ASTM F702-1998a(2003) Standard Specification for Polysulfone Resin for Medical Applications《医用聚砜树脂标准规范》.pdf

1、Designation: F 702 98a (Reapproved 2003)Standard Specification forPolysulfone Resin for Medical Applications1This standard is issued under the fixed designation F 702; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of las

2、t revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers polysulfone resin (poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phe

3、nylene) for medical applica-tions (as defined in Terminology D 883). This specificationprovides requirements and associated test methods for a formof this thermoplastic which is intended for use in manufactur-ing medical devices or components of medical devices.1.2 As with any material, some charact

4、eristics may bealtered by the processing techniques (such as molding, extru-sion, machining, sterilization, and so forth) required for aspecific application. Therefore, properties of fabricated formsof this resin should be evaluated using appropriate test methodsto assure safety and efficacy.1.3 The

5、 use of this resin in medical devices should berestricted to nonimplant applications until biocompatibilityevaluations appropriate for the intended applications are suc-cessfully completed.1.4 The biocompatibility of plastic compounds made up ofpolysulfone resin containing colorants, fillers, proces

6、sing aids,or other additives as well as polymer blends which containpolysulfone should not be assumed on the basis of resincompatibility alone. Their biocompatibility must be establishedby testing the final (end-use) compositions using evaluationmethods appropriate for the intended applications. Not

7、e thatthe types, levels, and biological effects of extractives yieldedby the additives contained in a compound or blend may alsohave to be evaluated for some end-use applications.1.5 All values in this standard are in SI units with theequivalent values in inch-pound units given in parentheseswhere a

8、pplicable.1.6 This standard does not purport to address all of theconcerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Do

9、cuments2.1 ASTM Standards:D 149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power Frequencies2D 256 Test Methods for Determining the Izod PendulumImpact Resistance of Plastics3D 570 Test Method for Water Absorption of Plas

10、tics3D 638 Test Method for Tensile Properties of Plastics3D 648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise Position3D 696 Test Method for Coefficient of Linear Thermal Ex-pansion of Plastics Between 30C and 30C with aVitreous Silica Dilatometer3D 883 Termin

11、ology Relating to Plastics3D 955 Test Method of Measuring Shrinkage from MoldDimensions of Molded Plastics3D 1238 Test Method for Flow Rates of Thermoplastics byExtrusion Plastometer3D 1505 Test Method for Density of Plastics by the Density-Gradient Technique3D 1898 Practice for Sampling of Plastics

12、4D 3750 Practice for Determination of Number-Average Mo-lecular Weight of Polymers by Membrane Osmometry5F 619 Practice for Extraction of Medical Plastics6F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices62.2 Code of Federal Regulations:Title 21 CFR Subpart 177.

13、165573. Chemical Requirements3.1 The polysulfone resin consists solely of the alternatingcopolymer which may be produced when the disodium salt of4,48-isopropylidenediphenol is made to react stoichiometri-cally with 4,48-dichlorodiphenyl sulfone such that the finishedresins have a minimum number ave

14、rage molecular weight of24 000. The molecular weight shall be determined by osmoticpressure in monochlorobenzene using the method described inPractice D 3750 or an equivalent method. The weight average1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Material

15、s and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Apr. 10, 2003. Published May 2003. Originallyapproved in 1981. Last previous edition approved in 1998 as F 702 98ae1.2Annual Book of ASTM Standards, Vol 10.01.3Annual Book of ASTM Sta

16、ndards, Vol 08.01.4Discontinued; See 1997 Annual Book of ASTM Standards, Vol 08.01.5Discontinued; See 1990 Annual Book of ASTM Standards, Vol 08.03.6Annual Book of ASTM Standards, Vol 13.01.7Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA 191

17、11-5094, Attn: NPODS.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.molecular weight shall be equal to or greater than two times thenumber average molecular weight.3.2 Polysulfone resins shall conform to the requirements of21 CFR 17

18、7.1655. In addition to the total extractables evalu-ation described in the CFR, maximum levels and types ofextractable metals shall be established in accordance with therequirements of the intended use of the resin (1, 2).83.3 The polysulfone resin shall yield an infrared transmit-tance spectrum whi

19、ch exhibits major transmittance bands onlyat the same wavelengths as appear on the attached referencespectrum (see Fig. 1).4. Physical Requirements4.1 Polysulfone resin may be processed by most techniquesavailable for thermoplastic polymers. Medical devices andcomponents of medical devices made of p

20、olysulfone may berepeatedly sterilized. Methods used successfully include steam,ethylene oxide, irradiation, and dry heat sterilization.4.2 Except for nonvolatile content and melt flow, the prop-erties listed in Table 1 are determined from specimens injectionmolded in accordance with the resin suppl

21、iers process recom-mendations. Additional or different treatments and processingsteps (such as extrusion, molding, machining, sterilization, andso forth) may alter the material properties.5. Sampling5.1 The material shall be sampled in accordance with theprocedure described in Practice D 1898 or equ

22、ivalent.6. Inspection, Marking, and Packaging6.1 The resin shall be inspected for particulate foreignmatter contamination using the following or equivalent proce-dure. Specimen plaques 2.67 6 0.25 mm (0.105 6 0.010 in.)thick shall be injection molded in accordance with the resinsuppliers process rec

