1、Designation: F 2527 05e1Standard 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 F 2527; the number immediately following
2、 the 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 (e) indicates an editorial change since the last revision or reapproval.e1NOTESection references in Sect
3、ion 5 were editorially changed in April 2006.1. Scope1.1 This specification covers 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, F 5
4、62, F 688, F 1058 or F 1537, Alloy 1. This specifica-tion addresses those product variables that differentiate smalldiameter medical tubing from the bar, wire, sheet and stripproduct forms covered in these specifications.1.2 This specification applies to straight length tubing with0.250 in. (6.3 mm)
5、 and smaller nominal outside diameter (OD)and 0.030 in. (0.76 mm) and thinner nominal wall thickness.1.3 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not cons
6、idered standard.2. Referenced Documents2.1 ASTM Material Standards:2F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplication
7、s (UNS R30035)F 688 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foilfor Surgical Implants (UNS R30035)F 1058 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip forSurgical Implant Applications (UNS R30003 and U
8、NSR30008)F 1537 Specification for Wrought Cobalt-28 Chromium-6Molybdenum Alloy for Surgical Implants2.2 ASTM Standards:A 632 Specification for Seamless and Welded AusteniticStainless Steel Tubing (Small-Diameter) for General Ser-viceE8 Test Methods for Tension Testing of Metallic MaterialsE45 Test M
9、ethods for Determining the Inclusion Content ofSteelE112 Test Method for Determining Average Grain Size2.3 ISO Standards:3ISO 5832- 5 Implants for SurgeryMetallic Materials Part5: Wrought Cobalt, Chromium, Tungsten, Nickel AlloyISO 5832- 6 Implants for SurgeryMetallic Materials Part6: Wrought Cobalt
10、, 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, Iron AlloyISO 5832- 12 Implants for SurgeryMetallic
11、MaterialsPart 12: Wrought Cobalt, Chromium, Molybdenum AlloyISO 6892 Metallic MaterialsTensile Testing2.4 American Society for Quality Standard:ASQ C1 Specification of General Requirements for a Qual-ity Program43. Terminology3.1 Definitions of Terms Specific to This Standard:1This specification is
12、under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2005. Published October 2005.2For referenced ASTM standards, visit the ASTM website, www.astm.o
13、rg, 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 10036.4Available from Amer
14、ican Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.1 average wall thicknessthe arithmetic average of theminimum wall thickness and the maximum wall thickness
15、measured on any one transverse cross section of the tube.3.1.2 concentricitytwo times the offset between the cen-ters of two circles, representing the outside diameter (OD) andthe inside diameter (ID) of the tube.3.1.2.1 DiscussionFor purposes of this specification, theminimum wall and the maximum w
16、all measured on any onetransverse cross section shall be used to calculate concentricity.The percent concentricity shall be calculated using the equa-tion:Percent Concentricity 5 2 3Smaximum wall minimum wallmaximum wall 1 minimum wallD3 100(1)3.1.3 nominal outside diameter (OD)the outside diameters
17、pecified on the customer order or engineering drawing withoutregard to tolerance.3.1.4 nominal wall thicknessthe wall thickness specifiedon the customer order or engineering drawing without regard totolerance.3.1.5 seamless tubingtubing made by a process in whichthe tube periphery is continuous at a
18、ll stages of the process.3.1.6 welded and drawn tubingtubing fabricated fromstrip or sheet using welding, drawing, and annealing opera-tions.3.1.6.1 DiscussionWelding shall be performed using aliquid phase weld process with no filler metal. Typical weldprocesses are tungsten inert gas (TIG) and lase
19、r. The drawingand annealing operations shall be performed in such a way thatthe weld bead and heat affected zone are virtually indistin-guishable microstructurally and dimensionally from the parentmetal when examined per 11.3.4. General Requirements for Delivery4.1 In addition to the requirements of
20、 this specification, 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 AST
21、M designation and date of issue,5.1.3 ASTM material standard and date of issue,5.1.4 Method of manufacture (seamless or welded anddrawn; see 6.1),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
22、, multiples) orengineering drawing reference number,5.1.8 Dimensional tolerances (see Section 9 and Table 1),5.1.9 Certification requirements, and5.1.10 Special requirements or supplementary requirements,if any.6. Materials and Manufacture6.1 Method of Manufacture:6.1.1 Seamless tubing shall be made
23、 from bar, hollow bar,rod, or hollow rod raw material forms that meet the chemicalrequirements of the appropriate material specification.6.1.1.1 Seamless tubing shall be made by a process consis-tent with the definition in 3.1.5.6.1.2 Welded and drawn tubing shall be made from strip orsheet raw mate
24、rial forms that meet the chemical requirementsof the appropriate material specification.6.1.2.1 Welded and drawn tubing shall be made by a processconsistent with the definition in 3.1.6.6.2 ConditionTubing shall be furnished, as specified, inthe annealed, solution annealed, warm worked or cold worke
25、dand 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 25 in. (0.63 m) Ra.6.3.2 The tubing inner surface sh
26、all be furnished with anas-drawn finish, bright annealed or conditioned finish. Innersurface roughness shall be a maximum of 30 in. (0.75 m) 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
27、and 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 mechanica
28、l 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 s
