ASTM International - ASTM F1635-04a
Standard Test Method for in Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
|Publication Date:||1 October 2004|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.
1.2 The requirements of this test method apply to HDPs in various forms:
1.2.1 Virgin polymer resins, or
1.2.2 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.
1.3 This test method has no provisions for mechanical loading, fluid flow, or other dynamic challenges.
1.4 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.