ASTM F702-2010 Standard Specification for Polysulfone Resin for Medical Applications《医用聚砜树脂的标准规范》.pdf

1、Designation: F702 10Standard Specification forPolysulfone Resin for Medical Applications1This standard is issued under the fixed designation F702; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision. A number

2、in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers polysulfone resin (poly(oxy-1,4-phenylenesulfonyl-1,4phenylene (dimethylmethylene)-1,4phenylene) as defined in ISO 2

3、51371, supplied by avendor in virgin form (pellets, powder, fabricated forms and soforth) for medical applications. This specification providesrequirements and associated test methods for this thermoplasticwhen it is intended for use in manufacturing medical devices orcomponents of medical devices.1

4、.2 As with any material, some characteristics may bealtered by the processing techniques (such as molding, extru-sion, machining, sterilization, and so forth) required for theproduction of a specific part or device. Therefore, properties offabricated forms of this resin should be evaluated using tes

5、tmethods which are appropriate to ensure safety and efficacy asagreed upon by the vendor, purchaser, and regulating bodies.1.3 The standard allows for designation of polysulfone resinfor all medical applications. The actual extent of performanceand suitability for a specific application must be eval

6、uated bythe vendor, purchaser, and regulating bodies.1.4 The properties included in this specification are thoseapplicable for unfilled polysulfone (PSU) polymers with theaddition of colorants and processing aids. Indicated propertiesare for injection molded forms. Forms containing fillers orother a

7、dditives, as well as polymer blends which contain PSU,or reclaimed materials, are not covered by this specification.1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.6 When evaluating material in accordance with this speci-f

8、ication, hazardous materials, operations, and equipment maybe involved. This standard does not purport to address all ofthe concerns, if any, associated with its use. It is the respon-sibility of the user of this standard to establish appropriatesafety and health practices and determine the applicab

9、ility ofregulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D256 Test Methods for Determining the Izod PendulumImpact Resistance of PlasticsD638 Test Method for Tensile Properties of PlasticsD648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the

10、Edgewise PositionD792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD6394 Specification for Sulfone Plastics (SP)F748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices2.2 ISO Standards:3ISO 10993 Biological Evaluation of

11、Medical DevicesISO 17025 General Requirements for the Competence ofTesting and Calibration LaboratoriesISO 251371 PlasticsSulfone Polymer Moulding and Ex-trusion MaterialsPart I: Designation System and Basisfor Specifications3. Significance and Use3.1 This specification is designed to recommend test

12、 meth-ods to establish a reasonable level of confidence concerning theperformance of unfilled polysulfone resins for use in medicaldevices. The properties listed should be considered in selectingmaterial according to specific end-use requirements.3.2 Polysulfones may be evaluated in implantable medi

13、caldevices as well as in non-implant medical applications.Polysulfone resins intended for use in implant applications aremanufactured with more rigorous use of manufacturing and/ortesting controls, to assure consistency of properties, cleanlinessand biocompatibility. This is further elaborated in 4.

14、1.4. Classification4.1 Polysulfone resin may be designated for either implantor non-implant medical applications. Designation of resins for1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee

15、F04.11 on Polymeric Materials.Current edition approved Sept. 1, 2010. Published October 2010. Originallyapproved in 1981. Last previous edition approved in 2003 as F702 98a (2003).DOI: 10.1520/F0702-10.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Serv

16、ice at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM International, 1

17、00 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.implant applications implies that the resins are manufactured incompliance with relevant aspects of GMP (Good Manufactur-ing Practices), use of process validation, enhanced controls,testing in a laboratory accredited

18、to ISO 17025, and compli-ance testing to ISO 10993:5 (cytotoxicity) and ISO 10993:18(physiochemical testing).NOTE 1Implant uses are medical applications implanted in the humanbody and devices that are in contact with bodily fluids or tissues forgreater than 24 h, that is, either prolonged or permane

19、nt exposure.Non-implant uses are medical applications in contact with bodily fluids ortissues for 24 h or less, that is, limited exposure.4.2 Classes and grades of unfilled polysulfone plastics aredescribed in Table SP, Group 1 of Specification D6394. Forexample, the material designation Specificati

20、on D6394 SP0112specifies a material from group 01 (polysulfone), class 1(general purpose), and grade 2 (5 to 9 melt flow rate grade)with mechanical properties as specified in Table SP of Speci-fication D6394.5. Properties and Sampling5.1 Specification D6394 defines a sulfone plastic as anaromatic po

21、lymer containing diphenyl sulfone in the backboneof the repeat unit, and polysulfones as a member of sulfoneplastics. Specification D6394 and ISO 251371 describe thechemical structure for polysulfone resin. The chemical struc-ture for polysulfone is further shown in Appendix X1, andincludes benzene

22、rings joined by diphenyl sulfone and etherlinkages, and includes a isopropylidene (CH3CH3C) group.5.2 The polysulfone resin shall yield an infrared transmit-tance spectrum which exhibits major transmittance bands onlyat the same wavelengths as appear on the attached referencespectrum (see Fig. 1). T

23、he infrared spectrum, as used in thisspecification, is to identify the polysulfone present and doesnot necessarily indicate an acceptable degree of material purity.The presence of additional bands in the IR spectrum of asample may indicate a different sulfone polymer, such aspolyether sulfone or pol

24、yphenylsulfone, or impurities, or both.5.3 The properties listed in Table 1 are determined fromspecimens injection molded in accordance with the resinsuppliers process recommendations and per SpecificationD6394. Additional or different treatments and processing steps(such as extrusion, molding, mach

25、ining, sterilization, and soforth) may alter the material properties. Table 1 lists typicalproperties of non-sterilized fabricated forms.5.4 Sampling shall be statistically adequate to satisfy therequirements of 7.3. The material shall be sampled withcommonly accepted sampling procedures or other sa

26、mplingtechniques as agreed upon between the customer and thesupplier.6. Inspection6.1 The resin shall be inspected for particulate foreignmatter contamination using the following or equivalent proce-dure suitable only for transparent material. Specimen plaques2.67 6 0.25 mm thick shall be injection

27、molded in accordancewith the resin suppliers process recommendation. A sufficientnumber of plaques shall be made to provide 390 cm2ofviewing surface, based on one side of the transparent plaques.The plaques shall be examined visually under fluorescent lightusinga2to33 magnifier to determine the numb

28、er of anycontaminant specks present. A total level of contaminationgreater than a count of 12 specks shall be cause for rejection ofFIG. 1 Polysulfone Infrared SpectrumPercent TransmittanceF702 102the material. It may not be possible to evaluate foreign mattercontamination by this method for opaque

29、materials.6.2 More sophisticated methods and/or stricter criteria forevaluating contamination may be agreed to between thesupplier and customer, especially for implant applications,including the use of tighter limits on the test proceduredescribed in 6.1.7. Certification7.1 Material suitable for med

30、ical applications shall be cer-tified to this specification. Additionally, certification shall be asindicated in the material Specification D6394, unless otherwiseagreed upon by the supplier and customer.7.2 Melt Flow Rate alone may be used as the validationproperty, being the single designated lot

31、acceptance propertyper subsection 12.2 of Specification D6394. However, as statedin Specification D6394, a periodic check of other designatedproperties may also be agreed to between the purchaser andsupplier, depending on the application. Agreement between thepurchaser and supplier may also include

32、testing of otherdesignated properties for validation and certification, depend-ing on the application.NOTE 2It is expected that testing for non-implant applications wouldbe minimal and melt flow rate alone may be used for lot validation.7.3 Certification shall be that the material was manufacturedby

33、 a process in statistical control, sampled, tested, and in-spected in accordance with this specification and that theaverage values for the lot meet the requirements of thespecification.NOTE 3The ASTM publication, Manual on Presentation of Data andControl Chart Analysis,4provides detailed informatio

34、n about statisticalprocess control.8. Biocompatibility8.1 Biocompatibility of PSU polymers and implant devicesmade using these materials shall be determined in accordancewith Practice F748 or the ISO 10993 series, unless otherwiseagreed upon between the supplier and the customer andregulating bodies

35、. It is intended that biocompatibility beestablished on the finished product by the appropriate proce-dures, after it has gone through all processing steps includingsterilization cycles, depending on the application.8.2 Past applications have indicated that polysulfones arenot suitable in load beari

36、ng implant applications in contact withbiological fluids containing lipids or phospholipids, such asbone marrow, due to susceptibility to environmental stress-cracking and crazing. Asgian et al5document a study usingbone marrow from the long bones of sheep. Examples ofsuccessful implant applications

37、 include pacemaker batteryhousings and infusion ports. Examples of non-implant appli-cations include handles of surgical curettes and heart valvesizers.8.3 Residual bis-phenol A (BPA) has been implicated as apotential health risk. At present, there is no consensus on theallowable amount of BPA in me

38、dical devices, but it issuggested that steps be taken to control and minimize it. Forapplications in which biocompatibility evaluation would not beappropriate or would not detect potentially harmful levels ofBPA, the concentration of BPAshould be determined by a validanalytical technique.9. Keywords

39、9.1 plastic surgical devices/applications; polymerssurgical applications; polysulfone resins; unfilled polysulfone(PSU)4Manual on Presentation of Data and Control Chart Analysis, 7th Edition,Stock Number MNL7A, ASTM International.5Asgian, Gilbertson, Blessing, and Crowninshield, “Environmentally Ind

40、ucedFracture of Polysulfones in Lipids,” Society for Biomaterials, 15th AnnualMeeting, 1989, pp. 17.TABLE 1 Typical Mechanical Properties of Fabricated FormsPropertyASTM TestMethodTypical Property ValuesADensity, g/cm3D792 1.24Izod impact at 22C of 3.2 mm specimen, J/m of notch D256 50Tensile elonga

41、tion at break, % D638 50Tensile modulus of elasticity, MPa D638 2480Tensile strength at yield, MPa D638 70Heat deflection temperature at 1820 kPa, unannealed, C D648 174ATypical property values are tabulated here for reference. Specification limits may be indicated by reference and use of Specificat

42、ion D6394.F702 103APPENDIXES(Nonmandatory Information)X1. CHEMICAL STRUCTURE OF POLYSULFONEX2. RATIONALEX2.1 This specification was established to provide guid-ance in the testing of polysulfone resin intended for use inmedical device applications. It recommends test methods forthe measurement of ch

43、emical, physical, and mechanical prop-erties of unfilled resin. Tests should be selected according toend-use applications. It is intended that biocompatibility beestablished on the finished product by the appropriate proce-dures, after it has gone through all processing steps and after alladjuvant s

44、ubstances have been incorporated.X2.2 Polysulfone resin may be processed by most tech-niques available for thermoplastic polymers. Medical devicesand components of medical devices made of polysulfone maybe repeatedly sterilized. Methods used successfully in pastapplications include steam, ethylene o

45、xide, irradiation, and dryheat sterilization. Actual suitability must be determined bytesting suitable for the application.X2.3 Polysulfones offer practical toughness in a stronginherently transparent polymer, and are available in resin formfor injection molding or extrusion, as well as stock shapes

46、 formachined components. Polysulfones are available both astransparent and opaque versions, as well as in colored versions.ASTM 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 expr

47、essly 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 technical committee and must be reviewed every five years andif not revise

48、d, 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 at a meeting of theresponsible technical committee, which you may

49、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 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 phot