AAMI 7198 2016
$140.32
ANSI/AAMI/ISO 7198:2016 – Cardiovascular implants-Tubular vascular prostheses
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 65 |
Specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this International Standard.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 7198:2016; Cardiovascular implants and extracorporeal systems—Vascular prostheses—Tubular vascular grafts and vascular patches |
| 2 | Objectives and uses of AAMI standards andrecommended practices |
| 3 | Title page |
| 4 | AAMI Standard Untitled |
| 5 | Contents Page |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 8 | Background of AAMI adoption of ISO 7198:2016 |
| 9 | Foreword |
| 10 | Introduction |
| 11 | 1 Scope |
| 12 | 2 Normative references 3 Terms and definitions |
| 17 | 4 General requirements 4.1 Configuration designation for tubular vascular grafts 4.2 Size designation 4.2.1 Uniform straight tubular vascular grafts 4.2.2 Uniform bifurcated tubular vascular grafts 4.2.3 Tapered tubular vascular grafts |
| 18 | 4.2.4 Other configurations of tubular vascular grafts 4.2.5 Vascular patches 4.3 Materials 4.3.1 General 4.3.2 Classification of tubular vascular grafts and vascular patches 4.3.3 Nomenclature 4.3.3.1 General 4.3.3.2 Synthetic materials 4.3.3.3 Biological materials |
| 19 | 4.3.3.4 Coatings 4.3.3.5 Storage fluids 4.4 Intended clinical use designation 5 Intended performance 6 Design attributes 6.1 General |
| 20 | 6.2 Tubular vascular grafts 6.3 Vascular patches 6.4 Coatings 6.5 Drug coatings and drug-eluting coatings |
| 21 | 7 Materials 8 Design evaluation 8.1 General 8.2 Sampling 8.3 Conditioning of test samples |
| 22 | 8.4 Reporting |
| 23 | 8.5 Biocompatibility 8.5.1 Residual chemicals 8.5.2 Biocompatibility 8.6 Biostability 8.7 Bench and analytical tests 8.7.1 General |
| 24 | 8.7.2 Tubular vascular grafts 8.7.2.1 Permeability 8.7.2.1.1 General 8.7.2.1.2 Integral water permeability/leakage 8.7.2.1.3 Porosity (non-textile materials) 8.7.2.1.4 Water entry pressure (non-textile materials) 8.7.2.1.5 Water permeability (textile materials) 8.7.2.2 Strength 8.7.2.2.1 General 8.7.2.2.2 Circumferential tensile strength 8.7.2.2.3 Diaphragm pressurized burst strength 8.7.2.2.4 Longitudinal tensile strength |
| 25 | 8.7.2.2.5 Pressurized burst strength 8.7.2.2.6 Probe burst strength 8.7.2.2.7 Strength after repeated puncture 8.7.2.3 Length 8.7.2.4 Relaxed internal diameter 8.7.2.5 Pressurized internal diameter 8.7.2.6 Wall thickness 8.7.2.7 Suture retention strength 8.7.2.8 Kink diameter/radius |
| 26 | 8.7.2.9 Dynamic radial compliance 8.7.3 Vascular patches 8.7.3.1 Permeability 8.7.3.1.1 General 8.7.3.1.2 Porosity 8.7.3.1.3 Water entry pressure 8.7.3.1.4 Water permeability 8.7.3.2 Strength 8.7.3.2.1 General 8.7.3.2.2 Diaphragm pressurized burst strength 8.7.3.2.3 Longitudinal tensile strength 8.7.3.2.4 Probe burst strength 8.7.3.3 Length and width 8.7.3.4 Wall thickness |
| 27 | 8.7.3.5 Suture retention strength 9 Preclinical in vivo evaluation test methods for vascular prostheses 9.1 Preclinical in vivo evaluation 9.1.1 Purpose 9.1.2 Specific aims 9.1.3 Protocol considerations |
| 28 | 9.1.4 Data acquisition |
| 29 | 9.1.5 Test report and additional information |
| 30 | 10 Clinical investigation methods for vascular prostheses 10.1 Clinical investigation 10.1.1 Purpose 10.1.2 Specific aims 10.1.3 Protocol considerations |
| 31 | 10.1.4 Data acquisition |
| 34 | 10.1.5 Final report |
| 35 | 10.2 Post market surveillance 11 Manufacturing 12 Sterility |
| 36 | 13 Packaging and labelling 13.1 General 13.2 Unit container 13.3 Outer container 13.4 Shipping container 13.5 Maintenance of sterility in transit 13.6 Marking 13.6.1 Container label |
| 37 | 13.6.2 Record label 13.6.3 General information and instructions for use |
| 38 | Annex A (informative) Test methods A.1 General A.2 Sampling A.3 Conditioning of test samples |
| 39 | A.4 Reporting |
| 40 | A.5 Test methods Table A.1 — Index of test methods |
| 41 | A.5.1 Permeability A.5.1.1 Porosity (N) |
| 42 | A.5.1.1.1 Planimetric porosity A.5.1.1.1.1 Purpose A.5.1.1.1.2 Materials A.5.1.1.1.3 Sampling A.5.1.1.1.4 Test procedure A.5.1.1.1.5 Expression of results A.5.1.1.1.6 Test report and additional information A.5.1.1.2 Gravimetric porosity |
