AAMI ISO 10993-4 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
Hardcopy , PDF
02-01-2018
ANSI/AAMI/ISO 10993-4:2002(R2009)
ANSI/AAMI/ISO 10993-4:2017
English
01-01-2009
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Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-4
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Types of devices in contact with blood (as categorized
in ISO 10993-1)
5.1 Non-contact devices
5.2 External communicating devices
5.3 Implant devices
6 Characterization of blood interactions
6.1 General requirements
6.2 Categories of tests and blood interactions
6.2.1 Recommended tests for interactions of devices
with blood
6.2.2 Non-contact devices
6.2.3 External communicating devices
6.2.4 Implant devices
6.2.5 Indications and limitations
6.3 Types of tests
6.3.1 In vitro tests
6.3.2 Ex vivo tests
6.3.3 In vivo tests
Annexes
A - Preclinical evaluation of cardiovascular devices and
prostheses
B - Laboratory tests-Principles, scientific basis, and
interpretation
C - Evaluation of hemolytic properties of medical devices
and their components
Bibliography
Tables
Figure
Describes general requirements for evaluating the interactions of medical devices with blood.
| Committee |
WG 09
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 10993-4:2017 | Identical |
| AAMI BF7 : 2012 | BLOOD TRANSFUSION MICROFILTERS |
| AAMI TIR17 : 2017 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| AAMI TIR17 : 2008 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| AAMI TIR14 : 2016 | CONTRACT STERILIZATION USING ETHYLENE OXIDE |
| ASTM F 2888 : 2013 | Standard Test Method for Platelet Leukocyte Count—An <emph type="bdit">In-Vitro</emph > Measure for Hemocompatibility Assessment of Cardiovascular Materials |
| ASTM F 756 : 2017 : REDLINE | Standard Practice for Assessment of Hemolytic Properties of Materials |
| CFR 29(PTS1900-1910) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| NFS 90 300 : 1981 | |
| BS 5736-11:1990 | Evaluation of medical devices for biological hazards Method of test for haemolysis |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 3826:1993 | Plastics collapsible containers for human blood and blood components |
| AAMI CVP3 : 1981 | CARDIAC VALVE PROSTHESES |
| ISO 7199:2016 | Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
| AAMI VP20 : 2ED 94 | CARDIOVASCULAR IMPLANTS - VASCULAR GRAFT PROSTHESES |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 5841-3:2013 | Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| DIN 58361-4:1980-09 | TRANSFUSION, INFUSION, TRANSFUSION CONTAINERS AND ACCESSORIES, PLASTIC CONTAINERS FOR BLOOD, REQUIREMENTS, TESTS, SUPERVISION AND LABELLING |
| ISO 5841-1:1989 | Cardiac pacemakers Part 1: Implantable pacemakers |
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