1、Designation:F218114Standard Specification forWrought Seamless Stainless Steel Tubing for SurgicalImplants1This standard is issued under the fixed designation F2181;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revi
2、sion.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 fivecompositions of wrought seamless stainless steel tubing for themanufacture of su
3、rgical implants.Material shall conform to theapplicable requirements of Specifications F138,F1314,F1586,F2229,or F2581.This specification addresses those productvariables that differentiate wrought seamless tubing from thebar and wire product forms covered in these specifications.1.2 This specificat
4、ion applies to cold finished,straightlength tubing from 3 to 34 mm 0.125 to 1.315 in.nominaloutside diameter(OD)and 0.5 mm 0.020 in.and greaternominal wall 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 SI
5、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 nonconformancewith the standard.2.Referenced Documents2.1 A
6、STM Material Standards:2F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F1314 Specification for Wrought Nitrogen Strengthened 22Chromium13 Nickel5 Manganese2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Impl
7、ants(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 Wir
8、e 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)2.2 ASTM Standards:A262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic
9、 Stainless SteelsA269 Specification for Seamless and Welded AusteniticStainless Steel Tubing for General ServiceA632 Specification for Seamless and Welded AusteniticStainless Steel Tubing(Small-Diameter)for General Ser-viceE29 Practice for Using Significant Digits in Test Data toDetermine Conformanc
10、e with SpecificationsF2257 Specification for Wrought Seamless or Welded andDrawn 18 Chromium-14Nickel-2.5Molybdenum StainlessSteel Small Diameter Tubing for Surgical Implants(UNSS31673)IEEE/ASTM SI 10 American National Standard for Use ofthe International System of Units(SI):The Modern MetricSystem2
11、.3 ISO Standards:3ISO 5832-1 Implants for SurgeryMetallic MaterialsPart1:Wrought Stainless SteelISO 5832-9 Implants for SurgeryMetallic MaterialsPart9:Wrought High Nitrogen Stainless Steel1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices
12、 and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct.1,2014.Published January 2015.Originallyapproved in 2002.Last previous edition approved 2009 as F2181 09.DOI:10.1520/F2181-14.2For referenced ASTM standards,visit the ASTM website,www.astm
13、.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 Summ
14、ary 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 ISO 9001 Quality Management SystemRequirementsISO 13485 Medical devices-Quality management systems-Requirements for regulatory purpo
15、ses2.4 ASME Standard: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 measurementany one ofthe wall thickness measurements taken around the circumfer-ence on any one transve
16、rse 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.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
