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ASTM F2914-12
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
6 стр.
Заменен
Электронный (pdf)Печатное издание
93.60 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
ICS:
11.040.40 Implants. Including pacemakers / Имплантаты для хирургии, протезирования и ортоптики. Включая кардиостимуляторы
Сборник (ASTM):
13.02 Medical and Surgical Materials and Devices (II): F2502–Latest; Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment / Медицинские и хирургические материалы и приборы (II): F2502-Latest; Скорая медицинская помощь; Поиск и Спасение; Оборудование для анестезии и искусственного дыхания
Тематика:
Medical Devices & Implants
Описание
Значение и использование

The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device.

Область применения

1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example drug-devices, biologic devices or drug biologics) may require additional considerations, depending on their nature.

1.2 This guide does not directly provide any test methods for conducting shelf-life testing.

1.3 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:
aging; establishment; shelf life; shelf-life; stability