1、Designation: F 2181 02aStandard Specification forWrought Seamless Stainless Steel Tubing for SurgicalImplants1This standard is issued under the fixed designation F 2181; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of l
2、ast revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the requirements for threecompositions of wrought seamless stainless steel tubing for theman
3、ufacture of surgical implants. Material shall conform to theapplicable requirements of Specifications F 138, F 1314, orF 1586. This specification addresses those product variablesthat differentiate wrought seamless tubing from the bar andwire product forms covered in these specifications.1.2 This sp
4、ecification applies to cold finished, straightlength tubing from 0.125 to 1.315 in. (3.18 to 33.4 mm)nominal outside diameter (OD) and 0.018 in. (0.46 mm) andgreater nominal wall thickness.1.3 The values stated in inch-pound units are to be regardedas the standard. The SI units in parentheses are ap
5、proximate.1.4 The specifications in 2.1 will be referred to as the ASTMmaterial standard(s) in the remainder of this specification.2. Referenced Documents2.1 ASTM Material Standards:F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (U
6、NS S31673)2F 1314 Specification for Wrought Nitrogen Strengthened-22Chromium-13Nickel-5Manganese-2.5MolybdenumStainless Steel Bar and Wire for Surgical Implants (UNSS20910)2F 1586 Specification for Wrought Nitrogen Strengthened-21Chromium-10Nickel-3Manganese-2.5MolybdenumStainless Steel Bar for Surg
7、ical Implants (UNS S31675)22.2 ASTM Tubing Standards:A 269 Specification for Seamless and Welded AusteniticStainless Steel Tubing for General Service3A 632 Specification for Seamless and Welded AusteniticStainless Steel Tubing (Small Diameter) for GeneralService32.3 ISO Standards:ISO 5832-1 Implants
8、 for SurgeryMetallic MaterialsPart 1: Wrought Stainless Steel4ISO 5832-9 Implants for SurgeryMetallic MaterialsPart 9: Wrought High Nitrogen Stainless Steel42.4 American Society for Quality Standard:C1 Specification of General Requirements for a QualityProgram53. Terminology3.1 Definitions of Terms
9、Specific to This Standard:3.1.1 average wall thicknessthe arithmetic average of theminimum wall thickness and the maximum wall thicknessmeasured on any one transverse cross section of the tube.3.1.2 concentricitytwo times the offset between the cen-ters of two circles, representing outside diameter
10、(OD) andinside diameter (ID) of the tube. For purposes of this specifi-cation, the minimum wall and the maximum wall measured onany one transverse cross section shall be used to calculateconcentricity. The percent concentricity shall be calculatedusing the equation:Percent Concentricity 5 2 3Smaximu
11、m wall 2 minimum wallmaximum wall 1 minimum wallD3 1003.1.3 nominal wall thicknessthe wall thickness specifiedby the purchaser without regard to tolerance.4. General Requirements for Delivery4.1 In addition to the requirements of this specification, allapplicable requirements of the appropriate ASTM
12、 materialstandard shall apply.4.2 In addition to the requirements of this specification, allapplicable seamless tubing requirements of SpecificationA 269 or Specification A 632 shall apply. Flare testing is notapplicable.4.3 In the case where a conflict exists between this specifi-cation and those l
13、isted in Section 2 or in the case where aconflict exists between those specifications listed in 2.1 andthose listed in 2.2 and 2.3, the following order of precedence1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct resp
14、onsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Nov. 10, 2002. Published December 2002. Originallyapproved in 2002. Last previous edition approved 2002 as F 2181 02.2Annual Book of ASTM Standards, Vol 13.01.3Annual Book of ASTM Standards, Vol 01.01.4Available fro
15、m American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.5Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, MI 53203.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United Stat