23、ommendation. A sufficient number ofplaques shall be made to provide 390 cm2(60 in.2) of viewingsurface, based on one side of the transparent plaques. Theplaques shall be examined visually under fluorescent lightusinga2to33 magnifier to determine the number and size ofany contaminant specks present,

24、rating them in accordancewithTable 2.The total level of contamination is then calculatedby multiplying the number of specks in each size range by theappropriate numerical rating and summing. A total ratinggreater than 12 shall be cause for rejection of the material.6.2 As determined by agreement bet

25、ween the purchaser andthe supplier, polysulfone resin may be inspected for pyrogeniccontamination using either of the following tests:6.2.1 USP Pyrogen Test (3).6.2.2 Limulus Amebocyte Lysate (LAL) Test for Pyrogens(3).6.3 The material shall be properly identified including lot orbatch numbers, date

26、 of manufacture, and recommendedmethod of storage.6.4 The material, before processing, as well as the end-usecomponent, shall be packaged in a suitable container to preventcontamination of contents.7. Certification7.1 The manufacturer shall certify that each batch of thepolysulfone resin passes Clas

27、s VI Biological Tests (5), Bio-logical Reactivity Tests (4), and Practice F 748 when indicatedfor specific applications.8. Biocompatibility8.1 Evaluation of the local and systemic tissue response toimplant devices, made wholly or in part from polysulfoneresin, must be carried out using biological te

28、sts appropriate tothe intended functions and implantation site of the device.8.2 Satisfactory tissue response must be established sepa-rately for any plastic compounds made up of polysulfone resinwhich contains colorants, fillers, processing aids, or otheradditives as well as for polymer blends whic

29、h contain polysul-fone. Note that the types, levels, and biological effects ofextractives yielded by the additives contained in a compoundor polymer blend may also have to be evaluated for someend-use applications as described in Practice F 619.8.3 In choosing appropriate test protocols for the mate

30、rial,based upon end use, the recommendations found in PracticeF 748 should be considered.9. Keywords9.1 plastic surgical devices/applications; polymerssurgical applications; polysulfone resins8The boldface numerals in parentheses refer to the list of references at the endof this specification.FIG. 1

31、 Polysulfone Infrared SpectrumPercent Transmittance for 0.0005 in. FilmF 702 98a (2003)2APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This specification was established to provide guid-ance in the testing of polysulfone resin intended for use inmedical device applications. It recommends test

32、 methods forthe measurement of chemical, 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 process

33、ing steps and after alladjuvant substances have been incorporated.X2. BIOCOMPATIBILITYX2.1 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 formulations of this

34、 material referred to inthis standard has shown that an acceptable level of biologicalresponse can be expected, if the material is used in appropriateapplications.TABLE 1 Physical PropertiesPropertyASTM TestMethodProperty ValueElectricalDielectric strength of 3-mm (18-in.) specimen, kV/mm (kV/in.) D

35、 149 13 (350) min; 16 (425) avgMechanical/Physical:Density, kg/m3D 1505 1230 to 1250Izod impact at 22C (72F) of 3 mm (18 in.) specimen, J/m (ftlb/in.) of notch D 256 50 (1.0) min; 69 (1.3) avgMold shrinkage, m/m D 955 0.006 to 0.008Tensile elongation at break, % D 638 20 minimum; 50 to 100 averageTe

36、nsile modulus of elasticity, MPa (psi) D 638 2300 (3.4 3 106) min; 2480 (3.6 3 106) avgTensile strength at yield, MPa (psi) D 638 65 (9500) min; 70 (10 200) avgWater absorption, gain in weight in 24 h, % D 570 0.35 max; 0.30 avgNonvolatile contentburned, then heated to 585C for 2 h, % by weight 0.01

37、0 max; 0.001 to 0.008 avgThermal:Coefficient of linear thermal expansion, m/mC (in./in.F) D 696 5.6 3 105(3.1 3 105) avgHeat deflection temperature at 1820 kPa (264 psi), unannealed, C (F) D 648 168 (335) min; 174 (345) avgMelt flow at 343C (650F), 298.2 kPa (43.25 psi), g/10 min D 1238 (modified) 9

38、.0 max; 6.5 avgTABLE 2 Rating Specimen PlaquesSpeck SizeARatingDescriptive Numerical0.005 to 0.009 small 10.010 to 0.024 medium 20.025 and over large 3AThe speck size is measured as the diameter, in inches, of the equivalentcircular area.F 702 98a (2003)3REFERENCES(1) United States Pharmacopeia, “Ph

39、ysico-Chemical TestsPlastics,”Vol 23, 1995, p. 1783.(2) NBS Special Publication No. 422; “Accuracy in Trace Analysis,” U.S.Government Printing Office, Washington, DC.(3) U.S. Pharmacopeia, Vol 23, 1995, pp. 1696 and 1718.(4) U.S. Pharmacopeia, Vol 23, 1995, pp. 16971699.(5) U.S. Pharmacopeia, Vol 23

40、, 1995, pp. 16991703.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 expressly advised that determination of the validity of any such patent rights, and the riskof infringemen

41、t 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 f

42、or 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 know

43、n 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).F 702 98a (2003)4