1、Designation: F 624 09Standard Guide forEvaluation of Thermoplastic Polyurethane Solids andSolutions for Biomedical Applications1This standard is issued under the fixed designation F 624; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revisi
2、on, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide covers the evaluation of thermoplastic poly-urethanes in both solid and solution form for b
3、iomedicalapplications. The polymers have been reacted to completionand require no further chemical processing.1.2 The tests and methods listed in this guide may bereferenced in specification containing minimum required val-ues and tolerances for specific end-use products.1.3 Standard tests for bioco
4、mpatibility are included to aid inthe assessment of safe utilization in biomedical applications.Compliance with these criteria shall not be construed as anendorsement of implantability. Since many compositions, for-mulations, and forms of thermoplastic polyurethanes in solidand solution forms are wi
5、thin this material class, the formulatoror fabricator must evaluate the biocompatibility of the specificcomposition or form in the intended use and after completionof all manufacturing processes including sterilization.1.4 Purchase specifications may be prepared by agreementbetween the buyer and sel
6、ler by selection of appropriate testsand methods from those listed applicable to the specificbiomedical end use.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate saf
7、ety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power FrequenciesD 150 Test Meth
8、ods for AC Loss Characteristics and Per-mittivity (Dielectric Constant) of Solid Electrical Insula-tionD 257 Test Methods for DC Resistance or Conductance ofInsulating MaterialsD 395 Test Methods for Rubber PropertyCompressionSetD 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersT
9、ensionD 570 Test Method for Water Absorption of PlasticsD 575 Test Methods for Rubber Properties in CompressionD 671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force3D 790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating
10、MaterialsD 792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD 1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD 1242 Test Methods for Resistance of Plastic Materials toAbrasion3D 1434 Test Method for Determining Gas Permea
11、bilityCharacteristics of Plastic Film and SheetingD 1544 Test Method for Color of Transparent Liquids(Gardner Color Scale)D 1638 Methods of Testing Urethane Foam Isocyanate RawMaterials3D 2124 Test Method for Analysis of Components in Poly-(Vinyl Chloride) Compounds Using an Infrared Spectro-photome
12、tric TechniqueD 2240 Test Method for Rubber PropertyDurometerHardnessD 2857 Practice for Dilute Solution Viscosity of PolymersD 2990 Test Methods for Tensile, Compressive, and Flex-ural Creep and Creep-Rupture of PlasticsD 3137 Test Method for Rubber PropertyHydrolytic Sta-bilityD 3418 Test Method f
13、or Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers by1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved Aug.
14、1, 2009. Published September 2009. Originallyapproved in 1981. Last previous edition approved in 2003 as F 624 98a(2003).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refe
15、r to the standards Document Summary page onthe ASTM website.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Differential Scanning CalorimetryE 96/E 96M Test Methods for Water Vapor Transmission ofMaterialsF 748 Practice fo
16、r Selecting Generic Biological Test Meth-ods for Materials and Devices2.2 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices43. Terminology3.1 Definitions:3.1.1 chain extender(1) an active hydrogen containing acompound such as a diol or diamine used to increase themolecular weight of an
17、 isocyanate-terminated prepolymer bychemical reaction; (2) a diisocyanate used to extend a polyol-terminated polyurethane by chemical reaction.3.1.2 chain terminating agentan active hydrogen contain-ing a compound such as a monofunctional alcohol, amine, oracid that reacts with the isocyanate group
18、of a prepolymer toprevent further chain growth.3.1.3 linear polyurethanea polymer whose backbone con-sists of urethane groups joined by hydrocarbon chains withlittle or no crosslinking.3.1.4 segmented polyurethaneA family of polymers inwhich ester or ether groups, connected by hydrocarbon chains,occ
19、ur as blocks that are coupled by urethane and urea groups.3.1.5 thermoplastic polyurethanelinear or segmentedpolyurethanes that can be melted for processing withoutsignificant crosslinking or degradation. They are most fre-quently synthesized by reacting diols with diisocyanates.4. Significance and
20、Use4.1 This guide is intended to aid device fabricators in theselection of proper commercially available polyurethane solidsand solutions for their application.4.2 The polyurethanes covered by this guide may be ther-moformed or solution cast into biomedical devices for use assurgical aids or for imp
21、lantation as determined to be appropri-ate, based on supporting biocompatibility and physical testdata.5. Descriptive Chemical Information5.1 DiolsDiols that can be used for biomedical applica-tions are as follows:5.1.1 Poly(oxypropylene).5.1.2 Poly(oxytetramethylene).5.1.3 Poly(caprolactone).5.1.4
22、Poly(ethylene adipate).5.1.5 1,4-dihydroxybutane.5.1.6 Mixture of the above diols.5.2 Difunctional DiisocyanatesDifunctional diisocyan-ates that can be used are: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-hexamethyle
23、ne diisocyanate (HMDI).5.3 Chain ExtendersChain extenders that can be used are:5.3.1 Water.5.3.2 Glycols.5.3.3 Aliphatic and aromatic diamines.5.4 Chain-Terminating AgentsChain-terminating agentssuitable for use are:5.4.1 Monofunctional alcohols, such as methanol or etha-nol.5.4.2 Monofunctional ami
