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ASTM F2313-08e1
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide (Includes all amendments And changes 12/31/2010).
Automaticky preložený názov:
Štandard Specification pre poly ( glykolid ) a poly ( glykolid - ko - laktid ) živice pre chirurgické implantáty s molárna zlomky väčší alebo rovné 70 % glykolidu
NORMA vydaná dňa 1.8.2008
Informácie o norme:
Označenie normy: ASTM F2313-08e1
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.8.2008
Kód tovaru: NS-53531
Počet strán: 9
Približná hmotnosť: 27 g (0.06 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Anotácia textu normy ASTM F2313-08e1 :
Keywords:
poly(glycolic acid), poly(glycolide), PGA, poly(glycolide:lactide), poly(glycolide-co-lactide), PLA, PGA:PLA, polyglycolic:lactic acid, Poly(glycolic acid)(PGA), Poly(glycolide), Poly(glycolide-co-lactide), Polymers--specifications, Surgical implants--specifications, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics), 83.080.10 (Thermosetting materials)
Doplňujúce informácie
| 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 PLA:PGA 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 these materials. 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard may suggest use of hazardous materials, operations, and equipment. 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. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||
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