ASTM F2527-2016 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

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1、Designation: F2527 16Standard 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-6Molybdenum Alloys for Surgical Implants (UNSR31537, UNS R31538, and UNS R31539)2.2 ASTM Standards:A632 Specification for Seamless and

9、Welded 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 T

10、est Methods for Determining Average Grain SizeF2819 Test Methods for Measurement of Straightness ofBar, Rod, Tubing and Wire to be used for Medical DevicesSI 10 American National Standard for Use of the Interna-tional System of Units (SI): The Modern Metric System2.3 ISO Standards:3ISO 5832- 5 Impla

11、nts for SurgeryMetallic Materials Part5: Wrought Cobalt, Chromium, Tungsten, Nickel AlloyISO 5832- 6 Implants for SurgeryMetallic Materials Part6: Wrought Cobalt, Nickel, Chromium, MolybdenumAlloyISO 5832- 7 Implants for SurgeryMetallic Materials Part7: Wrought Cobalt, Chromium, Molybdenum AlloyISO

12、5832- 8 Implants for SurgeryMetallic Materials Part8: Wrought Cobalt, Nickel, Chromium, Molybdenum,Tungsten, Iron AlloyISO 5832- 12 Implants for SurgeryMetallic Materials Part12: Wrought Cobalt, Chromium, Molybdenum AlloyISO 6892 Metallic MaterialsTensile Testing1This specification is under the juri

13、sdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved April 1, 2016. Published May 2016. Originallyapproved in 2005. Last previous edition approved in 2010 as F2527 10. DO

14、I:10.1520/F2527-16.2For referenced ASTM standards, 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 Standard

15、s Institute (ANSI), 25 W. 43rd St.,4th Floor, 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 Medical DevicesQuality Mana

16、gementSystemsRequirementsISO 13485 Medical DevicesQuality ManagementSystemsRequirements2.4 ASME Standard:ASME Y14.5.1M 1994 (R2004) Mathematical Definition ofDimensioning and Tolerancing Principles43. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 average wall thicknessthe arith

17、metic 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 ofthe wall thickness measurements taken around the circumfer-ence on any one transverse cross section of a single sampl

18、e 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 arithmetic average ofthe sample concentricities measured on a statistically represen-tative number of samples from the lot.3.1

19、.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 outside diameter (OD)the outside diameterspecified on the customer order or engineering drawing withoutregard to tolerance.

20、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 aver-age of all individual wall thickness measurements measured ona single sample.3.1.9 sample concentricitytwo times the

21、offset betweenthe centers of two circles, representing the outside diameter(OD) and the inside diameter (ID) of the tube.3.1.9.1 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

22、 used to calculate concentricity. The samplemaximum and sample minimum wall thickness shall be thelargest and smallest, respectively, of no less than four indi-vidual wall thickness measurements taken at uniformly spacedlocations around the circumference of a simple sample of thetube. Sample concent

23、ricity shall be expressed as a percent ofthe wall thickness and shall be calculated using the followingequation:Sample Concentricity Percent 5 2 3SA 2 BA1BD3100 (1)where:A = sample maximum wall, andB = sample minimum wall.3.1.10 sample maximum wall thicknessThe largest indi-vidual wall thickness mea

24、surement 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 any one transverse cross section of a single sampleof tube.3.1.12 seamless

25、 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.4. General Requirements for Delivery4.1 In addition to the requirements of this s

26、pecification, allapplicable requirements of the appropriate ASTM materialstandard shall apply.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 speci

27、fication 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 Method 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 an

28、d ID, OD andwall or ID and wall, length (exact, random, multiples) orengineering drawing reference number,5.1.9 Dimensional tolerances (see Section 10 and Table 1),5.1.10 Special requirements or supplementary requirements,if any, and5.1.11 Certification requirements.6. Materials and Manufacture6.1 M

29、ethod of Manufacture:6.1.1 Tubing shall be made by the seamless or the weldedand drawn process.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 ID Dime

30、nsionsNominal OD or IDmm in.Permissible Variationfrom NominalAmm in.Less than 1.5 0.060 0.013 0.00051.5 to 6.3 0.060 to 0.250 incl. 0.025 0.001AUnless otherwise specified, size tolerances are plus and minus as shown in thetable. When required by the purchaser, tolerances may be specified all plus an

