{"id":424604,"date":"2024-10-20T06:52:33","date_gmt":"2024-10-20T06:52:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-5840-1-2022\/"},"modified":"2024-10-26T12:55:52","modified_gmt":"2024-10-26T12:55:52","slug":"aami-5840-1-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-5840-1-2022\/","title":{"rendered":"AAMI 5840 1 2022"},"content":{"rendered":"

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. <\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 5840-1:2022; Cardiovascular implants\u2014Cardiac valve prostheses\u2014Part 1: General requirements <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents Page <\/td>\n<\/tr>\n
9<\/td>\nBackground of ANSI\/AAMI adoption of ISO 5840-1:2021 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
26<\/td>\n4 Abbreviations <\/td>\n<\/tr>\n
27<\/td>\n5 Fundamental requirements
6 Device description
6.1 General
6.2 Intended use
6.3 Design inputs
6.3.1 Operational specifications <\/td>\n<\/tr>\n
28<\/td>\nTable 1\u2014Heart valve substitute operational environment for left side of heart \u2014 Adult population <\/td>\n<\/tr>\n
29<\/td>\nTable 2\u2014Heart valve substitute operational environment for right side of heart \u2014 Adult population
6.3.2 Performance specifications
6.3.3 Implant procedure <\/td>\n<\/tr>\n
30<\/td>\n6.3.4 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 <\/td>\n<\/tr>\n
31<\/td>\n7.2 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\u2014Recommended pressure values for in vitro testing for left side of heart \u2014 Adult population <\/td>\n<\/tr>\n
32<\/td>\nTable 4\u2014Recommended pressure values for in vitro testing for right side of heart \u2014 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 <\/td>\n<\/tr>\n
33<\/td>\n7.2.3.3 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 <\/td>\n<\/tr>\n
34<\/td>\n7.2.5.3 Device structural component fatigue assessment
7.2.5.4 Component corrosion assessment <\/td>\n<\/tr>\n
35<\/td>\n7.2.6 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 <\/td>\n<\/tr>\n
36<\/td>\n7.3 Preclinical in vivo evaluation
7.4 Clinical investigations <\/td>\n<\/tr>\n
37<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
38<\/td>\nA.4 Rationale for echocardiographic assessment
A.5 Rationale for clinical evaluation reporting
A.6 Rationale for device sizing within labelling and instructions for use <\/td>\n<\/tr>\n
39<\/td>\nA.7 Rationale for human factors engineering <\/td>\n<\/tr>\n
40<\/td>\nAnnex B (normative) Packaging
B.1 Requirements
B.2 Principle
B.3 Containers
B.3.1 Unit container(s)
B.3.2 Outer container <\/td>\n<\/tr>\n
41<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
42<\/td>\nC.1.4 Instructions for use <\/td>\n<\/tr>\n
43<\/td>\nC.1.5 Labels for medical records
C.2 Training for physicians and support staff <\/td>\n<\/tr>\n
44<\/td>\nAnnex D (normative) Sterilization <\/td>\n<\/tr>\n
45<\/td>\nAnnex E (normative) In vitro test guidelines for paediatric devices
E.1 General and paediatric definitions
Table E.1\u2014Paediatric definitions <\/td>\n<\/tr>\n
46<\/td>\nE.2 Pulsatile flow test conditions \u2014 Left side
Table E.2\u2014Pulsatile flow test conditions \u2014 Left side
E.3 Pulsatile flow test conditions \u2014 Right side
Table E.3\u2014Pulsatile flow test conditions \u2014 Right side <\/td>\n<\/tr>\n
47<\/td>\nE.4 Steady back pressure and forward flow conditions \u2014 Left side
Table E.4\u2014Steady back pressure and forward flow conditions \u2014 Left side
E.5 Steady back pressure and forward flow conditions \u2014 Right side
Table E.5\u2014Steady back pressure and forward flow conditions \u2014 Right side <\/td>\n<\/tr>\n
48<\/td>\nE.6 Accelerated wear testing (AWT) test conditions \u2014 Left side
Table E.6\u2014AWT test conditions \u2014 Left side
E.7 Accelerated wear testing (AWT) test conditions \u2014 Right side
Table E.7\u2014AWT test conditions \u2014 Right side <\/td>\n<\/tr>\n
49<\/td>\nE.8 FEA\/life analysis conditions \u2014 Left side
Table E.8\u2014FEA\/life analysis conditions \u2014 Left side
E.9 FEA\/life analysis conditions \u2014 Right side
Table E.9\u2014FEA\/life analysis conditions \u2014 Right side <\/td>\n<\/tr>\n
50<\/td>\nAnnex F (informative) Corrosion assessment
F.1 Rationale
F.2 General
F.3 Pitting corrosion <\/td>\n<\/tr>\n
