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ASTM F1635

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

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Organization: ASTM
Publication Date: 1 December 2016
Status: active
Page Count: 7
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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 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.

Document History

ASTM F1635
December 1, 2016
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:...
March 1, 2011
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:...
October 1, 2004
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:...
May 1, 2004
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:...
November 10, 1995
Standard Test Method for In Vitro Degradation Testing of Poly (L-Lactic Acid) Resin and Fabricated Form for Surgical Implants
1. Scope 1.1 This test method covers poly(L-lactic acid) resin in-tended for use in surgical implants. 1.2 The requirements of this test method apply to poly(L-lactic acid) in various forms: 1.2.1...
January 1, 1995
Standard Test Method for In Vitro Degradation Testing of Poly (L-Lactic Acid) Resin and Fabricated Form for Surgical Implants
1. Scope 1.1 This test method covers poly(L-lactic acid) resin intended for use in surgical implants. 1.2 The requirements of this test method apply to poly(L-lactic acid) in various forms: 1.2.1...

References

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