ASTM F624-09
(Guide)Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
SIGNIFICANCE AND USE
This guide is intended to aid device fabricators in the selection of proper commercially available polyurethane solids and solutions for their application.
The polyurethanes covered by this guide may be thermoformed or solution cast into biomedical devices for use as surgical aids or for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data.
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 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.
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Designation: F624 − 09
StandardGuide for
Evaluation of Thermoplastic Polyurethane Solids and
1
Solutions for Biomedical Applications
ThisstandardisissuedunderthefixeddesignationF624;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope DielectricStrengthofSolidElectricalInsulatingMaterials
at Commercial Power Frequencies
1.1 This guide covers the evaluation of thermoplastic poly-
D150 Test Methods forAC Loss Characteristics and Permit-
urethanes in both solid and solution form for biomedical
tivity (Dielectric Constant) of Solid Electrical Insulation
applications. The polymers have been reacted to completion
D257 Test Methods for DC Resistance or Conductance of
and require no further chemical processing.
Insulating Materials
1.2 The tests and methods listed in this guide may be
D395 Test Methods for Rubber Property—Compression Set
referenced in specification containing minimum required val-
D412 Test Methods forVulcanized Rubber andThermoplas-
ues and tolerances for specific end-use products.
tic Elastomers—Tension
D570 Test Method for Water Absorption of Plastics
1.3 Standard tests for biocompatibility are included to aid in
the assessment of safe utilization in biomedical applications. D575 Test Methods for Rubber Properties in Compression
D671 Test Method for Flexural Fatigue of Plastics by
Compliance with these criteria shall not be construed as an
3
endorsement of implantability. Since many compositions, Constant-Amplitude-of-Force (Withdrawn 2002)
D790 Test Methods for Flexural Properties of Unreinforced
formulations, and forms of thermoplastic polyurethanes in
solid and solution forms are within this material class, the and Reinforced Plastics and Electrical Insulating Materi-
als
formulator or fabricator must evaluate the biocompatibility of
the specific composition or form in the intended use and after D792 Test Methods for Density and Specific Gravity (Rela-
tive Density) of Plastics by Displacement
completion of all manufacturing processes including steriliza-
tion. D1238 Test Method for Melt Flow Rates of Thermoplastics
by Extrusion Plastometer
1.4 Purchase specifications may be prepared by agreement
D1242 Test Methods for Resistance of Plastic Materials to
between the buyer and seller by selection of appropriate tests
3
Abrasion (Withdrawn 2003)
and methods from those listed applicable to the specific
D1434 TestMethodforDeterminingGasPermeabilityChar-
biomedical end use.
acteristics of Plastic Film and Sheeting
1.5 This standard does not purport to address all of the
D1544 Test Method for Color of Transparent Liquids (Gard-
safety concerns, if any, associated with its use. It is the
ner Color Scale)
responsibility of the user of this standard to establish appro-
D1638 Methods of Testing Urethane Foam Isocyanate Raw
priate safety and health practices and determine the applica- 3
Materials (Withdrawn 1989)
bility of regulatory limitations prior to use.
D2124 Test Method forAnalysis of Components in Poly(Vi-
nyl Chloride) Compounds Using an Infrared Spectropho-
2. Referenced Documents
tometric Technique
2
2.1 ASTM Standards:
D2240 Test Method for Rubber Property—Durometer Hard-
D149 Test Method for Dielectric Breakdown Voltage and
ness
D2857 Practice for Dilute Solution Viscosity of Polymers
D2990 Test Methods for Tensile, Compressive, and Flexural
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Creep and Creep-Rupture of Plastics
Surgical Materials and Devices and is the direct responsibility of Subcommittee
D3137 Test Method for Rubber Property—Hydrolytic Sta-
F04.11 on Polymeric Materials.
bility
Current edition approved Aug. 1, 2009. Published September 2009. Originally
approved in 1981. Last previous edition approved in 2003 as F624 – 98a(2003). D3418 Test Method for Transition Temperatures and En-
DOI: 10.1520/F0624-09.
thalpies of Fusion and Crystallization of Polymers by
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F624 − 09
Differential Scanning Calorimetry 5.2.3 1,5-naphthalene diisocyanate.
E96/E96M Test Methods for Water Vapor Transmission of 5.2.4 1,6-hexamethylene diisocyanate (HMDI).
Materials
5.3 Chain Exte
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F 624–98a (Reapproved 2003) Designation:F 624–09
Standard Guide for
Evaluation of Thermoplastic Polyurethane Solids and
1
Solutions for Biomedical Applications
This standard is issued under the fixed designation F 624; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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 specification containing minimum required values and
tolerances for specific end-use products.
1.3Test values shall be stated in SI units with inch-pound units in parentheses.
1.4Standard 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 constructedconstrued 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.
1.54 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.
1.61.5 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 149 Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at
Commercial Power Frequencies
D 150 Test Methods for acAC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulating
2
Materials Insulation
D 257 Test Methods for dcDC Resistance or Conductance of Insulating Materials
D 395 Test Methods for Rubber Property—Compression Set
3
D 412 Test Methods for Vulcanized Rubber and Thermoplastic Rubbers and Thermoplastic Elastomers-Tension Test Methods
for Vulcanized Rubber and Thermoplastic ElastomersTension
D 570 Test Method for Water Absorption of Plastics
D 575 Test Methods for Rubber Properties in Compression
D 671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force
D 790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D 792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D 1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D 1242 Test Methods for Resistance of Plastic Materials to Abrasion
D 1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D 1544 Test Method for Color of Transparent Liquids (Gardner Color Scale)
3
D 1638 Methods of Testing Urethane Foam Isocyanate Raw Materials
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.11
on Polymeric Materials.
´1
Current edition approved Apr. 10, 2003. Published May 2003. Originally approved in 1981. Last previous edition approved in 1998 as F624–98a .
Current edition approved Aug. 1, 2009. Published September 2009. Originally approved in 1981. Last previous edition approved in 2003 as F 624 – 98a(2003).
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 10.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F624–09
D 2124 Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric
...
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