Obstacles in Haemocompatibility Testing
ISO 10993-4 is an international standard describing the methods of testing of medical devices for interactions with blood for regulatory purpose. The complexity of blood responses to biomaterial surfaces and the variability of blood functions in different individuals and species pose difficulties in...
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| Format: | Article |
| Language: | English |
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Wiley
2013-01-01
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| Series: | Scientifica |
| Online Access: | http://dx.doi.org/10.1155/2013/392584 |
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| _version_ | 1849407966353031168 |
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| author | W. van Oeveren |
| author_facet | W. van Oeveren |
| author_sort | W. van Oeveren |
| collection | DOAJ |
| description | ISO 10993-4 is an international standard describing the methods of testing of medical devices for interactions with blood for regulatory purpose. The complexity of blood responses to biomaterial surfaces and the variability of blood functions in different individuals and species pose difficulties in standardisation. Moreover, in vivo or in vitro testing, as well as the clinical relevance of certain findings, is still matter of debate. This review deals with the major remaining problems, including a brief explanation of surface interactions with blood, the current ISO 10993 requirements for testing, and the role of in vitro test models. The literature is reviewed on anticoagulation, shear rate, blood-air interfaces, incubation time, and the importance of evaluation of the surface area after blood contact. Two test categories deserve further attention: complement and platelet function, including the effects on platelets from adhesion proteins, venipuncture, and animal derived- blood. The material properties, hydrophilicity, and roughness, as well as reference materials, are discussed. Finally this review calls for completing the acceptance criteria in the ISO standard based on a panel of test results. |
| format | Article |
| id | doaj-art-3eff8de01ecc41618913fb292e6c6f0c |
| institution | Kabale University |
| issn | 2090-908X |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Scientifica |
| spelling | doaj-art-3eff8de01ecc41618913fb292e6c6f0c2025-08-20T03:35:54ZengWileyScientifica2090-908X2013-01-01201310.1155/2013/392584392584Obstacles in Haemocompatibility TestingW. van Oeveren0HaemoScan and Department of Cardiothoracic Surgery, UMCG Groningen, The NetherlandsISO 10993-4 is an international standard describing the methods of testing of medical devices for interactions with blood for regulatory purpose. The complexity of blood responses to biomaterial surfaces and the variability of blood functions in different individuals and species pose difficulties in standardisation. Moreover, in vivo or in vitro testing, as well as the clinical relevance of certain findings, is still matter of debate. This review deals with the major remaining problems, including a brief explanation of surface interactions with blood, the current ISO 10993 requirements for testing, and the role of in vitro test models. The literature is reviewed on anticoagulation, shear rate, blood-air interfaces, incubation time, and the importance of evaluation of the surface area after blood contact. Two test categories deserve further attention: complement and platelet function, including the effects on platelets from adhesion proteins, venipuncture, and animal derived- blood. The material properties, hydrophilicity, and roughness, as well as reference materials, are discussed. Finally this review calls for completing the acceptance criteria in the ISO standard based on a panel of test results.http://dx.doi.org/10.1155/2013/392584 |
| spellingShingle | W. van Oeveren Obstacles in Haemocompatibility Testing Scientifica |
| title | Obstacles in Haemocompatibility Testing |
| title_full | Obstacles in Haemocompatibility Testing |
| title_fullStr | Obstacles in Haemocompatibility Testing |
| title_full_unstemmed | Obstacles in Haemocompatibility Testing |
| title_short | Obstacles in Haemocompatibility Testing |
| title_sort | obstacles in haemocompatibility testing |
| url | http://dx.doi.org/10.1155/2013/392584 |
| work_keys_str_mv | AT wvanoeveren obstaclesinhaemocompatibilitytesting |