GOST R ISO 17853-2012

ГОСТ Р ИСО 17853-2012

Implants for surgery. Wear of implant materials. Polymer and metal wear particles. Isolation and characterization

Имплантаты для хирургии. Износ имплантируемых материалов. Полимерные и металлические частицы износа. Выделение и характеристика

This standard establishes methods for the selection of particles formed during the wear of endoprostheses of human joints and in tests on joint simulators. It identifies instrumentation, reagents and test methods for isolating and describing both polymer and metal wear particles from tissue samples excised around joint endoprostheses obtained during revision operations and during anatomopathological examination, and from joint fluid test samples. Some of these procedures can certainly be adapted to isolate and characterize particles from human biological fluids (for example, synovial fluid). The methods given in this standard are not intended to quantify the degree of implant wear, nor are they intended to determine the degree of wear of any particular surface. This standard does not apply to the biological effects of wear particles and does not provide methods for assessing their biological safety.

Настоящий стандарт устанавливает методы отбора частиц, образованных при износе эндопротезов суставов человека и в испытаниях на симуляторах суставов. В нем определены аппаратура, реагенты и методы испытаний для выделения и описания как полимерных и металлических частиц износа из образцов тканей, иссеченных вокруг эндопротезов суставов, полученных при проведении ревизионных операциях и при патологоанатомическом исследовании, так и из образцов испытательных жидкостей симуляторов суставов. Некоторые из этих процедур, безусловно, могут быть адаптированы для выделения и характеристики частиц из биологических жидкостей человека (например, синовиальной жидкости). Методы, приведенные в настоящем стандарте, не предназначены для количественного определения степени износа имплантата, а также не предназначены для определения степени износа какой-либо отдельной поверхности. Настоящий стандарт не распространяется на биологические эффекты частиц износа и не предоставляет методы оценки их биологической безопасности

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