AAMI 5840 2 2015
$140.32
ANSI/AAMI/ISO 5840-2:2015 – Cardiovascular implants-Cardiac valve prostheses-Part 2: Surgically implanted heart valve substitutes
| Published By | Publication Date | Number of Pages |
| AAMI | 2015 | 67 |
Outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 5840-2:2015, Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background on AAMI adoption of ISO 5840-2:2015 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | Figure 1 — Designation of dimensions of surgical heart valve substitute sewing ring configurations |
| 16 | 4 Abbreviations |
| 17 | 5 Fundamental requirements 6 Device description 6.1 Intended use 6.2 Design inputs 6.2.1 Operational specifications 6.2.2 Performance specifications |
| 18 | 6.2.3 Packaging, labelling, and sterilization 6.3 Design outputs 6.3.1 General 6.4 Design transfer (manufacturing qualification) 6.5 Risk management 7 Design verification testing and analysis/design validation 7.1 General requirements |
| 19 | 7.2 In vitro assessment 7.2.1 Test conditions, sample selection, and reporting requirements 7.2.1.1 Test conditions and sample selection 7.2.1.2 Reporting requirements |
| 20 | 7.2.2 Material property assessment 7.2.2.1 General 7.2.2.2 Biological safety 7.2.2.3 Material and mechanical property testing 7.2.3 Hydrodynamic performance assessment |
| 21 | Table 1 — Minimum device performance requirements, Aortic Table 2—Minimum device performance requirements, Mitral |
| 22 | 7.2.4 Structural performance assessment 7.2.4.1 General 7.2.4.2 Device durability assessment 7.2.4.3 Component fatigue assessment |
| 23 | 7.2.4.4 Component corrosion assessment 7.2.4.5 Cavitation (rigid valves) 7.2.5 Device MRI safety 7.2.6 Additional implant design evaluation requirements 7.2.7 Design specific testing |
| 24 | 7.2.8 Simulated use 7.2.9 Human factors/usability assessment 7.3 Preclinical in vivo evaluation 7.3.1 Overall requirements |
| 25 | 7.3.2 Methods 7.3.2.1 General requirements |
| 26 | 7.3.3 Test report 7.4 Clinical investigation 7.4.1 General |
| 27 | 7.4.2 Statistical considerations 7.4.3 Distribution of subjects and investigators 7.4.4 Sample size 7.4.5 Entry criteria |
| 28 | 7.4.6 Duration of the study 7.4.7 Clinical data requirements 7.4.7.1 General 7.4.7.2 Baseline data |
| 29 | 7.4.7.3 Operative data 7.4.7.4 Early post-operative and follow-up data |
| 30 | 7.4.8 Clinical investigation report 7.4.8.1 General 7.4.8.2 Analysis and reporting |
| 31 | 7.4.8.3 Post-market clinical follow-up |
| 32 | Annex A: Heart valve substitute hazards, associated failure modes, and evaluation methods A.1 Hazards, failure modes, and evaluation methods A.1.1 General Table A.1—Examples of surgical heart valve substitute hazards, associated failure modes, and evaluation methods |
| 34 | A.1.2 Additional generic failure modes and causes |
| 35 | Annex B: In vitro procedures for testing unstented or similar valves in compliant chambers B.1 General B.2 Compliant chamber specifications B.3 Test procedures using compliant chambers B.3.1 Pulsatile-flow pressure difference |
| 36 | B.3.2 Pulsatile-flow regurgitation B.3.3 Reference valves for hydrodynamics testing B.3.4 Wear/durability |
| 37 | Annex C: Preclinical in vivo evaluation C.1 General Table C.1—Settings that can be evaluated C.2 Disposition of evaluations C.2.1 Hemodynamic performance |
| 38 | C.2.2 Ease of surgical implantation C.2.3 Acoustic characteristics C.2.4 Interference with adjacent anatomical structures C.2.5 Hemolysis C.2.6 Thrombo-embolic events C.2.7 Calcification/Mineralization C.2.8 Pannus formation/tissue ingrowth C.2.9 Structural valve deterioration and non-structural dysfunction |
