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ASTM F451-99a(2007)e1
Standard Specification for Acrylic Bone Cement
8 стр.
Заменен
Печатное изданиеЭлектронный (pdf)
96.72 $ (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 self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the predough or dough stage in accordance with the manufacturer's recommendations.

1.2 Units of premeasured powder and liquid are supplied in a form suitable for mixing. The mixture then sets in place.

1.3 While a variety of copolymers and comonomers may be incorporated, the composition of the set cement shall contain poly(methacrylic acid esters) as its main ingredient.

1.4 This specification covers compositional, physical performance, and biocompatibility as well as packaging requirements. The biocompatibility of acrylic bone cement as it has been traditionally formulated and used has been reported in the literature (1, 2).

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Ключевые слова:
acrylic bone cement; compression strength; doughing time; exothermic temperature; extrusion; intrusion; poly(methacrylic acid esters); setting time; Bone fixation; Compression testing--surgical applications; Doughing time; Hardness (indentation); Intrusion; Orthopaedic medical devices--specifications; Orthopaedic medical devices (bone)--specifications; Plastic surgical devices/applications--specifications; Polymers (surgical applications)--specifications; Rockwell hardness; Setting time; Temperature tests; Testing methods--surgical implants; Viscosity--acrylic resins; Water absorption