ASTM F1635: Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

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 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.

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

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.

absorbable

bioabsorbable

degradation

in vitro

hydrolytically degradable polymer

hydrolysis

PLA

poly(l-lacticacid)

poly(d-lactide)

poly(d,l-lactide)

PGA, poly(glycolide)

poly(caprolactone)

poly(p-dioxanone)

surgical implant