Каталог стандартов

+7 (495) 223-46-76 +7 (812) 309-78-59
inform@normdocs.ru

ASTM F1581-99

Заменен
Standard Specification for Composition of Anorganic Bone for Surgical Implants — 4 стр.
Область применения

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (hydroxylapatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix XI).

1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1, 2, 3, 4, 5) and by laboratory studies (6, 7, 8). Xenogeneic bone, due to its organic component, has been shown to be antigenic in the human host (9) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (10, 11).

1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate.

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