ASTM F639-2009(2015) Standard Specification for Polyethylene Plastics for Medical Applications《医疗器械用聚乙烯塑料的标准规格》.pdf

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1、Designation: F639 09 (Reapproved 2015)Standard Specification forPolyethylene Plastics for Medical Applications1This standard is issued under the fixed designation F639; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of la

2、st revision. A number 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 polyethylene plastics (as de-fined in Terminology D883) intended for use in medical deviceappl

3、ications involving 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

4、ultra-high molecu-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 c

5、oncerns, if any, 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:2D638 Test Method for Tensile Propert

6、ies of PlasticsD671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force (Withdrawn 2002)3D695 Test Method for Compressive Properties of RigidPlasticsD747 Test Method for Apparent Bending Modulus of Plas-tics by Means of a Cantilever BeamD790 Test Methods for Flexural Propertie

7、s of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD883 Terminology Relating to PlasticsD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1898 Practice for Sampling of P

8、lastics (Withdrawn 1998)3D4976 Specification for Polyethylene Plastics Molding andExtrusion MaterialsE117 Method for SpectrographicAnalysis of Pig Lead by thePoint-to-Plane Technique (Withdrawn 1995)3F748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standard

9、:ISO 10993 Biological Evaluation of Medical Devices43. 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 requi

10、re-ments.4. Classification4.1 Types of polyethylene plastics molding and extrusionmaterial are described in Specification D4976.5. General Requirements5.1 Polyethylene plastics consist of basic polymers madewith ethylene as essentially the sole monomer (as defined inTerminology D883).5.2 Polyethylen

11、e for use in medical applications shall havea maximum 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

12、end product. Thebiocompatibility of these adjuvant substances shall be estab-lished on the finished compound (see Section 9).1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Poly

13、meric Materials.Current edition approved March 1, 2015. Published May 2015. Originallyapproved in 1979. Last previous edition approved in 2009 as F639 09. DOI:10.1520/F0639-09R15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org.

14、 For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York,

15、NY 10036, http:/www.ansi.org.5Federal Register, Vol 21, Part 177.1520.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15.4 The formulated compound shall yield a consistent in-frared absorption spectrum characteristic of the established

16、formulation.5.5 Maximum levels and type of extractable metals shall beestablished in accordance with the intended use of the formu-lated resin6(see Appendix X1).NOTE 1Appendix X1 is a suggested method for determining extract-able metals utilizing the current state-of-the-art methodology. Alternative

17、methods with equal reliability may be used.5.6 The physical properties of polyethylene plastics may bedetermined by the methods given in Section 7.6. Sampling6.1 The material should be sampled in accordance withstandard sampling procedures such as those described inPractice D1898.7. Physical Methods

18、7.1 The following physical test procedures are suggestedwhere applicable to the intended application:7.1.1 DensityTest Method D1505.7.1.2 Melt FlowTest Method D1238.7.1.3 Tensile PropertiesTest Method D638.7.1.4 Compressive PropertiesTest Method D695.7.1.5 StiffnessTest Method D747.7.1.6 Flexural Fa

19、tigueTest Method D671.7.1.7 Flexural PropertiesTest Method D790.8. Packaging and Labeling8.1 The product shall be packaged in a suitable container toprevent contamination of contents.8.2 The material shall be identified, including lot or batchnumbers and recommended method of storage.9. Biocompatibi

20、lity9.1 The biological safety of each polyethylene plastic for-mulation shall be established. Specific biological tests shall bedetermined in accordance with the intended use. Formulatedcompounds used in these tests should include all colorants andother additives present in the final product.9.2 Bio

21、logical tests are appropriate to determine biologicalsafety and tissue reaction, depending on the end use applica-tion. These tests should be conducted when indicated forspecific applications. Additional tests may be necessary forcertain cases; Practice F748 and ISO 10993 may be used asguidelines.9.

