ASTM F639-2009 Standard Specification for Polyethylene Plastics for Medical Applications《医疗设备用聚乙烯塑料的标准规范》.pdf

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1、Designation: F 639 09Standard Specification forPolyethylene Plastics for Medical Applications1This standard is issued under the fixed designation F 639; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A n

2、umber in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers polyethylene plastics (as de-fined in Terminology D 883) intended for use in medical deviceapplications involv

3、ing human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices.The biocompatibility of these materials as a class has not beenestablished. Biocompatibility tests must be conducted on thefinal product.1.2 This specification is not applicable to ultra-high mole

4、cu-lar weight polyethylenes (UHMWPE) plastics, such as thoseused in joint implants, and so forth.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns, if any

5、, associated with its use. It is theresponsibility 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:2D 638 Test Method for Tensile Properties of Plastic

6、sD 671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force3D 695 Test Method for Compressive Properties of RigidPlasticsD 747 Test Method for Apparent Bending Modulus ofPlastics by Means of a Cantilever BeamD 790 Test Methods for Flexural Properties of Unreinforcedand Reinforc

7、ed Plastics and Electrical Insulating MaterialsD 883 Terminology Relating to PlasticsD 1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD 1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD 1898 Practice for Sampling of Plastics3D 4976 Specificati

8、on for Polyethylene Plastics Molding andExtrusion MaterialsE117 Method for Spectrographic Analysis of Pig-Lead bythe Point-To-Plane Technique3F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices2.2 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices43.

9、Significance3.1 This specification describes polyethylene plastics usedin the manufacture of medical devices or components ofmedical devices. The properties listed should be considered inselecting material according to the specific end-use require-ments.4. Classification4.1 Types of polyethylene pla

10、stics molding and extrusionmaterial are described in Specification D 4976.5. General Requirements5.1 Polyethylene plastics consist of basic polymers madewith ethylene as essentially the sole monomer (as defined inTerminology D 883).5.2 Polyethylene for use in medical applications shall havea maximum

11、 extractable fraction, expressed as weight percentin polymer, in n-hexane of 5.5 % at 50C.55.3 The formulated compound may contain optional adju-vant substances required in the production of the polymer or inthe fabrication or intended use of the end product. Thebiocompatibility of these adjuvant su

12、bstances shall be estab-lished on the finished compound (see Section 9).5.4 The formulated compound shall yield a consistent in-frared absorption spectrum characteristic of the establishedformulation.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials

13、 and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Aug. 1, 2009. Published September 2009. Originallyapproved in 1979. Last previous edition approved in 2003 as F 639 98a(2003).2For referenced ASTM standards, visit the ASTM website, ww

14、w.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036,

15、http:/www.ansi.org.5Federal Register, Vol 21, Part 177.1520.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.5 Maximum levels and type of extractable metals shall beestablished in accordance with the intended use of the formu-lated

16、resin6(see Appendix X1).NOTE 1Appendix X1 is a suggested method for determining extract-able metals utilizing the current state-of-the-art methodology. Alternativemethods with equal reliability may be used.5.6 The physical properties of polyethylene plastics may bedetermined by the methods given in

17、Section 7.6. Sampling6.1 The material should be sampled in accordance withstandard sampling procedures such as those described inPractice D 1898.7. Physical Methods7.1 The following physical test procedures are suggestedwhere applicable to the intended application:7.1.1 DensityTest Method D 1505.7.1

18、.2 Melt FlowTest Method D 1238.7.1.3 Tensile PropertiesTest Method D 638.7.1.4 Compressive PropertiesTest Method D 695.7.1.5 StiffnessTest Method D 747.7.1.6 Flexural FatigueTest Method D 671.7.1.7 Flexural PropertiesTest Method D 790.8. Packaging and Labeling8.1 The product shall be packaged in a s

19、uitable container toprevent contamination of contents.8.2 The material shall be identified, including lot or batchnumbers and recommended method of storage.9. Biocompatibility9.1 The biological safety of each polyethylene plastic for-mulation shall be established. Specific biological tests shall bed

20、etermined in accordance with the intended use. Formulatedcompounds used in these tests should include all colorants andother additives present in the final product.9.2 Biological tests are appropriate to determine biologicalsafety and tissue reaction, depending on the end use applica-tion. These tes

21、ts should be conducted when indicated forspecific applications. Additional tests may be necessary forcertain cases; Practice F 748 and ISO 10993 may be used asguidelines.9.2.1 Biocompatibility testing should be performed onspecimens that have been processed and sterilized using themethods intended f

22、or the final device. It should be noted thatradiation sterilization of the polyethylene has been shown tocause adverse effects on the properties of the material, such aschain scission and the creation of free radicals that lead tooxidation and subsequent deterioration of mechanical proper-ties.10. K

23、eywords10.1 plastic surgical devices/applications; polyethylene(PE) plasticssurgical implant applications; polymerssurgical applicationsAPPENDIXES(Nonmandatory Information)X1. SUGGESTED PRACTICE FOR EXTRACTABLE METALS ANALYSIS OF PLASTIC BY ATOMICABSORPTION SPECTROSCOPYX1.1 ScopeX1.1.1 This practice

