1、Designation: F 2633 07Standard Specification forWrought Seamless Nickel-Titanium Shape Memory AlloyTube for Medical Devices and Surgical Implants1This standard is issued under the fixed designation F 2633; the number immediately following the designation indicates the year oforiginal adoption or, in
2、 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.1. Scope1.1 This specification covers the requirements for wroughtnickel-titanium shape memory
3、 alloy tube, nominally 54.5 % to57.0 mass/mass (weight) % nickel, in the superelastic condi-tion, used for the manufacture of medical devices and surgicalimplants. Material shall conform to the applicable require-ments of Specification F 2063. This specification addressesthose product variables that
4、 differentiate drawn medical gradetube from the raw material and mill product forms covered inSpecification F 2063.1.2 This specification applies to tube with 10 mm (0.4 in.)and smaller nominal outside diameter and 2 mm (0.08 in.) andthinner nominal wall thickness.1.3 The values stated in SI units a
5、re to be regarded as thestandard. The values given in parentheses (inch-pound units)are for information only.2. Referenced Documents2.1 ASTM Standards:2A 632 Specification for Seamless and Welded AusteniticStainless Steel Tubing (Small-Diameter) for General Ser-viceF 2004 Test Method for Transformat
6、ion Temperature ofNickel-Titanium Alloys by Thermal AnalysisF 2005 Terminology for Nickel-Titanium Shape MemoryAlloysF 2063 Specification for Wrought Nickel-Titanium ShapeMemoryAlloys for Medical Devices and Surgical ImplantsF 2082 Test Method for Determination of TransformationTemperature of Nickel
7、-Titanium Shape Memory Alloys byBend and Free RecoveryF 2516 Test Method for Tension Testing of Nickel-TitaniumSuperelastic Materials2.2 ISO Standard:3ISO 9001 Quality Management SystemsRequirements2.3 American Society for Quality Standards:4ASQ C1 Specification of General Requirements for a Qual-it
8、y Program3. Terminology3.1 Definitions of Terms Specific to This Standard:3.2 See Terminology F 2005 for the definition of terms usedin this specification that are specific to nickel-titanium alloys.3.3 individual wall thickness measurement, nany one ofthe wall thickness measurements taken around th
9、e circumfer-ence on any one transverse cross-section of a single sample ofthe tube.3.4 lot, nthe total quantity of tube produced from thesame melt heat under the same conditions, at essentially thesame time.3.4.1 DiscussionFor purposes of this specification, con-version from bar to tubular form by e
10、xtrusion, gundrilling, orother method is included within the scope of this definition.3.5 lot average concentricity, nthe arithmetic average ofthe sample concentricities measured on a statistically represen-tative number of samples from the lot.3.6 lot average wall thickness, nthe grand average of t
11、hesample average wall thicknesses measured on a statisticallyrepresentative number of samples from the lot.3.7 nominal outside diameter (OD), nthe outside diam-eter specified by the purchaser without regard to tolerance.3.8 nominal wall thickness, nthe wall thickness specifiedby the purchaser withou
12、t regard to tolerance.3.9 sample average wall thickness, nthe arithmetic aver-age of all individual wall thickness measurements measured ona single sample.3.10 sample concentricity, ntwo times the offset betweenthe centers of the two circles representing the outside diameter(OD) and the inside diame
13、ter (ID) of the tube. For purposes ofthis specification, the sample minimum wall and the sample1This specification is 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 ed
14、ition approved April 1, 2007. Published May 2007.2For 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 f
15、rom American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West
16、 Conshohocken, PA 19428-2959, United States.maximum wall measured on any one transverse cross sectionof a single sample shall be used to calculate concentricity.Also,for purposes of this specification, sample concentricity shall beexpressed as a percent and shall be calculated using thefollowing equ
17、ation:Sample concentricity percent 5 2 3FA BA 1 BG3 100where:A = sample maximum wall, andB = sample minimum wall.3.11 sample maximum wall thickness, nthe largest indi-vidual wall thickness measurement taken around the circum-ference on any one transverse cross section of a single sampleof tube.3.11.
