ГОСТ ISO 10993-10—2011
Библиография
Общие ссылки по исследованию раздражающего действия на кожу и глаза, а также
сенсибилизирующего действия на кожу
(1] ISO 10993-6. Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (Оценка
биологического действия медицинских изделий. Часть 6. Исследование местногодействия после импланта
ции)
(2]AGNER Т. Noninvasive measuring methods for the investigation of inrtant patch test reactions. A study of patients
with hand eczema, atopic dermatitis and controls. Acta Derm. Venereoi. 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. and MAIBACH H.l. The sodium lauryl sulfate model: an overview. Contact Dermatitis. 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 imtabon 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 irritation/corrosion, OECD Publications. 1992
(9] Organization for Economic Cooperation and Development (OECD). Guidelines for testing of chemicals No. 405.
Acute eye irritatkxVcorrosion. OECD Publications. 1992
(10] PONEC M. In vitro 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-invasive methods and the skin. CRC Press. 1995
(13] SILVAO. de.. BASKETTER D.A., BARRATT M.D. et al. Alternative methods for skin sensitization testing. 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 Nonanorc acid irritation — Aposilive control at routine patch testing? Contact
dermatitis. 6. pp. 128-130. 1980
(19] WAHLBERG J.E.. WRANGSJO K. and HIETASOLAA. Skin irritancy from nonanoic acid. Contact dermatitis. 13. pp.
266-269. 1985
(20] WEIL S.C. and SCALA R.A. Study of intra- and interlaboratory variability in the results of rabbit eye and skin imtation
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 PA.. 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. et al. Evaluation of seven in vitro alternatives for ocular testing. Fundam.
Appl. Toxicol.. 17. pp. 136-149. 1991
(25] DRAIZE J.H. Dermal Toxicity. Association of food and drug officials of the U.S. FDA. Washington. D.C. pp. 46-59,
1955
(26] DRAIZE J.H. Appraisal of the safety of 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 Ecologyand ToxicologyCentre. Eye initation testing. Monograph 11. Brussels. Belgium.
1988
(28] European Chemical Industry Ecologyand Toxicology Centre. Skin initation. Monograph 15. Brussels. Belgium, 1990
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