ГОСТ ISO 10993-11-2021 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 11. Исследования общетоксического действия (с Поправкой)

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 S, Ismail N, Pfaus JG. Cecum location in rats and the implications for intraperitoneal injections. Lab. Anim. 2007, 36 (7) pp.25-30

[21]

OECD. (1981-2013): http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-thetesting-of-chemicals-section-4-health-efects_20745788

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