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ASTM F624-98a(2003)

(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 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-Apr-2003
ICS
11.100.99 - Other standards related to laboratory medicine
83.080.20 - Thermoplastic materials
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F624-98ae1 - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
Effective Date
10-Apr-2003
Replaced By
ASTM F624-09 - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
Effective Date
01-Aug-2009
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
10-Apr-2003

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ASTM F624-98a(2003) - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical ApplicationsASTM F624-98a(2003) - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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ASTM F624-98a(2003) - Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
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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 (Reapproved 2003)
Standard Guide for
Evaluation of Thermoplastic Polyurethane Solids and
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 dc Resistance or Conductance of
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
Set
applications. The polymers have been reacted to completion
D 412 Test Methods for Vulcanized Rubber and Thermo-
and require no further chemical processing.
plastic Rubbers and Thermoplastic Elastomers-Tension
1.2 The tests and methods listed in this guide may be
D 570 Test Method for Water Absorption of Plastics
referenced in specification containing minimum required val-
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
Constant-Amplitude-of-Force
units in parentheses.
D 790 TestMethodsforFlexuralPropertiesofUnreinforced
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.
als
Compliance with these criteria shall not be constructed as an
D 792 TestMethodsforDensityandSpecificGravity(Rela-
endorsement of implantability. Since many compositions, for-
tive Density) of Plastics by Displacement
mulations, and forms of thermoplastic polyurethanes in solid
D 1238 Test Method for Flow Rates of Thermoplastics by
andsolutionformsarewithinthismaterialclass,theformulator
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
Abrasion
of all manufacturing processes including sterilization.
D 1434 Test Method for Determining Gas Permeability
1.5 Purchase specifications may be prepared by agreement
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
(Gardner Color Scale)
biomedical end use.
D 1638 Methods ofTesting Urethane Foam Isocyanate Raw
1.6 This standard does not purport to address all of the
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-
photometric Technique
bility of regulatory limitations prior to use.
D 2240 Test Method for Rubber Property—Durometer
2. Referenced Documents Hardness
D 2857 Test Method for Dilute Solution Viscosity of Poly-
2.1 ASTM Standards:
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
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 ac Loss Characteristics and Permit-
bility
tivity (Dielectric Constant) of Solid Electrical Insulating
Materials
Annual Book of ASTM Standards, Vol 09.01.
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Annual Book of ASTM Standards, Vol 08.01.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
Discontinued; See 2001 Annual Book of ASTM Standards, Vol 08.01.
F04.11 on Polymeric Materials.
Annual Book of ASTM Standards, Vol 15.09.
Current edition approved Apr. 10, 2003. Published May 2003. Originally
Annual Book of ASTM Standards, Vol 06.01.
e1
approved in 1981. Last previous edition approved in 1998 as F 624 – 98a .
Discontinued; See 1998 Annual Book of ASTM Standards, Vol 08.01.
Annual Book of ASTM Standards, Vol 10.01.
Annual Book of ASTM Standards, Vol 08.02.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 624–98a (2003)
D 3418 Test Method for Transition Temperatures of Poly- 5.3 Chain Extenders—Chain extenders that can be used are:
mers by Thermal Analysis 5.3.1 Water.
E 96 Test Methods for Water Vapor Transmission of Mate- 5.3.2 Glycols.
rials 5.3.3 Aliphatic and aromatic diamines.
F 619 Practice for Extraction of Medical Plastics 5.4 Chain-Terminating Agents—Chain-terminating agents
F 748 Practice for Selecting Generic Biological Test Meth- suitable for use are:
ods for Materials and Devices 5.4.1 Monofunctional alcohols, such as methanol or etha-
nol.
3. Terminology
5.4.2 Monofunctional amines, such as dibutylamine or di-
3.1 Definitions: ethylamine.
3.1.1 chain extender—(1) an active hydrogen containing 5.5 Catalysts—Stannous octoate is suitable for prepolymer
compound such as a diol or diamine used to increase the preparation.
molecular weight of an isocyanate-terminated prepolymer by 5.6 Optional Additives:
chemical reaction; (2) a diisocyanate used to extend a polyol- 5.6.1 Pigments and dyes, such as titanium dioxide and
terminated polyurethane by chemical reaction. copper phthalocyanine blue.
5.6.2 Radiopaque materials, such as barium sulfate.
3.1.2 chain terminating agent—an active hydrogen contain-
ing a compound such as a monofunctional alcohol, amine, or 5.6.3 Antiblocking agents and lubricants, such as natural
and synthetic waxes.
acid that reacts with the isocyanate group of a prepolymer to
prevent further chain growth. 5.6.4 Optical brighteners, antioxidants, and light and heat
stabilizers.
3.1.3 linear polyurethane—a polymer whose backbone con-
sists of urethane groups joined by hydrocarbon chains with 5.6.5 The basic polymer bought may contain, as agreed
upon between the purchaser and supplier, optional adjunct
little or no cross linking.
3.1.4 segmented polyurethane—A family of polymers in substances required in the production of the polymer or
intended end use product, provided these substances are in
which ester or ether groups, connected by hydrocarbon chains,
occur as blocks that are coupled by urethane and urea groups. minor amounts and are biocompatible in the recommended
concen
...

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SCOPE
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