ASTM F2181-2009 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范》.pdf

1、Designation: F 2181 09Standard 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 la

2、st 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 themanuf

3、acture of surgical implants. Material shall conform to theapplicable requirements of Specifications F 138, F 1314,F 1586, F 2229,orF 2581. This specification addresses thoseproduct variables that differentiate wrought seamless tubingfrom the bar and wire product forms covered in these specifi-cation

4、s.1.2 This 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

5、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 systems

6、may result in non-conformance with the standard.2. Referenced Documents2.1 ASTM Material Standards:2F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nic

7、kel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5MolybdenumStainless Steel Alloy Bar for Surgical Implants (UNSS31675)F 2229 Specification for Wrought, Nitrogen Stren

8、gthened23Manganese-21Chromium-1Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S29108)F 2581 Specification for Wrought Nitrogen Strengthened11Manganese-17Chromium-3Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S29225)2.2 ASTM Tubi

9、ng Standards:A 262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA 269 Specification for Seamless and Welded AusteniticStainless Steel Tubing for General ServiceA 632 Specification for Seamless and Welded AusteniticStainless Steel Tubing (Small-Diameter)

10、 for General Ser-viceE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsF 2257 Specification for Wrought Seamless or Welded andDrawn 18 Chromium-14Nickel-2.5Molybdenum StainlessSteel Small Diameter Tubing for Surgical Implants (UNSS31673)SI 10 American

11、National Standard for Use of the Interna-tional System of Units (SI): The Modern Metric System2.3 ISO Standards:3ISO 5832-1 Implants for SurgeryMetallic MaterialsPart 1: Wrought Stainless SteelISO 5832-9 Implants for SurgeryMetallic MaterialsPart 9: Wrought High Nitrogen Stainless SteelISO 9001 Qual

12、ity Management SystemRequirements2.4 ASME Standard:4ASME Y14.5.1M Mathematical Definition of Dimension-ing and Tolerancing Principles1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12

13、 on Metallurgical Materials.Current edition approved Feb. 1, 2009. Published July 2009. Originally approvedin 2002. Last previous edition approved 2008 as F 2181 08.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Bo

14、ok 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), ASME

15、International Headquarters, Three Park Ave., New York, NY 10016-5990, http:/www.asme.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3. Terminology3.1 Definitions

16、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 transverse cross section of a single sample ofthe tube.3.1.2 lotthe total number of mill products produced fromthe same melt heat under t

17、he 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 me

18、asured on a statisticallyrepresentative number of samples from the lot.3.1.5 nominal outside diameter (OD)the outside diameterspecified by the purchaser without regard to tolerance.3.1.6 nominal wall thicknessthe wall thickness specifiedby the purchaser without regard to tolerance.3.1.7 sample avera

19、ge wall thicknessthe arithmetic aver-age of all individual 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

20、(OD) and the inside diameter (ID) of the tube.3.1.8.1 DiscussionFor 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 mini

21、mum wall thickness shallbe the largest and smallest respectively 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 b

22、e calculated using thefollowing equation:sample concentricity percent 5 2 3SA 2 BA 1 BD3 100where: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 sect

23、ion of a single sampleof tube.3.1.10 sample minimum wall thicknessthe 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 specific

24、ation, allapplicable requirements of the appropriate ASTM 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 If a conflict exis

25、ts between this specification and thoselisted in Section 2, or 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

26、other referenced specifications.5. Ordering Information5.1 Inquiries 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

27、standard and date ofissue,5.1.4 Units to be certifiedSI or inch-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 tolera

28、nces (see Table 1 and Table 2),5.1.9 Condition (see 6.2),5.1.10 Surface finish (see 6.3),5.1.11 Special requirements or supplements, if any, and5.1.12 Certification requirements.6. Materials and Manufacture6.1 Method of Manufacture:6.1.1 Tubing shall be made by the seamless process inwhich the tube

29、periphery is continuous at all stages of theprocess.6.2 Condition:6.2.1 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.6.3 Surface Finish:6.3.1 The tubing outer surface shall be f

30、urnished with apickled, cold drawn, bright annealed, ground, or polishedfinish. Outer surface roughness shall be 0.8 m (30 in.) Ramaximum.TABLE 1 Permissible Variation in OD DimensionsNominal OD,mm (in.)Permissible Variation from NominalAStandard Tolerance,mm (in.)Half Standard Tolerance,Bmm (in.)3.

