{"id":374185,"date":"2024-10-20T02:37:23","date_gmt":"2024-10-20T02:37:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-4-2017\/"},"modified":"2024-10-26T04:35:02","modified_gmt":"2024-10-26T04:35:02","slug":"aami-10993-4-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-4-2017\/","title":{"rendered":"AAMI 10993 4 2017"},"content":{"rendered":"

This third edition cancels and replaces the second edition (ISO 10993-4:2002), which has been technically revised. It also incorporates the Amendment ISO 10993-4:2002\/Amd 1:2006.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 10993-4:2017; Biological evaluation of medical devices\u2014Part 4: Selection of tests for interactions with blood <\/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 <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of ISO 10993-4:2017 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Abbreviated terms <\/td>\n<\/tr>\n
17<\/td>\n5 Types of devices in contact with blood (as categorized in ISO 10993-1)
5.1 Non-blood-contact devices
5.2 External communicating devices
5.2.1 General
5.2.2 External communicating devices that serve as an indirect blood path
5.2.3 External communicating devices directly contacting circulating blood <\/td>\n<\/tr>\n
18<\/td>\n5.3 Implant devices <\/td>\n<\/tr>\n
19<\/td>\n6 Characterization of blood interactions
6.1 General requirements <\/td>\n<\/tr>\n
20<\/td>\nFigure 1 \u2014 Decision tree to help determine whether testing for interaction with blood is necessary <\/td>\n<\/tr>\n
21<\/td>\nTable 1 \u2014 Circulating blood-contacting devices or device components and the categories of appropriate testing for consideration \u2014 External communicating devices and implant devices <\/td>\n<\/tr>\n
24<\/td>\n6.2 Categories of tests and blood interactions
6.2.1 Recommended tests for interactions of devices with blood <\/td>\n<\/tr>\n
25<\/td>\nTable 2 \u2014 Common tests used to assess interaction with blood
6.2.2 Non-contact devices
6.2.3 External communicating devices and implant devices
6.2.4 Limitations <\/td>\n<\/tr>\n
26<\/td>\n6.3 Types of tests
6.3.1 In vitro tests
6.3.2 Ex vivo tests
6.3.3 In vivo tests <\/td>\n<\/tr>\n
27<\/td>\nAnnex A (informative) Preclinical evaluation of cardiovascular devices and prostheses
A.1 General considerations
A.1.1 Background
A.1.2 Classification <\/td>\n<\/tr>\n
28<\/td>\nA.1.3 Advantages and limitations of animal models
A.1.4 Advantages and limitations of in vitro models <\/td>\n<\/tr>\n
29<\/td>\nA.1.5 Test protocols for animal testing
A.2 Cannulae used for direct vascular access and cannulae used for indirect access
A.3 Catheters and guide wires <\/td>\n<\/tr>\n
30<\/td>\nA.4 Extracorporeal blood oxygenators, haemodialysis\/haemofiltration devices, donor and therapeutic apheresis equipment, devices for adsorption of specific substances from blood
A.5 Ventricular-assist devices and total artificial hearts
A.6 Heart valve prostheses
A.7 Vascular grafts <\/td>\n<\/tr>\n
31<\/td>\nA.8 IVC filters, stents and stented grafts <\/td>\n<\/tr>\n
32<\/td>\nAnnex B (informative) Recommended laboratory tests \u2014 Principles, scientific basis and interpretation
B.1 General considerations
B.1.1 Background
B.1.2 In vitro versus ex vivo versus in vivo testing <\/td>\n<\/tr>\n
33<\/td>\nB.2 Thrombosis
B.2.1 Gross analysis \u2014 Retrieval and examination of device and autopsy of distal organs
B.2.2 Percentage occlusion, surface area covered by thrombus and thrombus-free surface area
