Оценка биологическая медицинских устройств. Часть 9. Деградация материалов, применяемых при биологических испытаниях
Название (англ.):
Biological evaluation of medical devices - Part 9: Degradation of materials related to biological testing
Описание (англ.):
Aims to facilitate the design of test procedures which are used to evaluate the biological responses to degradation products released from medical devices. Following brief descriptions of each major class of material used for medical devices, focuses on the likelymechanisms of degradation of these materials when they are used in a biological service environment. Accelerated time and real-time degradation testing environments for devices and materials are suggested along with characterization techniques for the degradation products. Finally, an approach for identifying and quantifying degradation products obtained from explanted devices and tissues is proposed.
Заменён стандартами:
ISO 10993(1999.03)
Дата введения:
01.07.94
Код КГС:
Р29
Код ОКСТУ:
9409
Код ОКП:
9409
Нормативные ссылки:
ISO 10993-1-1992*ISO 10993-3-1992*ISO 10993-5-1992*ISO 10993-6-1994*ISO 10993-7*ISO 10993-12
Ключевые слова:
BIOCHEMICALS BIODEGRADABILITY BIOLOGICAL TESTS BIOLOGY DENTISTRY EVALUATIONS MEDICAL EQUIPMENT MEDICAL PRODUCTS MEDICAL TECHNOLOGY TESTING MEDICINE