ASTM F2527-2010 Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003 UNS R30008 UNS R30035 UNS R306.pdf

1、Designation: F2527 10Standard Specification forWrought Seamless and Welded and Drawn Cobalt AlloySmall Diameter Tubing for Surgical Implants (UNS R30003,UNS R30008, UNS R30035, UNS R30605, and UNS R31537)1This standard is issued under the fixed designation F2527; the number immediately following the

2、 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 cover

3、s the requirements for wroughtseamless and welded and drawn cobalt alloy small diametertubing used for the manufacture of surgical implants. Materialshall conform to the applicable requirements of SpecificationsF90, F562, F688, F1058 or F1537, Alloy 1. This specificationaddresses those product varia

4、bles that differentiate small diam-eter medical tubing from the bar, wire, sheet and strip productforms covered in these specifications.1.2 This specification applies to straight length tubing with6.3 mm 0.250 in. and smaller nominal outside diameter (OD)and 0.76 mm 0.030 in. and thinner nominal wal

5、l 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 units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem s

6、hall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Material Standards:2F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F5

7、62 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F688 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foilfor Surgical Implants (UNS R30035)F1058 Specification for Wrought 40Cobalt-20Ch

8、romium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip forSurgical Implant Applications (UNS R30003 and UNSR30008)F1537 Specification for Wrought Cobalt-28Chromium-6MolybdenumAlloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)2.2 ASTM Standards:A632 Specification for Seamless and W

9、elded AusteniticStainless Steel Tubing (Small-Diameter) for General Ser-viceE8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Content ofSteelE112 Te

10、st Methods for Determining Average Grain SizeSI 10 American National Standard for Use of the Interna-tional System of Units (SI): The Modern Metric System2.3 ISO Standards:3ISO 5832- 5 Implants for SurgeryMetallic Materials Part5: Wrought Cobalt, Chromium, Tungsten, Nickel AlloyISO 5832- 6 Implants

11、for SurgeryMetallic Materials Part6: Wrought Cobalt, Nickel, Chromium, MolybdenumAlloyISO 5832- 7 Implants for SurgeryMetallic Materials Part7: Wrought Cobalt, Chromium, Molybdenum AlloyISO 5832- 8 Implants for SurgeryMetallic Materials Part8: Wrought Cobalt, Nickel, Chromium, Molybdenum,Tungsten, I

12、ron AlloyISO 5832- 12 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt, Chromium, Molybdenum AlloyISO 6892 Metallic MaterialsTensile TestingISO 9001 Quality Management SystemsRequirements1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials

13、 and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2010. Published January 2011. Originallyapproved in 2005. Last previous edition approved in 2005 as F2527 051. DOI:10.1520/F2527-10.2For referenced ASTM standards, visit th

14、e 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

15、10036, http:/www.ansi.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.2.4 ASME Standard:ASME Y14.5.1M 1994 (R2004) Mathematical Definition ofDimensioning and Toler

16、ancing Principles43. Terminology3.1 Definitions of Terms 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 individual wall thickness measurementAny one

17、 ofthe wall thickness measurements taken around the circumfer-ence on any one transverse cross section of a single sample ofthe tube.3.1.3 lotThe total quantity of product produced from thesame melt heat under the same conditions, at essentially thesame time.3.1.4 lot average concentricityThe arithm

18、etic average ofthe sample concentricities measured on a statistically represen-tative number of samples from the lot.3.1.5 lot average wall thicknessThe arithmetic average ofthe sample average wall thicknesses measured on a statisticallyrepresentative number of samples from the lot.3.1.6 nominal out

19、side diameter (OD)the outside diameterspecified on the customer order or engineering drawing withoutregard to tolerance.3.1.7 nominal wall thicknessthe wall thickness specifiedon the customer order or engineering drawing without regard totolerance.3.1.8 sample average wall thicknessThe arithmetic av

