AAMI 5840 3 2013
$162.84
ANSI/AAMI/ISO 5840-3:2013 – Cardiovascular implants-Cardiac valve prostheses-Part 3: Heart valve substitutes implanted by transcatheter techniques.
| Published By | Publication Date | Number of Pages |
| AAMI | 2013 | 128 |
Outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be 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 can 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 5840-3:2013, Cardiovascular implants —Cardiac valve prostheses —Part 3: Heart valve substitutes implanted by transcatheter techniques |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 8 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of ISO 5840-3:2013 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 15 | 3 Terms and definitions |
| 23 | 4 Abbreviations 5 Fundamental requirements 6 Device description 6.1 Intended use |
| 24 | 6.2 Design inputs 6.2.1 Operational specifications |
| 25 | 6.2.2 Performance specifications 6.2.2.1 Implantable device |
| 26 | 6.2.2.2 Delivery system 6.2.2.3 Transcatheter heart valve system |
| 27 | 6.2.3 Implant procedure 6.2.4 Packaging, labeling and sterilization 6.3 Design outputs 6.4 Design transfer (manufacturing verification/validation) 6.5 Risk management |
| 28 | 7 Design verification testing and analysis/design validation 7.1 General requirements 7.2 In vitro assessment 7.2.1 Test conditions, sample selection and reporting requirements |
| 29 | 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 |
| 30 | 7.2.3 Device hydrodynamic performance assessment |
| 32 | 7.2.4 Structural performance assessment 7.2.4.1 Device durability assessment |
| 33 | 7.2.4.2 Device structural component fatigue assessment 7.2.4.3 Component corrosion assessment |
| 34 | 7.2.5 Additional implant design evaluation requirements 7.2.5.1 Device migration resistance 7.2.5.2 Device MRI safety 7.2.5.3 Implant foreshortening (length to diameter) 7.2.5.4 Crush resistance 7.2.5.5 Recoil (balloon expandable stents) |
| 35 | 7.2.5.6 Dimensional verification 7.2.5.7 Radial resistive force 7.2.5.8 Chronic outward force (COF) 7.2.6 Delivery system design evaluation requirements 7.2.6.1 Implant interactions with delivery system 7.2.6.2 Loading of the device into the delivery system |
| 36 | 7.2.6.3 Ability to access and deploy 7.2.7 Design-specific testing |
| 37 | 7.2.8 Visibility 7.2.9 Simulated use 7.2.10 Human factors/usability assessment 7.3 Preclinical in vivo evaluation 7.3.1 Overall requirements |
| 39 | 7.3.2 Methods |
| 40 | 7.3.3 Test report |
| 41 | 7.4 Clinical investigations 7.4.1 General 7.4.2 Statistical considerations |
| 42 | 7.4.3 Distribution of subjects and investigators 7.4.4 Sample size 7.4.5 Entry criteria 7.4.6 Duration of the study |
| 43 | 7.4.7 Clinical data requirements 7.4.7.1 General 7.4.7.2 Baseline 7.4.7.3 Peri-procedure data |
| 44 | 7.4.7.4 Follow-up data |
| 45 | 7.4.8 Clinical investigation report 7.4.8.1 General 7.4.8.2 Analysis and reporting 7.4.8.3 Post-market clinical follow-up |
| 47 | Annex A (informative) Rationale for the provisions of this part of ISO 5840 A.1 Rationale for risk-based approach A.2 Rationale for preclinical in vivo evaluation |
| 48 | A.3 Rationale for design verification and design validation testing A.4 Rationale for Doppler echocardiographic assessment |
| 49 | A.5 Rationale for clinical evaluation reporting A.6 Rationale for device sizing within labeling and instructions for use A.7 Rationale for human factors engineering |
| 50 | Annex B (informative) Examples of transcatheter heart valve substitutes, components and delivery systems B.1 Examples of transcatheter heart valve substitutes |
| 53 | B.2 Examples of delivery systems |
| 56 | Annex C (normative) Packaging C.1 Requirements C.2 Principle C.3 Containers C.3.1 Unit container(s) C.3.2 Outer container |
| 57 | Annex D (normative) Product labels, instructions for use and training D.1 General D.1.1 Unit-container label D.1.2 Outer-container label |
| 58 | D.1.3 Instructions for use |
| 59 | D.1.4 Labels for medical records D.2 Training for physicians and support staff |
| 61 | Annex E (normative) Sterilization E.1 General |
| 62 | Annex F (informative) Valve description F.1 Description of transcatheter heart valve substitute F.2 Description of delivery system F.3 Chemical treatments, surface modifications or coatings |
| 63 | F.4 Component description F.5 Implant position F.6 Accessories |
