Obstacles in Haemocompatibility Testing
Author
Source
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-14, 14 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-05-07
Country of Publication
Egypt
No. of Pages
14
Main Subjects
Natural & Life Sciences (Multidisciplinary)
Diseases
Abstract EN
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.
American Psychological Association (APA)
van Oeveren, Wim. 2013. Obstacles in Haemocompatibility Testing. Scientifica،Vol. 2013, no. 2013, pp.1-14.
https://search.emarefa.net/detail/BIM-468544
Modern Language Association (MLA)
van Oeveren, Wim. Obstacles in Haemocompatibility Testing. Scientifica No. 2013 (2013), pp.1-14.
https://search.emarefa.net/detail/BIM-468544
American Medical Association (AMA)
van Oeveren, Wim. Obstacles in Haemocompatibility Testing. Scientifica. 2013. Vol. 2013, no. 2013, pp.1-14.
https://search.emarefa.net/detail/BIM-468544
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-468544