ASTM F1855-2000(2005) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications《医用聚甲醛（乙缩醛）标准规范》.pdf

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1、Designation: F 1855 00 (Reapproved 2005)Standard Specification forPolyoxymethylene (Acetal) for Medical Applications1This standard is issued under the fixed designation F 1855; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the ye

2、ar of 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 polyoxymethylene (acetal)resin for medical applications. This specification providesr

3、equirements and associated test methods for a form of thisthermoplastic which is intended for use in manufacturingmedical devices, instrumentation or components thereof.1.2 As will any material, some characteristics may bealtered by the processing techniques (such as molding, extru-sion, machining,

4、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 Although this resin has been used and for specificimplant applications in the United States, the

5、use of this resinin medical devices should be restricted to non-implant appli-cations until biocompatibility evaluations appropriate for theintended applications are successfully completed.1.4 The biocompatibility of plastic compounds made up ofpolyoxymethylene (acetal) resin containing colorants, f

6、illers,processing aids, or other additives as well as polymer blendswhich contain polyacetal should not be assumed on the basis ofresin biocompatibility alone. Their biocompatibility must beestablished by testing the final (end-use) compositions usingevaluation methods appropriate for the intended a

7、pplications. Itshould be noted that the types, test levels and biological effectsof extractives yielded by the additives contained in a com-pound or blend may also have to be evaluated for some end-useapplications.1.5 This standard does not purport to address all of thesafety concerns, if any, assoc

8、iated 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 4181 Specification for Acetal (POM) Molding and Extru-si

9、on MaterialsD 883 Terminology Relating to PlasticsD 1600 Terminology for Abbreviated Terms Relating toPlasticsF 748 Practices for Selecting Generic Biological Test Meth-ods for Materials and Devices3. Chemical Composition3.1 The chemical composition of the material shall conformto Specification D 41

10、81. The FTIR spectrum of the materialmust be consistent with a reference or standard piece of theappropriate grade of the polymer. It may be helpful for thereader to review Terminology D 883 and Terminology D 1600for clarification of terminology.3.2 Class 1, Grade 1 of polyoxymethylene of Group 1, 2

11、, or3 (as described in Specification D 4181), is recommended foruse in medical applications, however other grades of thispolymer may be found to be acceptable through appropriatetesting.4. Physical Properties4.1 The mechanical properties of the material shall conformto those listed in Specification

12、D 4181 for the appropriate gradeand class of polymer being evaluated. Table 1 provides typicalvalues for both physical and mechanical properties of medicalgrade polyoxymethylene (acetal) for medical applications.5. Inspection and Certification5.1 The following information shall be reported in themat

13、erial certification: Grade and color identification (that is,color number).NOTE 1Some coloring agents have the potential to elicit an adversebiological response, therefore any grades containing pigments, dyes, oradditives should be separately evaluated for biocompatibility as appropri-ate for the pa

14、rticular application.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 Polymeric Materials.Current edition approved Mar. 1, 2005. Published March 2005. Originallyapproved in 1998.

15、 Last previous edition approved in 2000 as F 1855 00.2For referenced ASTM standards, visit the ASTM website, www.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.1Copyrig

16、ht ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6. Biocompatibility6.1 Biocompatibility of acetal resins and implant devicesmade using these materials shall be determined in accordancewith Practice F 748, unless otherwise agreed upon by pack

17、agerand consumer, and regulating bodies.(1-5)3Any potential fillercolorants, processing aids, or sterilization processes, or all ofthese, anticipated for the end product should be incorporated inthese tests.7. Keywords7.1 acetal; copolymer; homopolymer; polyoxymethylene;thermoplastic resinAPPENDIX(N

18、onmandatory Information)X1. RATIONALEX1.1 The intent of this specification is to guide the user inselection of an appropriate grade of polyoxymethylene whenconsidering the use of this polymer in a medically relatedapplication. This specification does not attempt to cover alltests that may be applica

19、ble to the specific application, but ismeant to aid the user in the selection process.References(1) Autian, J., Toxicological Evaluation of Biomaterials: “Primary AcuteToxicity Screening Program,” Journal of Artificial Organs, Vol1,No.1, 1977.(2) Autian, J. “The New Field of Plastic Toxicological Me

20、thods andResults,” CRC Critics Review in Toxicology, 1973.(3) Homsy, C.A.,Ansevin, K.D., OBrannon, W., Thompson, S.H., Hodge,R., and Estrella, M.E., “Rapid in Vitro Screening of Polymers forBiocompatibility,” Journal of Macromolecular Science, Chemistry,Vol A4, No. 3, May 1970, pp 615-634.(4) Biolog

21、ical Evaluation of Medical Devices-Part 1: Guidance onSelection of Tests,” American National Standard, ANSI/AAMI10993-1: 1994.(5) Alpert, Susan, “Use of International Standard ISO-10993, BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing ”,General Program Memorandum #95-1, May 1,

22、 1995. Online:http:/www.fda.gov/cdrh/g951.htmlASTM 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, a

23、nd 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 revised, either reapproved or withdrawn. Your comments are invited either for revis

24、ion 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 attend. If you feel that your comments have not received a fair hearing you s

25、houldmake 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 ob

26、tained 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).3The boldface numbers given in parentheses refer to a list of references at theend of the text.TABLE 1 Physical and Mechanical Properti

27、es of Medical GradePolyoxymethylene (Acetal) for Medical ApplicationsTemperature Units ASTMTest MethodResultsPhysical:Specific Gravity 73 gms/cc D 792 1.41Water Absorption 73 % D 570 0.22Equilibrium 73 % D 570 0.8Mechanical:Tensile YeildStrength73 103psi D 638 8.8Tensile ElongationBreak73 % D 638 75Tensile Modulus 73 103psi D 638 380390Tensile ImpactStrengthft-lb/in. D 1822 90CompressiveStrength1% deflection 103psi D 695 4.510% deflection 103psi D 695 16.0Sheer Strength 73 103psi D 732 7.7F 1855 00 (2005)2