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ANSI/AAMI/ISO 5840-2:2015 - Cardiovascular implants-Cardiac valve prostheses-Part 2: Surgically implanted heart valve substitutes, 2015
- ANSI/AAMI/ISO 5840-2:2015, Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background on AAMI adoption of ISO 5840-2:2015
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions [Go to Page]
- Figure 1 — Designation of dimensions of surgical heart valve substitute sewing ring configurations
- 4 Abbreviations
- 5 Fundamental requirements
- 6 Device description [Go to Page]
- 6.1 Intended use
- 6.2 Design inputs [Go to Page]
- 6.2.1 Operational specifications
- 6.2.2 Performance specifications
- 6.2.3 Packaging, labelling, and sterilization
- 6.3 Design outputs [Go to Page]
- 6.3.1 General
- 6.4 Design transfer (manufacturing qualification)
- 6.5 Risk management
- 7 Design verification testing and analysis/design validation [Go to Page]
- 7.1 General requirements
- 7.2 In vitro assessment [Go to Page]
- 7.2.1 Test conditions, sample selection, and reporting requirements [Go to Page]
- 7.2.1.1 Test conditions and sample selection
- 7.2.1.2 Reporting requirements
- 7.2.2 Material property assessment [Go to Page]
- 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 [Go to Page]
- Table 1 — Minimum device performance requirements, Aortic
- Table 2—Minimum device performance requirements, Mitral
- 7.2.4 Structural performance assessment [Go to Page]
- 7.2.4.1 General
- 7.2.4.2 Device durability assessment
- 7.2.4.3 Component fatigue assessment
- 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
- 7.2.8 Simulated use
- 7.2.9 Human factors/usability assessment
- 7.3 Preclinical in vivo evaluation [Go to Page]
- 7.3.1 Overall requirements
- 7.3.2 Methods [Go to Page]
- 7.3.2.1 General requirements
- 7.3.3 Test report
- 7.4 Clinical investigation [Go to Page]
- 7.4.1 General
- 7.4.2 Statistical considerations
- 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
- 7.4.7 Clinical data requirements [Go to Page]
- 7.4.7.1 General
- 7.4.7.2 Baseline data
- 7.4.7.3 Operative data
- 7.4.7.4 Early post-operative and follow-up data
- 7.4.8 Clinical investigation report [Go to Page]
- 7.4.8.1 General
- 7.4.8.2 Analysis and reporting
- 7.4.8.3 Post-market clinical follow-up
- Annex A: Heart valve substitute hazards, associated failure modes, and evaluation methods [Go to Page]
- A.1 Hazards, failure modes, and evaluation methods [Go to Page]
- A.1.1 General [Go to Page]
- Table A.1—Examples of surgical heart valve substitute hazards, associated failure modes, and evaluation methods
- A.1.2 Additional generic failure modes and causes
- Annex B: In vitro procedures for testing unstented or similar valves in compliant chambers [Go to Page]
- B.1 General
- B.2 Compliant chamber specifications
- B.3 Test procedures using compliant chambers [Go to Page]
- B.3.1 Pulsatile-flow pressure difference
- B.3.2 Pulsatile-flow regurgitation
- B.3.3 Reference valves for hydrodynamics testing
- B.3.4 Wear/durability
- Annex C: Preclinical in vivo evaluation [Go to Page]
- C.1 General [Go to Page]
- Table C.1—Settings that can be evaluated
- C.2 Disposition of evaluations [Go to Page]
- C.2.1 Hemodynamic performance
- 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
- C.2.10 Assessment of valve and non-valve related pathology
- C.2.11 Cavitation
- Annex D: Description of the surgical heart valve substitute [Go to Page]
- D.1 General [Go to Page]
- 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 [Go to Page]
- D.3.1 Examples of components of some surgical heart valve substitutes
- D.4 Implant position
- D.5 Accessories
- Annex E: Examples of components of some surgical heart valve substitutes [Go to Page]
- Figure E.1 — Generic bi-leaflet rigid surgical heart valve substitute
- Figure E.2 — Generic mono-leaflet rigid surgical heart valve substitute
- 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)
- Figure E.5 — Generic flexible stented surgical heart valve substitute
- Figure E.6 — Generic Novel Surgical Valve Substitute, e.g. Sutureless
- Figure E.7 — Generic balloon expandable rapid deployment surgical heart valve system
- Figure E.8 — Generic self-expanding sutureless surgical heart valve
- Annex F: Guidelines for verification of hydrodynamic performance [Go to Page]
- F.1 General
- F.2 Steady forward-flow testing [Go to Page]
- F.2.1 Measuring equipment accuracy
- F.2.2 Test apparatus requirements [Go to Page]
- Figure F.1 — Standard nozzle; forward flow
- Figure F.2 — Forward flow nozzle gradients
- F.2.3 Test procedure
- F.2.4 Test report
- F.3 Steady back-flow leakage testing [Go to Page]
- F.3.1 Measuring equipment accuracy
- F.3.2 Test apparatus requirements [Go to Page]
- Figure F.3 —Standard nozzle; back flow
- Figure F.4 — Back flow nozzle gradients
- F.3.3 Test procedure
- F.3.4 Test report
- F.4 Pulsatile-flow testing [Go to Page]
- F.4.1 Measuring equipment accuracy
- F.4.2 Test apparatus requirements
- F.4.3 Test procedure [Go to Page]
- Table F.1 — Regurgitant volume test conditions
- F.4.4 Test report
- Annex G: Durability testing [Go to Page]
- 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
- Annex H: Examples of design specific testing [Go to Page]
- 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)
- H.9 Calcification (flexible valve)
- H.10 Leaflet kinematics
- H.11 Device Migration resistance
- Annex I: Fatigue assessment [Go to Page]
- I.1 General [Go to Page]
- 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
- I.3 Fatigue characterization [Go to Page]
- I.3.1 General
- I.3.2 Stress/life, S/N, characterization
- I.3.3 Strain/life, ε/N, characterization
- I.3.4 Fatigue crack growth, da/dN, characterization
- I.3.5 Component testing
- I.4 Fatigue lifetime assessment [Go to Page]
- 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
- I.4.5 Component demonstration assessment
- I.4.6 Test to Failure
- I.4.7 Post Fatigue Corrosion Evaluation
- Annex J: Methods of evaluating clinical data [Go to Page]
- J.1 General
- J.2 Objective performance criteria methodology [Go to Page]
- Table J.1—Objective performance criteria for surgical heart valve substitutes
- Bibliography [Go to Page]