ГОСТ ISO 10993-11-2021. Межгосударственный стандарт. Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 11. Исследования общетоксического действия
БИБЛИОГРАФИЯ
1 Общая литература | ||
[1] | ISO 10993 | Biological evaluation of medical devices (Оценка биологического действия медицинских изделий) |
[2] | ASTM F619-03 | Standard Practice for Extraction of Medical Plastics |
[3] | AAMI/ST72 | Bacterial Endotoxin - Test methods, routine monitoring, and alternatives to batch testing |
[4] | U.S./EPA PB 86/108958 and 89/124077 | |
[5] | U.S./FDA Toxicological principles for the safety assessment of direct food additives, 1982 | |
[6] | U.S. Code of Federal Regulation 1500.40: Method of Testing Toxic Substances | |
[7] | United States Pharmacopoeia 26: Biological Reactivity Tests, In Vivo; The National Formulary 21, Rockville, MD; Pharmacopoeial Convention, 2003, pp. 2028 - 2032 | |
[8] | European Pharmacopoeia. Eighth Edition, 2014 | |
[9] | MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20, March 1, 2012. Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices | |
[10] | OECD. Series on Testing and Assessment No. 129: Guidance Document on Using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests | |
2 Литература по объему доз | ||
[11] | 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 | |
[12] | Derelanko, M.J. and Hollinger, M.A. CRC Handbook of Toxicology, CRC Press, NY, 2nd edition, 2001, p. 98 | |
[13] | Diehl K.-H., Hull R., Morton D., Pfister R., Rabemampianina Y., Smith D. Vidal, J.-M, Van De Vorstenbosch. A good practice guide to the administration of substances and removal of blood, including routes and volumes. J. Appl. Toxicol. 2001, 21 pp. 15 - 23 | |
[14] | Morton D. Effects of infusion rates in rats receiving repeated large volumes of intravenous saline solution. Lab. Anim. Sci. 1997, 47 pp. 656 - 659 | |
[15] | 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 | |
[16] | Morton D.B. Refining procedures for the administration of substances. Report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement. Lab. Anim. 2001, 35 pp. 1 - 41 | |
[17] | Laboratory Animal Science Association (LASA) Good Practice Guidelines: Administration of Substances (Rat, Mouse, Guinea Pig, Rabbit) - Series 1/Issue 1 - October 1998 | |
[18] | Nebendahl K. Routes of Administration. In: The Laboratory Rat: A Volume in Handbook of Experimental Animals, (Krinke G.J. ed.). Elsevier Ltd, 2000, pp. 463 - 83. | |
[19] | Gaines Das R., & North D. Implications of experimental technique for analysis and interpretation of data from animal experiments: outliers and variability resulting from failure of intraperitoneal injection procedures. Lab Anim. (NY). 2007, 41 (3) pp. 312 - 320 | |
[20] | Coria-Avila GA, & Gavrila AM BA1, Shann | |
[21] | OECD. (1981 - 2013): http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-thetesting-of-chemicals-section-4-health-effects_20745788 | |
S, Ismail N, Pfaus JG. Cecum location in rats and the implications for intraperitoneal injections. Lab. Anim. 2007, 36 (7) pp. 25 - 30
УДК 615.46:002:006.354 | МКС 11.100.020 | IDT |
Ключевые слова: медицинские изделия, оценка биологического действия, исследования общетоксического действия, доза-эффект, субхроническая токсичность, выщелачиваемое вещество, хроническая токсичность | ||
Подписаться на обновления