31、2 to 12.7 excl.(0.125 to 0.500)6 0.050 (0.002) 60.025 (0.001)12.7 to 25.4 excl.(0.500 to 1.00)60.075 (0.003) 60.038 (0.0015)25.4to34incl.(1.00 to 1.315)60.100 (0.004) 60.050 (0.002)AUnless otherwise specified, size tolerances are plus and minus as shown inthe table. When required by the purchaser, t

32、olerances may be specified 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.BHalf standard tolerance may be used when specifying tubing for use onmachining centers w

33、ith tight collet clearance.F21810926.3.2 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 to determine surface roughness shallbe agreed upon between t

34、he 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 of the appropriate ASTM material standard.Alternative mechan

35、ical 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 reported for informationonly.8. Dimensions and Permissible Vari

36、ation8.1 Units of Measure:8.1.1 SelectionThis specification requires that the pur-chaser selects the units of measure (SI or inch-pound) to beused for product certification. In the absence of a statedselection of units on the purchase order, this selection may beexpressed by the purchaser in several

37、 alternate forms listed inorder of precedence.8.1.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.8.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the p

38、urchasers PO, specification,and engineering drawing are consistent, these units shall beused by the supplier for product certification8.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between purchaser andsupplier.8.1.2 Conversion of Units If the suppl

39、iers 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 and proper use ofsignificant digits should be observed when performing thisconversion. ASTM SI 10 provides guidelines f

40、or the use of SIunits. Annex A provides conversion tables and Annex Bprovides rules for conversion and significant digits.8.2 Permissible Variation in Dimensions:8.2.1 OD and IDThe permissible variations of OD and IDfrom the nominal dimension on the purchase order, or engi-neering drawing are listed

41、 in Tables 1 and 2.8.2.2 Wall Thickness:8.2.2.1 The range of total wall variation (including concen-tricity and average wall variation) shall not exceed 14 %(67 %) of nominal wall thickness.8.2.2.2 Concentricity shall not exceed 10 % (65%) ofaverage wall thickness for tubing with nominal wall thickn

42、essgreater 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.8.2.2.3 Wall thickness shall be measured directly with amicrometer or linear variable displac

43、ement 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.8.3 Length:8.3.1 For exact length orders up to

44、 and including 7.5 m (24ft), the length tolerance shall be 63 mm (0.125 in.).8.3.2 On random length orders, a maximum and minimumlength shall be specified by the purchaser. Up to 5 % of theshipped order quantity may be shorter than the minimumlength specified. No length shall be less than 1.5 m (5 f

45、t) unlesspermitted by the purchaser.8.4 StraightnessThe deviation from straightness shall notexceed 3 mm per 3 m (0.012 in. per foot) of tube length.9. Permissible Outer and Inner Surface Imperfections9.1 For tubes with wall thickness greater than or equal to 1.5mm (0.060 in.) and less than 6.5 mm (

46、0.250 in.), neither outernor inner surface imperfections shall exceed 0.08 mm (0.003in.) in depth. For tubes with wall thickness 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

47、1.5 mm (0.060 in.), outerand inner surface imperfection depth shall be agreed uponbetween 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 providi

48、ng that the resultant wall thickness doesnot violate the minimum wall thickness. The ground orpolished surface shall meet the surface finish requirements of6.3.1.10. Special Tests10.1 The material shall conform to the special test require-ments of the appropriate ASTM material standard.10.2 When req

49、uired by the appropriate ASTM materialstandard, both OD and ID surfaces of the finished tube shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A 262.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestTABLE 2 Permissible Variation in ID DimensionsNominal ID,mm (in.)Permissible Variationfrom Nominal, mm (in.)AUp