This document establishes an approach for verifying\/validating the design and manufacture of asurgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. <\/p>\n
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| 1<\/td>\n | ANSI\/AAMI\/ISO 5840-2:2022; Cardiovascular implants\u2014Cardiac valve prostheses\u2014Part 2: Surgically implanted heart valve substitutes <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents Page <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Background of ANSI\/AAMI adoption of ISO 5840-2:2021 <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4 Abbreviations <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5 Fundamental requirements 6 Device description 6.1 General 6.2 Intended use 6.3 Design inputs 6.3.1 Operational specifications 6.3.2 Performance specifications 6.3.2.1 General 6.3.2.2 Surgical heart valve substitute minimum performance requirements <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 6.3.2.3 Accessories 6.3.2.4 Implant procedure 6.3.3 Packaging, labelling, and sterilization 6.4 Design outputs <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 6.5 Design transfer (manufacturing verification\/validation) 6.6 Risk management 7 Design verification and validation 7.1 General requirements 7.2 In vitro assessment 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 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | Table 1\u2014Minimum device performance requirements, aortic Table 2\u2014Minimum device performance requirements, mitral 7.2.5 Structural performance assessment 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) <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 7.2.6 Design- or procedure-specific testing 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 7.3.1 General 7.3.2 Overall requirements <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 7.3.3 Methods <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 7.3.4 Test report <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 7.4 Clinical investigations 7.4.1 General <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 7.4.2 Study considerations <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 7.4.3 Study endpoints 7.4.4 Ethical considerations <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 7.4.5 Pivotal studies: Distribution of subjects and investigators <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 7.4.6 Statistical considerations including sample size and duration 7.4.6.1 General 7.4.6.2 Objective performance criteria for established device designs <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 7.4.6.3 Study designs for novel devices 7.4.7 Patient selection criteria <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 7.4.8 Valve thrombosis prevention 7.4.9 Clinical data requirements 7.4.9.1 General 7.4.9.2 Baseline data <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 7.4.9.3 Peri-procedure data 7.4.9.4 Follow-up data <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 7.4.9.5 Clinical investigation analysis and reporting <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 7.4.9.6 Post-market clinical follow-up <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Annex A (informative) Surgical heart valve substitute hazard analysis example A.1 Hazards, foreseeable sequence of events, hazardous situations, and associated harms Table A.1\u2014Example surgical heart valve substitute hazards, foreseeable sequence of events, hazardous situations, and associated harms <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers B.1 General B.2 Compliant chamber specifications B.3 Test procedures using compliant chambers B.3.1 Pulsatile-flow pressure difference B.3.2 Pulsatile-flow regurgitation <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | B.3.3 Reference valves for hydrodynamic testing B.3.4 Wear\/durability <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex C (informative) Preclinical in vivo evaluation C.1 General Table C.1\u2014Settings that can be evaluated C.2 Disposition of evaluations C.2.1 General C.2.2 Haemodynamic performance C.2.3 Usability <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Annex D (informative) Description of the surgical heart valve substitute and system D.1 General Table D.1\u2014Information to be included in the description of the surgical heart valve substitute D.2 Chemical treatments, surface modifications, or coatings D.3 Component description D.3.1 General D.3.2 Examples of components of some surgical heart valve substitutes <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | D.4 Accessories <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Annex E (informative) Examples of components of some surgical heart valve substitutes and systems <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Annex F (informative) Guidelines for verification of hydrodynamic performance \u2014 Pulsatile flow testing F.1 General F.2 Pulsatile-flow testing F.2.1 Measuring equipment accuracy F.2.2 Test apparatus requirements Table F.1\u2014Performance characterization of pulse duplicator testing using mechanical valves <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | F.2.3 Test procedure Table F.2\u2014Regurgitant volume test conditions <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | F.2.4 Test report <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Annex G (informative) Examples of design specific testing G.1 Sewing ring integrity G.2 Stent creep G.3 Environmental degradation G.4 Static pressure; \u201cburst\u201d test G.5 Calcification (flexible valve) G.6 Particulate generation G.7 Effects of device post-dilatation G.8 Leaflet impingement force (rigid valves) <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Annex H (informative) Fatigue assessment H.1 General <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | H.2 Fatigue crack growth, da\/dN, characterization H.3 Damage tolerance analysis <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Annex I (normative) Methods of evaluating clinical data against objective performance criteria I.1 General I.2 Objective performance criteria methodology Table I.1\u2014Objective performance criteria for surgical heart valve substitutes <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Annex J (normative) Adverse event classification during clinical investigation J.1 General J.2 Evaluation J.3 Data collection requirements J.4 Adverse events J.5 Adverse device effects J.6 Device deficiencies <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | J.7 Classification of causal relationships J.8 Classification of adverse events J.8.1 General <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | J.8.2 Examples of adverse events <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | J.9 Follow up of SAEs J.10 Device-related mortality <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 5840-2:2022, Cardiovascular implants\u2014Cardiac valve prostheses\u2014Part 2: Surgically implanted heart valve substitutes<\/b><\/p>\n |