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ASTM F1635-04a

Historical Revision

Standard Test Method for <emph type="ital">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

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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.


SDO ASTM: ASTM International
Document Number F1635
Publication Date Oct. 1, 2004
Language en - English
Page Count 5
Revision Level 04a
Supercedes
Committee F04.15
Publish Date Document Id Type View
Dec. 1, 2024 F1635-24 Revision
Dec. 1, 2016 F1635-16 Revision
March 1, 2011 F1635-11 Revision
Oct. 1, 2004 F1635-04A Revision
May 1, 2004 F1635-04 Revision
Jan. 1, 2000 F1635-95 Revision
Jan. 1, 2000 F1635-95R00 Reaffirmation