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ASTM F1925-99(2005)

Historical Reaffirmation

Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

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1.1 This specification covers virgin poly(L-lactic acid) resin (or abbreviated as PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric composition based on various D, L, DL copolymer ratios.

1.2 This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material.

1.3 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, etc.) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods which are appropriate to assure safety and efficacy.

1.4 The values stated in SI units are to be regarded as the standard.

1.5 The following precautionary statement pertains only to the test method portion, Section 6, of this specification: 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.


This specification covers virgin poly(L-lactic acid) resin (PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric compositions based on various D, L, or DL copolymer ratios. This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material. The virgin polymer shall be a homopolymer of L-lactide with the prescribed density. The molecular mass of the virgin polymer shall be indicated by relative solution viscosity (in chloroform). In addition, the weight average molecular mass and molecular mass distributions may be determined by gel permeation chromatography The virgin polymer shall be identified as a polylactide by infrared or 1H-NMR spectroscopy. Typical infrared transmission and 1H-NMR spectra are shown. The virgin polymer shall have a specific optical rotation (in dichloromethane) and residual monomer content within the prescribe values, and shall conform to the chemical and physical property requirements specified for: residual solvent, residual water, residual tin, heavy metals, and sulfated ash. The following test methods shall be used: (1) Karl-Fischer titration and (2) atomic absorption-emission (AA) spectroscopy or inductively coupled plasma (ICP) spectroscopy. Considerations for biocompatibility of the material from a human implant perspective is also given.


SDO ASTM: ASTM International
Document Number F1925
Publication Date March 1, 2005
Language en - English
Page Count 4
Revision Level 99(2005)
Supercedes
Committee F04.11
Publish Date Document Id Type View
Dec. 1, 2024 F1925-24 Revision
Feb. 1, 2022 F1925-22 Revision
Dec. 15, 2017 F1925-17 Revision
June 1, 2009 F1925-09 Revision
Nov. 11, 1999 F1925-99E01 Revision
March 1, 2005 F1925-99R05 Reaffirmation