ASTM F2181-2014 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants《外科植入物用锻造的无缝不锈钢管的标准规格》.pdf

1、Designation: F2181 14Standard 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

2、 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 fivecompositions of wrought seamless stainless steel tubing for themanufac

3、ture of surgical implants. Material shall conform to theapplicable requirements of Specifications F138, F1314, F1586,F2229,orF2581. This specification addresses those productvariables that differentiate wrought seamless tubing from thebar and wire product forms covered in these specifications.1.2 Th

4、is specification 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 s

5、tated in either SI 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. R

6、eferenced Documents2.1 ASTM 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 a

7、nd Wire for Surgical Implants(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-NickelStainl

8、ess Steel Alloy Bar and Wire 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 Interg

9、ranularAttack in Austenitic 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 Tes

10、t Data toDetermine Conformance 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 Unit

11、s (SI): The Modern MetricSystem2.3 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

12、and Surgical Materials and Devices 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 s

13、tandards, 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 Fl

14、oor, 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 States1ISO 9001 Quality Management SystemRequirementsISO 13485 Medical devices - Qua

15、lity management systems -Requirements for regulatory purposes2.4 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 meas

16、urements 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.3.1.3 lot average concentricitythe arithmetic average ofthe sample con

17、centricities 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

18、 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

19、wall thickness measurements measuredaround the circumference on any one transverse cross sectionof a single sample of tube.3.1.8 sample concentricitytwo times the offset betweenthe centers of the two circles representing the outside diameter(OD) and the inside diameter (ID) of the tube.3.1.8.1 Discu

20、ssionFor the purposes of this specification,the sample minimum wall and the sample maximum wallmeasured on any one transverse cross section of a singlesample shall be used to calculate sample concentricity. Thesample maximum, and sample minimum wall thickness shallbe the largest and smallest respect

21、ively of no less than fourindividual wall thickness measurements taken at uniformlyspaced locations around the circumference of a single sampleof the tube. Sample concentricity shall be expressed as apercent of the wall thickness and shall be calculated using thefollowing equation:sample concentrici

22、ty percent 5 2 3SA 2 BA1BD3100where:A = sample maximum wall, andB = sample minimum wall.3.1.9 sample maximum wall thicknessthe largest indi-vidual wall thickness measurement taken around the circum-ference on any one transverse cross section of a single sampleof tube.3.1.10 sample minimum wall thick

23、nessthe smallest indi-vidual wall thickness measurement taken around the circum-ference on any one transverse cross section of a single sampleof tube.4. General Requirements for Delivery4.1 In addition to the requirements of this specification, allapplicable requirements of the appropriate ASTM mate

24、rialstandard shall apply.4.2 In addition to the requirements of this specification, allapplicable seamless tubing requirements of Specification A269or Specification A632 shall apply. Flare testing is not appli-cable.4.3 If a conflict exists between this specification and thoselisted in Section 2, or

25、 if a conflict exists between thosespecifications listed in 2.1 and those listed in 2.2 and 2.3, thefollowing order of precedence applies: (1) this specification,(2) the ASTM material standard referenced on the purchaseorder, and (3) all other referenced specifications.5. Ordering Information5.1 Inq

26、uiries and orders for material under this specificationshould include the following information:5.1.1 Quantity (weight, total length or number of pieces),5.1.2 This ASTM specification and date of issue,5.1.3 The appropriate ASTM material standard and date ofissue,5.1.4 Units to be certifiedSI or inc

27、h-pound,5.1.5 Condition (see 6.2),5.1.6 Surface finish (see 6.3),5.1.7 Applicable dimensions including OD and ID, OD andwall or ID and wall, length (exact, random, multiples) orengineering drawing reference number,5.1.8 Dimensional tolerances (see Table 1 and Table 2),5.1.9 Condition (see 6.2),5.1.1

28、0 Surface finish (see 6.3),5.1.11 Special requirements or supplements, if any, and4Available from American Society of Mechanical Engineers (ASME), ASMEInternational Headquarters, Three Park Ave., New York, NY 10016-5990, http:/www.asme.org.TABLE 1 Permissible Variation in OD DimensionsNominal OD,mm

29、in.Permissible Variation from NominalAStandard Tolerance,mm in.Half StandardTolerance,Bmm in.3.2 to 12.7 excl.0.125 to 0.500 0.050 0.002 0.025 0.00112.7 to 25.4 excl.0.500 to 1.000.075 0.003 0.038 0.001525.4to34incl.1.00 to 1.3150.100 0.004 0.050 0.002)AUnless otherwise specified, size tolerances ar

30、e plus and minus as shown in thetable. When required by the purchaser, tolerances may be specified all plus andnothing minus, or all minus and nothing plus, or any combination of plus and minusif the total spread in size tolerance is not less than the total spread shown in thetable.BHalf standard to

31、lerance may be used when specifying tubing for use onmachining centers with tight collet clearance.F2181 1425.1.12 Certification requirements.6. Materials and Manufacture6.1 Method of Manufacture:6.1.1 Tubing shall be made by the seamless process inwhich the tube periphery is continuous at all stage

