ISO 14155-2020医疗器械临床实验管理规范-质量人文档

Clinical investigation of medical

devices for human subjects — Good

clinical practice

Investigation clinique des dispositifs médicaux pour sujets humains —

Bonne pratique clinique

INTERNATIONAL

STANDARD

ISO

14155

Third edition

2020-07

Reference number

ISO 14155:2020(E)

Copyright International Organization for Standardization

Provided by IHS Markit under license with Standards Council of Canada

Not for Resale, 08/01/2020 07:24:26 MDT

No reproduction or networking permitted without license from IHS

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ISO 14155:2020(E)

COPYRIGHT PROTECTED DOCUMENT



















Website: www.iso.org



Copyright International Organization for Standardization

Provided by IHS Markit under license with Standards Council of Canada

Not for Resale, 08/01/2020 07:24:26 MDT

No reproduction or networking permitted without license from IHS

--`,``,,`,``,`,,`,,,,,,,,,````-`-`,,`,,`,`,,`---

ISO 14155:2020(E)

Foreword ..........................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

  ..................................................................................................................................................................................... 1

4 Summary of good clinical practice (GCP) principles ....................................................................................................... 9

5 Ethical considerations .................................................................................................................................................................................10

  ........................................................................................................................................................................................................ 10

  ....................................................................................................................................10

 .................................................................................................................... 10

  .............................................................................................................. 11

5.5 Responsibilities ...................................................................................................................................................................................11

  ...................................................................................................11

 ................................................................................................................................................................................... 11

  ................................................................................................................................................. 11

 ................................................................................................... 12

  ................................................................................................... 12

  ..................................................................... 12

  ................................................................................................................................................................. 12

  ...............................................................................................................................................................................13

 ................................................................................................................................................................................... 13

  ..................................................................................................... 13

  ........................................................................................14

  ..............................................................................................15

  ................................................................................................................................ 17

  ...........................................................................................................................................................17

6 Clinical investigation planning ...........................................................................................................................................................17

  ........................................................................................................................................................................................................ 17

  .............................................................................................................................................................................. 

 ................................................................................................................................................................................... 

  .....

  ............................................................................................................................

  ....................................................................................

  ............................................................................................................................................ 

  ..................................................................................................................................................... 

  ............................................................................................................................................................ 20

  ................................................................................................................................................................................... 20

  ........................................................................................................................................................ 21

 ......................................................................................................................................................................................... 21

  .................................................................................................................................................................................................... 21

  ...................................................................................................................................21

7 Clinical investigation conduct ..............................................................................................................................................................22

  ........................................................................................................................................................................................................ 22

  ....................................................................................................................................................... 22

  ..................................................................................................................................................22

  .........................................................................................................................22

  ............................................................................................................. 22

7.4.2 Adverse events ................................................................................................................................................................ 23

  ......................................................................................................................................................23

  ..................................................23

  ...................................................................................... 24

7.5.1 Amendments .................................................................................................................................................................... 24

  ....................................................................................................................................... 24

Contents 

Copyright International Organization for Standardization

Provided by IHS Markit under license with Standards Council of Canada

Not for Resale, 08/01/2020 07:24:26 MDT

No reproduction or networking permitted without license from IHS

--`,``,,`,``,`,,`,,,,,,,,,````-`-`,,`,,`,`,,`---

ISO 14155-2020医疗器械临床实验管理规范

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