ГОСТ Р ИСО 10993.4-99 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 4. Исследование изделий, взаимодействующих с кровью

ПРИЛОЖЕНИЕ Г
(справочное)

     
Библиография

Г.1 Международные стандарты

[1] ISO 5840:1989, Cardiovascular implants - Cardiac Valve prostheses

[2] ISO 5841-1:1989, Cardiac pacemakers - Part 1: Implantable pacemakers

[3] ISO 5841-3:1992, Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers

[4] ISO 7198-1*, Cardiovascular implants - Tubular vascular prostheses - Part 1: Synthetic vascular protheses

[5] ISO 7198-2*, Cardiovascular implants - Tubular vascular prostheses - Part 2: Sterile vascular prostheses of biological origin - Specification and methods of test

[6] ISO 7199*, Cardiovascular implants and artificial organs - Blood-gas exchangers

[7] 10993-12*, Biological evaluation of medical devices - Part 12: Sample preparation and refrence materials

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* Будут опубликованы

Г.2 Национальные стандарты

[8] ANSI/AAMI CVP3-1981, Cardiac valve prostheses

[9] ANSI/AAMI VP20-1986, Vascular graft prostheses

[10] ASTM F 756-87, Standard practice for assessment of hemolytic properties of materials

[11] BS 5736-11:1990, Evaluation of medical devices for biological hazards - Part 11: Method of test for haemolysis

[12] DIN 58361-4:1980, Transfusionsbehaltnisse und Zubehor, Blutbeutel aus Kunststoffen, Sicherheitstechnische Anforderungen, Prufung, Uberwachung und Kennzeichnung

[13] NF 90-300:1981, Materiel medico-chirurgical - Oxygenateurs

Г.3 Научные статьи

[14] Bosch, Т., Schmidt, В., Blumenstein, M. and Gurland, H.J., Thrombogenicity markers in clinical and ex vivo assessment of membrane biocompatibility. Cont Nephrol, 59: 90-98, 1987

[15] Chenoweth, D.E., Complement activation produced by biomaterials. Trans Am Soc Artif Int Organs 32: 226-232, 1986

[16] Burns, G.L, Pantalos, G.M. and Olsen, D.В., The calf as a model for thromboemboloc events with the total artificial heart. Trans Am Soc Artif Int Organs 33: 398-403, 1987

[17] Cooper, S.R., Fabrizius, D.J. and Grasel, Т.G., Methods of assessment of thrombosis ex vivo. In: Leonard E.F., Turitto V.Т., and Vroman L. (Eds): Blood in contact with natural and artificial surfaces. Ann N.Y. Acad Sciences 516: 572-585, 1987

[18] Corriveau, D.M. and Fritsma, G.A. (Eds): Haemostasis and thrombosis in the clinical laboratory. J.B.Lippincott, Philadelphia, 1988, 443 pp

[19] Dawids, S et al. (eds): Test procedures for the blood compatibility of biomaterials. In preparation, 1992

[20] Dewanjee, M.K., Methods of assessment of thrombosis in vivo, In: Leonard E.F., Turitto V.T. and Vroman L. (Eds): Blood in contact with natural and artificial surfaces. Ann N.Y. Acad Sciences, 516: 541-571, 1987

[21] Dewanjee, M.K., Kapadvanjwala, M. and Sanchez, A. Quantiation of comparative thrombogenicity of dog, pig, and human platelets in a hemodialyzer. Am Soc Artif Int Organs Journal 38: 88-90, 1992

[22] Didisheim, P., Dewanjee, M. K., Frisk, C.S., Kaye, M.P. and Fass, D.N., Animal models for predicting clinical perfomance of biomaterials for cardiovascular use. In: Boretos J.W. and Eden M. (Eds): Contemporary Biomaterials, Noyes Publications, Park Ridge, NJ, USA, pp.132-179, 1984