1、Designation:F185500(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 of last
2、 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 providesrequirements and as
3、sociated 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,extrusion,machining,sterilization,and so fort
4、h)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 of this resinin medical d
5、evices 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,fillers,processing aids,or other
6、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 applications.Itshould be noted that t
7、he 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 of measurement are included in thisst
8、andard.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 regulatory limitations prior to use.2.Reference
9、d Documents2.1 ASTM Standards:2D4181 Classification for Acetal(POM)Molding and Extru-sion Materials(Withdrawn 2005)3D883 Terminology Relating to PlasticsD1600 Terminology forAbbreviated Terms Relating to Plas-ticsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices3.C
10、hemical 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 Terminology D883 and Terminology
11、 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 appropriatetesting.4.Physical Properties4.1 The
12、 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(acetal)for medical applications.5.Inspe
13、ction and Certification5.1 The following information shall be reported in thematerial certification:Grade and color identification(that is,color number).NOTE1Some coloring agents have the potential to elicit an adversebiological response,therefore any grades containing pigments,dyes,or1This specific
14、ation is under the jurisdiction 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
15、as F1855 00(2005).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.3The last approved versi
16、on of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 additives should be separately evaluated for biocompatibility 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
