Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
|Publication Date:||1 October 2006|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This specification covers virgin poly(lactide) and poly(lactide-co-glyc
Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no enantiomeric specificity and therefore also encompasses the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization. Therefore, specific reference to d,l-PLA is essential to appropriately differentiate the amorphous atactic/syndiotactic
This specification is not applicable to lactide based polymers or copolymers that possess isotactic polymeric segments sufficient in size to deliver potential for lactide based crystallization. This specification is not applicable to lactideco-glycolide copolymers that possess glycolide segments sufficient in size to deliver potential for glycolide based crystallization, thereby requiring fluorinated solvents for complete dissolution under room temperature conditions. This specification is specifically not applicable to lactide-co-glycolide
This specification addresses material characteristics of both poly(lactide) and poly(lactide-co-glyc
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 independently using appropriate test methods to assure safety and efficacy.
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.