| 64 | Annex G (informative) Transcatheter heart valve substitute hazards, associated failure modes and evaluation methods G.1 Hazards, failure modes and evaluation methods |
| 66 | G.2 Additional generic failure modes and causes |
| 68 | G.3 Additional generic failure modes and causes |
| 69 | Annex H (informative) In vitro test guidelines for pediatric devices H.1 Introduction and pediatric definitions |
| 70 | H.2 Pulsatile flow test conditions: left side H.3 Pulsatile flow test conditions: right side |
| 71 | H.4 Steady back pressure and forward flow conditions: left side H.5 Steady back pressure and forward flow conditions: right side |
| 72 | H.6 AWT test conditions: left side H.7 AWT test conditions: right side |
| 73 | H.8 FEA/life analysis conditions: left side H.9 FEA/life analysis conditions: right side |
| 74 | Annex I (informative) Statistical procedures when using performance criteria I.1 General I.2 Methods |
| 75 | Annex J (informative) Examples and definitions of some physical and material properties of transcatheter heart valve substitutes and their components J.1 General J.2 Bulk physical properties |
| 77 | J.3 Surface physical properties J.3.1 General |
| 78 | J.4 Mechanical and chemical engineering properties J.4.1 General |
| 83 | J.5 Nitinol properties |
| 90 | Annex K (informative) Examples of standards applicable to testing of materials and components of transcatheter heart valve substitutes K.1 Metals |
| 92 | K.2 Polymers |
| 95 | K.3 Ceramics and carbons K.4 Biological materials K.5 Textiles K.6 MRI compatibility |
| 97 | Annex L (informative) Raw and post-conditioning mechanical properties for support structure materials L.1 Raw material properties L.2 Post-conditioning mechanical properties L.3 Other mechanical properties |
| 99 | Annex M (informative) Corrosion assessment M.1 Rationale M.2 General M.3 Pitting corrosion |
| 100 | M.4 Crevice corrosion M.5 Galvanic corrosion |
| 101 | M.6 Corrosion fatigue M.7 Fretting (wear) and fretting corrosion M.8 Post-fatigue corrosion evaluation |
| 102 | Annex N (informative) Guidelines for verification of hydrodynamic performance N.1 General N.2 Steady forward flow testing N.3 Steady back flow leakage testing N.3.1 Measuring equipment accuracy N.3.2 Test apparatus requirements N.3.3 Test procedure |
| 103 | N.3.4 Test report N.4 Pulsatile-flow testing N.4.1 Measuring equipment accuracy N.4.2 Test apparatus requirements |
| 104 | N.4.3 Test procedure N.4.4 Test report |
| 105 | N.4.5 Paravalvular leakage assessment |
| 106 | Annex O (informative) Durability testing O.1 General O.2 Measurement equipment accuracy O.3 Test parameters O.4 Results evaluation |
| 107 | O.5 Real time wear testing O.6 Dynamic failure mode O.7 Report requirements |
| 108 | Annex P (informative) Fatigue assessment P.1 General |
| 109 | P.2 Stress/strain analysis of structural components under simulated in vivo conditions |
| 110 | P.3 Fatigue characterization P.3.1 General |
| 111 | P.3.2 Stress/life (S/N) characterization P.3.3 Strain/life (ε/N) characterization P.3.4 Fatigue crack growth (da/dN) characterization |
| 112 | P.3.5 Component testing P.4 Fatigue lifetime assessment P.4.1 General P.4.2 Stress-life (S/N) assessment |
| 113 | P.4.3 Strain-life (ε/N) assessment P.4.4 Damage tolerance analysis (DTA) P.4.5 Component demonstration assessment P.4.6 Test to failure |
| 114 | P.4.7 Post-fatigue corrosion evaluation |
| 115 | Annex Q (informative) Preclinical in vivo evaluation Q.1 General Q.2 Definitions |
| 116 | Q.3 Disposition of evaluations Q.3.1 Hemodynamic performance Q.3.2 Ease of use Q.3.3 Device migration or embolization Q.3.4 Interference with adjacent anatomical structures |
| 117 | Q.3.5 Hemolysis Q.3.6 Thrombo-embolic events Q.3.7 Calcification/mineralization Q.3.8 Pannus formation/tissue ingrowth Q.3.9 Structural valve dysfunction and non-structural dysfunction Q.3.10 Assessment of valve and non-valve related pathology |
| 118 | Annex R (normative) Adverse event classification during clinical investigation R.1 General R.2 Evaluation R.3 Data collection requirements R.4 Classification of serious adverse events R.5 Adverse device effects |
| 119 | R.6 Classification of causal relationships R.7 Adverse events R.7.1 General |
| 120 | R.7.2 Examples of adverse events |
| 121 | R.8 Outcome severity rankings |
| 123 | R.9 Follow up of SAEs |
| 124 | Annex S (informative) Echocardiographic protocol S.1 General S.2 Echocardiographic studies |
| 125 | S.3 Data collected |
| 126 | S.4 3D Echocardiography studies |
| 127 | Bibliography |
