGTISHENGCHANHUOZHILIANGKONGZHIFANGAN

7

FENGXIANFENXI

EN ISO 14971:2007

YOUGUDINGMOBAN,XUTIJIAOYINGWENWENJIAN

8

LINCHUANGBAOGAO

详细的临床数据见Part B

9

皇冠篮球比分网BIAOQIAN,BAOKUOCHANPINBIAOQIAN、BAOZHUANGBIAOQIAN

(需提交英文文件)

10

皇冠篮球比分网SHIYONGSHUOMING、HUANZHEXINXI、GUANGGAOCAILIAO

(需提交英文文件)

11

FUHEXINGSHENGMING

(有固定模板,需提交英文文件)

皇冠篮球比分网Part B

12

皇冠篮球比分网YUCHANPINYOUGUANDEZHILIANGTIXIDEXINXI

13

XIANGXIDECHANPINMIAOSHU

13.1

SHEJITUJICHANPINJISHUGUIFAN

13.2

BAOZHUANGTIAOJIANJIGUIGE

(需提交英文文件)

13.3

SHENGCHANGUOCHENGMIAOSHU

皇冠篮球比分网BAOKUOLIUCHENGTU、ZIGEQUEREN、BIAOQIANKONGZHI、ZHUISUXING、CHANPINJISHENGCHANHUANJINGKONGZHI、GUOCHENGDEYUFANGJIANKONG、XIAODUHUOFANGHUGUOCHENGDENG

13.4

YUANCAILIAOHEGONGFANG

14

SHIYAN、YANZHENGJIPINGGUBAOGAO

14.1

皇冠篮球比分网MIEJUNFANGFAHEYANZHENGDEGAISHU,MIEJUNZHENGSHU(SHIYONGSHI)

IQ/OQ/PQ

14.2

BAOZHUANGYANZHENG(SHIYONGSHI)

BAOKUOBAOZHUANGYOUXIAOQIYANZHENG

14.3

HUAXUE、WULIHESHENGWUXUESHIYAN、YANZHENGHUOPINGGUBAOGAO

15

LINCHUANGSHUJU

LINCHUANGPINGJIABAOGAOBIXUBAOHANZAIJISHUWENDANGDEDIYIBUFENZHONG,BAOGAOZHONGYINYONGDECHUBANWUBIXUYIYUANSHIWENJIAN、ZHONGYINBENHUOFUYINJIANDEXINGCHENGZAIJISHUWENDANGDEDIERBUFENTIGONG

15.1

LINCHUANGQIANPINGGU,ZHUANJIAYIJIAN

15.2

LINCHUANGFANGAN

15.3

LINCHUANGSHUJU

15.4

LINCHUANGZONGJIE,ZHUANJIAYIJIAN

15.5

LINCHUANGBAOGAO

15.6

XIANGGUANWENXIAN

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