ASTM F624 - 25 医疗用热塑性聚氨酯固体和溶液评估标准指南

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Designation: F624 −25
Standard Guide for
Evaluation of Thermoplastic Polyurethane Solids and
Solutions for Medical Applications
1
This standard is issued under the ﬁxed designation F624; 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 poly-
urethanes in both solid and solution forms for medical appli-
cations. 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 medical 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
medical device manufacturer must evaluate the biocompatibil-
ity of devices that contain the polyurethane of the speciﬁc
composition or form in the intended use and after completion
of all manufacturing processes including sterilization.
1.4 Material 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
medical 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 appro-
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
2
D149 Test Method for Dielectric Breakdown Voltage and
Dielectric Strength of Solid Electrical Insulating Materials
at Commercial Power Frequencies
D150 Test Methods for AC Loss Characteristics and Permit-
tivity (Dielectric Constant) of Solid Electrical Insulation
D257 Test Methods for DC Resistance or Conductance of
Insulating Materials
D395 Test Methods for Rubber Property—Compression Set
D412 Test Methods for Vulcanized Rubber and Thermoplas-
tic Elastomers—Tension
D570 Test Method for Water Absorption of Plastics
D575 Test Methods for Rubber Properties in Compression
D638 Test Method for Tensile Properties of Plastics
D648 Test Method for Deﬂection Temperature of Plastics
Under Flexural Load in the Edgewise Position
D671 Test Method for Flexural Fatigue of Plastics by
Constant-Amplitude-of-Force (Withdrawn 2002)
3
D790 Test Methods for Flexural Properties of Unreinforced
and Reinforced Plastics and Electrical Insulating Materi-
als
D792 Test Methods for Density and Speciﬁc Gravity (Rela-
tive Density) of Plastics by Displacement
D1238 Test Method for Melt Flow Rates of Thermoplastics
by Extrusion Plastometer
D1242 Test Methods for Resistance of Plastic Materials to
Abrasion (Withdrawn 2003)
3
D1434 Test Method for Determining Gas Permeability Char-
acteristics of Plastic Film and Sheeting
D2240 Test Method for Rubber Property—Durometer Hard-
ness
D2990 Test Methods for Tensile, Compressive, and Flexural
Creep and Creep-Rupture of Plastics
D3137 Test Method for Rubber Property—Hydrolytic Sta-
bility
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.
Current edition approved May 15, 2025. Published June 2025. Originally
approved in 1981. Last previous edition approved in 2024 as F624 – 09 (2024).
DOI: 10.1520/F0624-25.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at www.astm.org/contact. For Annual Book of
ASTM Standards volume information, refer to the standard’s Document Summary
page on the ASTM website.
3
The last approved version of this historical standard is referenced on
www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1