51<\/td>\nF.4 Crevice corrosion
F.5 Galvanic corrosion
F.6 Corrosion fatigue <\/td>\n<\/tr>\n
52<\/td>\nF.7 Fretting (wear) and fretting corrosion
F.8 Post-fatigue corrosion evaluation <\/td>\n<\/tr>\n
53<\/td>\nAnnex G (informative) Echocardiographic protocol
G.1 General <\/td>\n<\/tr>\n
54<\/td>\nG.2 Echocardiographic studies
G.3 Data collected <\/td>\n<\/tr>\n
55<\/td>\nAnnex H (informative) Assessment of implant thrombogenic and haemolytic potential
H.1 Rationale
H.2 General <\/td>\n<\/tr>\n
56<\/td>\nFigure H.1\u2014Example of integrated thrombus and haemolytic potential assessment approach
H.3 Experimental flow field assessment
H.3.1 General <\/td>\n<\/tr>\n
57<\/td>\nH.3.2 Test apparatus requirements
H.3.3 Test procedure <\/td>\n<\/tr>\n
58<\/td>\nFigure H.2\u2014Example imaging planes (axial view) for symmetric trileaflet (left) and a symmetric D-shaped (right) valve
H.3.4 Test report <\/td>\n<\/tr>\n
59<\/td>\nH.4 Computational flow field assessment
H.4.1 General
H.4.2 Computational Model <\/td>\n<\/tr>\n
60<\/td>\nH.4.3 Error analysis and estimation <\/td>\n<\/tr>\n
61<\/td>\nFigure H.3\u2014Examples of flow domains for aortic\/pulmonary valve (left) and mitral\/tricuspid valve (right)
Figure H.4\u2014Example planes to be used for computational validation (intersections of planes define lines for comparison purposes) <\/td>\n<\/tr>\n
62<\/td>\nH.4.4 Computational simulations
H.4.5 Study report
H.5 Ex vivo blood testing
H.5.1 General <\/td>\n<\/tr>\n
63<\/td>\nH.5.2 Test apparatus requirements
H.5.3 Test procedure <\/td>\n<\/tr>\n
64<\/td>\nH.5.4 Test report <\/td>\n<\/tr>\n
66<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
67<\/td>\nFigure I.1\u2014Standard nozzle, forward flow <\/td>\n<\/tr>\n
68<\/td>\nFigure I.2\u2014Forward flow nozzle gradients
I.2.3 Test procedure
I.2.4 Test report <\/td>\n<\/tr>\n
69<\/td>\nI.3 Steady back flow leakage testing
I.3.1 Measuring equipment accuracy
I.3.2 Test apparatus requirements <\/td>\n<\/tr>\n
70<\/td>\nFigure I.3\u2014Standard nozzle, back flow <\/td>\n<\/tr>\n
71<\/td>\nFigure I.4\u2014Back flow nozzle leakage rates
I.3.3 Test procedure
I.3.4 Test report <\/td>\n<\/tr>\n
73<\/td>\nAnnex J (normative) Durability testing
J.1 Rationale
J.2 General <\/td>\n<\/tr>\n
74<\/td>\nFigure J.1\u2014Example of an integrated durability assessment
J.3 Accelerated wear testing
J.3.1 General <\/td>\n<\/tr>\n
75<\/td>\nJ.3.2 Sample requirements
J.3.3 Test apparatus requirements
J.3.4 Test procedure <\/td>\n<\/tr>\n
76<\/td>\nJ.3.5 Test report <\/td>\n<\/tr>\n
77<\/td>\nJ.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 <\/td>\n<\/tr>\n
78<\/td>\nJ.4.5 Test report <\/td>\n<\/tr>\n
79<\/td>\nJ.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 <\/td>\n<\/tr>\n
80<\/td>\nJ.5.5 Test report <\/td>\n<\/tr>\n
81<\/td>\nAnnex K (informative) Fatigue assessment
K.1 General <\/td>\n<\/tr>\n
82<\/td>\nFigure K.1\u2014Example schematic of a structural component fatigue assessment using a stress-life or strain-life approach
K.2 Determination of in vivo boundary conditions <\/td>\n<\/tr>\n
83<\/td>\nK.3 Structural component stress\/strain analysis <\/td>\n<\/tr>\n
84<\/td>\nK.4 Material fatigue strength determination
K.5 Fatigue safety factor or probability of fatigue fracture determination <\/td>\n<\/tr>\n
85<\/td>\nK.6 Component fatigue demonstration test <\/td>\n<\/tr>\n
86<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
87<\/td>\nL.3 Heart failure hospitalization definition <\/td>\n<\/tr>\n
88<\/td>\nL.4 Composite endpoints
L.5 Timing of endpoints <\/td>\n<\/tr>\n
89<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 5840-1:2022, Cardiovascular implants\u2014Cardiac valve prostheses\u2014Part 1: General requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2022<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":424610,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-424604","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/424604","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/424610"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=424604"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=424604"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=424604"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}