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ASTM F 1635 : 2016 : REDLINE

Current
Current

The latest, up-to-date edition.

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Available format(s)

PDF

Language(s)

English

Published date

12-01-2016

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2017 Describes in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.

1.1This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.

1.2The requirements of this test method apply to HDPs in various forms:

1.2.1Virgin polymer resins, or

1.2.2Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.

1.3This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.

1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5This 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.

Committee
F 04
DocumentType
Redline
Pages
8
PublisherName
American Society for Testing and Materials
Status
Current

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