UNE-EN ISO 10993-4:2018
Current
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
Spanish, Castilian, English
Published date
24-01-2018
Publisher
€159.60
Excluding VAT
This document specifies general requirements for evaluating the interactions of medical devices with blood.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 30993-4. (02/2007)
|
| DocumentType |
Standard
|
| Pages |
101
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 10993-4:2017 | Identical |
| ISO 10993-4:2017 | Identical |
| NS EN ISO 10993-4 : 2017 | Identical |
| DIN EN ISO 10993-4:2009-10 | Identical |
| NF EN ISO 10993-4 : 2017 | Identical |
| BS EN ISO 10993-4:2017 | Identical |
| NBN EN ISO 10993-4 : 2009 | Identical |
| DIN EN ISO 10993-4:2016-02 (Draft) | Identical |
| I.S. EN ISO 10993-4:2017 | Identical |
| NEN EN ISO 10993-4 : OCT 2017 | Identical |
| 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 |
| 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 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 |
| 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 |
| 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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