ASTM F624-2009(2015)e1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications《评估医学用热塑性聚氨基甲酸乙酯固体及溶液的标准指南》.pdf

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1、Designation: F624 09 (Reapproved 2015)1Standard Guide forEvaluation of Thermoplastic Polyurethane Solids andSolutions for Biomedical Applications1This standard is issued under the fixed designation F624; the number immediately following the designation indicates the year of originaladoption or, in t

2、he case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1NOTESection 1.2 was editorially corrected in May 2015.1. Scope1.1 This guide covers the evaluati

3、on of thermoplastic poly-urethanes in both solid and solution form for biomedicalapplications. 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 specifications containing minimum requiredvalues an

4、d tolerances for specific end-use products.1.3 Standard tests for biocompatibility 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,formulations, and f

5、orms of thermoplastic polyurethanes insolid and solution forms are within this material class, theformulator or fabricator must evaluate the biocompatibility ofthe specific composition or form in the intended use and aftercompletion of all manufacturing processes including steriliza-tion.1.4 Purchas

6、e specifications may be prepared by agreementbetween the buyer and seller 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 theres

7、ponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electric

8、al Insulating Materialsat Commercial Power FrequenciesD150 Test Methods for AC Loss Characteristics and Permit-tivity (Dielectric Constant) of Solid Electrical InsulationD257 Test Methods for DC Resistance or Conductance ofInsulating MaterialsD395 Test Methods for Rubber PropertyCompression SetD412

9、Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD570 Test Method for Water Absorption of PlasticsD575 Test Methods for Rubber Properties in CompressionD671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force (Withdrawn 2002)3D790 Test Methods for Flexura

10、l Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1242 Test Methods for Resistance o

11、f Plastic Materials toAbrasion (Withdrawn 2003)3D1434 Test Method for Determining Gas Permeability Char-acteristics of Plastic Film and SheetingD1544 Test Method for Color of Transparent Liquids (Gard-ner Color Scale)D1638 Methods of Testing Urethane Foam Isocyanate RawMaterials (Withdrawn 1989)3D21

12、24 Test Method for Analysis of Components in Poly(Vi-nyl Chloride) Compounds Using an Infrared Spectropho-tometric TechniqueD2240 Test Method for Rubber PropertyDurometer Hard-nessD2857 Practice for Dilute Solution Viscosity of PolymersD2990 Test Methods for Tensile, Compressive, and FlexuralCreep a

13、nd Creep-Rupture of Plastics1This 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 March 1, 2015. Published May 2015. Originallyapproved in 1981. L

14、ast previous edition approved in 2009 as F624 09. DOI:10.1520/F0624-09R15E01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page ont

15、he ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1D3137 Test Method for Rubber PropertyHydrolytic Sta-bilityD3418 Test Method for Transi

16、tion Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryE96/E96M Test Methods for Water Vapor Transmission ofMaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standard:ISO 10993 Biological Evalu

17、ation 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 isocyanate-terminated prepolymer bychemical reaction; (2) a diisocyanate used to extend a polyol-terminated poly

18、urethane 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 of a prepolymer toprevent further chain growth.3.1.3 linear polyurethanea polymer whose backbone con-sists of ure

19、thane 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,occur as blocks that are coupled by urethane and urea groups.3.1.5 thermoplastic polyurethanelinear or segmentedpoly

20、urethanes that can be melted for processing withoutsignificant crosslinking or degradation. They are most fre-quently synthesized by reacting diols with diisocyanates.4. Significance and Use4.1 This guide is intended to aid device fabricators in theselection of proper commercially available polyuret

21、hane 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 implantation as determined to beappropriate, based on supporting biocompatibility and physicaltest data.5. Descripti

22、ve 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 Poly(ethylene adipate).5.1.5 1,4-dihydroxybutane.5.1.6 Mixture of the above diols.5.2 Difunctional DiisocyanatesDif

23、unctional diisocyanatesthat 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-hexamethylene diisocyanate (HMDI).5.3 Chain ExtendersChain extenders that can be used are:5.3.1 Water.5.3.2 Glycols.5.3.3 Alipha

24、tic 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 amines, such as dibutylamine or di-ethylamine.5.5 CatalystsStannous octoate is suitable for prepolymerpreparation.5.6 Op

25、tional 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 lubricants, such as naturaland synthetic waxes.5.6.4 Optical brighteners, antioxidants, and light and heatstabilizers.5.6.

