ASTM F1635-11
ASTM F1635-11

ASTM F1635-11

March 2011
Standard Cancelled

Standard Test Method for <i>in vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

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Additional informations

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 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.

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

1.5 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.

Main informations

Collections

ASTM american standards

Publication date

March 2011

Number of pages

7 p.

Reference

ASTM F1635-11

Classification index

F1635-11
Standard replaced by (1)
ASTM F1635-16
ASTM F1635-16
December 2016
Standard Cancelled
Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

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