ASTM F1635-16 PDF

Scope: 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.

ASTM F1635-16 Referenced Document

ASTM D1708 Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens
ASTM D1822 Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials
ASTM D2857 Standard Practice for Dilute Solution Viscosity of Polymers
ASTM D638 Standard Test Method for Tensile Properties of Plastics
ASTM D671 Standard test method and practice guide for evaluating fleece floor coverings
ASTM D695 Standard Test Method for Compressive Properties of Rigid Plastics
ASTM D747 Standard Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-21 Update
ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 13781 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing*， 2017-06-30 Update

2016 ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
2011 ASTM F1635-11 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
2004 ASTM F1635-04a Standard Test Method for in Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
2004 ASTM F1635-04 Standard Test Method for in Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
2000 ASTM F1635-95(2000) Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants
2000 ASTM F1635-95 Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants