ASTM_F_2257_-_14.pdf

Designation:F225714Standard Specification forWrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small DiameterTubing for Surgical Implants(UNS S31673)1This standard is issued under the fixed designation F2257;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 requirements for wrought18chromium-14nickel-2.5molybdenum stainless steel tubingused for the manufacture of surgical implants.Material shallconform to the applicable requirements of Specification F138(for seamless)or Specification F139(for welded and drawn).This specification addresses those product variables that dif-ferentiate small-diameter medical grade tubing from the bar,wire,sheet,and strip product forms covered in these specifi-cations.1.2 This specification applies to cold finished straight lengthtubing with 3 mm 0.125 in.and smaller nominal outsidediameter(OD)and 0.5 mm 0.020 in.and thinner nominalwall thickness.1.3 The specifications in 2.1 are referred to as the ASTMmaterial standard(s)in this specification.1.4 The values stated in either inch-pound or SI units are tobe regarded separately as standard.Inch-pound units are shownin parentheses.The values stated in each system may not beexact equivalents;therefore,each system shall be used inde-pendently of the other.Combining values from the two systemsmay result in non-conformance with the standard.2.Referenced Documents2.1 ASTM Material Standards:2F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Sur-gical Implants(UNS S31673)2.2 ASTM Standards:2A632 Specification for Seamless and Welded AusteniticStainless Steel Tubing(Small-Diameter)for General Ser-viceE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeF2181 Specification for Wrought Seamless Stainless SteelTubing for Surgical ImplantsIEEE/ASTM SI 10 American National Standard for Use ofthe International System of Units(SI):The Modern MetricSystem2.3 ISO Standards:3ISO 5832-1 Implants for SurgeryMetallic Materials Part1:Wrought Stainless SteelISO 6892 Metallic Materials Tensile TestingISO 9001 Quality Management Systems RequirementsISO 13485 Medical devices Quality management systems Requirements for regulatory purposes2.4 ASME Standards:4ASME Y14.5.1M Mathematical Definition of Dimensioningand Tolerancing Principles3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 individual wall thickness measurement any one ofthe wall thickness measurements taken around the circumfer-ence on any one transverse cross section of a single sample ofthe tube.3.1.2 lotthe total number of product produced from thesame melt heat under the same conditions at essentially thesame time.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 Nov.1,2014.Published February 2015.Originallyapproved in 2003.Last previous edition approved in 2009 as F2257 09.DOI:10.1520/F2257-14.2For 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 National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from American Society of Mechanical Engineers(ASME),ASMEInternational Headquarters,Three Park Ave.,New York,NY 10016-5990,http:/www.asme.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 3.1.3 lot average concentricitythe arithmetic average ofthe sample concentricities measured on a statistically represen-tative number of samples from the lot.3.1.4 lot average wall thicknessthe arithmetic average ofthe sample average wall thicknesses measured on a statisticallyrepresentative number of samples from the lot.3.1.5 nominal outside diameter(OD)the outside diameterspecified on the purchasers order or engineering drawingwithout regard to tolerance.3.1.6 nominal wall thicknessthe wall thickness specifiedon the purchasers order or engineering drawing without regardto tolerance.3.1.7 sample average wall thicknessthe arithmetic aver-age of all individual wall thickness measurements measured ona