| 39 | C.2.10 Assessment of valve and non-valve related pathology C.2.11 Cavitation |
| 40 | Annex D: Description of the surgical heart valve substitute D.1 General Table D.1—Information to be included in description of surgical heart valve substitute D.2 Chemical treatments, surface modifications, or coatings D.3 Component description D.3.1 Examples of components of some surgical heart valve substitutes |
| 41 | D.4 Implant position D.5 Accessories |
| 42 | Annex E: Examples of components of some surgical heart valve substitutes Figure E.1 — Generic bi-leaflet rigid surgical heart valve substitute Figure E.2 — Generic mono-leaflet rigid surgical heart valve substitute |
| 43 | Figure E.3 — Generic flexible surgical heart valve substitute (flexible, unstented, scalloped) Figure E.4 — Generic flexible surgical heart valve substitute (flexible, unstented, full root) |
| 44 | Figure E.5 — Generic flexible stented surgical heart valve substitute Figure E.6 — Generic Novel Surgical Valve Substitute, e.g. Sutureless |
| 45 | Figure E.7 — Generic balloon expandable rapid deployment surgical heart valve system Figure E.8 — Generic self-expanding sutureless surgical heart valve |
| 46 | Annex F: Guidelines for verification of hydrodynamic performance F.1 General F.2 Steady forward-flow testing F.2.1 Measuring equipment accuracy F.2.2 Test apparatus requirements |
| 47 | Figure F.1 — Standard nozzle; forward flow |
| 48 | Figure F.2 — Forward flow nozzle gradients F.2.3 Test procedure F.2.4 Test report |
| 49 | F.3 Steady back-flow leakage testing F.3.1 Measuring equipment accuracy F.3.2 Test apparatus requirements |
| 50 | Figure F.3 —Standard nozzle; back flow |
| 51 | Figure F.4 — Back flow nozzle gradients F.3.3 Test procedure |
| 52 | F.3.4 Test report F.4 Pulsatile-flow testing F.4.1 Measuring equipment accuracy F.4.2 Test apparatus requirements F.4.3 Test procedure |
| 53 | Table F.1 — Regurgitant volume test conditions F.4.4 Test report |
| 55 | Annex G: Durability testing G.1 General G.2 Measuring equipment accuracy G.3 Real time testing G.4 Dynamic Failure Mode G.5 Results evaluation G.6 Report requirements |
| 57 | Annex H: Examples of design specific testing H.1 Sewing ring integrity H.2 Stent creep H.3 Leaflet impingement force (rigid valves) H.4 Leaflet escape force (rigid valves) H.5 Environmental degradation H.6 Static pressure; “burst” test H.7 Sewing ring push-off H.8 Sewing ring torque (rigid valves) |
| 58 | H.9 Calcification (flexible valve) H.10 Leaflet kinematics H.11 Device Migration resistance |
| 59 | Annex I: Fatigue assessment I.1 General Figure I.1 — Example schematic of a structural component fatigue assessment using a stress- or strain-life approach I.2 Stress/strain analysis under simulated in vivo conditions |
| 61 | I.3 Fatigue characterization I.3.1 General I.3.2 Stress/life, S/N, characterization I.3.3 Strain/life, ε/N, characterization |
| 62 | I.3.4 Fatigue crack growth, da/dN, characterization I.3.5 Component testing |
| 63 | I.4 Fatigue lifetime assessment I.4.1 General I.4.2 Stress-life, S/N, assessment I.4.3 Strain-life, ε/N, assessment I.4.4 Damage tolerance analysis, DTA |
| 64 | I.4.5 Component demonstration assessment I.4.6 Test to Failure I.4.7 Post Fatigue Corrosion Evaluation |
| 65 | Annex J: Methods of evaluating clinical data J.1 General J.2 Objective performance criteria methodology Table J.1—Objective performance criteria for surgical heart valve substitutes |
| 66 | Bibliography |
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