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ASTM F1088-04ae1

Заменен
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation — 2 стр.
Реферат

This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate for surgical implant applications. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalcium phosphate. The calcium and phosphorus content shall be determined using a suitable method such X-ray fluorescence. A quantitative X-ray diffraction analysis shall indicate a minimum beta-tricalcium phosphate content of 95 % as determined using powder diffraction method. The analysis of other trace elements may be required, based on the conditions, apparatus, or environment. It is recommended that all metals or oxides present in concentrations equal or greater than 0.1 % be noted in material descriptions.

Область применения

1.1 This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate (β-TCP) for surgical implant applications. For a material to be identified as medical grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).

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