EN 30993-4 : 1993
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
01-10-2002
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Abbreviations
5 Devices contacting blood
6 Tests
Annex A (informative) - Evaluation of cardiovascular devices
and prostheses during in vivo function
Annex B (informative) - Laboratory tests: principles and
scientific basis
Annex C (informative) - Bibliography
Provides guidance to agencies, manufacturers, research laboratories and others for evaluating the interactions of medical devices with blood.
| Committee |
TC 206
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN 30993-4:1994 | Identical |
| ISO 10993-4:2017 | Identical |
| NF EN 30993-4 : 1994 | Identical |
| SN EN 30993-4 : 1994 | Identical |
| NBN EN 30993-4 : 1994 | Identical |
| UNI EN 30993-4 : 1995 | Identical |
| BS EN 30993-4:1994 | Identical |
| I.S. EN 30993-4:1994 | Identical |
| NEN ISO 10993-4 : 1994 | Identical |
| NS ISO 10993-4 : 1994 | Identical |
| DIN EN 30993-4:1994-06 | Identical |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| I.S. EN 12442-1:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ASTM F 756 : 2017 : REDLINE | Standard Practice for Assessment of Hemolytic Properties of Materials |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| NFS 90 300 : 1981 | |
| 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) |
| BS EN 30993-1:1994 | Biological evaluation of medical devices Guidance on selection of tests |
| 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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