20、er-age of all individual wall thickness measurements measured ona single sample.3.1.9 sample concentricitytwo times the offset betweenthe centers of two circles, representing the outside diameter(OD) and the inside diameter (ID) of the tube.3.1.9.1 DiscussionFor purposes of this specification, themi

21、nimum wall and the maximum wall measured on any onetransverse cross section shall be used to calculate concentricity.The percent concentricity shall be calculated using the equa-tion:Sample Concentricity Percent 5 2 3SA BA 1 BD3 100 (1)where:A = sample maximum wall, andB = sample minimum wall.3.1.10

22、 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.3.1.11 sample minimum wall thicknessThe smallest indi-vidual wall thickness measurement taken around the circum-ference on an

23、y one transverse cross section of a single sampleof tube.3.1.12 seamless tubingtubing made by a process in whichthe tube periphery is continuous at all stages of the process.3.1.13 welded and drawn tubingtubing fabricated fromstrip or sheet using welding, drawing, and annealing opera-tions.3.1.13.1

24、DiscussionWelding shall be performed using aliquid phase weld process with no filler metal. Typical weldprocesses are tungsten inert gas (TIG) and laser. The drawingand annealing operations shall be performed in such a way thatthe weld bead and heat affected zone are virtually indistin-guishable mic

25、rostructurally and dimensionally from the parentmetal when examined per 11.3.4. General Requirements for Delivery4.1 In addition to the requirements of this specification, allapplicable requirements of the appropriate ASTM materialstandard shall apply.5. Ordering Information5.1 Inquiries and orders

26、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 inch-pound,5.1.5 Met

27、hod of manufacture (seamless or welded anddrawn; see 6.1),5.1.6 Condition (see 6.2),5.1.7 Surface finish (see 6.3),5.1.8 Applicable dimensions including OD and ID, OD andwall or ID and wall, length (exact, random, multiples) orengineering drawing reference number,5.1.9 Dimensional tolerances (see Se

28、ction 9 and Table 1),5.1.10 Special requirements or supplementary requirements,if any, and5.1.11 Certification requirements.6. Materials and Manufacture6.1 Method of Manufacture:6.1.1 Seamless tubing shall be made from bar, hollow bar,rod, or hollow rod raw material forms that meet the chemicalrequi

29、rements of the appropriate material specification.6.1.1.1 Seamless tubing shall be made by a process consis-tent with the definition in 3.1.12.6.1.2 Welded and drawn tubing shall be made from strip orsheet raw material forms that meet the chemical requirementsof the appropriate material specificatio

30、n.6.1.2.1 Welded and drawn tubing shall be made by a processconsistent with the definition in 3.1.13.4Available 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 and I

31、D DimensionsNominal OD or IDmm in.Permissible Variationfrom NominalAmm in.Less than 1.54 0.060 60.013 0.00051.54 to 6.30 0.060 to 0.250 incl. 60.025 0.001AUnless otherwise specified, size tolerances are plus and minus as shown inthe table. When required by the purchaser, tolerances may be specified

32、all plusand nothing minus, or all minus and nothing plus, or any combination of plus andminus if the total range of size tolerance is not less than the total range shown inthe table.F2527 1026.2 ConditionTubing shall be furnished, as specified, inthe annealed, solution annealed, warm worked or cold

33、workedand aged condition as defined in the appropriate ASTMmaterial standard.6.3 Surface Finish:6.3.1 The tubing outer surface shall be furnished with acold-drawn, bright annealed, ground or polished finish. Outersurface roughness shall be a maximum of 0.6 m 25 in. Ra.6.3.2 The tubing inner surface

34、shall be furnished with anas-drawn finish, bright annealed or conditioned finish. Innersurface roughness shall be a maximum of 0.8 m 30 in. Ra.6.3.3 The method used to determine surface roughness shallbe agreed upon between purchaser and supplier.7. Chemical Composition7.1 The heat analysis limits a