29、heet or strip with thickness similarto the tubing wall thickness shall apply. Tensile testing shall bein accordance with Test Methods E8using unmachined tubularspecimens. Alternative mechanical properties may be agreedupon between purchaser and supplier.8.2 In the event that both tensile properties
30、and hardness arespecified on the purchase order, tensile properties shall be usedto accept or reject. Hardness shall be reported for informationonly.8.3 Elongation of bar and wire material 0.063 in. (1.6 mm)or greater in diameter (D) shall be measured using a gaugeTABLE 1 Permissible Variation in OD
31、 and ID DimensionsNominal OD or IDin. (mm)Permissible Variationfrom NominalAin. (mm)Less than 0.060 (1.54) 60.0005 (0.013)0.060 to 0.250 (1.54 to 6.30) incl. 60.001 (0.025)AUnless otherwise specified, size tolerances are plus and minus as shown inthe table. When required by the purchaser, tolerances
32、 may be specified 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.F252705e12length of 2 in. (50 mm), or 4D. The gauge length must bereported with the test results. Th
33、e method for determiningelongation of material under 0.063 in. (1.6 mm) 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 beused when agreed upon between purc
34、haser and supplier.8.4 Elongation for sheet and strip product shall be tested andreported as required in the appropriate material specification.9. Permissible Variation in Dimensions9.1 OD and ID:9.1.1 Permissible variations of OD and ID from the nominaldimension on the purchase order or engineering
35、 drawing arelisted in Table 1.9.1.2 OD may be measured by hand micrometer, by linearvariable displacement transducer (LVDT), by laser micrometeror by other non-contact method.9.2 Wall Thickness:9.2.1 For wall thickness of 0.004 in. (0.10 mm) or greater,the range of total wall variation (including co
36、ncentricity andaverage wall variation) shall not exceed 14 % (67%) ofnominal wall thickness. Tolerance for wall thickness less than0.004 in. (0.10 mm) will be agreed upon between purchaserand supplier.9.2.2 For wall thickness of 0.004 in. (0.10 mm) or greater,concentricity shall not exceed 10 % (65
37、%) of average wallthickness for tubing with nominal wall thickness greater thanor equal to 10 % of the nominal OD dimension. For tubing withnominal wall thickness less than 0.004 in. (0.10 mm) or 10 %of the nominal OD dimension, concentricity shall be agreedupon between purchaser and supplier.9.2.3
38、Wall thickness measurement shall be made directlywith a hand micrometer, LVDT, by optical measurement on atransverse metallographic cross section, or by some otherappropriate method. The method of wall thickness measure-ment shall be agreed upon between purchaser and supplier.9.3 Length:9.3.1 For ex
39、act length orders, length variation on all lengthsup to and including 24 ft (7.3 m) shall be plus or minus 0.125in. (3 mm).9.3.2 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 s
40、hall be less than 2 ft (0.6 m), unless permitted by thepurchaser.9.4 StraightnessThe deviation from straightness shall notexceed 0.012 in. per foot (0.30 mm per 300 mm) of tube length.The method of measuring straightness shall be negotiatedbetween purchaser and supplier. Alternative requirements may
41、be agreed upon between purchaser and supplier.10. Permissible Outer and Inner Surface Imperfections10.1 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 t
42、hickness meets the minimum wallthickness, and that the ground or polished surface meets thesurface finish requirements of 6.3.1.10.2 Inner surface imperfections shall not exceed 10 % ofwall thickness in depth.10.3 The method of inspecting for these imperfections shallbe agreed upon between the purch
43、aser and supplier.11. Special Tests11.1 The material shall conform to the special test require-ments of the appropriate ASTM material specification listed in2.1. Ultrasonic inspection will be limited to wall thickness of0.020 in. (0.5 mm) or thicker.11.2 The grain size shall be ASTM 6 or finer whene
44、valuated after the final annealing operation in accordance withTest Method E112. In addition, on any one of the transversemetallographic sections examined, there must be a minimum ofthree grains intercepted by any radial line drawn across thewall thickness. The number of grains required for wall thi
45、ck-ness less than 0.004 in. (0.1 mm) shall be agreed upon betweenpurchaser and supplier.11.2.1 If samples are selected after a final cold workingoperation, specimens shall be tested in accordance with TestMethod E112 or as agreed upon between purchaser andsupplier.11.3 For welded and drawn tubing, a
46、 transverse cross-section through the weld bead shall be metallurgicallymounted, polished, etched, and viewed at 100 times magnifi-cation. The microstructures of the weld bead and heat affectedzone will exhibit a grain size and grain morphology similar tothe parent metal. The ASTM grain size in the
47、weld bead, heataffected zone and parent metal will not differ by more than 1ASTM number. The wall thickness at the weld bead shall bethe same as the parent metal.11.4 The raw material supplier will rate non metallic inclu-sion content per Test Methods E45, Method A except usingplate I-r on material
48、with a diameter or shortest dimension of3.0 in. (7.6 mm) or larger. The rating will meet the non metallicinclusion requirements listed in Table 2.11.4.1 If the non metallic inclusion requirement for aparticular type and heaviness in the appropriateASTM materialspec is more restrictive than that in T
49、able 2, the non metallicinclusion requirements in the appropriate ASTM materialspecification shall apply.11.4.2 Alternative methods of rating and reporting nonmetallic inclusions on tubing at finish size may be agreed uponbetween purchaser and supplier.12. Certification12.1 The supplier shall provide certification that the mate-rial meets the requirements of this specification. CertificationTABLE 2 Maximum Allowable Inclusion RatingNOTEThe inclusion type description in parentheses is not intended torepresent the chemistry of the rated inclusion. The inclusion typ