18、1 DiscussionIn practice, the sample maximum wallthickness may be the largest of no less than four individual wallthickness measurements taken at uniformly spaced locationsaround the circumference of a single sample of the tube.3.12 sample minimum wall thickness, nthe smallest indi-vidual wall thickn
19、ess measurement taken around the circum-ference on any one transverse cross section of a single sampleof tube.3.12.1 DiscussionIn practice, the sample minimum wallthickness may be the smallest of no less than four individualwall thickness measurements taken at uniformly spaced loca-tions around the
20、circumference of a single sample of the tube.4. Ordering Information4.1 Inquiries and orders for material under this specificationmay include the following information:4.1.1 Quantity (total length or number of pieces),4.1.2 This ASTM specification and date of issue,4.1.3 Condition (see 5.2),4.1.4 Ac
21、tive Austenite Finish Temperature (see 7.2),4.1.5 Mechanical Properties (see Table 1),4.1.6 Surface Finish (see 5.3),4.1.7 Nominal Dimensions including either OD and ID, ODand wall, or ID and wall,4.1.8 Length (exact or random, see 9.4),4.1.9 Dimensional Tolerances (see Table 2 and Table 3),4.1.10 C
22、ertification requirements (see Section 11), and4.1.11 Special requirements or supplementary requirements,if any.5. Materials and Manufacture5.1 Method of Manufacture:5.1.1 Seamless tube shall be made from bar, hollow bar, ortube raw material forms that meet the requirements of Speci-fication F 2063.
23、5.1.2 Seamless tube shall be made by a process in which thetube periphery is continuous at all stages of the process.5.2 ConditionTube shall be furnished in the superelasticcondition or as agreed upon between purchaser and supplier.5.3 Surface Finish:5.3.1 The tube outer surface shall be furnished,
24、as specifiedby the purchaser, with a uniform, adherent oxide of any color,pickled, ground, or mechanically polished finish. Other finishesmay be agreed upon between purchaser and supplier.5.3.2 The tube inner surface shall be furnished, as specifiedby the purchaser, with a uniform, adherent oxide of
25、 any color,pickled, or mechanically conditioned finish.5.3.3 Inner and outer surface roughness and the method ofmeasurement shall be as agreed upon between the purchaserand supplier.6. Chemical Composition6.1 Seamless tube shall be made from bar, hollow bar, ortube raw material forms that meet the c
26、hemical compositionrequirements of Specification F 2063.NOTE 1Non-metallic inclusions shall be rated and reported on thestarting bar, hollow bar, or tube raw material forms by the raw materialsupplier per Specification F 2063. Alternate non-metallic inclusion re-quirements and rating methods may be
27、agreed upon between purchaserand supplier.6.2 Hydrogen content shall be analyzed and reported whenrequired by the purchaser. The analysis shall be made on thefinished tube.7. Austenite Finish Temperature7.1 The austenite finish temperature of the raw material(ingot Af) shall be measured on fully ann
28、ealed raw material bythe raw material manufacturer per Test Method F 2004 or TestMethod F 2082 as required in Specification F 2063.7.2 The austenite finish temperature of the finished tube(active Af) with outer diameter in the range of 0.3 to 3.0 mmTABLE 1 Mechanical PropertiesUTS Uniform Elongation
29、 Upper Plateau Strength Lower Plateau Strength Residual ElongationCondition Min MPa (ksi) Min % in 50 mm (2 in.) or 4D Min MPa (ksi) at 3 % strain Min MPa (ksi) at 2.5 % strain Max % after 6 % strainSuperelasticA1000 (145) 10 380 (55)B0.3 %ASuperelastic properties are measured per Test Method F 2516
30、 at room temperature.BLower plateau strength value may be measured and reported for information only.TABLE 2 Permissible Variation in OD or ID DimensionsNominal OD or ID in mm (in.) Permissible Variationfrom Nominal in mm (in.)Less than or equal to 1.5 (0.059) 60.025 (0.001)1.5 to 6.5 (0.059 to 0.25
31、6) incl 60.050 (0.002)6.5 to 10 (0.256 to 1.2) incl 60.075 (0.003)TABLE 3 Permissible Variation in Wall Thickness DimensionsNominal Wall Thickness Permissible WallThickness VariationLess than 0.2 mm (0.008 in.) 60.025 mm (0.010 in.)from nominal wall thicknessGreater than or equal to 0.2 mm(0.008 in.
