15/30290736 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
Hardcopy , PDF
English
31-05-2017
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 10993-1:2009)
6 Characterization of blood interactions
Annex A (informative) - Preclinical evaluation of
cardiovascular devices and prostheses
Annex B (informative) - Recommended laboratory
tests - principles, scientific basis and Interpretation
Annex C (informative) - Thrombosis - Methods for
in vivo testing
Annex D (informative) - Haematology/haemolysis
Methods for testing - Evaluation of haemolytic
properties of medical devices and medical device
materials
Annex E (informative) - Complement - Methods for testing
Annex F (informative) - Less common laboratory tests
Annex G (informative) - Tests which are not recommended
Bibliography
BS EN ISO 10993-4.
| Committee |
CH/194
|
| DocumentType |
Draft
|
| Pages |
83
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| 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 |
| ANSI/AAMI/ISO 15675:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| ISO 8637:2010 | Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ISO 14708-5:2010 | Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices |
| ISO 3826-3:2006 | Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| ISO 15675:2016 | Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters |
| ISO 14708-2:2012 | Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers |
| AAMI RD16 : 2007 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
| ANSI/AAMI/ISO 7198:2016 | Cardiovascular implants—Tubular vascular 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 15674:2016 | Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| CFR 21(PTS1-99) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
| SAC GB/T 16175 : 1996 | BIOLOGICAL EVALUATION TEST METHODS FOR MEDICAL ORGANIC SILICON MATERIALS |
| BS EN 30993-4:1994 | Biological evaluation of medical devices Selection of tests for interactions with blood |
| ISO 12891-1:2015 | Retrieval and analysis of surgical implants — Part 1: Retrieval and handling |
| 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 |
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