D3418 Test Method for Transition Temperatures and Enthal-
pies of Fusion and Crystallization of Polymers by Differ-
ential Scanning Calorimetry
E96/E96M Test Methods for Gravimetric Determination of
Water Vapor Transmission Rate of Materials
E1131 Test Method for Compositional Analysis by Thermo-
gravimetry
F748 Practice for Selecting Biological Test Methods for
Materials and Devices
2.2 ISO Standards:
4
ISO 10993-1 Biological Evaluation of Medical Devices—
Part 1: Evaluation and Testing within a Risk Management
Process
ISO 14971 Medical Devices—Application of Risk Manage-
ment to Medical Devices
2.3 FDA Publications:
5
CDRH, FDA Guidance for Industry Guidance for the Sub-
mission of Research and Marketing Applications for
Permanent Pacemaker Leads and for Pacemaker Lead
Adaptor 510(k) Submissions
CDRH, FDA Guidance for Industry and Food and Drug
Administration Staff Use of International Standard ISO
10993-1, “Biological evaluation of medical devices—Part
1: Evaluation and testing within a risk management
process”
3. Terminology
3.1 Deﬁnitions:
3.1.1 batch polymerization process—a synthetic process in
which a ﬁnite amount of material is made in a tank-type reactor
instead of an extruder-type reactor. A typical process involves
polyol and diisocyanate reacting to form a prepolymer fol-
lowed by adding chain extender for the polymerization to
continue and achieve intended molecular weight.
3.1.2 chain extender—an active hydroxyl or amine contain-
ing compound such as a diol or diamine used to increase the
molecular weight of an isocyanate-terminated prepolymer by
chemical reaction; or a diisocyanate used to extend a hydroxyl-
terminated or amine-terminated prepolymer.
3.1.3 chain-terminating agent—an active monofunctional
compound such as a monofunctional alcohol, amine, or car-
boxylic acid that reacts with isocyanate chain ends of a
polyurethane to prevent further chain growth.
3.1.4 continuous polymerization process—a synthetic pro-
cess in which diisocyanate, polyol, and chain extender are all
mixed together and continuously polymerize to directly
achieve the intended molecular weights.
3.1.5 linear polyurethane—a polyurethane with each chain
having two ends and having no crosslinking between chains,
branches, or side chains.
3.1.5.1 Discussion—An introduction to polyurethane for
medical applications is presented in Appendix X2.
3.1.6 long-term implants—medical devices whose cumula-
tive sum of single, multiple, or repeated patient body contact
time exceeds 30 days.
3.1.7 polyol—a low molecular weight polymer with its
chain ends being hydroxyl.
3.1.8 prepolymer—the reaction product of polyol and diiso-
cyanate with one chemical in excess.
3.1.9 segmented polyurethane—a polyurethane whose chain
is composed of different segments that are alternatively con-
nected together. A typical segmented polyurethane is composed
of hard segments and soft segments. Hard segments contain
urethane or urea groups (isocyanate and chain extender). Soft
segments are composed of hydrocarbon, ether, ester, carbonate,
silicone, etc. (polyol).
3.1.10 thermoplastic polyurethane—a linear polyurethane
that can be melted and processed into desired forms at elevated
temperatures.
3.1.11 thermoplastic polyurethane elastomer—a thermo-
plastic polyurethane that can recover from deformation once
the force is removed. For example, an elastomer may have
300 % elongation upon application of a tensile force and more
than 200 % can be recovered after the tension is removed.
4. Signiﬁcance and Use
4.1 This guide is intended to aid device developers and
manufacturers in the synthesis and/or the selection of proper
commercially available solid polyurethane resins, monomers,
or partially reacted polymers, and/or solutions for their appli-
cations.
4.2 The polyurethanes covered by this guide may be ther-
mally processable or solutions that can be cast into medical
devices or components. They may also be used to coat certain
surfaces of a medical device.
5. Descriptive Chemical Information
5.1 Diols—Diols may include:
5.1.1 Polyether diol.
5.1.2 Polyester diol.
5.1.3 Polydimethylsiloxane diol.
5.1.4 Polyhydrocarbon diol.
5.1.5 Polycarbonate diol.
5.1.6 Mixture of the above diols.
5.2 Difunctional Diisocyanates—Difunctional diisocyanates
may include:
5.2.1 Diphenylmethane 4,4-diisocyanate (MDI).
5.2.2 2,4-tolylene diisocyanate (TDI).
5.2.3 1,5-naphthalene diisocyanate.
5.2.4 1,6-hexamethylene diisocyanate (HMDI).
5.2.5 Hydrogenated MDI.
5.3 Chain Extenders—Chain extenders may include:
5.3.1 1,4-butanediol.
5.3.2 Glycols.
5.3.3 Aliphatic and aromatic diamines.
5.3.4 Water.
5.4 Chain-Terminating Agents—Chain-terminating agents
may include:
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
5
Available from U.S. Food and Drug Administration (FDA), 10903 New
Hampshire Ave., Silver Spring, MD 20993, http://www.fda.gov.
F624 − 25
2