22、2.1 Biocompatibility testing should be performed onspecimens that have been processed and sterilized using themethods intended for 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 ascha

23、in scission and the creation of free radicals that lead tooxidation and subsequent deterioration of mechanical proper-ties.10. Keywords10.1 plastic surgical devices/applications; polyethylene(PE) plasticssurgical implant applications; polymerssurgical applicationsAPPENDIXES(Nonmandatory Information)

24、X1. SUGGESTED PRACTICE FOR EXTRACTABLE METALS ANALYSIS OF PLASTIC BY ATOMICABSORPTION SPECTROSCOPYX1.1. ScopeX1.1.1 This practice 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.

25、 SignificanceX1.2.1 Concentrations of trace metals are measured asextracts in simulated body fluids. The metals concentration inextracts 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 SpecimensX

26、1.3.1 Use suitable molded test strips of the formulatedcompound. The total surface area of the specimen to beexposed should be equivalent 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 in

27、ert spacers to ensure contact with theextraction solvent.X1.3.2 After the plastic sample has been prepared, extractthe specimens using 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 formetal

28、s 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 10-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 wit

29、hout dilution.6Accuracy in Trace Analysis, NBS Special Publication No. 422, U.S. Govern-ment Printing Office, Washington, DC, Catalog No. C-13.10:422.F639 09 (2015)2X1.5 Preparation of Atomic Absorption StandardsX1.5.1 Prepare certified aqueous standard solutions by di-luting 1000 ppm of aqueous sto

30、ck solutions with the 0.9 %saline solution used for extractions. Use the saline solutionalone as the blank.X1.5.2 Prepare the CSO standards by dissolving the appro-priate organometallic compound in CSO to give intermediatesolutions which are then diluted by volume 1 + 1 with hexane,giving final stan

31、dard solutions of metal in the same matrix asthe samples. Use a 1 + 1 dilution of CSO with hexane as theblank. Obtain the concentration analysis on organometallicstandards from the manufacturer.X1.6. ProcedureX1.6.1 Place the hollow cathode lamp for the element beingtested in the instrument and set

32、the instrument conditions forthat element in accordance with the manufacturers recom-mended procedure.X1.6.2 When the lamp has warmed up, light 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 aspirat

33、ing 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 Aspirate 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 aspirat

34、ing blank solu-tions.X1.6.6 Starting with the lowest, aspirate the standard solu-tions and record the absorbance corresponding to each. Be-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

35、the blank solution andcheck the zero between samples.X1.6.8 If there are many samples to be run, recheck thestandards periodically during the 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 absorbance

36、versus concentration.X1.7.2 Calculate the concentrations of metal in the sampleextracts by reference to the standard curve.X1.7.3 Calculate the total amount of metal extracted asfollows:g metalml extract3ml of extracts 5 total metal extracted, g (X1.1)X1.7.4 Calculate the amount of metal extracted p

37、er squarecentimetre of sample, g/cm2:total metal extracted, gsurface area of film, cm2(X1.2)X1.8. Precision and AccuracyX1.8.1 The precision and accuracy of this practice has notyet been determined. It is dependent upon several factors,including sample matrix, ionization interferences, sophistica-ti

38、on of instrumentation, and so forth.X1.8.2 Determine the precision for each test system inaccordance with Method E117.NOTE X1.1Pertinent data and other information regarding this speci-fication may be reported to Committee F04 Staff Manager, ASTMInternational Headquarters, 100 Barr Harbor Drive, W.

39、Conshohocken, PA19428. Comments and suggestions will be considered in future standardsdevelopment activities.X2. BIOCOMPATIBILITYX2.1 The suitability of these materials from a humanimplant perspective is dependent on the specific application.The biological tests appropriate for the specific site, su

40、ch asrecommended in Practice F748 or ISO 10993, should be usedas a guideline.X2.2 No known implant material has ever been shown to becompletely 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

41、 standardhas shown that an acceptable level of biological response canbe expected, if the material is used in appropriate applications.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this stand

42、ard 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 technical committee and must be reviewed every five years andi

43、f 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 at a meeting of theresponsible technical committee, wh

44、ich 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 Drive, PO Box C700, West Conshohocken, PA 19428-2959,

45、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)3