B.2.3 Light microscopy <\/td>\n<\/tr>\n
34<\/td>\nB.2.4 Scanning electron microscopy (SEM)
B.3 In vitro haemocompatibility
B.3.1 Haemolysis \u2014 Methods for testing
B.3.2 Coagulation \u2014 Methods for testing
B.3.2.1 General <\/td>\n<\/tr>\n
36<\/td>\nFigure B.1 \u2014 Coagulation cascade
B.3.2.2 Thrombin-antithrombin (TAT), F1.2 and fibrin (FPA) ELISA assays
B.3.2.3 Partial thromboplastin time (PTT)
B.3.3 Platelets \u2014 Methods for testing
B.3.3.1 General <\/td>\n<\/tr>\n
37<\/td>\nB.3.3.2 Platelet count <\/td>\n<\/tr>\n
38<\/td>\nB.3.3.3 Platelet activation: Platelet granule-release proteins beta-thromboglobulin (\u00df-TG) and platelet factor 4 (PF4), thromboxane B2 (TxB2) and platelet morphological changes
B.3.4 Haematology \u2014 Methods for testing
B.3.4.1 Complete blood count (CBC)
B.3.4.2 Leukocyte activation
B.3.5 Complement system \u2014 Methods for testing for C3a and SC5b-9 <\/td>\n<\/tr>\n
40<\/td>\nFigure B.2 \u2014 Alternative complement pathway
B.4 Methodology considerations for testing of plasma factors specific to coagulation, platelet and leucocyte activation and complement activation using ELISA (or other similar) techniques
B.4.1 General <\/td>\n<\/tr>\n
41<\/td>\nB.4.2 General assay methods and documentation
B.4.2.1 General
B.4.2.1.1 Reference documents
B.4.2.2 Storage and stability
B.4.2.3 Procedure
B.4.2.3.1 Sample preparation
B.4.2.3.2 Dilution factor (DF)
B.4.2.3.3 Data selection in cases of testing with multiple DFs
B.4.2.3.4 Preparation of standards
B.4.2.3.5 Method
B.4.2.3.6 Evaluation
B.4.2.3.7 Statistical analysis <\/td>\n<\/tr>\n
42<\/td>\nB.4.2.3.8 Limitations and interferences
B.4.2.3.9 Reference interval
B.4.3 Attachments <\/td>\n<\/tr>\n
43<\/td>\nAnnex C (informative) Thrombosis \u2014 Methods for in vivo testing
C.1 General considerations
C.2 In vivo implant study of final device in pre-clinical animal study <\/td>\n<\/tr>\n
44<\/td>\nC.3 In vivo NAVI and AVI thrombogenicity tests <\/td>\n<\/tr>\n
45<\/td>\nFigure C.1 \u2014 Main implant positions used in the NAVI\/AVI model
Figure C.2 \u2014 Other less-frequently used NAVI and AVI implant positions <\/td>\n<\/tr>\n
46<\/td>\nTable C.1 \u2014 NAVI\/AVI scoring scheme A
Table C.2 \u2014 NAVI\/AVI scoring scheme B <\/td>\n<\/tr>\n
47<\/td>\nTable C.3 \u2014 Main caveats in using the NAVI or AVI models[143] <\/td>\n<\/tr>\n
48<\/td>\nTable C.4 \u2014 Advantages in using the NAVI or AVI models <\/td>\n<\/tr>\n
49<\/td>\nAnnex D (informative) Haematology\/haemolysis \u2014 Methods for testing \u2014 Evaluation of haemolytic properties of medical devices and medical device materials
D.1 General considerations
D.2 Causes of haemolysis
D.2.1 Osmotic pressure (osmotic pressure-induced haemolysis)
D.2.2 Mechanical forces (mechanically-induced haemolysis)
D.2.3 Biochemical factors (material-induced haemolysis) <\/td>\n<\/tr>\n
50<\/td>\nD.3 Clinical significance of haemolysis
D.3.1 Toxic effects
D.3.2 Thrombosis and anaemia
D.4 Determining a pass\/fail assessment for haemolysis <\/td>\n<\/tr>\n
51<\/td>\nD.5 Haemolysis testing \u2014 General considerations
D.5.1 Methods
D.5.1.1 General
D.5.1.2 Total blood haemoglobin concentration measurements
D.5.1.2.1 Cyanmethaemoglobin method <\/td>\n<\/tr>\n
52<\/td>\nD.5.1.2.2 Iron method
D.5.1.3 Plasma or supernatant haemoglobin concentration measurements
D.5.1.3.1 Direct optical and added chemical techniques
D.5.1.3.2 Immunonephelometric method
D.5.2 Blood and blood component preservation <\/td>\n<\/tr>\n
