Development and performance evaluation of a positive reference material for hemolysis testing

This study deals with the development and performance evaluation of a positive reference material for hemolysis testing, which is used for evaluating the biological safety of medical devices. Genapol X-080, a nonionic detergent, was selected as a candidate hemolytic substance in a survey of 23 chemi...

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Veröffentlicht in:	Journal of biomedical materials research. Part B, Applied biomaterials Applied biomaterials, 2014-11, Vol.102 (8), p.1809-1816
Hauptverfasser:	Haishima, Yuji, Hasegawa, Chie, Nomura, Yusuke, Kawakami, Tsuyoshi, Yuba, Toshiyasu, Shindo, Tomoko, Sakaguchi, Keisuke, Tanigawa, Takahiro, Inukai, Kaori, Takenouchi, Mika, Isama, Kazuo, Matsuoka, Atsuko, Niimi, Shingo
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Assaying Biological and medical sciences biological safety evaluation Biomedical materials Contact guidance Hematologic Tests - methods Hematologic Tests - standards Hemolysis hemolysis test Materials research Materials science Medical sciences Micelles Performance evaluation Polyethylene Glycols - chemistry Polyvinyl Chloride Polyvinyl chlorides positive control Rabbits Reference materials Reference Standards Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgical implants Technology. Biomaterials. Equipments
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