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ASTM F2901-12

Заменен
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices — 3 стр.
Значение и использование

The objective of this guide is to recommend a panel of biological tests that can be used in addition to the testing recommended in Practice F748. This guide is designed to detect neurotoxicity caused by medical devices that contact nervous tissue.

The testing recommendations should be considered for new materials, established materials with different manufacturing methods that could affect nervous tissue response, or materials used in new nervous tissue applications.

Chemical characterization can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.

Область применения

1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748, and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact nervous system tissue or cerebral spinal fluid (CSF).

1.2 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.

ICS
11.040.01 Medical equipment in general / Медицинское оборудование в целом
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