AS ISO 10993.4-2002

Name: AS ISO 10993.4-2002 - Biological evaluation of medical devices - Selection of tests for interactions with blood
Brand: Standards Australia

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Biological evaluation of medical devices - Selection of tests for interactions with blood

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Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

01-01-2002

Publisher

Standards Australia

Superseded date

30-06-2017

Superseded by

AS ISO 10993.4-2003

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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

Provides guidance for selection of tests for evaluating the interactions of medical devices with blood.

Committee	HE-012
DocumentType	Standard
ISBN	0 7337 4713 2
Pages	34
PublisherName	Standards Australia
Status	Superseded
SupersededBy	AS ISO 10993.4-2003
Supersedes	DR 02216 CP
UnderRevision	DR 03172-03177 CP

Standards	Relationship
ISO 10993-4:1992	Identical
ISO 10993-4:2002	Identical

First published as AS ISO 10993.4-2002.

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AS ISO 10993.4-2002

Biological evaluation of medical devices - Selection of tests for interactions with blood

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