1、Designation:F89912bStandard Specification forWrought Stainless Steels for Surgical Instruments1This standard is issued under the fixed designation F899;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber
2、 in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1.Scope*1.1 This specification covers the chemistry requirements forwrought
3、stainless steels used for the manufacture of surgicalinstruments.The data contained in Tables 1-4 of thisspecification,including typical hardness values,common heattreating cycles,and examples of selected stainless steels thathave been used for surgical instruments,is provided forreference only.Mech
4、anical property requirements,heat treat-ing requirements,hardness requirements and all other require-ments except chemistry are governed by the appropriatematerial standards as referenced below or as agreed uponbetween the purchaser and supplier.1.2 The values stated in inch-pound units are to be re
5、gardedas standard.The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2.Referenced Documents2.1 ASTM Standards:2A276 Specification for Stainless Steel Bars and ShapesA313/A313M Specification for Stainless Steel
6、 Spring WireA314 Specification for Stainless Steel Billets and Bars forForgingA480/A480M Specification for General Requirements forFlat-Rolled Stainless and Heat-Resisting Steel Plate,Sheet,and StripA484/A484M Specification for General Requirements forStainless Steel Bars,Billets,and ForgingsA555/A5
7、55M Specification for General Requirements forStainless Steel Wire and Wire RodsA564/A564M Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and ShapesA582/A582M Specification for Free-Machining StainlessSteel BarsA751 Test Methods,Practices,and Terminology for Chemi-
8、cal Analysis of Steel Products2.2 ISO Standards:3ISO 7153/1 Instruments For SurgeryMetallic MaterialsPart 1:Stainless SteelISO 9001 Quality Management SystemsRequirements2.3 American Society for Quality(ASQ)Standard:4ASQ C1 Specification of General Requirements for a Qual-ity Program3.Classification
9、 and Type3.1 ClassesStainless steel material requirements for sur-gical instruments shall conform to one of the following classes,as specified:3.1.1 Class 3Austenitic Stainless Steel.3.1.2 Class 4Martensitic Stainless Steel.3.1.3 Class 5Precipitation Hardening Stainless Steel.3.1.4 Class 6Ferritic S
10、tainless Steel.3.2 TypeWhere applicable,the commercially recognizedtype of stainless steel is included in Tables 5 and 6.4.Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information as agreed upon by thepurchaser and supplier:4.1.1 Quant
11、ity(weight or number of pieces),4.1.2 Classification,optional,4.1.3 Type,4.1.4 Form,4.1.5 Condition(see 5.1),4.1.6 Finish(see 5.3),4.1.7 Mechanical properties or hardness,and4.1.8 Applicable dimensions including size,thickness,width,and length(exact,random,or multiples)or drawingnumber.1This specifi
12、cation 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 in 1984.Last previous edition approved
13、in 2012 as F899 12a.DOI:10.1520/F0899-12B.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 American
14、 National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203,http:/www.asq.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,
15、100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.Manufacture5.1 ConditionStainless steels shall be furnished to thepurchaser,as specified,in the hot-finished,cold-finished,annealed,solution-treated,solution-treated and aged,quench-hardened and tempered,or as specifi
16、ed by the purchaser.(Notethat highly hardenable martensitic stainless billets and barssuch as Types 420A,420B,420C,420 Mod,420F,420F Mod.,440A,440B,and 440C intended for forging are commonlyannealed prior to shipment and so specified in order to avoidthe possibility of thermal cracking.Other hardenable marten-sitic grades such as Types 403,410,416,416 Mod.,and 431,which also may require annealing,depending on their compo-sition and size,are furnished suitable for cold cutting when sospecified on