16、es.applies: (1) this specification, (2) the ASTM material standardreferenced on the purchase order, and (3) all other referencedspecifications.5. Ordering Information5.1 Inquiries and orders for material under this specificationshould include the following information:5.1.1 Quantity (weight, total l
17、ength or number of pieces),5.1.2 This ASTM designation and date of issue,5.1.3 ASTM material standard and date of issue,5.1.4 Condition (see 6.1.2),5.1.5 Surface finish (see 6.2),5.1.6 Applicable dimensions including OD and ID, OD andwall or ID and wall, length (exact, random, multiples) orengineeri
18、ng drawing reference number,5.1.7 Dimensional tolerances (see Tables 1 and 2),5.1.8 Certification requirements, and5.1.9 Special requirements or supplements, if any.6. Materials and Manufacture6.1 Method of Manufacture:6.1.1 Tubing shall be made by a seamless process in whichthe tube periphery is co
19、ntinuous at all stages of the process.6.1.2 Tubing shall be furnished, as specified, in the an-nealed, cold worked, medium hard, hard or extra hard condi-tion as defined in the appropriate ASTM material standard.6.2 Surface Finish:6.2.1 Tubing outer surface shall be furnished with a pickled,cold dra
20、wn, ground, or polished finish. Outer surface rough-ness will be 30 in. (0.75 m) Ra maximum.6.2.2 Tubing inner surface shall be furnished with a pickled,cold drawn, or blasted finish. Inner surface roughness will be60 in. (1.5 m) Ra maximum.6.2.3 The method used to determine surface roughness shallb
21、e agreed upon between the purchaser and supplier.7. Chemical Composition, Metallurgical Requirements,and Mechanical Properties7.1 The chemical composition, metallurgical requirementsand mechanical properties shall conform to the requirements ofthe appropriate ASTM material standard.7.2 In the event
22、that both tensile properties and hardness arespecified on the purchase order, tensile properties shall be usedto accept or reject. Hardness shall be reported for informationonly.8. Permissible Variation in Dimensions8.1 OD and ID:8.1.1 The permissible variations of OD and ID from thenominal dimensio
23、n on the purchase order, or engineeringdrawing are listed in Tables 1 and 2.8.2 Wall Thickness:8.2.1 The range of total wall variation (including concen-tricity and average wall variation) shall not exceed 14 %(67 %) of nominal wall thickness.8.2.2 Concentricity shall not exceed 10 % (65 %) of aver-
24、age wall thickness for tubing with nominal wall thicknessgreater than or equal to 10 % of the nominal OD dimension.For tubing with nominal wall thickness less than 10 % of thenominal OD dimension, concentricity shall be negotiatedbetween purchaser and supplier.8.2.3 Wall thickness measurement shall
25、be made directlywith a micrometer or linear variable displacement transducer(LVDT) or by optical measurement on a transverse metallo-graphic cross section or other appropriate method. The methodof wall thickness measurement shall be agreed upon betweenpurchaser and supplier.8.3 Length:8.3.1 Length v
26、ariation on all cut lengths up to and including24 ft (7300 mm) shall be plus18 in. (3 mm), minus 0.8.3.2 On random length orders, a maximum and minimumlength shall be specified by the purchaser. Up to 5 % of theorder may ship short of the minimum length specified. In nocase shall any length be less
27、than 5 ft (1500 mm).8.4 Straightness:8.4.1 The deviation from straightness shall not exceed 0.012in./ft (0.25 mm per 300 mm) of tube length.9. Permissible Outer and Inner Surface Imperfections9.1 For tubes with wall thickness greater than or equal to0.060 in. (1.5 mm) and less than 0.250 in. (6.4 mm
28、), neitherouter nor inner surface imperfections shall exceed 0.003 in.(0.08 mm) in depth. For tubes with wall thickness greater thanor equal to 0.250 in. (6.4 mm), neither outer nor inner surfaceimperfections shall exceed 0.005 in. (0.13 mm) in depth. Fortubes with wall thickness less than 0.060 in.
