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Ergänzende Informationen

ASTM F1925-99(2005)

Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants

Automatische name übersetzung:

Standard-Spezifikation für Virgin Poly (L -Milchsäure) Resin für chirurgische Implantate

NORM herausgegeben am 1.3.2005

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Informationen über die Norm:

Bezeichnung normen: ASTM F1925-99(2005)
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 1.3.2005
SKU: NS-52105
Zahl der Seiten: 4
Gewicht ca.: 12 g (0.03 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM

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Die Annotation des Normtextes ASTM F1925-99(2005) :

Keywords:

PLLA, poly(L-lactic acid), polylactide, virgin polymer, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics), 83.080.20 (Thermoplastic materials)

Ergänzende Informationen

1. Scope

1.1 This specification covers virgin poly(L-lactic acid) resin (or abbreviated as PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric composition based on various D, L, DL copolymer ratios.

1.2 This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material.

1.3 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, etc.) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods which are appropriate to assure safety and efficacy.

1.4 The values stated in SI units are to be regarded as the standard.

1.5 The following precautionary statement pertains only to the test method portion, Section 6, of this specification: 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

D3418-21	Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
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
D3593-80(1986)	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 (Withdrawn 1993)
D3536-91	Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by Liquir Exclusion Chromatography (Gel Permeation Chromatography - GPC) (Withdrawn 1996)
D2857-22	Standard Practice for Dilute Solution Viscosity of Polymers
F2579-18	Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
F2313-18	Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
E1994-09(2023)	Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
E1356-23	Standard Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
E1252-98(2021)	Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
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
E967-18	Standard Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal Analyzers
E794-06(2018)	Standard Test Method for Melting And Crystallization Temperatures By Thermal Analysis
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).
D3417-99	Standard Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC) (Withdrawn 2004)
ANSI/ISO/ASQ Q9001-2000	Quality Management Systems; Requirements
D1505-18	Standard Test Method for Density of Plastics by the Density-Gradient Technique

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