ГОСТ Р ИСО 10993-11-2009 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 11. Исследования общетоксического действия

1 Общая литература

[1]

U.S./EPA РВ 86/108958 and 89/124077

[2]

U.S./FDA Toxicological principles for the safety assessment of direct food additives, 1982

[3]

U.S. Code of Federal Regulation 1500.40: Method of Testing Toxic Substances

[4]

United States Pharmacopoeia 26: Biological Reactivity Tests, In Vivo; The National Formulary 21, Rockville, MD; Pharmacopoeial Convention, 2003, pp.2028-2032

[5]

ASTM F619-03, Standard Practice for Extraction of Medical Plastics

[6]

SN 119800:1990, Biological Evaluation of Dental Materials

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European Pharmacopoeia 4th Edition, 2002

[8]

MHLW Notification No. 0213001 (2003.02.13): Principles for Biological Safety Evaluation of Medical Devices

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HALLE, W. (2003) The Registry of Cytotoxicity: Toxicity testing in cell cultures to predict acute toxicity (LD) and to reduce animal testing, ATLA 31:89-98

2 Библиография по объему доз

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HULL, R.M. Guideline limit volumes for dosing animals in the preclinical stage of safety evaluation, Human and Environmental Toxicology, 1995, 14, pp.305-307

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DERELANKO, M.J. and HOLLINGER, M.A. CRC Handbook of Toxicology, CRC Press, NY, 2nd edition, 2001, p.98

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DIEHL, K.-H. et al. A good practice guide to the administration of substances and removal of blood, including routes and volumes, J.Applied Toxicology, 21, 2001, pp.15-23

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MORTON, D. et al. Effects of infusion rates in rats receiving repeated large volumes of intravenous saline solution, Laboratory Animal Sciences, 47, 1997, pp.656-659

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RICHMOND, J.D.Dose limit volumes: The United Kingdom view - past and present. Presented at the Humane Society of the United States - Refinement in Toxicology Testing: Dosing Data: Volume and Frequency, March 14, 1999, New Orleans, LA

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MORTON, D.B. et al. Refining procedures for the administration of substances. Report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement, Laboratory Animals, 35, 2001, pp.1-41