AAMI 5840 2 2022

$153.60

ANSI/AAMI/ISO 5840-2:2022, Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes

Published By	Publication Date	Number of Pages
AAMI	2022	59

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Description

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.

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PDF Pages	PDF Title
1	ANSI/AAMI/ISO 5840-2:2022; Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
3	Title page
4	AAMI Standard Copyright information
5	Contents Page
9	Committee representation
10	Background of ANSI/AAMI adoption of ISO 5840-2:2021
11	Foreword
12	Introduction
13	1 Scope 2 Normative references 3 Terms and definitions
15	4 Abbreviations
16	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
17	6.3.2.3 Accessories 6.3.2.4 Implant procedure 6.3.3 Packaging, labelling, and sterilization 6.4 Design outputs
18	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
19	Table 1—Minimum device performance requirements, aortic Table 2—Minimum 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)
20	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
21	7.3.3 Methods
22	7.3.4 Test report
23	7.4 Clinical investigations 7.4.1 General
24	7.4.2 Study considerations
25	7.4.3 Study endpoints 7.4.4 Ethical considerations
26	7.4.5 Pivotal studies: Distribution of subjects and investigators
27	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
28	7.4.6.3 Study designs for novel devices 7.4.7 Patient selection criteria
29	7.4.8 Valve thrombosis prevention 7.4.9 Clinical data requirements 7.4.9.1 General 7.4.9.2 Baseline data
30	7.4.9.3 Peri-procedure data 7.4.9.4 Follow-up data
31	7.4.9.5 Clinical investigation analysis and reporting
32	7.4.9.6 Post-market clinical follow-up
34	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—Example surgical heart valve substitute hazards, foreseeable sequence of events, hazardous situations, and associated harms
35	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
36	B.3.3 Reference valves for hydrodynamic testing B.3.4 Wear/durability
37	Annex C (informative) Preclinical in vivo evaluation C.1 General Table C.1—Settings that can be evaluated C.2 Disposition of evaluations C.2.1 General C.2.2 Haemodynamic performance C.2.3 Usability
38	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
39	Annex D (informative) Description of the surgical heart valve substitute and system D.1 General 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 D.3.1 General D.3.2 Examples of components of some surgical heart valve substitutes
40	D.4 Accessories
41	Annex E (informative) Examples of components of some surgical heart valve substitutes and systems
46	Annex F (informative) Guidelines for verification of hydrodynamic performance — 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—Performance characterization of pulse duplicator testing using mechanical valves
47	F.2.3 Test procedure Table F.2—Regurgitant volume test conditions
48	F.2.4 Test report
49	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; “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)
50	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
51	Annex H (informative) Fatigue assessment H.1 General
52	H.2 Fatigue crack growth, da/dN, characterization H.3 Damage tolerance analysis
53	Annex I (normative) Methods of evaluating clinical data against objective performance criteria I.1 General I.2 Objective performance criteria methodology Table I.1—Objective performance criteria for surgical heart valve substitutes
54	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
55	J.7 Classification of causal relationships J.8 Classification of adverse events J.8.1 General
56	J.8.2 Examples of adverse events
58	J.9 Follow up of SAEs J.10 Device-related mortality
59	Bibliography

Additional information

Standard Title	ANSI/AAMI/ISO 5840-2:2022, Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes
Published Code	AAMI
Publication Date	2022
Pages Count	59

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AAMI 5840 2 2022

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