ASTM F624-09(2015)e1
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

Standard No.

ASTM F624-09(2015)e1

Release Date

2015

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F624-09(2015)e1

Scope

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 specifications 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.

ASTM F624-09(2015)e1 Referenced Document

• ASTM D1238 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
• ASTM D1242 Standard Test Methods for Resistance of Plastic Materials to Abrasion
• ASTM D1434 Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
• ASTM D149 Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
• ASTM D150 Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
• ASTM D1544 Standard Test Method for Color of Transparent Liquids (Gardner Color Scale)
• ASTM D1638 Methods of Testing Urethane Foam Isocyanate Raw Materials
• ASTM D2124 Standard Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique
• ASTM D2240 Standard Test Method for Properties of Rubber &8212; Durometer Hardness*， 2024-04-21 Update
• ASTM D257 Standard Test Methods for DC Resistance or Conductance of Insulating Materials
• ASTM D2857 Standard Practice for Dilute Solution Viscosity of Polymers
• ASTM D2990 Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
• ASTM D3137 Standard Test Method for Rubber Property—Hydrolytic Stability*， 2018-08-01 Update
• ASTM D3418 Standard Test Method for Transition Temperatures of Polymers By Differential Scanning Calorimetry
• ASTM D395 Standard Test Methods for Rubber Property-Compression Set
• ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
• ASTM D570 Standard Test Method for Water Absorption of Plastics*， 2018-08-01 Update
• ASTM D575 Standard Test Methods for Rubber Properties in Compression*， 2018-06-01 Update
• ASTM D671 Standard test method and practice guide for evaluating fleece floor coverings
• ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-21 Update
• ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• ASTM E96/E96M Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials*， 2024-03-01 Update
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update

ASTM F624-09(2015)e1 history

• 2015 ASTM F624-09(2015)e1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
• 2009 ASTM F624-09 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
• 1998 ASTM F624-98a(2003) Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
• 1998 ASTM F624-98ae1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
• 1998 ASTM F624-98a Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications