ASTM_F_621_-_12.pdf

Designation:F62112Standard Specification forStainless Steel Forgings for Surgical Implants1This standard is issued under the fixed designation F621;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 This specification covers the requirements of forgedstainless steel for surgical implants when the material forgedconforms to Specifications F138(UNS S31673),F1314(UNSS21910),F1586(UNS S31675),F2229(UNS S29108),orF2581(UNS R56320).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:2A262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA473 Specification for Stainless Steel ForgingsE8 Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE92 Test Method for Vickers Hardness of Metallic Materials(Withdrawn 2010)3E112 Test Methods for Determining Average Grain SizeE165 Practice for Liquid Penetrant Examination for GeneralIndustryE353 Test Methods for Chemical Analysis of Stainless,Heat-Resisting,Maraging,and Other Similar Chromium-Nickel-Iron AlloysF138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImplants(UNS S31675)F2229 Specification for Wrought,Nitrogen Strengthened23Manganese-21Chromium-1Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S29108)F2581 Specification for Wrought Nitrogen Strengthened11Manganese-17Chromium-3Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S29225)IEEE/ASTM SI 10 American National Standard for MetricPractice2.2 ISO Standards:4ISO 5832-1 Implants for SurgeryMetallic Materials Part1:Wrought Stainless SteelISO 5832-9 Implants for SurgeryMetallic Materials Part9:Wrought High Nitrogen Stainless SteelISO 9001 Quality Managements SystemsRequirements3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lotthe total number of forgings produced from thesame heat under the same conditions at essentially the sametime.4.Ordering Information4.1 Inquiries and orders for forgings under this specificationshall include the following information:4.1.1 Quantity,4.1.2 ASTM designation and date of issue,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 Oct.1,2012.Published October 2012.Originallyapproved in 1979.Last previous edition approved in 2008 as F621 08.DOI:10.1520/F0621-12.2For 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.3The last approved version of this historical standard is referenced onwww.astm.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 4.1.3 ASTM material(alloy)standard and date of issue,4.1.4 Condition,4.1.5 Mechanical properties,4.1.6 Finish,4.1.7 Applicable dimensions or drawing number,4.1.8 Special tests(if any),and4.1.9 Other special requirements.5.General Requirements for Delivery5.1 Material furnished to this specification shall conform tothe applicable requirements in the current edition of Specifi-cation A473.5.2 In the case where a conflict exists between this specifi-cation and that listed in 5.1,this specification shall takeprecedence.6.Materials and Manufacture6.1 Material for forgings shall be bars or wire fabricated inaccordance with Specifications F138,F1314,F1586,F2229,orF2581,generally in the unannealed condition with a finishsuitable for forging.6