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ASTM F2313-03
Standard Specification for Virgin Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70% Glycolide
Automaticky přeložený název:
Standardní specifikace pro Virgin poly ( glykolid) a poly ( glykolidový - ko - laktid) pryskyřice pro chirurgických implantátů s molární zlomky větší nebo roven 70% glykolidem
NORMA vydána dne 1.11.2003
Informace o normě:
Označení normy: ASTM F2313-03
Poznámka: NEPLATNÁ
Datum vydání normy: 1.11.2003
Kód zboží: NS-53529
Počet stran: 7
Přibližná hmotnost: 21 g (0.05 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Anotace textu normy ASTM F2313-03 :
Keywords:
poly(glycolic acid), poly(glycolide), PGA, poly(glycolide:lactide), poly(glycolide-co-lactide), PLA, PGA:PLA, polyglycolic:lactic acid, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics), 83.080.10 (Thermosetting materials)
Doplňující informace
| 1. Scope | ||||||||||||||||||||||||||||||||||||
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1.1 This specification covers both virgin poly(glycolide) resin and poly(glycolide-co-lactide) resin with mole fractions greater than or equal to 70 % glycolide. This specification is not applicable to glycolide:lactide copolymers with mole fractions exceeding 30 % lactide. 1.2 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 and PGA:PLA resins for the hydrolytic byproducts to which they respectively degrade. 1.3 This specification addresses material characteristics of both virgin poly(glycolide) and poly(≥70 % glycolide-co-lactide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from this material. 1.4 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 ensure safety and efficacy. 1.5 This standard may suggest use of hazardous materials, operations, and equipment. This standard does not purport to address safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||
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