AS ISO 10993.4-2002

1 - AS ISO 10993.4-2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
4 - PREFACE
6 - CONTENTS
7 - INTRODUCTION
9 - 1 Scope
9 - 2 Normative references
9 - 3 Terms and definitions
9 - 3.1 blood/device interaction
10 - 3.2 ex vivo
10 - 3.3 thrombosis
10 - 3.4 coagulation
10 - 3.5 platelet
10 - 3.6 haematology
10 - 3.7 complement system
10 - 4 Abbreviated terms
11 - 5 Types of device in contact with blood
11 - 5.1 Non-contact devices
11 - 5.2 External communicating devices
12 - 5.3 Implant devices
13 - 6 Characterization of blood interactions
13 - 6.1 General requirements
16 - 6.2 Categories of tests and blood interactions
16 - 6.2.1 Recommended tests for interactions of devices with blood
18 - 6.2.2 Non-contact devices
18 - 6.2.3 External communicating devices
19 - 6.2.4 Implant devices
19 - 6.2.5 Indications and limitations
19 - 6.3 Types of test
19 - 6.3.1 In vitro tests
19 - 6.3.2 Ex vivo tests
19 - 6.3.3 In vivo tests
21 - Annex A - Preclinical evaluation of cardiovascular devices and prostheses
21 - A.1 General considerations
23 - A.2 Cannulae
23 - A.3 Catheters and guidewires
23 - A.4 Extracorporeal oxygenators, haemodialysers, therapeutic apheresis equipment, and devices for absorption of specific...
23 - A.5 Ventricular-assist devices and total artificial hearts
23 - A.6 Heart valve prostheses
24 - A.7 Vascular grafts
24 - A.8 IVC filters, stents and stented grafts
25 - Annex B - Laboratory tests - Principles, scientific basis and interpretation
25 - B.1 General
25 - B.2 Thrombosis
26 - B.3 Coagulation
28 - B.4 Platelets and platelet functions
30 - B.5 Haematology
30 - B.6 Complement system – CH 50 and C3a, C5a, TCC, Bb, iC3b, C4d, SC5b-9
31 - Annex C - Evaluation of haemolytic properties of medical devices and their components
31 - C.1 General considerations
31 - C.2 Terms and definitions
32 - C.3 Causes of haemolysis
32 - C.4 Clinical significance of haemolysis
32 - C.5 Determining a Pass/Fail assessment for haemolysis
33 - C.6 Haemolysis testing - General considerations
38 - Bibliography
38 - International Standards
38 - National standards
38 - Scientific papers
41 - Scientific papers referenced in Annex C