Standard No.:	YY/T 0510-2009
English Name:	Amorphous Poly(lactide) and Poly(lactide-co-glyclide) Resins for Surgical Implants
Chinese Name:	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
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	SDA
Issued on:	2009-12-30
Implemented on:	2011-6-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	7000 words
Translation Price(USD):	210.0
Delivery:	via email in 1 business day

YY/T 0510-2009 Amorphous poly(lactide) and poly(lactide-co-glycolide) resins for surgical implants 1 Scope This standard is applicable to virgin poly(lactide) and poly(lactide-co-glycolide) resins able to be fully solvated at 30℃ by either methylene chloride (dichloromethane) or chloroform (trichloromethane). The poly(d,l-lactide) homopolymers covered by this standard are considered to be amorphous (that is, void of crystallinity) and are polymerized either from meso-lactide or from equimolar (racemic) combinations of d-lactide and l-lactide. The poly(d,l-lactide-co-glycolide) copolymers covered by this standard are also considered to be amorphous and are co-polymerized from a combination of glycolide and either meso-lactide or racemic quantities of d-lactide and l-lactide, and typically possess nominal mole fractions that equal or exceed 50% lactide. 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 d,l-lactide based homopolymers and copolymers covered by this standard. This standard is not applicable to lactide based homopolymers or copolymers that possess isotactic polymeric segments sufficient in size to deliver potential for lactide based crystallization. This standard is not applicable to lactide-co-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 standard is specifically not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70% (65.3% in mass fraction). This standard is not applicable to block copolymers or to homopolymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by more than 1.5 total mole percent (1.5% of total moles). This standard addresses material characteristics of both poly(lactide) and poly(lactide-co-glycolide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials. As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, and sterilization) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin shall be evaluated 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 practices and determine the applicability of regulatory limitations prior to use. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For undated references, the latest edition of the normative document applies. GB/T 16886.9 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (GB/T 16886.9-2001, idt ISO 10993-9:1999) ASTM D 1505 Standard test method for density of plastics by the density-gradient technique ASTM D 1898 Standard practice for sampling of plastics ASTM D 2857 Standard practice for dilute solution viscosity of polymers ASTM D 3536 Standard test method for molecular weight averages and molecular weight distribution of polystyrene by liquid exclusion chromatography (gel permeation chromatography - GPC) ASTM D 3593 Standard test method for molecular weight averages and molecular weight distribution of certain polymers by liquid size-exclusion chromatography (gel permeation chromatography - GPC) using universal calibration ASTM D 4603 Standard test method for determining inherent viscosity of poly(ethylene terephthalate) (PET) by glass capillary viscometer ASTM E 386 Standard practice for data presentation relating to high-resolution nuclear magnetic resonance (NMR) spectroscopy ASTM E 1252 Standard practice for general techniques for obtaining infrared spectra for qualitative analysis ASTM F 748 Standard practice for selecting generic biological test methods for materials and devices United States Pharmacopeia (USP), Edition 26 ICH Q3C(R3) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline: Impurities: Residual Solvents 3 Terms and definitions 3.1 virgin polymer the initially delivered form of a polymer as synthesized from its monomers and prior to any processing or fabrication into a medical device 4 Materials and manufacture

Contents Foreword II 1 Scope 2 Normative references 3 Terms and definitions 4 Materials and manufacture 5 Chemical composition 6 Physical properties 7 Performance requirements 8 Dimensions, mass, and permissible variations 9 Sampling 10 Certification 11 Packaging and package marking Annex A (Normative) Biocompatibility Annex B (Informative) Nomenclature and rationale