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ASTM F763-99
Standard Practice for Short-Term Screening of Implant Materials
4 стр.
Заменен
Электронный (pdf)Печатное издание
84.24 $ (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 practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted.

1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.

1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material.

1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.

Ключевые слова:
Biocompatibility; Implants; New Zealand rabbits; Orthopaedic medical devices; Rabbits; Rapid screen test; Rats; Seals; Test animals; Tissue compatibility; short-term screening (of surgical implant materials in vivo ), practice,; Short-term screening; surgical implant materials ( in vivo ), practice