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ASTM F1609-95
Standard Specification for Calcium Phosphate Coatings for Implantable Materials
3 стр.
Заменен
Электронный (pdf)Печатное издание
81.12 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
ICS:
11.040.40 Implants. Including pacemakers / Имплантаты для хирургии, протезирования и ортоптики. Включая кардиостимуляторы
Сборник (ASTM):
13.01 Medical and Surgical Materials and Devices (I): E667 – F2477 / Медицинские и хирургические материалы и приборы (I): E667 - F2477
Тематика:
Medical Devices & Implants
Описание
Область применения

1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.

1.2 In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1, 2) and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems.

1.3 This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions (10% or less, as opposed to trace elements) of other ceramic or metallics, and applied by methods including, but not limited to, the following: ( ) mechanical capture, ( ) plasma spray deposition, ( ) dipping/sintering, ( ) electrophoretic deposition, ( ) porcelainizing, and ( ) sputtering.

1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms.

1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species.

Ключевые слова:
Airborne bacteria; Bacteria/bacterial control; Biological barrier; Exposure chamber method; Log reduction value (LRV); Loss of sterility; Medical packaging; Microbial barrier; Microbial ranking; Microorganisms; Packaging materials;emmedical; Porous packaging materials; Quantitative analysis/measurement; Spore detection; Sterile barrier/packaging; Sterility; microbial ranking;emporous packaging materials, by exposure chamber; method, test,;Order Form