ISO 10993-1-2009 医疗器械生物学评价第1部分评价和试验

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Reference number

ISO 10993-1:2009(E)

INTERNATIONAL

STANDARD

ISO

10993-1

Fourth edition

2009-10-15

Biological evaluation of medical

devices —

Part 1:

Evaluation and testing within a risk

management process

Évaluation biologique des dispositifs médicaux —

Partie 1: Évaluation et essais au sein d'un processus de gestion

du risque

ISO 10993-1:2009(E)

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ISO 10993-1:2009(E)

Contents Page

Foreword ............................................................................................................................................................iv

Introduction........................................................................................................................................................vi

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

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

3 Terms and definitions ...........................................................................................................................2

4 General principles applying to biological evaluation of medical devices.......................................3

5 Categorization of medical devices ......................................................................................................6

5.1 General ...................................................................................................................................................6

5.2 Categorization by nature of body contact ..........................................................................................6

5.3 Categorization by duration of contact.................................................................................................7

6 Biological evaluation process..............................................................................................................8

6.1 Material characterization ......................................................................................................................8

6.2 Biological evaluation tests ...................................................................................................................8

7 Interpretation of biological evaluation data and overall biological safety assessment ..............14

Annex A (informative) Biological evaluation tests ........................................................................................15

Annex B (informative) Guidance on the risk management process ............................................................16

Annex C (informative) Suggested procedure for literature review ..............................................................19

Bibliography......................................................................................................................................................21

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标签： #医疗器械 #ISO #生物学评价

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