CSA ISO 10993-4 : 1997
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
Hardcopy , PDF
01-09-2009
English
01-01-2006
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1 Scope
2 Normative reference
3 Definitions
4 Abbreviations
5 Devices contacting blood
5.1 Non-contact devices
5.2 External communicating devices
5.3 Implant devices
6 Tests
6.1 General recommendations
6.2 Test methods
6.3 Types of tests
Annexes
A Evaluation of cardiovascular devices and prostheses
during in vivo function
B Laboratory tests: principles and scientific basis
C Bibliography
Provides guidance to agencies, manufacturers, research laboratories and others for evaluating the interactions of medical devices with blood.
| DocumentType |
Standard
|
| Pages |
35
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-4:2017 | Identical |
| CSA Z8638 : 2008 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
| CSA ISO 10993-13 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
| CSA ISO 10993-16 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
| CSA ISO 10993-9 : 0 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
| CSA Z8637 : 2008 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| ASTM F 756 : 2017 : REDLINE | Standard Practice for Assessment of Hemolytic Properties of Materials |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| BS 5736-11:1990 | Evaluation of medical devices for biological hazards Method of test for haemolysis |
| AAMI CVP3 : 1981 | CARDIAC VALVE PROSTHESES |
| ISO 7199:2016 | Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
| 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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