Special Section Technical Briefs

Thrombogenicity Testing for Blood-Contacting Medical Devices in an In Vitro Ovine Blood-Loop1

[+] Author and Article Information
Kent Grove, Steve Deline, Tim Schatz, Sarah Howard, Mark Smith

American Preclinical Services,
Minneapolis, MN 55433

DOI: 10.1115/1.4033116Manuscript received March 1, 2016; final manuscript received March 16, 2016; published online May 12, 2016. Editor: William Durfee.

J. Med. Devices 10(2), 020904 (May 12, 2016) (2 pages) Paper No: MED-16-1056; doi: 10.1115/1.4033116 History: Received March 01, 2016; Revised March 16, 2016

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ISO, 2002, “ Biological Evaluation of Medical Devices—Part 4: Selection of Tests for Interactions With Blood (Amended 2006),” Association for the Advancement of Medical Instrumentation, Arlington, VA, Standard No. ISO 10993-4.
Wolf, M. F. , and Anderson, J. M. , 2012, “ Practical Approach to Blood Compatibility Assessments: General Considerations and Standards,” Biocompatibility and Performance of Medical Devices, J.-P. Boutrand , ed., Woodhead Publishing, Oxford, UK.
FDA, 2014, “ Methods for Thrombogenicity Testing,” U.S. Food and Drug Administration, Silver Spring, MD, Public Workshop, Apr. 14, 2014.
van Oeveren, W. , Tielliu, I. F. , and de Hart, J. , 2012, “ Comparison of Modified Chandler, Roller Pump, and Ball Valve Circulation Models for In Vitro Testing in High Blood Flow Conditions,” Int. J. Biomater., 2012, p. 673163. [CrossRef] [PubMed]


Grahic Jump Location
Fig. 1

A dual loop configuration showing both loops, the water bath, and two peristaltic pumps

Grahic Jump Location
Fig. 2

Cumulative scores and representative images of the positive and negative scores (median with range) are shown in the inset

Grahic Jump Location
Fig. 3

Close-up and scanning electron microscopic images of the thrombus deposition on the control materials: (a) positive control and (b) negative control



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