ASTM F 1635 REV A Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
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ASTM F 1635 REV A Document Information:
Title
Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
ASTM International
Publication Date:
Oct 1, 2004
Scope:
This test method covers in vitro degradation of hydrolytically
degradable polymers (HDP) intended
for use in surgical implants.
The requirements of this test method apply to HDPs in various forms:
Virgin polymer resins, or
Any 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.
This test method has no provisions for mechanical loading, fluid flow,
or other dynamic challenges.
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.
Keywords:
- absorbable
- bioabsorbable
- degradation
- in vitro
- hydrolytically degradable polymer
- hydrolysis
- PLA, poly(l-lactic acid)
- poly(d-lactide)
- poly(d,l-lactide)
- PGA, poly(glycolide)
- poly(caprolactone)
- poly(p-dioxanone)
- surgical implant
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