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AAMI 10993 4 2017

AAMI 10993 4 2017

$140.32

ANSI/AAMI/ISO 10993-4:2017, Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood

Published By Publication Date Number of Pages
AAMI 2017 77
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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.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 10993-4:2017; Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
3 Title page
4 AAMI Standard
Copyright information
5 Contents
6 Committee representation
8 Background of ANSI/AAMI adoption of ISO 10993-4:2017
9 Foreword
11 Introduction
13 1 Scope
2 Normative references
3 Terms and definitions
16 4 Abbreviated terms
17 5 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
18 5.3 Implant devices
19 6 Characterization of blood interactions
6.1 General requirements
20 Figure 1 — Decision tree to help determine whether testing for interaction with blood is necessary
21 Table 1 — Circulating blood-contacting devices or device components and the categories of appropriate testing for consideration — External communicating devices and implant devices
24 6.2 Categories of tests and blood interactions
6.2.1 Recommended tests for interactions of devices with blood
25 Table 2 — 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
26 6.3 Types of tests
6.3.1 In vitro tests
6.3.2 Ex vivo tests
6.3.3 In vivo tests
27 Annex A (informative) Preclinical evaluation of cardiovascular devices and prostheses
A.1 General considerations
A.1.1 Background
A.1.2 Classification
28 A.1.3 Advantages and limitations of animal models
A.1.4 Advantages and limitations of in vitro models
29 A.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
30 A.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
31 A.8 IVC filters, stents and stented grafts
32 Annex B (informative) Recommended laboratory tests — 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
33 B.2 Thrombosis
B.2.1 Gross analysis — 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
34 B.2.4 Scanning electron microscopy (SEM)
B.3 In vitro haemocompatibility
B.3.1 Haemolysis — Methods for testing
B.3.2 Coagulation — Methods for testing
B.3.2.1 General
36 Figure B.1 — 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 — Methods for testing
B.3.3.1 General
37 B.3.3.2 Platelet count
38 B.3.3.3 Platelet activation: Platelet granule-release proteins beta-thromboglobulin (ß-TG) and platelet factor 4 (PF4), thromboxane B2 (TxB2) and platelet morphological changes
B.3.4 Haematology — Methods for testing
B.3.4.1 Complete blood count (CBC)
B.3.4.2 Leukocyte activation
B.3.5 Complement system — Methods for testing for C3a and SC5b-9
40 Figure B.2 — 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
41 B.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
42 B.4.2.3.8 Limitations and interferences
B.4.2.3.9 Reference interval
B.4.3 Attachments
43 Annex C (informative) Thrombosis — Methods for in vivo testing
C.1 General considerations
C.2 In vivo implant study of final device in pre-clinical animal study
44 C.3 In vivo NAVI and AVI thrombogenicity tests
45 Figure C.1 — Main implant positions used in the NAVI/AVI model
Figure C.2 — Other less-frequently used NAVI and AVI implant positions
46 Table C.1 — NAVI/AVI scoring scheme A
Table C.2 — NAVI/AVI scoring scheme B
47 Table C.3 — Main caveats in using the NAVI or AVI models[143]
48 Table C.4 — Advantages in using the NAVI or AVI models
49 Annex D (informative) Haematology/haemolysis — Methods for testing — 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)
50 D.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
51 D.5 Haemolysis testing — 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
52 D.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
53 D.5.3 Protection of employees handling blood
D.5.4 Blood collection (phlebotomy)
D.5.5 Species selection
D.5.6 Evaluation of haemolysis — In vitro, ex vivo and in vivo exposure to blood or blood components
54 D.5.7 Direct contact versus indirect methods
55 Annex E (informative) Complement — 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)
56 E.3 Complement activation tests method considerations
58 Annex F (informative) Less common laboratory tests
F.1 General
Table F.1 — 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
59 F.2.4 Adsorbed protein analysis (via antibody binding)
F.2.5 Imaging techniques — 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
60 F.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
61 Annex G (informative) Tests which are not recommended
G.1 General
Table G.1 — 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
62 G.4 Haematology
G.4.1 Reticulocyte count
G.5 Complement system
G.5.1 Complement activation assessment of CH-50, C3 convertase, C5 convertase
63 Bibliography
International Standards
National standards
64 US FDA guidance documents
65 Thrombosis
66 Coagulation
67 Platelets
69 Haematology (including haemolysis)
70 Complement
72 Animal models
Anticoagulation
Blood pumps
Cardiopulmonary bypass
73 Catheters
General
74 Heart valves
Hemodialysis
75 In vitro models
In vitro versus in vivo models
76 Pathology
Statistics
Vascular grafts
77 Vascular stents
Ventricular-assist devices

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