ГОСТ Р ИСО 10993-4-2009 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 4. Исследования изделий, взаимодействующих с кровью

Международные стандарты

[1]

ИСО 5840:1996 Сердечно-сосудистые имплантаты. Протезы клапанов сердца

ISO 5840:1996 Cardiovascular implants - Cardiac valve prostheses

[2]

ИСО 5841-1 Кардиостимуляторы. Часть 1. Имплантируемые кардиостимуляторы

ISO 5841-1 Cardiac pacemakers - Part 1: Implantable pacemakers

[3]

ИСО 5841-3 Имплантаты для хирургии. Кардиостимуляторы. Часть 3. Низкопрофильные соединители [IS-1] для имплантируемых кардиостимуляторов

ISO 5841-3 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers

[4]

ИСО 7198 Имплантаты для сердечно-сосудистой системы. Трубчатые сосудистые протезы

ISO 7198 Cardiovascular implants - Tubular vascular prostheses

[5]

ИСО 7199 Имплантаты для сердечно-сосудистой системы и искусственные органы. Устройства для экстракорпорального насыщения крови кислородом (оксигенаторы)

ISO 7199 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

[6]

ИСО 10993-12 Оценка биологического действия медицинских изделий. Часть 12. Приготовление проб и стандартные образцы

ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

[7]

ИСО 3826 Контейнеры складные пластмассовые для человеческой крови и ее компонентов

ISO 3826 Plastics collapsible containers for human blood and blood components

Национальные стандарты

[8]

AANSI/AAMI CVP3-1981, Cardiac valve prostheses

[9]

ANSI/AAMI VP20-1986, Vascular graft prostheses

[10]

ASTM F 756-00, Standard practice for assessment of hemolytic properties of materials

[11]

GB/T 16175-1996 Organic silicone material material for medical use - Biological evaluation test methods

[12]

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

[13]

ASTM F 1984-99, Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

[14]

ASTM F 2065-00, Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials

[15]

DIN 58 361-4:1980, und , Blutbeutel aus Kunststoffen, Sicherheitstechnische Anforderungen, und Kennzeichnung

[16]

NF 90-300:1981,

Научные статьи

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CORRIVEAU, D.M. and FRITSMA, G.A. (Eds): Hemostasis and thrombosis in the clinical laboratory. J.B. Lippincott, Philadelphia, 1988, p.443

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DAWIDS, S. (Ed): Test procedures for the blood compatibility of biomaterials. Kluwer, Dordrecht, Boston, 1993, p.684

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SCHOEN, F.J., ANDERSON, J.M., DIDISHEIM, P., DOBBINS, J.J., GRISTINA, A.G., HARASAKI, H., and SIMMONS, R.L., Ventricular assist device (VAD) pathology analyses: guidelines for clinical studies. J. Appl. Mater., 1, 1990, pp.49-56

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SCHOEN, F.J., Interventional and surgical cardiovascular pathology. Appendix: Pathologic analysis of the cardiovascular system and prosthetic devices, W.B. Saunders Co., Phildelphia, 1989, pp.369-396

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ANDERSON, J.M., Cardiovascular Device Retrieval and Evaluation. In: Harker, L.A., Ratner, B.D., Didisheim, P. (Eds): Cardiovascular Biomaterials and Biocompatibility. Supplement to Cardiovasc. Pathol., 2, (3) (Suppl.), Jul-Sept 1993, pp.199S-208S

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SPENCER, P.C., SCHMIDT, В., SAMTLEBEN, W., BOSCH, T. and GURLAND, H.J., Ex vivo model of hemodialysis membrane biocompatibility. Trans. Amer. Soc. Artif. Int. Organs, 31, 1985, pp.495-498

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Tripartite Biocompatibility Guidance for Medical Devices. Prepared by toxicology sub-group of the Tripartite Subcommittee on medical devices, September 1986

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ICSH Panel on Diagnostic Application of Radionuclides. Recommended method or 111Indium Platelet survival studies. J. Nuclear Med., 29, 1988, pp.564-566

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NCCLS and ICSH. Methods for reticulocyte counting (Flow cytometry and supravital dyes), approved guideline. NCCLS document H44-A. Vol.17, No.15, 1997

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