1. 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 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D638 Test Method for Tensile Properties of Plastics

D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force

D695 Test Method for Compressive Properties of Rigid Plastics

D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam

D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

D882 Test Method for Tensile Properties of Thin Plastic Sheeting

D1708 Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens

D1822 Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials

D2857 Practice for Dilute Solution Viscosity of Polymers

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

Keywords

absorbable; bioabsorbable; degradation; in vitro; hydrolytically degradable polymer; hydrolysis; PLA, poly(l-lactic acid); poly(d-lactide); poly(d,l-lactide); PGA, poly(glycolide); poly(caprolactone); poly(p-dioxanone); surgical implant; in vitro Evaluation; Biodegradation; Degradation--surgical devices/applications; PLLA (poly(L-lactic acid)) resin; Polymers (surgical applications); Surgical implant resins; Surgical implants; Testing methods--surgical implants ;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F1635-04A

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