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AAMI 5840 1 2022

AAMI 5840 1 2022

$177.85

ANSI/AAMI/ISO 5840-1:2022, Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements

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AAMI 2022
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Outlines an approach for verifying/validating the design and manufacture of a 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 heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. 

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 5840-1:2022; Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements
3 Title page
4 AAMI Standard
Copyright information
5 Contents Page
9 Background of ANSI/AAMI adoption of ISO 5840-1:2021
10 Foreword
11 Introduction
13 1 Scope
2 Normative references
14 3 Terms and definitions
26 4 Abbreviations
27 5 Fundamental requirements
6 Device description
6.1 General
6.2 Intended use
6.3 Design inputs
6.3.1 Operational specifications
28 Table 1—Heart valve substitute operational environment for left side of heart — Adult population
29 Table 2—Heart valve substitute operational environment for right side of heart — Adult population
6.3.2 Performance specifications
6.3.3 Implant procedure
30 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
7.1 General requirements
31 7.2 In vitro assessment
7.2.1 General
7.2.2 Test conditions, sample selection and reporting requirements
7.2.2.1 Test articles and sample selection
7.2.2.2 Test conditions
Table 3—Recommended pressure values for in vitro testing for left side of heart — Adult population
32 Table 4—Recommended pressure values for in vitro testing for right side of heart — Adult population
7.2.2.3 Reporting requirements
7.2.3 Material property assessment
7.2.3.1 General
7.2.3.2 Biological safety
33 7.2.3.3 Material and mechanical property testing
7.2.4 Hydrodynamic performance assessment
7.2.5 Structural performance assessment
7.2.5.1 General
7.2.5.2 Implant durability assessment
34 7.2.5.3 Device structural component fatigue assessment
7.2.5.4 Component corrosion assessment
35 7.2.6 Design- or procedure-specific testing
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
36 7.3 Preclinical in vivo evaluation
7.4 Clinical investigations
37 Annex A (informative) Rationale for the provisions of ISO 5840-1
A.1 Rationale for a risk-based approach
A.2 Rationale for preclinical in vivo evaluation
A.3 Rationale for design verification and design validation testing
38 A.4 Rationale for echocardiographic assessment
A.5 Rationale for clinical evaluation reporting
A.6 Rationale for device sizing within labelling and instructions for use
39 A.7 Rationale for human factors engineering
40 Annex B (normative) Packaging
B.1 Requirements
B.2 Principle
B.3 Containers
B.3.1 Unit container(s)
B.3.2 Outer container
41 Annex C (normative) Product labels, instructions for use, and training
C.1 General
C.1.1 General requirements
C.1.2 Unit-container label
C.1.3 Outer-container label
42 C.1.4 Instructions for use
43 C.1.5 Labels for medical records
C.2 Training for physicians and support staff
44 Annex D (normative) Sterilization
45 Annex E (normative) In vitro test guidelines for paediatric devices
E.1 General and paediatric definitions
Table E.1—Paediatric definitions
46 E.2 Pulsatile flow test conditions — Left side
Table E.2—Pulsatile flow test conditions — Left side
E.3 Pulsatile flow test conditions — Right side
Table E.3—Pulsatile flow test conditions — Right side
47 E.4 Steady back pressure and forward flow conditions — Left side
Table E.4—Steady back pressure and forward flow conditions — Left side
E.5 Steady back pressure and forward flow conditions — Right side
Table E.5—Steady back pressure and forward flow conditions — Right side
48 E.6 Accelerated wear testing (AWT) test conditions — Left side
Table E.6—AWT test conditions — Left side
E.7 Accelerated wear testing (AWT) test conditions — Right side
Table E.7—AWT test conditions — Right side
49 E.8 FEA/life analysis conditions — Left side
Table E.8—FEA/life analysis conditions — Left side
E.9 FEA/life analysis conditions — Right side
Table E.9—FEA/life analysis conditions — Right side
50 Annex F (informative) Corrosion assessment
F.1 Rationale
F.2 General
F.3 Pitting corrosion
51 F.4 Crevice corrosion
F.5 Galvanic corrosion
F.6 Corrosion fatigue
52 F.7 Fretting (wear) and fretting corrosion
F.8 Post-fatigue corrosion evaluation
53 Annex G (informative) Echocardiographic protocol
G.1 General
54 G.2 Echocardiographic studies
G.3 Data collected
55 Annex H (informative) Assessment of implant thrombogenic and haemolytic potential
H.1 Rationale
H.2 General
56 Figure H.1—Example of integrated thrombus and haemolytic potential assessment approach
H.3 Experimental flow field assessment
H.3.1 General
57 H.3.2 Test apparatus requirements
H.3.3 Test procedure
58 Figure H.2—Example imaging planes (axial view) for symmetric trileaflet (left) and a symmetric D-shaped (right) valve
H.3.4 Test report
59 H.4 Computational flow field assessment
H.4.1 General
H.4.2 Computational Model
60 H.4.3 Error analysis and estimation
61 Figure H.3—Examples of flow domains for aortic/pulmonary valve (left) and mitral/tricuspid valve (right)
Figure H.4—Example planes to be used for computational validation (intersections of planes define lines for comparison purposes)
62 H.4.4 Computational simulations
H.4.5 Study report
H.5 Ex vivo blood testing
H.5.1 General
63 H.5.2 Test apparatus requirements
H.5.3 Test procedure
64 H.5.4 Test report
66 Annex I (informative) Guidelines for hydrodynamic performance characterization by steady flow testing
I.1 General
I.2 Steady forward flow testing
I.2.1 Measuring equipment accuracy
I.2.2 Test apparatus requirements
67 Figure I.1—Standard nozzle, forward flow
68 Figure I.2—Forward flow nozzle gradients
I.2.3 Test procedure
I.2.4 Test report
69 I.3 Steady back flow leakage testing
I.3.1 Measuring equipment accuracy
I.3.2 Test apparatus requirements
70 Figure I.3—Standard nozzle, back flow
71 Figure I.4—Back flow nozzle leakage rates
I.3.3 Test procedure
I.3.4 Test report
73 Annex J (normative) Durability testing
J.1 Rationale
J.2 General
74 Figure J.1—Example of an integrated durability assessment
J.3 Accelerated wear testing
J.3.1 General
75 J.3.2 Sample requirements
J.3.3 Test apparatus requirements
J.3.4 Test procedure
76 J.3.5 Test report
77 J.4 Dynamic failure mode testing
J.4.1 General
J.4.2 Sample requirements
J.4.3 Test apparatus requirements
J.4.4 Test procedure
78 J.4.5 Test report
79 J.5 Real-time wear testing
J.5.1 General
J.5.2 Test apparatus requirements
J.5.3 Test apparatus requirements
J.5.4 Test procedure
80 J.5.5 Test report
81 Annex K (informative) Fatigue assessment
K.1 General
82 Figure K.1—Example schematic of a structural component fatigue assessment using a stress-life or strain-life approach
K.2 Determination of in vivo boundary conditions
83 K.3 Structural component stress/strain analysis
84 K.4 Material fatigue strength determination
K.5 Fatigue safety factor or probability of fatigue fracture determination
85 K.6 Component fatigue demonstration test
86 Annex L (normative) Clinical investigation endpoints for heart valve replacement devices
L.1 General
L.2 Single endpoints
L.2.1 General
L.2.2 Safety
L.2.3 Effectiveness
87 L.3 Heart failure hospitalization definition
88 L.4 Composite endpoints
L.5 Timing of endpoints
89 Bibliography

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