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ANSI/AAMI/ISO 5840-3:2022, Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques, 2022
- ANSI/AAMI/ISO 5840-3:2022; Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques
- Title page
- AAMI Standard
- Copyright information
- Contents Page
- Committee representation
- Background of ANSI/AAMI adoption of ISO 5840-3:2021
- 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 Transcatheter heart valve system
- 6.3.2.3 Implantable device
- 6.3.2.4 Delivery system
- 6.3.3 Implant procedure
- 6.3.4 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 [Go to Page]
- 7.2.3.1 General
- 7.2.3.2 Biological safety
- 7.2.3.3 Material and mechanical property testing
- 7.2.4 Hydrodynamic performance assessment [Go to Page]
- Table 1—Minimum in vitro hydrodynamic device performance requirements, aortic
- Table 2—Minimum in vitro hydrodynamic 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
- 7.2.6 Design- or procedure-specific testing [Go to Page]
- 7.2.6.1 General
- 7.2.6.2 Device migration resistance
- 7.2.6.3 Implant foreshortening (length to diameter)
- 7.2.6.4 Crush resistance
- 7.2.6.5 Recoil
- 7.2.6.6 Radial resistive force (RRF)
- 7.2.6.7 Chronic outward force
- 7.2.6.8 Delivery system design evaluation requirements
- 7.2.6.9 Visibility
- 7.2.7 Device MRI compatibility
- 7.2.8 Simulated use
- 7.2.9 Human factors and 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]
- Table 3—Patient-years required to exclude a linearized event rate that is double the expected rate with 80 % power
- 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
- 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) Description of the transcatheter heart valve system [Go to Page]
- A.1 General
- A.2 Description of the transcatheter heart valve substitute
- A.3 Description of delivery system
- A.4 Chemical treatments, surface modifications or coatings
- A.5 Component description
- A.6 Implant procedure
- Annex B (informative) Transcatheter heart valve substitute hazard analysis example [Go to Page]
- B.1 Hazards, foreseeable sequence of events, hazardous situations, and associated harms [Go to Page]
- Table B.1—Example transcatheter heart valve substitute hazards, foreseeable sequence of events, hazardous situations, and associated harms
- Annex C (informative) Guidelines for verification of hydrodynamic performance — Pulsatile flow testing [Go to Page]
- C.1 General
- C.2 Pulsatile-flow testing [Go to Page]
- C.2.1 General
- C.2.2 Measuring equipment accuracy
- C.2.3 Test apparatus requirements [Go to Page]
- Table C.1—Performance characterization of pulse duplicator testing using mechanical valves
- C.2.4 Test fixture parameters — Minimum performance testing (for transcatheter aortic valves only) [Go to Page]
- Table C.2—Aortic fixture parameters
- C.2.5 Test fixture parameters — Minimum performance testing (for transcatheter mitral valves only) [Go to Page]
- Table C.3—Mitral fixture parameters
- C.2.6 Test parameters — Multi-range hydrodynamic characterization testing (all transcatheter valves) [Go to Page]
- Table C.4—Regurgitant volume test conditions
- C.2.7 Test procedure
- C.2.8 Test report
- Annex D (normative) Requirements for delivery system design and evaluation [Go to Page]
- D.1 General
- D.2 Implant interactions with delivery system
- D.3 Loading of the device into/onto the delivery system
- D.4 Ability to access and deploy
- Annex E (informative) Examples of design specific testing [Go to Page]
- E.1 Stent creep
- E.2 Environmental degradation
- E.3 Static pressure; “burst” test
- E.4 Calcification
- E.5 Particulate generation
- E.6 Effects of device post-dilatation
- E.7 Expansion uniformity
- E.8 Bailout option evaluation
- E.9 Intentional cracking of a pre-existing prosthesis
- Annex F (informative) Preclinical in vivo evaluation [Go to Page]
- F.1 General [Go to Page]
- Table F.1—Examples of evaluations
- F.2 Disposition of evaluations [Go to Page]
- F.2.1 General
- F.2.2 Haemodynamic performance
- F.2.3 Ease of use
- F.2.4 Device migration or embolization
- F.2.5 Interference with or damage to adjacent anatomical structures
- F.2.6 Haemolysis
- F.2.7 Thrombo-embolic events
- F.2.8 Calcification/mineralization
- F.2.9 Pannus formation/tissue ingrowth
- F.2.10 Structural valve deterioration and non-structural dysfunction
- F.2.11 Assessment of valve and non-valve related pathology
- Annex G (normative) Adverse event classification during clinical investigation [Go to Page]
- G.1 General
- G.2 Evaluation
- G.3 Data collection requirements
- G.4 Adverse events
- G.5 Adverse device effects
- G.6 Device deficiencies
- G.7 Classification of causal relationships
- G.8 Classification of adverse events [Go to Page]
- G.8.1 General
- G.8.2 Examples of adverse events
- G.9 Comparison to surgical valve replacement
- G.10 Follow up of SAEs
- G.11 Device-related mortality
- Annex H (informative) Multimodality imaging of TAVI and TMVI pre, peri and post-implantation assessments — Examples [Go to Page]
- H.1 General
- H.2 Multimodality imaging capabilities [Go to Page]
- Table H.1—Multimodality imaging capabilities: TAVI
- Table H.2—Multimodality imaging capabilities: TMVI
- H.3 Echocardiographic (TTE and TEE) data acquisition
- H.4 Computed tomography data acquisition and reconstruction
- H.5 TAVI & TMVR imaging
- Bibliography [Go to Page]
