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ANSI/AAMI/ISO 5840-2:2022, Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes, 2022
- ANSI/AAMI/ISO 5840-2:2022; Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
- Title page
- AAMI Standard
- Copyright information
- Contents Page
- Committee representation
- Background of ANSI/AAMI adoption of ISO 5840-2:2021
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Abbreviations
- 5 Fundamental requirements
- 6 Device description [Go to Page]
- 6.1 General
- 6.2 Intended use
- 6.3 Design inputs [Go to Page]
- 6.3.1 Operational specifications
- 6.3.2 Performance specifications [Go to Page]
- 6.3.2.1 General
- 6.3.2.2 Surgical heart valve substitute minimum performance requirements
- 6.3.2.3 Accessories
- 6.3.2.4 Implant procedure
- 6.3.3 Packaging, labelling, and sterilization
- 6.4 Design outputs
- 6.5 Design transfer (manufacturing verification/validation)
- 6.6 Risk management
- 7 Design verification and validation [Go to Page]
- 7.1 General requirements
- 7.2 In vitro assessment [Go to Page]
- 7.2.1 General
- 7.2.2 Test conditions, sample selection, and reporting requirements
- 7.2.3 Material property assessment
- 7.2.4 Hydrodynamic performance assessment [Go to Page]
- Table 1—Minimum device performance requirements, aortic
- Table 2—Minimum device performance requirements, mitral
- 7.2.5 Structural performance assessment [Go to Page]
- 7.2.5.1 General
- 7.2.5.2 Implant durability assessment
- 7.2.5.3 Device structural component fatigue assessment
- 7.2.5.4 Component corrosion assessment
- 7.2.5.5 Cavitation (rigid valves)
- 7.2.6 Design- or procedure-specific testing [Go to Page]
- 7.2.6.1 General
- 7.2.6.2 Visibility
- 7.2.7 Device MRI compatibility
- 7.2.8 Simulated use
- 7.2.9 Human factors/usability assessment
- 7.2.10 Implant thrombogenic and haemolytic potential assessment
- 7.3 Preclinical in vivo evaluation [Go to Page]
- 7.3.1 General
- 7.3.2 Overall requirements
- 7.3.3 Methods
- 7.3.4 Test report
- 7.4 Clinical investigations [Go to Page]
- 7.4.1 General
- 7.4.2 Study considerations
- 7.4.3 Study endpoints
- 7.4.4 Ethical considerations
- 7.4.5 Pivotal studies: Distribution of subjects and investigators
- 7.4.6 Statistical considerations including sample size and duration [Go to Page]
- 7.4.6.1 General
- 7.4.6.2 Objective performance criteria for established device designs
- 7.4.6.3 Study designs for novel devices
- 7.4.7 Patient selection criteria
- 7.4.8 Valve thrombosis prevention
- 7.4.9 Clinical data requirements [Go to Page]
- 7.4.9.1 General
- 7.4.9.2 Baseline data
- 7.4.9.3 Peri-procedure data
- 7.4.9.4 Follow-up data
- 7.4.9.5 Clinical investigation analysis and reporting
- 7.4.9.6 Post-market clinical follow-up
- Annex A (informative) Surgical heart valve substitute hazard analysis example [Go to Page]
- A.1 Hazards, foreseeable sequence of events, hazardous situations, and associated harms [Go to Page]
- Table A.1—Example surgical heart valve substitute hazards, foreseeable sequence of events, hazardous situations, and associated harms
- Annex B (informative) 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 hydrodynamic testing
- B.3.4 Wear/durability
- Annex C (informative) 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 General
- C.2.2 Haemodynamic performance
- C.2.3 Usability
- C.2.4 Acoustic characteristics
- C.2.5 Interference with adjacent anatomical structures
- C.2.6 Haemolysis
- C.2.7 Thrombo-embolic events
- C.2.8 Calcification/mineralization
- C.2.9 Pannus formation/tissue ingrowth
- C.2.10 Structural valve deterioration and non-structural dysfunction
- C.2.11 Assessment of valve and non-valve related pathology
- C.2.12 Cavitation
- Annex D (informative) Description of the surgical heart valve substitute and system [Go to Page]
- D.1 General [Go to Page]
- Table D.1—Information to be included in the description of the surgical heart valve substitute
- D.2 Chemical treatments, surface modifications, or coatings
- D.3 Component description [Go to Page]
- D.3.1 General
- D.3.2 Examples of components of some surgical heart valve substitutes
- D.4 Accessories
- Annex E (informative) Examples of components of some surgical heart valve substitutes and systems
- Annex F (informative) Guidelines for verification of hydrodynamic performance — Pulsatile flow testing [Go to Page]
- F.1 General
- F.2 Pulsatile-flow testing [Go to Page]
- F.2.1 Measuring equipment accuracy
- F.2.2 Test apparatus requirements
- F.2.3 Test procedure [Go to Page]
- Table F.1—Performance characterization of pulse duplicator testing using mechanical valves
- F.2.4 Test report
- Table F.2—Regurgitant volume test conditions
- Annex G (informative) Examples of design specific testing [Go to Page]
- G.1 Sewing ring integrity
- G.2 Stent creep
- G.3 Environmental degradation
- G.4 Static pressure; “burst” test
- G.5 Calcification (flexible valve)
- G.6 Particulate generation
- G.7 Effects of device post-dilatation
- G.8 Leaflet impingement force (rigid valves)
- G.9 Leaflet escape force (rigid valves)
- G.10 Sewing ring push-off
- G.11 Sewing ring torque (rigid valves)
- G.12 Device migration resistance
- Annex H (informative) Fatigue assessment [Go to Page]
- H.1 General
- H.2 Fatigue crack growth, da/dN, characterization
- H.3 Damage tolerance analysis
- Annex I (normative) Methods of evaluating clinical data against objective performance criteria [Go to Page]
- I.1 General
- I.2 Objective performance criteria methodology [Go to Page]
- Table I.1—Objective performance criteria for surgical heart valve substitutes
- Annex J (normative) Adverse event classification during clinical investigation [Go to Page]
- J.1 General
- J.2 Evaluation
- J.3 Data collection requirements
- J.4 Adverse events
- J.5 Adverse device effects
- J.6 Device deficiencies
- J.7 Classification of causal relationships
- J.8 Classification of adverse events [Go to Page]
- J.8.1 General
- J.8.2 Examples of adverse events
- J.9 Follow up of SAEs
- J.10 Device-related mortality
- Bibliography [Go to Page]