32、s of theprocess.6.2 Condition:6.2.1 Tubing shall be furnished, as specified, in theannealed, cold worked, medium hard, hard or extra hardcondition as defined in the appropriate ASTM material stan-dard.6.3 Surface Finish:6.3.1 The tubing outer surface shall be furnished with apickled, cold drawn, bri

33、ght annealed, ground, or polishedfinish. Outer surface roughness shall be 0.8 m 30 in. Ramaximum.6.3.2 The tubing inner surface shall be furnished with apickled, cold drawn, bright annealed, or abrasive conditionedfinish. Inner surface roughness shall be 1.5 m 60 in. Ramaximum.6.3.3 The method used

34、to determine surface roughness shallbe agreed upon between the purchaser and supplier.7. Chemical Composition, Metallurgical Requirements,and Mechanical Properties7.1 The chemical composition, metallurgical requirements,and mechanical properties of the finished tube shall conform tothe requirements

35、of the appropriate ASTM material standard.Alternative mechanical properties may be agreed upon be-tween the purchaser and the supplier.7.2 If both tensile properties and hardness are specified onthe purchase order, tensile properties shall be used to accept orreject the tubing. Hardness shall be rep

36、orted for informationonly.8. Permissible Outer and Inner Surface Imperfections8.1 For tubes with wall thickness greater than or equal to 1.5mm 0.060 in. and less than 6.5 mm 0.250 in., neither outernor inner surface imperfections shall exceed 0.08 mm 0.003in. in depth. For tubes with wall thickness

37、greater than orequal to 6.5 mm. 0.250 in, neither outer nor inner surfaceimperfections shall exceed 0.13 mm 0.005 in. in depth. Fortubes with wall thickness less than 1.5 mm 0.060 in., outerand inner surface imperfection depth shall be agreed uponbetween purchaser and supplier.8.2 The method of insp

38、ecting for these imperfections shallbe negotiated between the purchaser and supplier.8.3 Outer surface imperfections may be removed by grind-ing or polishing providing that the resultant wall thickness doesnot violate the minimum wall thickness. The ground orpolished surface shall meet the surface f

39、inish requirements of6.3.1.9. Special Tests9.1 The material shall conform to the special test require-ments of the appropriate ASTM material standard.9.2 When required by the appropriate ASTM materialstandard, both OD and ID surfaces of the finished tube shall becapable of passing the intergranular

40、corrosion susceptibilitytest in accordance with Practice E of Practices A262.10. Dimensions and Permissible Variation10.1 Units of Measure:10.1.1 SelectionThis specification requires that the pur-chaser selects the units of measure (SI or inch-pound) to beused for product certification. In the absen

41、ce of a statedselection of units on the purchase order, this selection may beexpressed by the purchaser in several alternate forms listed inorder of precedence.10.1.1.1 If the purchaser and supplier have a history ofusing specific units, these units shall continue to be certifieduntil expressly chan

42、ged by the purchaser.10.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers PO, specification,and engineering drawing are consistent, these units shall beused by the supplier for product certification.10.1.1.3 If the purchasers selection of units is

43、unclear, theunits of measure shall be agreed upon between purchaser andsupplier.10.1.2 Conversion of UnitsIf the suppliers test equipmentdoes not report in the selected units, the test equipment unitsmay be converted to the selected units for certification pur-poses. Accurate arithmetic conversion a

44、nd proper use ofsignificant digits should be observed when performing thisconversion. IEEE/ASTM SI 10 provides guidelines for the useof SI units.AnnexAof IEEE/ASTM SI 10 provides conversiontables and Annex B of IEEE/ASTM SI 10 provides rules forconversion and significant digits.10.2 Permissible Vari

45、ation in Dimensions:10.2.1 OD and IDThe permissible variations of OD andID from the nominal dimension on the purchase order, orengineering drawing, are listed in Tables 1 and 2.10.2.2 Wall Thickness:10.2.2.1 The range of total wall variation (including con-centricity and average wall variation) shal

46、l not exceed 14 %(67 %) of nominal wall thickness.10.2.2.2 Concentricity shall not exceed 10 6 5 % of aver-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 dimensi

47、on, concentricity shall be negotiatedbetween purchaser and supplier.TABLE 2 Permissible Variation in ID DimensionsNominal ID,mm in.Permissible Variationfrom Nominal, mm in.AUp to 12.7 excl. 0.500 0.050 0.00212.7 to 25.4 excl. 0.500 to 1.00 0.075 0.00325.4 and over 1.00 0.100 (0.004AUnless otherwise

48、specified, size tolerances are plus and minus as shown in thetable. When required by the purchaser, tolerances may be specified all plus andnothing minus, or all minus and nothing plus, or any combination of plus and minusif the total spread in size tolerance is not less than the total spread shown

49、in thetable.F2181 14310.2.2.3 Wall thickness shall be measured directly with amicrometer or linear variable displacement transducer (LVDT),coordinate measuring machine (CMM), or by optical measure-ment on a transverse metallographic cross section or otherappropriate method. The method of wall thickness measure-ment shall be agreed upon between purchaser and supplier.10.3 Length:10.3.1 For exact length orders up to and including 7.5 m 24ft, the length tolerance shall be 63mm60