ГОСТ Р ИСО 10993-10—2009
Библиография
Общие ссылки по исследованию раздражающего действия на кожу и глаза,
а также сенсибилизирующего действия на кожу
(1] ИСО 10993-6 Оценка биологического действия медицинских изделий. Часть 6. Исследование местного
действия после имплантации
ISO 10993-6 Biological evaluation of medical devices — Part 6. Tests for local effects after Implantation
(2] AGNER T. Nomnvaslve measuring methods for the Investigation of irritant patch test reactions. A study of patients
with hand есгета. atopic dermatitis and controls. Acta Derm. Venereol. Suppl. Stockh., 173, pp. 1—26. 1992
(3]World Medical Association. Declaration of Helsinki. Recommendation guiding physicians in biomedical research
Involving human subjects. Adopted by the 18th World Medical Assembly. Helsinki, June 1964, amended by the 29th
World Medical Assembly. Tokyo. October 1975. the 35th World Medical Assembly. Venice. October 1983 and 41st
World Medical Assembly. Hong Kong. September 1989. Proc. XXVIth Conf.. Geneva. 1993
(4]LEE C.H. andMAIBACH H I.The sodium laurylsulfate model:an overview. ContactDermatitis. 33. pp. 1—7.1995
(5]MARZULLI F.N. and MAIBACH H.l. (eds.) Dermatotoxicology. 5th edn.. Hemisphere Publ. Corp.. 1996
(6] Organization for Economic Cooperation and Development (OECD) Guideline for the testing of chemicals. Acute
dermal irritation study in human volunteers. Draft document. Nov. 1997
(7] Organization for Economic Cooperation and Development (OECD) Guidelines for the testing of chemicals No. 406.
Skin sensitization. OECD Publications. 1992
(8] Organization for Economic Cooperation and Development (OECD) Guidelines for testing of chemicals No. 404.
Acute skin irritationicorroslon. OECD Publications, 1992
(9] Organization for Economic Cooperation and Development (OECD). Guidelines for testing of chemicals No. 405,
Acute eye irritation/corrosion. OECD Publications. 1992
(10] PONEC M. Invitro models to predict skin irritation. In: The Irritant Contact Dermatitis Syndrome. Van der Valk P.G.M
and Maibach H.l. (eds). Boca Raton. CRC Press, pp. 335—341,1996
(11]RUSSEL W.M.S. and BURCH R.L. The principles of humane experimental technique. 238 pp.. London. Methuen.
1959
(12]SERUP J. and JEMEC G.B.E. Handbook of non-invaslve methods and the skin. CRC Press. 1995
(13] SILVA 0.de..BASKETTER D.A.. BARRATT M.D. etal.Alternative methods for skin sensitizationtesting. The Report
and Recommendations of ECVAM Workshop 19. ATLA. 24. pp. 683—705. 1996
(14] SIMION F.A. In vivo models to predict skin irritation. In: The Irritant Contact Dermatitis Syndrome. Van der Valk
P.G.M. and Maibach H.l. (eds). Boca Raton. CRC Press, pp. 329—334, 1996
(15] SVENDSEN O.. GARTHOFF B.. SPIELMANN H. et al. Alternatives to the animal testing of medical devices. ALTA.
24. pp. 659—670, 1996
(16] WAHLBERG J.E. Assessment of skin Irritancy: measurement of skin fold thickness. Contact Dermatitis. 9. pp.
21—26, 1983
(17]WAHLBERG J.E. and WAHLBERG E.N. Quantification of skin blood flow at patch test sites. Contact Dermatitis. 17.
pp. 229—233. 1987
(18]WAHLBERG J.E. and MAILBACH H.l. Nonanolc acid irritation — A positive control atroutine patch testing? Contact
dermatitis. 6. pp. 128—130. 1980
(19] WAHLBERG J.E.. WRANGSJO K. and HIETASOLA A. Skin irritancy from nonanolcacid. Contact dermatitis. 13. pp.
266—269. 1985
(20] WEIL S.C. and SCALA R A. Study ofmtra- and interlaboratory variability Inthe results of rabbit eye and skin Irritation
tests. Toxicol. Appl. Pharmacol.. 12. pp. 276—360. 1971
Библиография по исследованию раздражающего действия на кожу и глаза
(21] BALLS М.. BERG N. and BRUNER L.H. et al. Eye irritation testing: the way forward. ATLA. 27. pp. 53—78. 1999
(22] BASKETTER D A . WHITTLE E.. GRIFFITHS H.A. et al. The identification and classification of skin Irritation hazard
by a human patch test. Food Chem. Toxicol., 32. pp. 769—775. 1994
(23] BOTHAM P.A.. EARL L.K.. FENTEM J.H. et al. Alternative methods for skin irritation testing: the current status.
ALTA. 26. pp. 195—212. 1998
(24] BRUNER L.H.. KAIN D.J., ROBERTS D.A. etal. Evaluation of seven in vitro alternatives forocular testing. Fundam.
Appl. Toxicol.. 17. pp. 136—149. 1991
(25]DRAlZE J.H. Dermal Toxicity. Association of food and drug officials of the U.S. FDA, Washington. D.C. pp. 46—59.
1955
(26] DRAlZE J.H. Appraisal ofthe safetyof chemicals in foods, drugs, and cosmetics. Austin. Texas. Association of food
and drug officials of the United States. Texas State Department of Health. Texas. 1959
(27] European Chemical Industry Ecology and Toxicology Centre. Eye Irritation testing. Monograph 11. Brussels.
Belgium. 1988
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