AAMI 25539 1 2017
$115.49
ANSI/AAMI/ISO 25539-1:2017 – Cardiovascular implants- Endovascular devices-Part 1: Endovascular prostheses
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 140 |
Specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) 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 document.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 25539-1:2017; Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses |
| 2 | Objectives and uses of AAMI standards andrecommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 8 | Background of AAMI adoption of ISO 25539-1:2017 |
| 9 | Foreword |
| 10 | Introduction |
| 13 | 1 Scope |
| 14 | 2 Normative references 3 Terms and definitions |
| 16 | 4 General requirements for endovascular system 4.1 Type of endovascular prosthesis |
| 17 | 4.2 Materials and construction for endovascular system 4.3 Configuration and size designation for endovascular prosthesis 4.4 Intended clinical use for endovascular system |
| 18 | 4.5 Balloon designation 5 Intended performance 6 Design attributes 6.1 General |
| 19 | 6.2 Endovascular system 6.3 Endovascular prosthesis 6.4 Endovascular system and endovascular prosthesis 7 Materials |
| 20 | 8 Design evaluation 8.1 General |
| 21 | 8.2 Sampling 8.3 Conditioning of test samples 8.4 Reporting |
| 22 | 8.5 Bench and analytical tests 8.5.1 Endovascular system and delivery system 8.5.1.1 Balloon testing |
| 23 | 8.5.1.1.1 Balloon burst pressure for non-compliant balloons 8.5.1.1.2 Balloon deflation times 8.5.1.1.3 Balloon rated fatigue 8.5.1.1.4 Balloon volume to burst for compliant balloons 8.5.1.2 Dimensional verification of the endovascular system 8.5.1.3 Dislodgement force (pre-mounted, balloon-expandable endovascular prosthesis) 8.5.1.4 Force to deploy for self-expanding endovascular prostheses 8.5.1.5 Simulated use 8.5.1.6 Tensile bond strength |
| 24 | 8.5.1.7 Torsional bond strength 8.5.1.8 Haemostasis 8.5.1.9 Biocompatibility 8.5.1.10 Sterilization assurance 8.5.1.11 Visibility 8.5.2 Endovascular prosthesis 8.5.2.1 Corrosion 8.5.2.2 Fatigue and durability—Computational analyses 8.5.2.3 Fatigue and durability—in vitro testing |
| 25 | 8.5.2.3.1 General considerations 8.5.2.3.2 Radial fatigue and durability 8.5.2.3.3 Active fixation fatigue and durability 8.5.2.3.4 Axial fatigue and durability 8.5.2.3.5 Bending fatigue and durability 8.5.2.3.6 Torsional fatigue and durability |
| 26 | 8.5.2.4 Fixation and seal 8.5.2.4.1 Leakage at seal zone 8.5.2.4.2 Migration resistance 8.5.2.4.3 Separation force for overlapping endovascular prostheses 8.5.2.5 Patency-related tests |
| 27 | Table 1—Rationale for crush and compression resistance and radial force requirements |
| 28 | 8.5.2.5.1 Compression resistance to perpendicularly applied load (self-expanding, non-aortic endovascular prostheses) 8.5.2.5.2 Crush resistance with perpendicularly applied load (balloon-expandable, non-aortic endovascular prostheses) 8.5.2.5.3 Crush resistance with radially applied load (balloon-expandable endovascular prostheses) 8.5.2.5.4 Radial force (self-expanding endovascular prostheses) 8.5.2.5.5 Resistance to kinking (flexibility) 8.5.2.6 Permeability 8.5.2.6.1 Integral water leakage 8.5.2.6.2 Porosity (non-textile materials) |
| 29 | 8.5.2.6.3 Water entry pressure (non-textile materials) 8.5.2.6.4 Water permeability (textile materials) 8.5.2.7 Sizing-related testing 8.5.2.7.1 Dimensional verification of the endovascular prosthesis 8.5.2.7.2 Implant diameter to balloon inflation pressure (balloon-expandable endovascular prostheses) 8.5.2.7.3 Implant length to diameter relationship (endovascular prostheses that have clinically relevant length changes with diameter changes) 8.5.2.7.4 Recoil (balloon-expandable endovascular prostheses) 8.5.2.8 Strength 8.5.2.8.1 Burst strength 8.5.2.8.2 Factory seam strength (endovascular prostheses with seams in the graft material) 8.5.2.8.3 Longitudinal tensile strength |
| 30 | 8.5.2.8.4 Strength after repeated puncture (endovascular prostheses for vascular access) 8.5.2.8.5 Strength of the connection(s) between the graft material and a discrete fixation system(s) 8.5.2.9 Magnetic resonance imaging (MRI) safety 8.6 Preclinical in vivo evaluation 8.6.1 Purpose |
| 31 | 8.6.2 Specific aims 8.6.3 Protocol considerations 8.6.4 Data acquisition |
| 33 | 8.6.5 Test report and additional information |
| 34 | 8.7 Clinical evaluation 8.7.1 Purpose 8.7.2 Specific aims |
| 35 | 8.7.3 Protocol considerations |
| 36 | 8.7.4 Data acquisition |
| 39 | 8.7.5 Final report |
| 40 | 9 Post-market surveillance 10 Manufacturing 11 Sterilization 11.1 Products supplied sterile |
| 41 | 11.2 Sterilization residuals 12 Packaging 12.1 Protection from damage in storage and transport 12.1.1 General 12.1.2 Unit container 12.1.3 Outer container 12.1.4 Shipping container 12.1.5 Maintenance of sterility in transit 12.2 Labelling 12.2.1 Container label |
| 42 | 12.2.2 Record label 12.3 Instructions for use 12.3.1 General 12.3.2 Information and instructions for use for endovascular systems |
| 44 | Annex A (informative) Relationship between testing requirements and device attributes and potential failure modes |
| 46 | Table A.1—Table headings and explanations for Tables A.3 and A.4 and for a device-specific DESa |
| 47 | Table A.2—Legend for grouped associated clinical effects of failure |
| 48 | Table A.3—Device evaluation strategy for the endovascular system |
| 53 | Table A.4—Device evaluation strategy for endovascular prosthesis |
| 60 | Table A.5—Design comparison between a previously evaluated device and the modified device |
| 61 | Table A.6—Indication for use comparison of a previously evaluated device and the study devicea |
| 62 | Table A.7—Device evaluation strategy for device design modifications and/or changes in intended use |
| 63 | Annex B (informative) Description of clinical and device effects of failure Table B.1—Description of clinical effects of failure |
| 65 | Table B.2—Description of device effects of failure |
| 67 | Annex C (informative) Bench and analytical tests Table C.1—Bench and analytical tests |
| 74 | Annex D (informative) Test methods |
| 76 | Table D.1—Index of test methods |
| 123 | Figure D.1—Determination of outward force |
| 139 | Bibliography |
