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ASTM F2313-08

Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

Automaticky přeložený název:

Standard Specification pro poly ( glykolid) a poly ( glykolid -ko- laktid) pryskyřice pro chirurgické implantáty s molární zlomky větší než nebo rovno 70% glykolidu

NORMA vydána dne 1.8.2008

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1 709.30 Kč

Informace o normě:

Označení normy: ASTM F2313-08
Poznámka: NEPLATNÁ
Datum vydání normy: 1.8.2008
Kód zboží: NS-53530
Počet stran: 9
Přibližná hmotnost: 27 g (0.06 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Anotace textu normy ASTM F2313-08 :

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)

Doplňující informace

1. Scope

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.

2. Referenced Documents

E967-18	Standard Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers
F1925-22	Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
E793-06(2018)	Standard Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry
E473-23b	Standard Terminology Relating to Thermal Analysis and Rheology (Includes all amendments and changes 10/5/2023).
E386-90(1999)	Standard Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy
D4603-18	Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
D5296-19	Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
D3418-21	Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
D2857-22	Standard Practice for Dilute Solution Viscosity of Polymers
D1505-18	Standard Test Method for Density of Plastics by the Density-Gradient Technique
E1142-23b	Standard Terminology Relating to Thermophysical Properties (Includes all amendments and changes 10/5/2023).
E968-02	Standard Practice for Heat Flow Calibration of Differential Scanning Calorimeters
E1356-23	Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
F2579-18	Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
E1994-09(2023)	Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
E1252-98(2021)	Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
E794-06(2018)	Standard Test Method for Melting And Crystallization Temperatures By Thermal Analysis

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