| 43 | A.5.1.1.2.1 Purpose A.5.1.1.2.2 Materials A.5.1.1.2.3 Sampling A.5.1.1.2.4 Test procedure A.5.1.1.2.5 Expression of results A.5.1.1.2.6 Test report and additional information A.5.1.1.3 Microscopic porosity (inter-nodal distance) A.5.1.1.3.1 Purpose |
| 44 | A.5.1.1.3.2 Materials A.5.1.1.3.3 Sampling A.5.1.1.3.4 Test procedure A.5.1.1.3.5 Expression of results A.5.1.1.3.6 Test report and additional information A.5.1.2 Water permeability (B, T, C) A.5.1.2.1 Purpose A.5.1.2.2 Materials |
| 45 | A.5.1.2.3 Sampling A.5.1.2.4 Test procedure A.5.1.2.5 Expression of results |
| 46 | A.5.1.2.6 Test report A.5.1.3 Integral water permeability/leakage (A) A.5.1.3.1 Purpose A.5.1.3.2 Materials A.5.1.3.3 Sampling A.5.1.3.4 Test procedure |
| 47 | A.5.1.3.5 Expression of results A.5.1.3.6 Test report and additional information A.5.1.4 Water entry pressure (N) A.5.1.4.1 Purpose A.5.1.4.2 Materials A.5.1.4.3 Sampling A.5.1.4.4 Test procedure A.5.1.4.5 Expression of results A.5.1.4.6 Test report and additional information |
| 48 | A.5.2 Strength A.5.2.1 General A.5.2.2 Pressurized burst strength (A) A.5.2.2.1 Purpose A.5.2.2.2 Materials A.5.2.2.3 Sampling A.5.2.2.4 Procedure |
| 49 | A.5.2.3 Longitudinal tensile strength (A) A.5.2.3.1 Purpose A.5.2.3.2 Materials A.5.2.3.3 Sampling A.5.2.3.4 Test procedure A.5.2.3.5 Expression of results A.5.2.2.5 Expression of results A.5.2.2.6 Test report and additional information |
| 50 | A.5.2.3.6 Test report and additional information A.5.2.4 Circumferential tensile strength – tubular vascular graft only (A) A.5.2.4.1 Purpose A.5.2.4.2 Materials |
| 51 | Figure A.1—Split bar tester |
| 52 | A.5.2.4.3 Sampling A.5.2.4.4 Test procedure A.5.2.4.5 Expression of results A.5.2.4.6 Test report and additional information A.5.2.5 Diaphragm pressurized burst strength (A) A.5.2.5.1 Purpose A.5.2.5.2 Materials |
| 53 | A.5.2.5.3 Sampling A.5.2.5.4 Test procedure A.5.2.5.5 Expression of results A.5.2.5.6 Test report and additional information A.5.2.6 Probe burst strength (A) A.5.2.6.1 Purpose A.5.2.6.2 Materials |
| 54 | Figure A.2—Example of a probe burst tester A.5.2.6.3 Sampling A.5.2.6.4 Test procedure A.5.2.6.5 Expression of results |
| 55 | A.5.2.6.6 Test report and additional information A.5.2.7 Strength after repeated puncture — tubular prosthesis only (A) A.5.2.7.1 Purpose A.5.2.7.2 Materials A.5.2.7.3 Sampling A.5.2.7.4 Test procedure A.5.2.7.5 Expression of results A.5.2.7.6 Test report and additional information A.5.3 Length (including width for vascular patches) (A) A.5.3.1 Purpose |
| 56 | A.5.3.2 Materials A.5.3.3 Sampling A.5.3.4 Test procedure A.5.3.5 Expression of results A.5.3.6 Test report and additional information A.5.4 Relaxed internal diameter — tubular prosthesis only (A) A.5.4.1 Purpose A.5.4.2 Materials |
| 57 | Figure A.3 — Example of a conical gauge for relaxed internal diameter A.5.4.3 Sampling A.5.4.4 Test procedure A.5.4.5 Expression of results |
| 58 | A.5.4.6 Test report and additional information A.5.5 Pressurized internal diameter — tubular prosthesis only (A) (if appropriate, see 8.7.2.5) A.5.5.1 Purpose A.5.5.2 Materials A.5.5.3 Sampling A.5.5.4 Test procedure |
| 59 | A.5.5.5 Expression of results A.5.5.6 Test report and additional information A.5.6 Wall thickness (A) A.5.6.1 Purpose A.5.6.2 Materials A.5.6.3 Sampling A.5.6.4 Test procedure A.5.6.4.1 Non-contact determination of wall thickness |
| 60 | A.5.6.4.2 Constant-load gauge determination of wall thickness A.5.6.5 Expression of results A.5.6.6 Test report and additional information A.5.7 Suture retention strength (A) A.5.7.1 Purpose A.5.7.2 Materials Figure A.4 — Example of suture retention strength test — Side view |
| 61 | A.5.7.3 Sampling A.5.7.4 Test procedure A.5.7.4.1 Straight-across procedure (longitudinally oriented suture) A.5.7.4.2 Oblique procedure A.5.7.4.3 Longitudinal procedure (transverse oriented suture) A.5.7.5 Expression of results A.5.7.6 Test report and additional information A.5.8 Kink diameter/radius — tubular vascular grafts only (A) A.5.8.1 Purpose A.5.8.2 Materials |
| 62 | A.5.8.3 Sampling A.5.8.4 Test procedure A.5.8.5 Expression of results A.5.8.6 Test report and additional information A.5.9 Dynamic radial compliance — tubular vascular grafts only (A) A.5.9.1 Purpose A.5.9.2 Materials |
| 63 | A.5.9.3 Sampling A.5.9.4 Test procedure |
| 64 | A.5.9.5 Expression of results A.5.9.6 Test report and additional information |
| 65 | Bibliography |