32、)612 % ofnominal wall thicknessAAThe 612 % tolerance for a particular nominal wall thickness may be convertedto a decimal by multiplying 0.12 times the nominal wall thickness and rounding tothe appropriate decimal place.F2633072(0.012 to 0.12 in.) shall be measured by the supplier onrepresentative f
33、ull round tube sample(s) using the bend andfree recovery method described in Test Method F 2082 whenrequired by the purchaser.7.3 Alternate transformation temperatures and alternatemeasurement methods may be agreed upon between purchaserand supplier.8. Mechanical Properties8.1 Tensile testing shall
34、be performed using full round tubespecimens with no reduced center section. Mechanical proper-ties are listed in Table 1 for the superelastic condition tested atroom temperature. Alternate conditions, test temperatures, andmechanical properties may be agreed upon between purchaserand supplier.9. Per
35、missible Variation in Dimensions9.1 OD or ID:9.1.1 Permissible variations of OD or ID are listed in Table2. Alternate tolerances may be agreed upon between purchaserand supplier.9.1.2 OD may be measured by hand micrometer, dialindicator, linear variable displacement transducer (LVDT),coordinate meas
36、uring machine (CMM), or laser micrometer orother non-contact method.9.2 Wall Thickness:9.2.1 The wall thickness variation throughout the lot shallbe as shown in Table 3, or as agreed upon between purchaserand supplier. All individual wall thickness readings shall fallwithin the indicated range.9.2.2
37、 Wall thickness measurement may be made directlywith a hand micrometer, dial indicator, LVDT, or CMM.Alternately, wall thickness may be measured optically on atransverse metallographic cross section, or by some otherappropriate method. The method of wall thickness measure-ment shall be agreed upon b
38、etween purchaser and supplier.9.3 Concentricity:9.3.1 Concentricity shall be measured and reported whenspecified by the purchaser.9.3.1.1 For wall thickness of 0.2 mm (0.008 in.) or greaterand OD/W ratio of 15 or less, all sample concentricities shallbe less than or equal to 10 %. For tube with nomi
39、nal wallthickness less than 0.2 mm (0.008 in.) or OD/W ratio greaterthan 15, concentricity shall be agreed upon between purchaserand supplier.9.3.2 This concentricity requirement does not apply to tubespecified as OD and ID unless agreed upon between purchaserand supplier.9.3.3 Alternate means of ca
40、lculating and reporting concen-tricity may be agreed upon between purchaser and supplier.9.4 Length:9.4.1 For exact length orders, nominal length and lengthvariation shall be agreed upon between purchaser and supplier.9.4.2 For random length orders, a maximum and minimumlength shall be agreed upon b
41、etween purchaser and supplier.9.5 Straightness:9.5.1 Straightness shall be measured and reported whenspecified by the purchaser.9.5.2 The deviation from straightness shall not exceed 0.50mm per 300 mm (0.020 in. per 12 in.) of tube length.9.5.3 Alternate straightness requirements and measurementmeth
42、ods may be agreed upon between purchaser and supplier.10. Permissible Outer and Inner Surface Imperfections10.1 Outer and inner surface imperfections on tubes withnominal wall thickness greater than 0.2 mm (0.008 in.) shall beno deeper than 10 % of the nominal wall thickness. Imperfec-tion depths on
43、 thinner wall thickness may be agreed upon bypurchaser and supplier.10.2 The method of detecting and measuring surface imper-fections may be agreed upon between the purchaser andsupplier.11. Certification11.1 The supplier shall provide certification that the materialmeets the requirements of this sp
44、ecification.Areport of the testresults shall be furnished at the time of shipment.11.2 Certification of raw material compliance to chemistry(except for hydrogen), non-metallic inclusion and ingot trans-formation temperature requirements may be provided as evi-dence of compliance of the finished tube
45、 to the requirements ofthis specification.12. Quality Program Requirements12.1 The supplier shall maintain a quality program such asdefined in ASQ C1 or ISO 9001.13. Keywords13.1 medical devices; metals (for surgical implant); nickel-titanium alloys; niti; nitinol; shape memory alloy; stents;superel
46、astic alloys; surgical implants; tubeF2633073SUPPLEMENTARY REQUIREMENTSThe following supplementary requirements shall apply only when specified by the purchaser in theinquiry, contract, or order.S1. Inner Diameters Surface CleanlinessS1.1 Tube with ID size of greater than or equal to 1.5 mm(0.060 in
47、.) shall meet the requirements of Specification A 632Supplement 3 for cleanliness. The method for inspecting insidesurface cleanliness for smaller ID sizes shall be agreed uponbetween purchaser and supplier. This supplementary require-ment does not apply to the ID oxide condition.APPENDIXES(Nonmanda
48、tory Information)X1. RATIONALEX1.1 The primary reason for this specification is to estab-lish a tubular product standard specification for wrought,seamless nickel titanium shape memory alloy tube used tofabricate stents and other medical devices.X1.2 Nickel titanium alloy tube made to this specifica
49、tionis typically intended to perform a super elastic function. Therelationship between the operating temperature of the device,and the transformation temperature of the material from whichthe device is made will determine how the device will perform.The device design and the specification of material transfor-mation temperature to ensure effective super elastic perfor-mance is beyond the scope of this specification. In thisspecification, the use of the term superelastic is a convenientway to characterize the finished tubes room temperaturemechanical behavior. This
