ISO 10993-6-2026 Tests for local effects after implantation

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Biological evaluation of medical

devices —

Part 6:

Tests for local effects after

implantation

Évaluation biologique des dispositifs médicaux —

Partie 6: Essais concernant les effets locaux après implantation

International

Standard

ISO 10993-6

Fourth edition

2026-04

Reference number

ISO 10993-6:2026(en) © ISO 2026

ISO 10993-6:2026(en)

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

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

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

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ISO 10993-6:2026(en)

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

Introduction .............................................................................................................................................................................................................................................v

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

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

3 Termsanddefinitions ................................................................................................................................................................................................ 1

4 Common provisions for implantation test methods .................................................................................................................. 2

  ........................................................................................................................................... ............................................................................. 2

  .....................................................................................................................................3

  .................................................................................................................................................................... 4

5 General aspects and requirements for implantation test ................................................................................................... 4

  ................................................................................................................................................................... 4

  ........................................................................................................................................................................................................ 5

5.3 Test periods ............................................................................................................................................................................................................6

  ............................................................................................................................................................. 8

  ................................................................................................................................................................................................................9

  .....................................................................................................................................................................................................9

  ..........................................................................................................................................................9

  ....................................................................................................9

  ......................................................................................................................................................... 10

  .........................................................................................................................................................11

6 Test report ........................................................................................................................................................................................................................... 11

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

  ................................................................................................................................................................................................ 12

  ............................................................................................................................................................................................. 12

  ..................................................................................................................................................................... 12

  .......................................................................................................................................... 12

  ................................................................................................................................ 13

  .............................................................................................................................................................................................. 13

Annex A  Test methods for implantation in subcutaneous tissue ................................................................ 14

Annex B  Test method for implantation in muscle ........................................................................................................ 16

Annex C  Test method for implantation in bone .............................................................................................................. 18

Annex D  Test method for implantation in neural tissue ....................................................................................... 21

Annex E  Test methods for devices contacting peripheral nerve tissue ............................................ 26

Annex F  Examples of scoring systems used to support the evaluation of local

biological effects after implantation .......................................................................................................................................................30

Annex G  Microscopic evaluation of tissue responses to implanted materials .......................... 33

Bibliography .........................................................................................................................................................................................................................................38

iii

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标签： #ISO # 10993 #2026

摘要：

Biologicalevaluationofmedicaldevices—Part6:TestsforlocaleffectsafterimplantationÉvaluationbiologiquedesdispositifsmédicaux—Partie6:EssaisconcernantleseffetslocauxaprèsimplantationInternationalStandardISO10993-6Fourthedition2026-04ReferencenumberISO10993-6:2026(en)\bISO2026iiISO10993-6:2026(en)©ISO20...

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ISO 10993-6-2026 Tests for local effects after implantation

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