26、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 product, provided these substances are inminor amounts and are biocompatible in the recommendedconcentrations.5.7 Descript

27、ive Information on Polyurethane Solutions:5.7.1 Solvent or solvents.5.7.2 Percent solids.55.7.3 Solution viscosityTest Method D2857.5.7.4 Infrared identity testTest Method D2124.5.7.5 Recommended diluents.5.7.6 Gardner color testTest Method D1544.6. Processing Recommendations for Fabrication (bySupp

28、lier)6.1 Drying conditions before fabrication.6.2 Suggested optimum time, temperature, and pressure forinjection molding, extrusion, or thermoforming to desiredshapes.6.3 Polymer stability at elevated temperatures of dry poly-mer in air or under an inert atmosphere.6.4 Recommended storage conditions

29、.7. Suggested Physical Tests on a Solid Specimen or Film7.1 Tensile StrengthTest Methods D412.7.2 Ultimate ElongationTest Methods D412.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5David and Staley, Analytical Chemistr

30、y of the Polyurethanes, Wiley Inter-science Publishers, 1969, p. 359 .F624 09 (2015)127.3 Compression Deflection CharacteristicsTest MethodsD575.7.4 Tensile Stress at 100, 200, and 300 % StrainTestMethods D412.7.5 Flexural StrengthTest Methods D790.7.6 Indentation Hardness (Durometer)Test MethodD224

31、0.7.7 Flow Rate by Extrusion PlastometerTest MethodD1238.7.8 Compression SetTest Methods D395.7.9 Abrasion Resistance (Taber)Test Methods D1242.7.10 Specific GravityTest Methods D792.7.11 Hydrolytic Stability of ElastomersTest MethodD3137.7.12 Tensile Creep and Creep Rupture TestTest MethodsD2990.7.

32、13 Gas Transmission Rate of Plastic FilmTest MethodD1434.7.14 Water Vapor Transmission of Plastic FilmTest Meth-ods E96/E96M.7.15 Water Absorption of PlasticsTest Method D570.7.16 Flexural Fatigue of PlasticsTest Method D671.7.17 Thermal AnalysesTest Method D3418.8. Suggested Chemical Tests8.1 Isocy

33、anate Group ContentMethods D1638.8.2 Amine Equivalent Weight.68.3 Ash.79. Suggested Electrical Tests9.1 Volume ResistivityTest Methods D257.9.2 Surface ResistivityTest Methods D257.9.3 Dielectric StrengthTest Method D149.9.4 Dielectric ConstantTest Methods D150.10. Suggested Biological Tests10.1 Bio

34、compatibility TestingBiocompatibility of poly-mers and implant devices made using these materials shall bedetermined in accordance with Practice F748 or the ISO 10993series, unless otherwise agreed upon between the supplier andthe consumer and regulating bodies. These standards recom-mend specific b

35、iocompatibility testing, depending on the in-tended use of the device.10.1.1 Biocompatibility testing should be performed onspecimens that have been processed and sterilized per themethods intended for the final device.10.1.2 Toxicological tests on individual batches of productmay be made upon agree

36、ment between the purchaser andsupplier.11. Packaging, Labeling, and Preservation11.1 The solid polymer should be packaged in a suitablecontainer to avoid contamination and deterioration. An airtightcontainer, capable of excluding moisture, should be used whennecessary.11.2 The polyurethane solutions

37、 should be packaged innonreactive, noncontaminating containers to ensure productintegrity.11.3 The product should be properly identified includingproduct and lot numbers, and, if necessary, a storage expirationdate and conditions.12. Keywords12.1 plastic surgical devices/applications; polymers-surgi

38、cal applications; polyurethane-medical applicationsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This guide provides definitions and a standard descrip-tion for thermoplastic polyurethanes in both solid and solutionforms for biomedical applications. The guide enumeratesrelevant test methods

39、and describes generic criteria whichshould assist in developing more specific specifications forimplantable devices containing thermoplastic polyurethaneswith values and limits covering end-use applications.6David and Staley, Analytical Chemistry of the Polyurethanes, Wiley Inter-science Publishers,

40、 1969, p. 8789.7U.S. Pharmacopeia, available from U.S. Pharmacopeia (USP), 12601 Twin-brook Pkwy., Rockville, MD 20852-1790, http:/www.usp.orgF624 09 (2015)13X2. BIOCOMPATIBILITYX2.1 The suitability of these materials from a humanimplant perspective is dependent on the specific application.The biolo

41、gic tests appropriate for the specific site, such asrecommended in Practice should be used as a guideline.X2.2 No 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

42、formulations of this material class referred toin this standard has shown that an acceptable level of biologicalresponse can be expected, if the material is used in appropriateapplications.ASTM International takes no position respecting the validity of any patent rights asserted in connection with a

43、ny 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 of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technica

44、l 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 additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration

45、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 to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor

46、 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). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 09 (2015)14