ASTM F639-1998a(2003) Standard Specification for Polyethylene Plastics for Medical Applications《医疗设备用聚乙烯塑料标准规范》.pdf

1、Designation: F 639 98a (Reapproved 2003)Standard 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

2、 last 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 polyethylene plastics (as de-fined in Terminology D 883) intended for use in medical devic

3、eapplications involving human tissue contact devices, short termindwellings of 30 days or less, and fluid transfer devices. Thebiocompatibility of these materials as a class has not beenestablished. Biocompatibility tests must be conducted on thefinal product.1.2 This specification is not applicable

4、 to ultra-high molecu-lar weight polyethylenes (UHMWPE) plastics, such as thoseused in joint implants, and so forth.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate

5、 safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:D 638 Test Method for Tensile Properties of Plastics2D 671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force3D 695 Test Method for C

6、ompressive Properties of RigidPlastics2D 747 Test Method for Apparent Bending Modulus ofPlastics by Means of a Cantilever Beam2D 790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-als2D 883 Terminology Relating to Plastics2D 1238 Test Met

7、hod for Flow Rates of Thermoplastics byExtrusion Plastometer2D 1505 Test Method for Density of Plastics by the Density-Gradient Technique2D 1898 Practice for Sampling of Plastics4D 2238 Test Methods for Absorbance of Polyethylene Dueto Methyl Groups at 1378 cm1 2D 2576 Test Method for Metals in Wate

8、r and Waste Waterby Atomic Absorption Spectrophotometry5D 4976 Specification for Polyethylene Plastics Molding andExtrusion Materials6F 619 Practice for Extraction of Medical Plastics7F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices73. Significance3.1 This spec

9、ification 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 plastics molding and extrusi

10、onmaterial 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 extractable fraction, ex

11、pressed as weight percentin polymer, in n-hexane of 5.5 % at 50C (1).85.3 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 substances shall be est

12、ab-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 and Devices and is t

13、he direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Apr. 10, 2003. Published May 2003. Originallyapproved in 1979. Last previous edition approved in 1998 as F 639 98a.2Annual Book of ASTM Standards, Vol 08.01.3Discontinued; See 2001 Annual Book of ASTM Stan

14、dards, Vol 08.01.4Discontinued; See 1997 Annual Book of ASTM Standards, Vol 08.01.5DiscontinuedSee 1980 Annual Book of ASTM Standards, Part 31.6Annual Book of ASTM Standards, Vol 08.03.7Annual Book of ASTM Standards, Vol 13.01.8The boldface numbers in parentheses refer to the list of references at t

15、he end ofthis standard.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 resin (2) (see Appendix X1).NOTE 1App

16、endix 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 Section 7.6. Sampling6.1 The mate

17、rial 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 1505.7.1.2 Melt FlowTest Method D 1238.7.

18、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 suitable container toprevent conta

19、mination 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 bedetermined in accordance with the i

20、ntended 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 application.These tests should be conducted when indicated

21、 for specificapplications. Additional tests may be necessary for certaincases; Practice F 748 and USP Class IVI Biological Tests (3)may be used as guidelines.10. Keywords10.1 plastic surgical devices/applications; polyethylene(PE) plasticssurgical implant applications; polymerssurgical applicationsA

22、PPENDIXES(Nonmandatory Information)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

23、finished products maybe used.X1.2 Referenced DocumentsX1.2.1 ASTM Standards:D 2576 Test Method for Metals in Water and Waste Waterby Atomic Absorption Spectrophotometry9E 117 Method for Spectrographic Analysis of Pig Leadby the Point-to-Plane Technique10X1.3 SignificanceX1.3.1 Concentrations of trac

24、e 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.X1.4 Preparation of SpecimensX1.4.1 Use suitable molded test strips of t

25、he 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 inert spacers to ensure contact with theextr

26、action solvent.X1.4.2 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 formetals as described in Section X1.5.9Annual Boo

27、k of ASTM Standards, Vol 11.01.10Annual Book of ASTM Standards, Vol 03.06.F 639 98a (2003)2X1.5 Preparation of Extract SolutionX1.5.1 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

28、 in thesame manner.X1.5.2 Run the saline eluate directly without dilution.X1.6 Preparation of Atomic Absorption StandardsX1.6.1 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 solutionalo

29、ne as the blank.X1.6.2 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 standard solutions of metal in the same matrix asthe samples. Use a 1 + 1 dilution of CSO with

30、hexane as theblank. Obtain the concentration analysis on organometallicstandards from the manufacturer.X1.7 ProcedureX1.7.1 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

31、procedure.X1.7.2 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 aspirating the blank solution.X1.7.3 Zero the instrument while aspirating the blank solu-tion corre

32、sponding to the matrix to be analyzed.X1.7.4 Aspirate a high standard and adjust the burnerposition and flame for the optimum signal and optimumsignal-to-noise ratio.X1.7.5 Rezero the instrument while aspirating blank solu-tions.X1.7.6 Starting with the lowest, aspirate the standard solu-tions and r

33、ecord the absorbance corresponding to each. Be-tween standards, aspirate the blank solution and check the zero.X1.7.7 Aspirate the sample solutions and record the corre-sponding absorbance readings. Aspirate the blank solution andcheck the zero between samples.X1.7.8 If there are many samples to be

34、run, recheck thestandards periodically during the analysis. In any case, reana-lyze the standards after all the samples have been run.X1.8 CalculationX1.8.1 Prepare a calibration chart by plotting absorbanceversus concentration.X1.8.2 Calculate the concentrations of metal in the sampleextracts by re

35、ference to the standard curve.X1.8.3 Calculate the total amount of metal extracted asfollows:g metalml extract3 ml of extracts 5 total metal extracted, g (X1.1)X1.8.4 Calculate the amount of metal extracted per squarecentimetre of sample, g/cm2:total metal extracted, gsurface area of film, cm2(X1.2)

36、X1.9 Precision and AccuracyX1.9.1 The precision and accuracy of this practice has notyet been determined. It is dependent upon several factors, suchas, sample matrix, ionization interferences, sophistication ofinstrumentation, and so forth.X1.9.2 Determine the precision for each test system inaccord

37、ance with Method E 117.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. Conshohocken, PA19428. Comments and suggestions will be considered in future standardsdevelopme

38、nt activities.X2. BIOCOMPATIBILITYX2.1 The suitability of these materials from a humanimplant perspective is dependent on the specific application.The biologic tests appropriate for the specific site, such asrecommended in Practice F 748 should be used as a guideline.X2.2 No known implant material h

39、as 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 standardhas shown that an acceptable level of biological response canbe expected, if the material is used in

40、 appropriate applications.F 639 98a (2003)3REFERENCES(1) Federal Register, Vol 21, Part 177.1520.(2) Accuracy in Trace Analysis, NBS Special Publication No. 422, U.S.Government Printing Office, Washington, DC, Catalog No.C-13.10:422.(3) U.S. Pharmacopeia, Vol XXIII, 1995, pp. 16991703.ASTM Internati

41、onal 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 entirely thei

42、r 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 standardsand should b

43、e 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 on Standard

44、s, 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 639 98a (2003)4