AAMI 5840 1 2015
$140.32
ANSI/AAMI/ISO 5840-1:2015 – Cardiovascular implants-Cardiac valve prostheses-Part 1: General requirements
| Published By | Publication Date | Number of Pages |
| AAMI | 2015 | 67 |
Outlines an approach for qualifying the design and manufacture of a 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 heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 5840-1:2015, Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements |
| 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 |
| 8 | Background on AAMI adoption of ISO 5840-1:2015 |
| 9 | Foreword |
| 10 | Introduction |
| 11 | 1 Scope 2 Normative references |
| 12 | 3 Terms and definitions |
| 14 | Figure 1 — Schematic representation of flow waveform and regurgitant volumes for one cycle |
| 19 | Figure 2 — Schematic representation of the positive pressure period of an aortic forward flow interval |
| 21 | Figure 3 — Wiggers Diagram, showing various events of a cardiac cycle |
| 22 | 4 Abbreviations 5 Fundamental requirements 6 Device description 6.1 Intended use 6.2 Design inputs 6.2.1 Operational specifications |
| 23 | 6.2.2 Performance specifications 6.2.3 Implant procedure Table 1 — Heart valve substitute operational environment for left side of heart — Adult population 6.2.4 Packaging, labelling, and sterilization |
| 24 | 6.3 Design outputs Table 2 — Heart valve substitute operational environment for right side of heart — Adult population 6.4 Design transfer (manufacturing verification/validation) |
| 25 | 6.5 Risk management 7 Design verification testing and analysis/design validation 7.1 General requirements 7.2 In vitro assessment 7.3 Preclinical in vivo evaluation 7.4 Clinical investigations |
| 26 | Annex A: Rationale for the provisions of this part of ISO 5480 A.1 Rationale for risk-based approach A.2 Rationale for preclinical in vivo evaluation |
| 27 | A.3 Rationale for design verification and design validation testing A.4 Rationale for echocardiographic assessment A.5 Rationale for clinical evaluation reporting |
| 28 | A.6 Rationale for device sizing within labelling and instructions for use A.7 Rationale for Human Factors Engineering |
| 29 | Annex B: Packaging B.1 Requirements B.2 Principle B.3 Containers B.3.1 Unit container(s) B.3.2 Outer container |
| 30 | Annex C: Product labels, instructions for use, and training C.1 General C.1.1 Unit-container label C.1.2 Outer-container label |
| 31 | C.1.3 Instructions for use |
| 32 | C.1.4 Labels for medical records C.2 Training for physicians and support staff |
| 33 | Annex D: Sterilization |
| 34 | Annex E: In vitro test guidelines for pediatric devices E.1 General and pediatric definitions Table E.1 — Pediatric definitions E.2 Pulsatile flow test conditions: left side Table E.2 — Pulsatile flow test conditions: left side |
| 36 | E.3 Pulsatile flow test conditions: right side Table E.3 — Pulsatile flow test conditions: right side E.4 Steady back pressure and forward flow conditions: left side Table E.4 — Steady back pressure and forward flow conditions: left side E.5 Steady back pressure and forward flow conditions: right side Table E.5 — Steady back pressure and forward flow conditions: right side |
| 37 | E.6 Accelerated Wear Testing (AWT) conditions: left side Table E.6 — AWT test conditions: left side E.7 AWT test conditions: right side Table E.7 — AWT test conditions: right side |
| 38 | E.8 FEA/life analysis conditions: left side Table E.8 — FEA/life analysis conditions: left side E.9 FEA/life analysis conditions: right side Table E.9 — FEA/life analysis conditions: right side |
| 39 | Annex F: Statistical procedures when using in vitro performance criteria F.1 General F.2 Methods |
| 40 | Annex G: Examples and definitions of some physical and material properties of heart valve systems G.1 General G.2 Bulk physical properties |
| 41 | G.3 Surface physical properties |
| 42 | G.4 Mechanical and chemical engineering properties |
| 45 | G.5 Nitinol properties |
| 46 | Figure G.1 — Example DSC graph for single-stage transformation nickel-titanium alloy |
| 50 | Figure G.2 — Typical stress-strain curve of superelastic (SE) nitinol indicating various reportable parameters Figure G.3 — Force-diameter curve of a superelastic (SE) nitinol support structure demonstrating chronic outward force (COF) and radial resistive force (RRF) |
| 51 | Annex H: Examples of standards applicable to testing of materials and components of heart valve systems H.1 Metals H.1.1 Specifications for materials for metal surgical implants H.1.2 Tensile test with extensometer to failure H.1.3 Poisson’s ratio H.1.4 Durability crack initiation and endurance limit; S-N curves |
| 52 | H.1.5 Fatigue crack growth rate; crack growth velocity H.1.6 Hardness H.1.7 Microstructure H.1.8 Thermal expansion H.1.9 Fracture toughness H.1.10 Fatigue life H.1.11 Corrosion |
| 53 | H.2 Polymers H.2.1 Viscosimetry H.2.2 Melt flow index H.2.3 Specifications for high molecular weight polyethylene H.2.4 Determination of breaking strength under static load H.2.5 Tensile test with extensometer to failure (if possible) H.2.6 Tensile properties H.2.7 Poisson’s ratio H.2.8 Determination of dynamic mechanical properties |
| 54 | H.2.9 Resistance to surface wear H.2.10 Resistance to scratch H.2.11 Flexural properties; determination of breaking strength under dynamic bending load H.2.12 Fatigue crack initiation and endurance limit; S-N curves H.2.13 Fatigue crack growth rate H.2.14 Determination of compressive properties H.2.15 Specification of surgical implants made from high-density silicone elastomer H.2.16 Density H.2.17 Liquid diffusivity (porosity and permeability; water absorption) H.2.18 Hardness H.2.19 Wear resistance H.2.20 Creep |
| 55 | H.2.21 Fracture toughness H.2.22 Hydraulic expansion H.3 Ceramics and carbons H.3.1 Physical and chemical properties H.3.2 Fatigue rate H.3.3 Hardness H.3.4 Thermal expansion H.3.5 Fracture toughness H.4 Biological materials H.4.1 Possible adaptation of tensile properties H.5 Textiles H.5.1 Determination of tear-out resistance H.5.2 Determination of water absorption H.6 MRI compatibility |
| 57 | Annex I: Raw and post-conditioning mechanical properties for support structure materials I.1 Raw material properties I.2 Post-conditioning mechanical properties |
| 58 | I.3 Other mechanical properties |
| 59 | Annex J: Corrosion assessment J.1 Rationale J.2 General J.3 Pitting corrosion |
| 60 | J.4 Crevice corrosion J.5 Galvanic corrosion J.6 Corrosion fatigue |
| 61 | J.7 Fretting (wear) and fretting corrosion J.8 Post-fatigue corrosion evaluation |
| 62 | Annex K: Echocardiographic protocol K.1 General K.2 Echocardiographic Studies |
| 63 | K.3 Data collected |
| 64 | K.4 3D Echocardiography studies |
| 65 | Bibliography |
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