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

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 Test values shall be stated in SI units with inch-pound units in parentheses.
1.4 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be constructed 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.
1.5 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.
1.6 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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Status
Historical
Publication Date
09-Oct-1998
Current Stage
Ref Project

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ASTM F624-98ae1 - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: F 624 – 98a
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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—10.1 was editorially corrected in May 2001.
1. Scope Permittivity (Dielectric Constant) of Solid Electrical Insu-
2
lating Materials
1.1 This guide covers the evaluation of thermoplastic poly-
D 257 Test Methods for D-C Resistance or Conductance of
urethanes in both solid and solution form for biomedical
2
Insulating Materials
applications. The polymers have been reacted to completion
D 395 Test Methods for Rubber Property—Compression
and require no further chemical processing.
3
Set
1.2 The tests and methods listed in this guide may be
D 412 Test Methods for Vulcanized Rubber and Thermo-
referenced in specification containing minimum required val-
3
plastic Rubbers and Thermoplastic Elastomers-Tension
ues and tolerances for specific end use products.
4
D 570 Test Method for Water Absorption of Plastics
1.3 Test values shall be stated in SI units with inch-pound
3
D 575 Test Methods for Rubber Properties in Compression
units in parentheses.
D 671 Test Method for Flexural Fatigue of Plastics by
1.4 Standard tests for biocompatibility are included to aid in
4
Constant-Amplitude-of-Force
the assessment of safe utilization in biomedical applications.
D 790 Test Methods for Flexural Properties of Unreinforced
Compliance with these criteria shall not be constructed as an
and Reinforced Plastics and Electrical Insulating Materi-
endorsement of implantability. Since many compositions, for-
4
als
mulations, and forms of thermoplastic polyurethanes in solid
D 792 Test Methods for Density and Specific Gravity (Rela-
and solution forms are within this material class, the formulator
4
tive Density) of Plastics by Displacement
or fabricator must evaluate the biocompatibility of the specific
D 1238 Test Method for Flow Rates of Thermoplastics by
composition or form in the intended use and after completion
4
Extrusion Plastometer
of all manufacturing processes including sterilization.
D 1242 Test Methods for Resistance of Plastic Materials to
1.5 Purchase specifications may be prepared by agreement
4
Abrasion
between the buyer and seller by selection of appropriate tests
D 1434 Test Method for Determining Gas Permeability
and methods from those listed applicable to the specific
5
Characteristics of Plastic Film and Sheeting
biomedical end use.
D 1544 Test Method for Color of Transparent Liquids
1.6 This standard does not purport to address all of the
6
(Gardner Color Scale)
safety concerns, if any, associated with its use. It is the
D 1638 Methods of Testing Urethane Foam Isocyanate Raw
responsibility of the user of this standard to establish appro-
7
Materials
priate safety and health practices and determine the applica-
D 2124 Test Method for Analysis of Components in Poly-
bility of regulatory limitations prior to use.
(Vinyl Chloride) Compounds Using an Infrared Spectro-
8
2. Referenced Documents photometric Technique
D 2240 Test Method for Rubber Property—Durometer
2.1 ASTM Standards:
3
Hardness
D 149 Test Method for Dielectric Breakdown Voltage and
D 2857 Test Method for Dilute Solution Viscosity of Poly-
Dielectric Strength of Solid Electrical Insulating Materials
9
2
mers
at Commercial Power Frequencies
D 2990 Test Methods for Tensile, Compressive, and Flex-
D 150 Test Methods for A-C Loss Characteristics and
9
ural Creep and Creep Rupture of Plastics
3
Annual Book of ASTM Standards, Vol 09.01.
1 4
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Annual Book of ASTM Standards, Vol 08.01.
5
Surgical Materials and Devices and is the direct responsibility of Subcommittee Annual Book of ASTM Standards, Vol 15.09.
6
F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 06.01.
7
Current edition approved October 10, 1998. Published March 1999. Originally Annual Book of ASTM Standards, Vol 06.03.
8
published as F 624 – 81. Last previous edition F 624 – 93. Annual Book of ASTM Standards, Vol 08.01.
2 9
Annual Book of ASTM Standards, Vol 10.02. Annual Book of ASTM Standards, Vol 08.02.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
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NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 624
D 3137 Test Method for Rub
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