24、nes, such as dibutylamine or di-ethylamine.5.5 CatalystsStannous octoate is suitable for prepolymerpreparation.5.6 Optional Additives:5.6.1 Pigments and dyes, such as titanium dioxide andcopper phthalocyanine blue.5.6.2 Radiopaque materials, such as barium sulfate.5.6.3 Antiblocking agents and lubri
25、cants, such as naturaland synthetic waxes.5.6.4 Optical brighteners, antioxidants, and light and heatstabilizers.5.6.5 The basic polymer bought may contain, as agreedupon between the purchaser and supplier, optional adjunctsubstances required in the production of the polymer orintended end use produ
26、ct, provided these substances are inminor amounts and are biocompatible in the recommendedconcentrations.5.7 Descriptive Information on Polyurethane Solutions:5.7.1 Solvent or solvents.5.7.2 Percent solids.55.7.3 Solution viscosityTest Method D 2857.5.7.4 Infrared identity testTest Method D 2124.5.7
27、.5 Recommended diluents.5.7.6 Gardner color testTest Method D 1544.6. Processing Recommendations for Fabrication (bySupplier)6.1 Drying conditions before fabrication.6.2 Suggested optimum time, temperature, and pressure forinjection molding, extrusion, or thermoforming to desiredshapes.6.3 Polymer s
28、tability at elevated temperatures of dry poly-mer in air or under an inert atmosphere.6.4 Recommended storage conditions.7. Suggested Physical Tests on a Solid Specimen or Film7.1 Tensile StrengthTest Methods D 412.7.2 Ultimate ElongationTest Methods D 412.7.3 Compression Deflection CharacteristicsT
29、est MethodsD 575.7.4 Tensile Stress at 100, 200, and 300 % StrainTestMethods D 412.7.5 Flexural StrengthTest Methods D 790.7.6 Indentation Hardness (Durometer)Test MethodD 2240.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.
30、org.5David and Staley, Analytical Chemistry of the Polyurethanes, Wiley Inter-science Publishers, 1969, p. 359 .F6240927.7 Flow Rate by Extrusion PlastometerTest MethodD 1238.7.8 Compression SetTest Methods D 395.7.9 Abrasion Resistance (Taber)Test Methods D 1242.7.10 Specific GravityTest Methods D
31、792.7.11 Hydrolytic Stability of ElastomersTest MethodD 3137.7.12 Tensile Creep and Creep Rupture TestTest MethodsD 2990.7.13 Gas Transmission Rate of Plastic FilmTest MethodD 1434.7.14 Water Vapor Transmission of Plastic FilmTest Meth-ods E 96/E 96M.7.15 Water Absorption of PlasticsTest Method D 57
32、0.7.16 Flexural Fatigue of PlasticsTest Method D 671.7.17 Thermal AnalysesTest Method D 3418.8. Suggested Chemical Tests8.1 Isocyanate Group ContentMethods D 1638.8.2 Amine Equivalent Weight.68.3 Ash.79. Suggested Electrical Tests9.1 Volume ResistivityTest Methods D 257.9.2 Surface ResistivityTest M
33、ethods D 257.9.3 Dielectric StrengthTest Method D 149.9.4 Dielectric ConstantTest Methods D 150.10. Suggested Biological Tests10.1 Biocompatibility TestingBiocompatibility of poly-mers and implant devices made using these materials shall bedetermined in accordance with Practice F 748 or theISO 10993
34、 series, unless otherwise agreed upon between thesupplier and the consumer and regulating bodies. These stan-dards recommend specific biocompatibility testing, dependingon the intended use of the device.10.1.1 Biocompatibility testing should be performed onspecimens that have been processed and ster
35、ilized per themethods intended for the final device.10.1.2 Toxicological tests on individual batches of productmay be made upon agreement between the purchaser andsupplier.11. Packaging, Labeling, and Preservation11.1 The solid polymer should be packaged in a suitablecontainer to avoid contamination
36、 and deterioration. An airtightcontainer, capable of excluding moisture, should be used whennecessary.11.2 The polyurethane solutions should be packaged innonreactive, noncontaminating containers to ensure productintegrity.11.3 The product should be properly identified includingproduct and lot numbe
37、rs, and, if necessary, a storage expirationdate and conditions.12. Keywords12.1 plastic surgical devices/applications; polymers-surgical applications; polyurethane-medical applicationsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This guide provides definitions and a standard de-scription fo
38、r thermoplastic polyurethanes in both solid andsolution forms for biomedical applications. The guide enumer-ates relevant test methods and describes generic criteria whichshould assist in developing more specific specifications forimplantable devices containing thermoplastic polyurethaneswith values
39、 and limits covering end-use applications.X2. BIOCOMPATIBILITYX2.1 The suitability of these materials from a humanimplant perspective is dependent on the specific application.The biologic tests appropriate for the specific site, such asrecommended in Practice 748 should be used as a guideline.X2.2 N
40、o known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. However, long-term clinical experience of use of specificcompositions and formulations of this material class referred toin this standard has shown that an acceptable level of biological
41、response can be expected, if the material is used in appropriateapplications.6David and Staley, Analytical Chemistry of the Polyurethanes, Wiley Inter-science Publishers, 1969, p. 8789.7U.S. Pharmacopeia, available from U.S. Pharmacopeia (USP), 12601 Twin-brook Pkwy., Rockville, MD 20852-1790, http:
42、/www.usp.orgF624093ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement
43、of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for
44、 additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known
45、to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F624094
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