Development and performance evaluation of a positive reference material for hemolysis testing-Reference-Cited by-同舟云学术

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

Published:2014-04-08 Issue:8 Volume:102 Page:1809-1816
ISSN:1552-4973
Container-title:Journal of Biomedical Materials Research Part B: Applied Biomaterials
language:en
Short-container-title:J. Biomed. Mater. Res.

Author:

Haishima Yuji¹,Hasegawa Chie¹,Nomura Yusuke¹,Kawakami Tsuyoshi²,Yuba Toshiyasu³,Shindo Tomoko⁴,Sakaguchi Keisuke⁵,Tanigawa Takahiro⁵,Inukai Kaori⁵,Takenouchi Mika⁵,Isama Kazuo²,Matsuoka Atsuko⁶,Niimi Shingo¹

Affiliation:

1. Division of Medical Devices; National Institute of Health Sciences; 1-18-1 Kamiyoga Setagaya-ku Tokyo 158-8501 Japan

2. Division of Environmental Chemistry; National Institute of Health Sciences; 1-18-1 Kamiyoga Setagaya-ku Tokyo 158-8501 Japan

3. Kawasumi Laboratories, Inc.; Corporate Research and Development Division; Shinagawa Intercity Tower B, Konan Minato-ku Tokyo 108-6109 Japan

4. Hatano Research Institute, Food and Drug Safety Center; 729-5 Ochiai Hadano Kanagawa 257-8523 Japan

5. R&D Headquarters, Evaluation Center, TERUMO Corporation; 1500 Inokuchi, Nakai-machi Ashigarakami-gun Kanagawa 259-0151 Japan

6. Office of Standards and Guidelines Development; Pharmaceuticals and Medical Devices Agency; 3-3-2 Kasumigaseki Chiyoda-ku Tokyo 100-0013 Japan

Funder

Health and Labor Sciences Research Grants (Japanese Ministry of Health, Labor, and Welfare)

Publisher

Wiley

Subject

Biomedical Engineering,Biomaterials

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/jbm.b.33169/fullpdf

Reference24 articles.

1. ISO 14971:2007. Medical devices-Application of risk management to medical devices

2. ISO 10993-1:2009. Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process

3. ISO 10993-4:2002/Amd.1:2006. Biological evaluation of medical devices-Part 4: Selection of tests for interaction with blood

4. ASTM Standard F756-08:2008. Practice for assessment of hemolytic properties of materials. ASTM International, West Conshohocken, PA

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