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ASTM F 624 : 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-08-2009

CONTAINED IN VOL. 13.01, 2015 Defines the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications.

1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications. The polymers have been reacted to completion and require no further chemical processing.

1.2 The tests and methods listed in this guide may be referenced in specification containing minimum required values and tolerances for specific end-use products.

1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.

1.4 Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use.

1.5 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.

Committee
F 04
DocumentType
Guide
Pages
4
ProductNote
Reconfirmed 2009
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM D 2857 : 2016 Standard Practice for Dilute Solution Viscosity of Polymers
ASTM E 96/E96M : 2016 : REDLINE Standard Test Methods for Water Vapor Transmission of Materials
ASTM D 3418 : 2015 : REDLINE Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
ASTM D 671 : 1993 Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
ASTM D 1238 : 2013 : REDLINE Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM D 3137 : 1981 : R2018 Standard Test Method for Rubber Property—Hydrolytic Stability
ASTM D 257 : 2014 : REDLINE Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D 1242 : 1995 : REV A Standard Test Methods for Resistance of Plastic Materials to Abrasion (Withdrawn 2004)
ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
ASTM D 2990 : 2017 : REDLINE Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics

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