1. Scope

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.

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

D1505 Test Method for Density of Plastics by the Density-Gradient Technique

D2857 Practice for Dilute Solution Viscosity of Polymers

D3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)

D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry

D3536 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by Liquid Exclusion Chromatography (Gel Permeation Chromatography--GPC)

D3593 Test Method for Molecular Weight Averages/ Distribution of Certain Polymers by Liquid Size-Exclusion Chromatography (Gel Permeation Chromatography GPC) Using Universal Calibration

D4603 Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer

E386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy

E473 Terminology Relating to Thermal Analysis and Rheology

E793 Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry

E794 Test Method for Melting And Crystallization Temperatures By Thermal Analysis

E967 Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers

E968 Practice for Heat Flow Calibration of Differential Scanning Calorimeters

E1142 Terminology Relating to Thermophysical Properties

E1252 Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis

E1356 Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry

E1994 Practice for Use of Process Oriented AOQL and LTPD Sampling Plans

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

F2313 Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

F2579 Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

ANSI Standards

Keywords

PGA:PLA; PLA; PLA:PGA; PLGA; P l LA; polyglycolic:lactic acid; poly(glycolide:lactide); poly(lactic acid); polylactic:glycolic acid; polylactide; poly(lactide); poly(lactide:glycolide); poly( l -lactic acid); Plastic surgical devices/applications--specifications; PLLA (poly(L-lactic acid)) resin; Polymers (surgical applications)--specifications; Surgical implant resins--specifications; Surgical implants--specifications;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.080.20 (Thermoplastic materials)

DOI: 10.1520/F1925-99E01

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