35、nd product analysis tolerancesof the appropriate ASTM material specification shall apply.7.2 Alternative chemistries with more restrictive limits thanthose in the ASTM material specifications may be specified asagreed upon by purchaser and supplier.8. Mechanical Properties8.1 The required mechanical

36、 properties shall be selectedfrom the tables for similar product forms in the appropriatematerial specification. Where bar or wire data is presented, themechanical properties listed for bar or wire of similar OD sizeshall apply. Where sheet or strip data is presented, themechanical properties for sh

37、eet or strip with thickness similarto the tubing wall thickness shall apply. Tensile testing shall bein accordance with Test Methods E8 using unmachined tubularspecimens. Alternative mechanical properties may be agreedupon between purchaser and supplier.8.2 If both tensile properties and hardness ar

38、e specified onthe purchase order, tensile properties shall be used to accept orreject. Hardness shall be reported for information only.8.3 Elongation of bar and wire material 1.6 mm 0.063 in.or greater in diameter (D) shall be measured using a gaugelength of 50 mm 2 in., or 4D. The gauge length must

39、 bereported with the test results. The method for determiningelongation of material under 1.6 mm 0.063 in. shall be agreedupon between purchaser and supplier. Alternatively, a gaugelength corresponding to ISO 6892 (5.65 times the square rootof So, where So is the original cross sectional area) may b

40、eused when agreed upon between purchaser and supplier.8.4 Elongation for sheet and strip product shall be tested andreported as required in the appropriate material specification.9. Dimensions and Permissible Variation9.1 Units of Measure:9.1.1 SelectionThis specification requires that the pur-chase

41、r 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 alternate forms listed inorder of precedence.9.1.1.1 If the purchaser and supplier hav

42、e a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.9.1.1.2 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 b

43、eused by the supplier for product certification.9.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between purchaser andsupplier.9.1.2 Conversion of UnitsIf the suppliers test equipmentdoes not report in the selected units, the test equipment unitsmay b

44、e converted to the selected units for certification pur-poses. Accurate arithmetic conversion and proper use ofsignificant digits should be observed when performing thisconversion. ASTM provides guidelines for the use of SI units.Annex A provides conversion tables and Annex B providesrules for conve

45、rsion and significant digits.9.2 Permissible Variation in Dimensions:9.2.1 OD and IDPermissible variations of OD and IDfrom the nominal dimension on the purchase order or engi-neering drawing are listed in Table 1.9.2.2 OD may be measured by hand micrometer, by linearvariable displacement transducer

46、 (LVDT), by laser micrometeror by other non-contact method.9.3 Wall Thickness:9.3.1 For wall thickness of 0.10 mm 0.004 in. or greater,the range of total wall variation (including concentricity andaverage wall variation) shall not exceed 14 % (67%) ofnominal wall thickness. Tolerance for wall thickn

47、ess less than0.10 mm 0.004 in. will be agreed upon between purchaserand supplier.9.3.2 For wall thickness of 0.10 mm 0.004 in. or greater,concentricity shall not exceed 10 % (65 %) of average wallthickness for tubing with nominal wall thickness greater thanor equal to 10 % of the nominal OD dimensio

48、n. For tubing withnominal wall thickness less than 0.10 mm 0.004 in. or 10 %of the nominal OD dimension, concentricity shall be agreedupon between purchaser and supplier.9.3.3 Wall thickness measurement shall be made directlywith a hand micrometer, LVDT, CMM, by optical measure-ment on a transverse

49、metallographic cross section, or by someother appropriate method. The method of wall thicknessmeasurement shall be agreed upon between purchaser andsupplier.9.4 Length:9.4.1 For exact length orders, length variation on all lengthsup to and including 7.3 m 24 ft shall be plus or minus 3 mm0.125 in.9.4.2 For 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. Nolength shall be less than 0.6 m 2 ft, unles