ASTM_F_1350_-_15.pdf

Designation:F135015Standard Specification forWrought 18Chromium-14Nickel-2.5Molybdenum StainlessSteel Surgical Fixation Wire(UNS S31673)1This standard is issued under the fixed designation F1350;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 wrought 18chromium-14 nickel-2.5 molybdenum stainless steel in theform of surgical fixation wire.1.2 UnitsThe values stated in either SI units or inch-pound units are to be regarded separately as standard.Thevalues stated in each system may not be exact equivalents;therefore,each system shall be used independently of the other.Combining values from the two systems may result in non-conformance with this specification.2.Referenced Documents2.1 ASTM Standards:2A555/A555M Specification for General Requirements forStainless Steel Wire and Wire RodsE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsF86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneIEEE/ASTM SI 10 American National Standard for MetricPractice2.2 USP Standard:3Nonabsorbable Surgical Suture,U.S.Pharmacopeia2.3 ISO Standard:4ISO 9001 Quality Management SystemRequirements3.General Requirements for Delivery3.1 In addition to the requirements of this specification,allrequirements of the current editions of Specifications A555/A555M and F138 apply.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,5.1.4 Mechanical properties,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 the requirements of Specification F138.6.2 Surgical fixation wire shall conform to the specifiedchemical requirements of Specification F138.Conformancewith this standard shall be so identified by suitable packaging,labeling,or both.1This 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 May 1,2015.Published June 2015.Originallyapproved in 1991.Last previous edition approved in 2008 as F1350 08.DOI:10.1520/F1350-15.2For 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 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/E8M using a 254 mm 10 in.gage length and a cross-headspeed of 254 mm/min 10 in./min.Should any of the testspecimens not meet the specified requirements,test two addi-tional test pieces representative of the same lot,in the samemanner,for each failed test piece.The lot shall be consideredin compliance only if all additional test pieces meet thespecified requirements.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 MethodsE8/E8M.If the elongation is less than the minimumrequirement,discard the test and retest.Retest one specimenfor each specimen that