AAMI 10993 6 2016
$93.55
ANSI/AAMI/ISO 10993-6:2016 – Biological evaluation of medical devices-Part 6: Tests for local effects after implantation
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 41 |
Specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-6:2016; Biological evaluation of medical devices—Part 6: Tests for local effects after implantation |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 9 | Background of AAMI adoption of ISO 10993-6:2016 |
| 10 | Foreword |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions 4 Common provisions for implantation test methods 4.1 General |
| 15 | 4.2 Preparation of samples for implantation 4.3 Study design 5 Test methods, general aspects 5.1 Tissue and implantation site |
| 16 | 5.2 Animals 5.3 Test periods |
| 18 | Table 1—Possible test periods for long-term implantation of biomaterials 5.4 Surgery and testing conditions |
| 19 | 5.5 Evaluation |
| 21 | 6 Test report 6.1 General 6.2 Test laboratory 6.3 Implant samples 6.4 Animals and implantation |
| 22 | 6.5 Retrieval and histological procedure 6.6 Macroscopic and microscopic evaluation 6.7 Final evaluation |
| 23 | Annex A (normative) Test methods for implantation in subcutaneous tissue A.1 Field of application A.2 Principle A.3 Test samples A.4 Test animals and implant sites |
| 24 | A.5 Implantation procedure A.6 Implantation period A.7 Evaluation of biological response A.8 Test report |
| 25 | Annex B (normative) Test method for implantation in muscle B.1 Field of application B.2 Principle B.3 Test samples B.4 Test animals and implant sites |
| 26 | B.5 Implantation procedure B.6 Implantation period B.7 Evaluation of biological response B.8 Format of test report |
| 27 | Annex C(normative)Test method for implantation in bone C.1 Field of application C.2 Principle C.3 Test samples |
| 28 | C.4 Test animals and implant sites C.5 Implantation procedure |
| 29 | C.6 Implantation period C.7 Evaluation of biological response C.8 Test report |
| 30 | Annex D(normative)Test method for implantation in brain tissue D.1 Field of application D.2 Principle D.3 Test samples |
| 31 | D.4 Test animals and implant sites D.5 Implantation procedure |
| 32 | D.6 Implantation period D.7 Post-implantation observation D.8 Evaluation of biological response |
| 33 | Table D.1—Examples brain biomarkers and stains |
| 34 | D.9 Test report |
| 35 | Annex E (informative) Examples of evaluation of local biological effects after implantation E.1 General Table E.1—An example of a histological evaluation system—Cell type/response |
| 36 | Table E.2—An example of a histological evaluation system—Tissue responseResponseScore |
| 37 | Table E.3—Example of semiquantitative scoring scheme |
| 38 | E.2 Conclusion E.3 Comments Table E.4—An example of a histological evaluation system—Neural tissue response |
| 39 | Bibliography |
