ASTM_F_1091_-_12.pdf

Designation:F109112Standard Specification forWrought Cobalt-20Chromium-15Tungsten-10Nickel AlloySurgical Fixation Wire(UNS R30605)1This standard is issued under the fixed designation F1091;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year 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.Scope*1.1 This specification covers the chemical,mechanical,andmetallurgical requirements for the manufacture of wroughtcobalt-20chromium-15tungsten-10nickel surgical fixationwire.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the standard.2.Referenced Documents2.1 ASTM Standards:2E8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsF86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)2.2 USP Standards:3Nonabsorbable Surgical Suture,U.S.Pharmacopeia2.3 ISO Standard:4ISO 9001 Quality Management SystemsRequirements3.General Requirements for Delivery3.1 In addition to the requirements of this specification,allrequirements of the current editions of Specification F90 shallapply.3.2 In cases where a conflict exists between this specifica-tion and the standards listed in Section 2,this specificationshall take precedence.4.Terminology4.1 Definitions of Terms Specific to This Standard:4.1.1 lot,nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.5.Ordering Information5.1 Inquiries and orders for material under this specificationshall include the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Material requirements(see Section 6),5.1.4 Mechanical properties(see Section 7),5.1.5 Form,5.1.6 Dimensional requirements,including diameter anddiameter tolerance,5.1.7 Surface condition and handling,5.1.8 Special tests(if applicable),and5.1.9 Other requirements.6.Material Requirements6.1 The starting material used to make fixation wire mustmeet Specification F90.6.2 Surgical fixation wire shall conform to the specifiedchemical requirements of Specification F90.7.Mechanical Requirements7.1 Surgical fixation wire shall conform to the appropriatemechanical properties specified in Table 1.7.2 Perform tension tests in accordance with Test MethodsE8 using a 254-mm(10-in.)gage length and crosshead speedof 254 mm/min(10 in./min).Should any of the test specimensnot meet the specified requirements,test two additional test1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Dec.1,2012.Published December 2012.Originallyapproved 1991.Last previous edition approved in 2008 as F1091 08.DOI:10.1520/F1091-12.2For 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.3Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 pieces representative of the same lot,in the same manner,foreach failed test piece.The lot shall be considered in complianceonly if all additional test pieces meet the specified require-ments.7.3 Tensile test results for which any specimen fracturesoutside the gage length shall be considered acceptable if theelongation meets the minimum requirements specified in Table1.Refer to subsections 7.11.4 and 7.11.5 of Test Methods E8.If the elongation is less than the minimum requirement,discardthe test and retest.Retest one specimen for each specimen thatdid not meet the minimum requirement.7.4 The wire shall meet the requirements of USP forNonabsorbable Surgical Sutures,when tested in accordancewith 7.2.8.Dimensional Requirements8.1 Surgical fixation wire shall be fabricated in accordancewith the dimensions and tolerances specified in Table 1.8.2 Unless otherwise specified,size tolerances are plus andminus as shown in Table 1.When required by the purchaser,round wire tolerances may be specified al