Standard Number: YY/T 0510-2009(YY/T0510-2009)
Chinese:外科植入物用无定形聚丙交酯树脂和丙交酯-乙交酯共聚树脂
English:Amorphous Poly(lactide)and Poly(lactide-co-glycolide)calImplants
Effective Date:2011-06-01
ICS:11.040.40
Standard Applicability:This standard applies to virgin polypropylene cross ester and propylene cross ester-ethylene cross ester copolymer resins capable of being completely solubilized at 30°C by dichloromethane or trichloromethane. The homopolymers of poly(D,L-propylene cross ester) described in this standard are amorphous (i.e., non-crystalline) and are produced by polymerization of endo-propylene cross ester or equal moles of D-propylene cross ester and L-propylene cross ester (racemic). D,L-propiolate-ethylene glycolide copolymers as described in this standard are also defined as amorphous, copolymerized from ethylene glycolide and racemic propylene glycolide or equimolar racemic D-propylene glycolide and L-propylene glycolide, with the mole fraction of propylene glycolide in the typical copolymer being equal to or greater than 50 percent. This standard does not apply to homopolymers or copolymers that contain sufficient scale of isotactic polymerized chain segments of the propylene glycol ester to cause potential crystallization. This standard does not apply to propylene glycol ester-ethylene glycol ester copolymers that are potentially crystalline due to the presence of sufficiently dimensioned ethylenic ester chain segments so that fluorinated solvents are required for complete solubility at room temperature. In particular, this standard does not apply to propylene glycol ester-ethylene glycol ester copolymers with a molar fraction of ethyl ester greater than or equal to 70% (65.3% by mass). This standard does not apply to block copolymers or homopolymers or copolymers synthesized from D-propiolyester and L-propiolyester with a difference in the total mole fraction of more than 1.5 (1.5% of the total mole fraction).
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