31、dnothing minus, or all minus and nothing plus, or any combination of plus and minusif the total range of size tolerance is not less than the total range shown in the table.F2527 1626.1.1.1 Seamless tubing shall be made from bar, hollow bar,rod, or hollow rod raw material forms that meet the chemical

32、requirements of the appropriate material specification.6.1.1.2 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 fabricated fromstrip or sheet using welding, drawing, and annealing opera-tions. Welding shall be performed using

33、 a liquid phase weldprocess with no filler metal. Typical weld processes aretungsten inert gas (TIG) and laser. The drawing and annealingoperations shall be performed in such a way that the weld beadand heat affected zone are virtually indistinguishable micro-structurally and dimensionally from the

34、parent metal whenexamined per 11.3.6.2 ConditionTubing shall be furnished, as specified, inthe annealed, solution annealed, warm worked or cold 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

35、-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 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 met

36、hod used to determine surface roughness shallbe agreed upon between purchaser and supplier.7. Chemical Composition7.1 The heat analysis limits and product analysis tolerancesof the appropriate ASTM material specification shall apply.7.2 Alternative chemistries with more restrictive limits thanthose

37、in the ASTM material specifications may be specified asagreed upon by purchaser and supplier.8. Mechanical Properties8.1 The required mechanical properties shall be selectedfrom the tables for similar product forms in the appropriatematerial specification. Where bar or wire data is presented, themec

38、hanical properties listed for bar or wire of similar OD sizeshall apply. Where sheet or strip data is presented, themechanical properties for sheet or strip with thickness similarto the tubing wall thickness shall apply. Tensile testing shall bein accordance with Test Methods E8 using unmachined tub

39、ularspecimens. Alternative mechanical properties may be agreedupon between purchaser and supplier.8.2 If both tensile properties and hardness are specified onthe purchase order, tensile properties shall be used to accept orreject. Hardness shall be reported for information only.8.3 Elongation of bar

40、 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 bereported with the test results. The method for determiningelongation of material under 1.6 mm 0.063 in. shall be agreedupon between purchaser and supplie

41、r. Alternatively, a gaugelength corresponding to ISO 6892 (5.65 times the square rootof So, where So is the original cross sectional area) may beused when agreed upon between purchaser and supplier.8.4 Elongation for sheet and strip product shall be tested andreported as required in the appropriate

42、material specification.9. Permissible Outer and Inner Surface Imperfections9.1 Outer surface imperfection shall not exceed 10 % ofwall thickness in depth. Outer surface imperfections may beremoved by grinding or polishing prior to shipment, providingthat the resultant wall thickness meets the minimu

43、m wallthickness, and that the ground or polished surface meets thesurface finish requirements of 6.3.1.9.2 Inner surface imperfections shall not exceed 10 % ofwall thickness in depth.9.3 The method of inspecting for these imperfections shallbe agreed upon between the purchaser and supplier.10. Dimen

44、sions 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 absence of a statedselection of units on the purchase order, this selection may beexpressed

45、 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 changed by the purchaser.10.1.1.2 In the absence of historic precedence, if the unitsused

46、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 unclear, theunits of measure shall be agreed upon between purchaser andsupplier.10.1.2

47、 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 and proper use ofsignificant digits should be observed when performing thisconversion.

48、ASTM SI 10 provides guidelines for the use of SIunits. Annex A provides conversion tables and Annex Bprovides rules for conversion and significant digits.10.2 Permissible Variation in Dimensions:10.2.1 OD and ID10.2.1.1 Permissible variations of OD and ID from thenominal dimension on the purchase or

49、der or engineeringdrawing are listed in Table 1.10.2.1.2 OD may be measured by hand micrometer, bylinear variable displacement transducer (LVDT), by lasermicrometer or by other non-contact method.10.3 Wall Thickness:10.3.1 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%) ofF2527 163nominal wall thickness. Tolerance for wall thickness less than0.10 mm 0.004 in. will be agreed upon between purchasera