5.4.1 Monofunctional alcohols.
5.4.2 Monofunctional amines.
5.4.3 Monofunctional isocyanates.
5.4.4 Monofunctional acids.
5.5 Catalysts—Catalysts may include:
5.5.1 Stannous octoate.
5.5.2 Dibutyltin dilaurate.
5.6 Additives—Additives may include:
5.6.1 Colorants including pigments and dyes.
5.6.2 Radiopaque materials such as barium sulfate,
tantalum, tungsten, tungsten carbide, etc.
5.6.3 Antiblocking agents and lubricants such as natural and
synthetic ethylene bisstearamide.
5.6.4 Stabilizers such as antioxidants, light, moisture, and
heat stabilizers.
5.6.5 Special additives such as bactericide.
5.7 Descriptive Information—Descriptive information on
full polyurethane solutions may include:
5.7.1 Solvent or solvents.
5.7.2 Weight or volume percent for polyurethane solids.
6
5.7.3 Additives.
5.7.4 Diluents.
5.7.5 Solution viscosity and test methods.
5.7.6 Chemical identity and test methods.
5.7.7 Color or appearance and test methods.
5.7.8 Water weight or volume percentage and testing meth-
ods.
5.7.9 Storage conditions.
6. Processing Recommendations
6.1 Drying conditions before process including dryer types
and typical temperatures and time.
6.2 Processing conditions for injection molding.
6.3 Processing conditions for extrusion.
6.4 Processing conditions for thermoforming.
6.5 Post-processing conditioning such as annealing, etc.
6.6 Post-process shrinkage.
6.7 Packaging.
6.8 Sterilization.
6.9 Storage conditions and shelf life.
7. Suggested Physical Tests on a Solid Specimen or Film
NOTE 1—It is noted that the testing methods should be chosen based on
speciﬁc needs, samples, and requirements. The methods and data presen-
tation should be validated for the application purposes. It should not
necessarily be limited to the following recommendation.
7.1 Tensile Strength—Test Methods D412,D638.
7.2 Ultimate Elongation—Test Methods D412,D638.
7.3 Tensile Stress at 100, 200, and 300 % Strain—Test
Methods D412,D638.
7.4 Compression Deﬂection Characteristics—Test Methods
D575.
7.5 Flexural Strength—Test Methods D790.
7.6 Indentation Hardness (Duromater)—Test Method
D2240.
7.7 Melt Flow Rate—Test Method D1238.
7.8 Compression Set—Test Methods D395.
7.9 Abrasion Resistance (Taber)—Test Methods D1242.
7.10 Speciﬁc Gravity—Test Methods D792.
7.11 Hydrolytic Stability of Elastomers—Test Method
D3137.
7.12 Tensile Creep Test—Test Methods D2990.
7.13 Gas Transmission Rate of Plastic Film—Test Method
D1434.
7.14 Water Vapor Transmission of Plastic Film—Test Meth-
ods E96/E96M.
7.15 Water Absorption of Plastics—Test Method D570.
7.16 Flexural Fatigue of Plastics—Test Method D671.
7.17 Thermogravimetric Analysis (TGA)—Test Method
E1131.
7.18 Differential Scanning Calorimetry (DSC)—Test
Method D3418.
7.19 Heat Deﬂection Temperature (HDT)—Test Method
D648.
8. Suggested Chemical Tests
8.1 Chemical composition—FTIR, NMR, etc.
8.2 Molecular weight and molecular weight distribution—
GPC.
8.3 Leachables and extractables.
8.4 Volatile contents.
8.5 Heavy metals and other relevant elements.
8.6 Isocyanate group content.
8.7 Amine equivalent weight.
7
8.8 Ash for ﬁlled polyurethane.
8
NOTE 2—Per application, other chemical analyses may be carried out.
9. Suggested Electrical Tests
9.1 Volume Resistivity—Test Methods D257.
9.2 Surface Resistivity—Test Methods D257.
9.3 Dielectric Strength—Test Method D149.
9.4 Dielectric Constant—Test Methods D150.
NOTE 3—Per application, other analyses may be carried out. Other
methods may be used if they are validated to the application’s condition
and purposes.
6
David and Staley, Analytical Chemistry of the Polyurethanes, Wiley Inter-
science Publishers, 1969, p. 359.
7
David and Staley, Analytical Chemistry of the Polyurethanes, Wiley Inter-
science Publishers, 1969, pp. 87–89.
8
U.S. Pharmacopeia, available from U.S. Pharmacopeia (USP), 12601 Twin-
brook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
F624 − 25
3

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标签： #评估 #评估标准 #热塑性

摘要：

本指南ASTM F624 - 25详细介绍了医疗用热塑性聚氨酯（TPU）固体及其溶液的标准评估方法，涵盖物理性能、化学纯度、生物相容性及加工适用性等关键参数。该标准为医疗器械制造商、材料研发人员及质量检测机构提供统一、可靠的评估框架，确保热塑性聚氨酯材料在植入物、导管、输液器及其他高风险医疗应用中的安全性与有效性。通过系统化测试方法，该指南有助于减少材料批次差异带来的风险，优化产品开发流程，并支持国际法规合规要求。适用于医疗级TPU供应商、实验室及监管评估，是推动医用高分子材料标准化与质量控制的

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