YY/T 1670.1-2019医疗器械神经毒性评价　第1部分：评价潜在神经毒性的试验选择指南.pdf

YY/T 1670.1— 2019 l | Z O L 6 参 考 文 献 定 ． [1] Polikov, V. S., Tresca , P. A., Reichert, W. M., Response of brain tissue to chronically implanted / .L L 9 neural electrodes,J Neurosci Methods, Vol 148, No.1, 2005, pp.1-18. [2] Schmued,L.C.,Stowers,C.C.,Scallet,A.C.,Xu ,L.,Fluoro-Jade C results in ultra high reso­ A A lution and contrast labeling of degenerating neurons, Brain Res, Vol 1035, No. l, 2005, pp.24-31. [3] OCallaghan,J.P.,Sriram,K.,Glial fibrillary ac心c protein and related glial proteins as bio­ markers of neurotoxicity,.Expert Opin Drug Saf,Vol 4,No.3,2005,pp.433-442. Vol 4, [4] Cunningham, B. W., Basic scientific considerations in total disc arthroplasty, Spine J, No.6 Suppl , 2004 , pp.219S-230S. [5] Raffaele , K.C., Fisher ,J.E.J r., Hancock , S., Hazelden , K., Sobrian, S.K., Determining normal variab山ty in a developmental neurotoxicity test: a report from the ILSI Research Foundation/Risk Sci­ ence Institute expert working group on neurodevelopmental endpoints, Neurotoxicol Teratol, Vol 30, No.4, 2008 , pp.288-325. [6] U.S.Food and Drug Administration Redhook: Toxicological Principles for the Safety Assessment of Food Ingredients , Neurotoxicity Studies , 2000 , Chapter IV. C.10. [ 7] U.S. Environmental Protection Agency, Health Effects Test , Guidelines OPPTS 870. 6200 Neuro- toxicity Screening Battery. [8] Harry,J.G. ,Billingsley, M. ,Bruinink, A., Campbell , L. L., Classen, W., Dorman, D.C., Galli , C., Ray, D., Smit