1、Designation: F1855 00 (Reapproved 2011)Standard Specification forPolyoxymethylene (Acetal) for Medical Applications1This standard is issued under the fixed designation F1855; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year
2、 of last revision. A number 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 polyoxymethylene (acetal)resin for medical applications. This specification providesrequ
3、irements 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, ste
4、rilization, 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 use
5、 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, fill
6、ers,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 appl
7、ications. 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 The values stated in inch-pound units are to be regardedas standard. No other units o
8、f measurement are included in thisstandard.1.6 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 safety and health practices and determine the applica-bility of regulato
9、ry limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D4181 Classification for Acetal (POM) Molding and Extru-sion Materials3D883 Terminology Relating to PlasticsD1600 Terminology for Abbreviated Terms Relating toPlasticsF748 Practice for Selecting Generic Biological Test Meth-ods f
10、or Materials and Devices3. Chemical Composition3.1 The chemical composition of the material shall conformto Specification D4181. 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 Te
11、rminology D883 and Terminology D1600for clarification of terminology.3.2 Class 1, Grade 1 of polyoxymethylene of Group 1, 2, or3 (as described in Specification D4181), is recommended foruse in medical applications, however other grades of thispolymer may be found to be acceptable through appropriate
12、testing.4. Physical Properties4.1 The mechanical properties of the material shall conformto those listed in Specification D4181 for the appropriate gradeand class of polymer being evaluated. Table 1 provides typicalvalues for both physical and mechanical properties of medicalgrade polyoxymethylene (
13、acetal) for medical applications.5. Inspection and Certification5.1 The following information shall be reported in thematerial certification: Grade and color identification (that is,color number).NOTE 1Some coloring agents have the potential to elicit an adverse1This specification is under the juris
14、diction ofASTM CommitteeF04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved Dec. 1, 2011. Published January 2012. Originallyapproved in 1998. Last previous edition approved in 2005 as F1855 00 (2005).
15、DOI: 10.1520/F1855-00R11.2For 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.3Withdrawn. The last approved versio
16、n of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.biological response, therefore any grades containing pigments, dyes, oradditives should be separately evaluated for biocompati
17、bility as appropri-ate for the particular application.6. Biocompatibility6.1 Biocompatibility of acetal resins and implant devicesmade using these materials shall be determined in accordancewith Practice F748, unless otherwise agreed upon by packagerand consumer, and regulating bodies.(1-5)4Any pote
18、ntial 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(Nonmandatory Information)X1. RATIONALEX1.1 The intent o
19、f 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 applicable to the specific application, but ismeant to aid th
20、e 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 Methods andResults,” CRC Critics Review in Toxicology, 1
21、973.(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) Biological Evaluation of Medical Devices-Part 1: Guidance on
22、Selection 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, 1995. Online:http:/www.fda.gov/cdrh/g951.htmlASTM Int
23、ernational 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 entirel
24、y 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 standardsand sh
25、ould 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 on St
26、andards, 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 61
27、0-832-9585 (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 ASTM website (www.astm.org/COPYRIGHT/).4The boldface numbers given in parentheses refer to a list of references at
28、theend of the text.TABLE 1 Physical and Mechanical Properties of Medical GradePolyoxymethylene (Acetal) for Medical ApplicationsTemperature Units ASTMTest MethodResultsPhysical:Specific Gravity 73 gms/cc D792 1.41Water Absorption 73 % D570 0.22Equilibrium 73 % D570 0.8Mechanical:Tensile YeildStrength73 103psi D638 8.8Tensile ElongationBreak73 % D638 75Tensile Modulus 73 103psi D638 380390Tensile ImpactStrengthft-lb/in. D1822 90CompressiveStrength1 % deflection 103psi D695 4.510 % deflection 103psi D695 16.0Sheer Strength 73 103psi D732 7.7F1855 00 (2011)2