53<\/td>\nD.5.3 Protection of employees handling blood
D.5.4 Blood collection (phlebotomy)
D.5.5 Species selection
D.5.6 Evaluation of haemolysis \u2014 In vitro, ex vivo and in vivo exposure to blood or blood components <\/td>\n<\/tr>\n
54<\/td>\nD.5.7 Direct contact versus indirect methods <\/td>\n<\/tr>\n
55<\/td>\nAnnex E (informative) Complement \u2014 Methods for testing
E.1 Background information
E.2 Complement activation tests and documentation (suggested to consider in reporting complement test results for scientific or regulatory purposes) <\/td>\n<\/tr>\n
56<\/td>\nE.3 Complement activation tests method considerations <\/td>\n<\/tr>\n
58<\/td>\nAnnex F (informative) Less common laboratory tests
F.1 General
Table F.1 \u2014 Less common tests used to assess interactions with blood
F.2 Thrombosis
F.2.1 Flow reduction
F.2.2 Gravimetric analysis (thrombus mass)
F.2.3 Pressure drop across device <\/td>\n<\/tr>\n
59<\/td>\nF.2.4 Adsorbed protein analysis (via antibody binding)
F.2.5 Imaging techniques \u2014 Angiography, intravascular ultrasound, Doppler ultrasound, CT and MRI
F.3 Coagulation
F.3.1 Thrombin generation assay using chromogenic substrates
F.3.2 Fibrinogen and fibrin degradation products (FDP)
F.3.3 D-dimer
F.4 Platelets
F.4.1 Platelet adhesion assessments
F.4.2 Flow cytometry analysis of platelet activation <\/td>\n<\/tr>\n
60<\/td>\nF.4.3 Gamma imaging of radiolabelled platelets
F.4.4 Platelet aggregometry
F.5 Haematology
F.5.1 Leucocyte state and morphology
F.5.2 Blood cell adhesion assessments
F.5.3 Platelet leucocyte complexes (PLCs)
F.6 Complement system
F.6.1 Complement activation assessment of Bb, C3bBb and C5a <\/td>\n<\/tr>\n
61<\/td>\nAnnex G (informative) Tests which are not recommended
G.1 General
Table G.1 \u2014 Tests not used in preclinical assessment of medical device safety
G.2 Coagulation
G.2.1 Activated partial thromboplastin time (APTT), prothrombin time (PT) and thrombin time (TT)
G.3 Platelets
G.3.1 Template bleeding time
G.3.2 Platelet lifespan <\/td>\n<\/tr>\n
62<\/td>\nG.4 Haematology
G.4.1 Reticulocyte count
G.5 Complement system
G.5.1 Complement activation assessment of CH-50, C3 convertase, C5 convertase <\/td>\n<\/tr>\n
63<\/td>\nBibliography
International Standards
National standards <\/td>\n<\/tr>\n
64<\/td>\nUS FDA guidance documents <\/td>\n<\/tr>\n
65<\/td>\nThrombosis <\/td>\n<\/tr>\n
66<\/td>\nCoagulation <\/td>\n<\/tr>\n
67<\/td>\nPlatelets <\/td>\n<\/tr>\n
69<\/td>\nHaematology (including haemolysis) <\/td>\n<\/tr>\n
70<\/td>\nComplement <\/td>\n<\/tr>\n
72<\/td>\nAnimal models
Anticoagulation
Blood pumps
Cardiopulmonary bypass <\/td>\n<\/tr>\n
73<\/td>\nCatheters
General <\/td>\n<\/tr>\n
74<\/td>\nHeart valves
Hemodialysis <\/td>\n<\/tr>\n
75<\/td>\nIn vitro models
In vitro versus in vivo models <\/td>\n<\/tr>\n
76<\/td>\nPathology
Statistics
Vascular grafts <\/td>\n<\/tr>\n
77<\/td>\nVascular stents
Ventricular-assist devices <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 10993-4:2017, Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n77<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374190,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-374185","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\/374185","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\/374190"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374185"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374185"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}