Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
|Publication Date:||1 December 2010|
This specification covers virgin amorphous poly(lactide)
homopolymer 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
stereoisomeric specificity and therefore encompasses both the
This specification covers virgin amorphous poly(lactide)-based
resins able to be fully solvated at 30°C by either methylene
chloride (dichloromethane) or chloroform (trichloromethane). This
specification is not applicable to lactide-based polymers or
copolymers that possess isotactic polymeric segments sufficient in
size to carry potential for lactide-based crystallization, which
are covered by Specification F1925 and typically possess nominal
mole fractions that equal or exceed 50 % L-lactide. This
specification is not applicable to lactide-co-glycolide
This specification addresses material characteristics of both
poly(DL-lactide) and poly(DL-lactide-co-g
As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) 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.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.