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ASTM F624-98a

(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

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.

General Information

Status
Historical
Publication Date
09-Oct-1998
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaced By
ASTM F624-98ae1 - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
Effective Date
10-Oct-1998

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ASTM F624-98a - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical ApplicationsASTM F624-98a - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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ASTM F624-98a - 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 superseded and replaced by a new version or
withdrawn. Contact ASTM International (www.astm.org) for the latest information.
Designation: F 624 – 98a
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
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. Scope D 257 Test Methods for D-C Resistance or Conductance of
2
Insulating Materials
1.1 This guide covers the evaluation of thermoplastic poly-
D 395 Test Methods for Rubber Property—Compression
urethanes in both solid and solution form for biomedical
3
Set
applications. The polymers have been reacted to completion
D 412 Test Methods for Vulcanized Rubber and Thermo-
and require no further chemical processing.
3
plastic Rubbers and Thermoplastic Elastomers-Tension
1.2 The tests and methods listed in this guide may be
4
D 570 Test Method for Water Absorption of Plastics
referenced in specification containing minimum required val-
3
D 575 Test Methods for Rubber Properties in Compression
ues and tolerances for specific end use products.
D 671 Test Method for Flexural Fatigue of Plastics by
1.3 Test values shall be stated in SI units with inch-pound
4
Constant-Amplitude-of-Force
units in parentheses.
D 790 Test Methods for Flexural Properties of Unreinforced
1.4 Standard tests for biocompatibility are included to aid in
and Reinforced Plastics and Electrical Insulating Materi-
the assessment of safe utilization in biomedical applications.
4
als
Compliance with these criteria shall not be constructed as an
D 792 Test Methods for Density and Specific Gravity (Rela-
endorsement of implantability. Since many compositions, for-
4
tive Density) of Plastics by Displacement
mulations, and forms of thermoplastic polyurethanes in solid
D 1238 Test Method for Flow Rates of Thermoplastics by
and solution forms are within this material class, the formulator
4
Extrusion Plastometer
or fabricator must evaluate the biocompatibility of the specific
D 1242 Test Methods for Resistance of Plastic Materials to
composition or form in the intended use and after completion
4
Abrasion
of all manufacturing processes including sterilization.
D 1434 Test Method for Determining Gas Permeability
1.5 Purchase specifications may be prepared by agreement
5
Characteristics of Plastic Film and Sheeting
between the buyer and seller by selection of appropriate tests
D 1544 Test Method for Color of Transparent Liquids
and methods from those listed applicable to the specific
6
(Gardner Color Scale)
biomedical end use.
D 1638 Methods of Testing Urethane Foam Isocyanate Raw
1.6 This standard does not purport to address all of the
7
Materials
safety concerns, if any, associated with its use. It is the
D 2124 Test Method for Analysis of Components in Poly-
responsibility of the user of this standard to establish appro-
(Vinyl Chloride) Compounds Using an Infrared Spectro-
priate safety and health practices and determine the applica-
8
photometric Technique
bility of regulatory limitations prior to use.
D 2240 Test Method for Rubber Property—Durometer
3
2. Referenced Documents
Hardness
D 2857 Test Method for Dilute Solution Viscosity of Poly-
2.1 ASTM Standards:
9
mers
D 149 Test Method for Dielectric Breakdown Voltage and
D 2990 Test Methods for Tensile, Compressive, and Flex-
Dielectric Strength of Solid Electrical Insulating Materials
9
2
ural Creep and Creep Rupture of Plastics
at Commercial Power Frequencies
D 3137 Test Method for Rubber Property—Hydrolytic Sta-
D 150 Test Methods for A-C Loss Characteristics and
3
bility
Permittivity (Dielectric Constant) of Solid Electrical Insu-
2
lating Materials
3
Annual Book of ASTM Standards, Vol 09.01.
4
1
Annual Book of ASTM Standards, Vol 08.01.
This guide is under the jurisdiction of ASTM Committee F-4 on Medical and
5
Surgical Materials and Devicesand is the direct responsibility of Subcommittee Annual Book of ASTM Standards, Vol 15.09.
6
F04.11on 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.
1

---------------------- Page: 1 ----------------------
F 624
D 3418 Test Method for Transition Temperatures of Poly- 5.2.4 1,6-hexamethylene diisocyanate (HMDI).
10
mers by Thermal Analy
...

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3.1 The compression resistance perpendicular to the faces, the resistance to the extrusion during compression, and the ability to recover after release of the load are indicative of a joint filler's ability to continuously fill a concrete expansion joint and thereby prevent damage that might otherwise occur during thermal expansion. The asphalt content is a measure of the fiber-type joint filler's durability and life expectancy. In the case of cork-type fillers, the resistance to water absorption and resistance to boiling hydrochloric acid are relative measures of durability and life expectancy.
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1.1 These test methods cover the physical properties associated with preformed expansion joint fillers. The test methods include:    
Property  
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7.1  
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Boiling in Hydrochloric Acid  
7.4  
Asphalt Content  
7.5  
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Note 1: Specific test methods are applicable only to certain types of joint fillers, as stated herein.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
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1.1 This specification covers asphalt plank used for bridge decks as well as for industrial floors.  
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