29、 (1.5 mm), outerand inner surface imperfection depth shall be negotiatedbetween purchaser and supplier.9.2 The method of inspecting for these imperfections shallbe negotiated between the purchaser and supplier.9.3 Outer surface imperfections may be removed by grind-ing or polishing providing that th
30、e resultant wall thickness doesTABLE 1 Permissible Variation in OD DimensionsNominal OD,in. (mm)Permissible Variation from NominalAStandard Tolerance,in. (mm)12 Standard Tolerance,Bin. (mm)0.125 to 0.500 excl.(3.2 to 12.7)60.002 (0.051) 60.001 (0.025)0.500 to 1.00 excl.(12.7 to 25.4)60.003 (0.076) 6
31、0.0015 (0.038)1.00 to 1.315 incl.(25.4 to 33.4)60.004 (0.102) 60.002 (0.051)AUnless otherwise specified, size tolerances are plus and minus as shown inthe table. When required by the purchaser, tolerances may be specified all plusand nothing minus, or all minus and nothing plus, or any combination o
32、f plus andminus if the total spread in size tolerance is not less than the total spread shownin the table.B 12 standard tolerance may be used when specifying tubing for use onmachining centers with tight collet clearance.TABLE 2 Permissible Variation in ID DimensionsNominal ID,in. (mm)Permissible Va
33、riationfrom Nominal, in. (mm)AUp to 0.500 excl. (3.18 to 12.7) 60.002 (0.051)0.500 to 1.00 excl. (12.7 to 25.4) 60.003 (0.076)1.00 (and over) (25.4) 60.004 (0.102)AUnless otherwise specified, size tolerances are plus and minus as shown inthe table. When required by the purchaser, tolerances may be s
34、pecified all plusand nothing minus, or all minus and nothing plus, or any combination of plus andminus if the total spread in size tolerance is not less than the total spread shownin the table.F 2181 02a2not violate the minimum wall thickness. The ground orpolished surface shall meet the surface fin
35、ish requirements of6.2.1.10. Special Tests10.1 The material shall conform to the special test require-ments of the appropriate ASTM material standard.10.2 When required by the appropriate ASTM materialstandard, intergranular corrosion susceptibility testing shall beperformed on both OD and ID surfac
36、es.11. Certification11.1 The supplier shall provide certification that the materialmeets the requirements of this specification. A report of the testresults shall be furnished at the time of shipment.12. Quality Program Requirements12.1 The producer shall maintain a quality program such asdefined in
37、 ASQ C1.13. Keywords13.1 metals (for surgical implant); seamless tubing; stain-less steel; surgical applications tubing; surgical implantsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary reason for this specification is to estab-lish a tubular product standard for Specifications F 1
38、38,F 1314, and F 1586 stainless steels typically used in cannulatedintramedullary nails and medical bone screws.X1.2 ISO Standards are listed for reference only. Althoughthe ISO Standards listed in 2.4 are similar to the correspondingASTM standards, they may not be identical. Use of an ISOstandard i
39、n addition to or instead of a preferred ASTM standardmay be negotiated between the purchaser and supplier. In thisspecification, ISO 5832-1 Composition D is similar to Speci-fication F 138. The Composition of ISO 5832-9 is similar toSpecification F 1586.X1.3 In the event that OD, ID, and wall thickn
40、ess arespecified on the purchase order, the supplier and purchasershall resolve which two of these will apply. Only two of thesethree tube dimensions can be controlled to a nominal size andtolerance. The third dimension is determined by the interactionof the two controlled dimensions.X1.4 When measu
41、ring wall thickness, tubing to be mea-sured shall be sufficiently prepared to eliminate any burr orother material that will interfere with accurate contact oroptical measurement. This preparation can be done by endfinishing procedures such as reaming and deburring or wireEDM cutting, (for micrometer
42、 or LVDT measurement) ormetallographic mounting, grinding and polishing (for opticalmeasurement). Metallographic preparation for optical mea-surement will be performed in such a way as to maximizesample edge retention and minimize sample deviation fromperpendicular. Micrometers shall have a pin diam
43、eter oreffective anvil diameter less than the tube minimum ID size.LVDTs shall have a precision consistent with the requiredwall thickness tolerance.X1.5 Percent concentricity as defined in 3.1.2 representsthe full range of concentricity. It is preferred that purchasersspecify this full range of con
44、centricity with no plus/minusmodifier. For purposes of tolerancing, however, the percentconcentricity may be divided by two and the resulting valuemay be used as a plus and minus tolerance, which, whenapplied to the nominal wall thickness, will define the allowablerange of wall variation due to conc
45、entricity. In addition, thepercent concentricity calculated using the equation in 3.1.2,when divided by two, may be added to and subtracted from theaverage wall thickness to express the actual range of wallvariation due to concentricity.X1.6 Concentricity may be used in conjunction with OD,ID, or wa
46、ll tolerances to better define the allowable variation inwall thickness. For example, when a tube is specified using ODand ID dimensions and tolerances, concentricity may be usedto limit wall variation within the larger range allowed bycomparison of the upper and lower OD and ID tolerance limits.In
47、this application, concentricity should not be interpreted as awall tolerance requiring resolution per section X1.3.F 2181 02a3X2. BIOCOMPATIBILITYX2.1 Biocompatibility is addressed in the ASTM materialstandards.ASTM International takes no position respecting the validity of any patent rights asserte
48、d in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by th
49、e responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is cop