24、 covers the analysis of extractablemetals from plastics intended for use in medical deviceapplication.X1.1.2 Formulated raw materials or finished products maybe used.X1.2 SignificanceX1.2.1 Concentrations of trace metals are measured asextracts in simulated body fluids. The metals concentration inex

25、tracts is based on the surface area of the plastic extractedfrom which the total amount of metal deliverable to the patientmay be estimated.X1.3 Preparation of SpecimensX1.3.1 Use suitable molded test strips of the formulatedcompound. The total surface area of the specimen to beexposed should be equ

26、ivalent to 120 cm2when the specimenthickness is 0.5 mm or less or 60 cm2when the thickness isgreater than 0.5 mm. Specimens may be separated from eachother by suitable inert spacers to ensure contact with theextraction solvent.X1.3.2 After the plastic sample has been prepared, extractthe specimens u

27、sing 20 ml of the desired solvent for 72 h at50C or 24 h at 70C, as appropriate for the particular plastic.Then remove the plastic strips and analyze the extract formetals as described in Section X1.4.X1.4 Preparation of Extract SolutionX1.4.1 Pipet 5.0 ml of the cottonseed oil (CSO) extract intoa 1

28、0-ml volumetric flask and dilute to volume with hexane.Dilute the CSO atomic absorption standards and controls in thesame manner.X1.4.2 Run the saline eluate directly without dilution.6Accuracy in Trace Analysis, NBS Special Publication No. 422, U.S. Govern-ment Printing Office, Washington, DC, Cata

29、log No. C-13.10:422.F639092X1.5 Preparation of Atomic Absorption StandardsX1.5.1 Prepare certified aqueous standard solutions by di-luting 1000 ppm of aqueous stock solutions with the 0.9 %saline solution used for extractions. Use the saline solutionalone as the blank.X1.5.2 Prepare the CSO standard

30、s by dissolving the appro-priate organometallic compound in CSO to give intermediatesolutions which are then diluted by volume 1 + 1 with hexane,giving final standard solutions of metal in the same matrix asthe samples. Use a 1 + 1 dilution of CSO with hexane as theblank. Obtain the concentration an

31、alysis on organometallicstandards from the manufacturer.X1.6 ProcedureX1.6.1 Place the hollow cathode lamp for the element beingtested in the instrument and set the instrument conditions forthat element in accordance with the manufacturers recom-mended procedure.X1.6.2 When the lamp has warmed up, l

32、ight the flame,adjust to the proper mixture, and allow to burn for 1 min toequilibrate the instrument. For the CSO-hexane mixtures,adjust the flame while aspirating the blank solution.X1.6.3 Zero the instrument while aspirating the blank solu-tion corresponding to the matrix to be analyzed.X1.6.4 As

33、pirate a high standard and adjust the burnerposition and flame for the optimum signal and optimumsignal-to-noise ratio.X1.6.5 Rezero the instrument while aspirating blank solu-tions.X1.6.6 Starting with the lowest, aspirate the standard solu-tions and record the absorbance corresponding to each. Be-

34、tween standards, aspirate the blank solution and check the zero.X1.6.7 Aspirate the sample solutions and record the corre-sponding absorbance readings. Aspirate the blank solution andcheck the zero between samples.X1.6.8 If there are many samples to be run, recheck thestandards periodically during t

35、he analysis. In any case, reana-lyze the standards after all the samples have been run.X1.7 CalculationX1.7.1 Prepare a calibration chart by plotting absorbanceversus concentration.X1.7.2 Calculate the concentrations of metal in the sampleextracts by reference to the standard curve.X1.7.3 Calculate

36、the total amount of metal extracted asfollows:g metalml extract3 ml of extracts 5 total metal extracted, g (X1.1)X1.7.4 Calculate the amount of metal extracted per squarecentimetre of sample, g/cm2:total metal extracted, gsurface area of film, cm2(X1.2)X1.8 Precision and AccuracyX1.8.1 The precision

37、 and accuracy of this practice has notyet been determined. It is dependent upon several factors,including sample matrix, ionization interferences, sophistica-tion of instrumentation, and so forth.X1.8.2 Determine the precision for each test system inaccordance with Method E117.NOTE X1.1Pertinent dat

38、a and other information regarding this speci-fication may be reported to Committee F04 Staff Manager, ASTMInternational Headquarters, 100 Barr Harbor Drive, W. Conshohocken, PA19428. Comments and suggestions will be considered in future standardsdevelopment activities.X2. BIOCOMPATIBILITYX2.1 The su

39、itability of these materials from a humanimplant perspective is dependent on the specific application.The biological tests appropriate for the specific site, such asrecommended in Practice F 748 or ISO 10993, should be usedas a guideline.X2.2 No known implant material has ever been shown to becomple

40、tely free of adverse reactions in the human body.However, long-term clinical experience of use of specificformulations of this material class referred to in this standardhas shown that an acceptable level of biological response canbe expected, if the material is used in appropriate applications.ASTM

41、 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 of such rights, are ent

42、irely 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 additional standardsan

43、d 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 to the ASTM Committee o

44、n 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).F639093