ASTM_F_2633_-_13.pdf

Designation:F263313Standard Specification forWrought Seamless Nickel-Titanium Shape Memory AlloyTube for Medical Devices and Surgical Implants1This standard is issued under the fixed designation F2633;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 wroughtnickel-titanium shape memory alloy tube,nominally 54.5 to57.0 mass/mass(weight)%nickel,in the superelasticcondition,used for the manufacture of medical devices andsurgical implants.Material shall conform to the applicablerequirements of Specification F2063.This specification ad-dresses those product variables that differentiate drawn medicalgrade tube from the raw material and mill product formscovered in Specification F2063.1.2 This specification applies to tube with 10 mm(0.4 in.)and smaller nominal outside diameter and 2 mm(0.08 in.)andthinner nominal wall thickness.1.3 The values stated in SI units are to be regarded as thestandard.The values given in parentheses(inch-pound units)are for information only.2.Referenced Documents2.1 ASTM Standards:2A632 Specification for Seamless and Welded AusteniticStainless Steel Tubing(Small-Diameter)for General Ser-viceF2004 Test Method for Transformation Temperature ofNickel-Titanium Alloys by Thermal AnalysisF2005 Terminology for Nickel-Titanium Shape MemoryAlloysF2063 Specification for Wrought Nickel-Titanium ShapeMemory Alloys for Medical Devices and Surgical Im-plantsF2082 Test Method for Determination of TransformationTemperature of Nickel-Titanium Shape Memory Alloysby Bend and Free RecoveryF2516 Test Method for Tension Testing of Nickel-TitaniumSuperelastic Materials2.2 ISO Standard:3ISO 9001 Quality Management SystemsRequirementsISO 13485 Quality Management Standard for Medical De-vices3.Terminology3.1 Definitions of Terms Specific to This Standard:3.2 See Terminology F2005 for the definition of terms usedin this specification that are specific to nickel-titanium alloys.3.3 individual wall thickness measurement,nany one ofthe wall thickness measurements taken around the circumfer-ence on any one transverse cross-section of a single sample ofthe tube.3.4 lot,nthe total quantity of product produced from thesame melt heat under the same conditions,at essentially thesame time.3.4.1 DiscussionFor purposes of this specification,con-version from bar to tubular form by extrusion,gundrilling,orother method is included within the scope of this definition.3.5 lot average concentricity,nthe arithmetic average ofthe sample concentricities measured on a statistically represen-tative number of samples from the lot.3.6 lot average wall thickness,nthe grand average of thesample average wall thicknesses measured on a statisticallyrepresentative number of samples from the lot.3.7 nominal outside diameter(OD),nthe outside diameterspecified on the purchasers order or engineering drawingwithout regard to tolerance.3.8 nominal wall thickness,nthe wall thickness specifiedby the purchasers order or engineering drawing without regardto tolerance.3.9 sample average wall thickness,nthe arithmetic aver-age of all individual wall thickness measurements measured ona single sample.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.1,2013.Published November 2013.Originallyapproved in 2007.Last previous edition approved in 2007 as F263307.DOI:10.1520/F2633-13.2For 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.*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 3.10 sample concentricity,ntwo times the offset betweenthe centers of the two circles representing the outside diameter(OD)and the inside diameter(ID)of the tube.3.10.1 DiscussionFor purposes of this specification,thesample minimum wall and the sample maximum wall mea-sured on any one transverse cross section of a single sampleshall be used to calculate concentricity.Also,for purposes ofthis specification,sample concentricity shall be expressed as apercent and shall be calculated using the following equation:Sample concentricity percent5 2 3FA 2 BA1BG3100where:A=sample maximum wall,andB=sample minimum wall.3.11 sample maximum wall thickness,nthe largest indi-vidual wall thickness measurement taken a