ASTM F2633-2013 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants《医疗器械和外科植入物用锻造无缝镍钛形状记忆合金管的标准规范》.pdf

1、Designation: F2633 07F2633 13Standard Specification forWrought Seamless Nickel-Titanium Shape Memory AlloyTube for Medical Devices and Surgical Implants1This standard is issued under the fixed designation F2633; the number immediately following the designation indicates the year oforiginal adoption

2、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 Scope*1.1 This specification covers the requirements for wrought nickel-titanium

3、 shape memory alloy tube, nominally 54.5 %54.5 to57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants.Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product

4、 variablesthat differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F2063.1.2 This specification applies to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinnernominal wall thickness.1.3 The values stat

5、ed in SI units are to be regarded as the standard. The values given in parentheses (inch-pound units) are forinformation only.2. Referenced Documents2.1 ASTM Standards:2A632 Specification for Seamless and Welded Austenitic Stainless Steel Tubing (Small-Diameter) for General ServiceF2004 Test Method

6、for Transformation Temperature of Nickel-Titanium Alloys by Thermal AnalysisF2005 Terminology for Nickel-Titanium Shape Memory AlloysF2063 Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical ImplantsF2082 Test Method for Determination of Transformation Temp

7、erature of Nickel-Titanium Shape Memory Alloys by Bend andFree RecoveryF2516 Test Method for Tension Testing of Nickel-Titanium Superelastic Materials2.2 ISO Standard:3ISO 9001 Quality Management SystemsRequirementsISO 13485 Quality Management Standard for Medical Devices2.3 American Society for Qua

8、lity Standards:4ASQ C1 Specification of General Requirements for a Quality Program3. Terminology3.1 Definitions of Terms Specific to This Standard:3.2 See Terminology F2005 for the definition of terms used in this specification that are specific to nickel-titanium alloys.3.3 individual wall thicknes

9、s measurement, nany one of the wall thickness measurements taken around the circumference onany one transverse cross-section of a single sample of the tube.3.4 lot, nthe total quantity of tubeproduct produced from the same melt heat under the same conditions, at essentially the sametime.3.4.1 Discus

10、sion1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved April 1, 2007Oct. 1, 2013. Published May 2007November 2013. Originally app

11、roved in 2007. Last previous edition approved in 2007 asF263307. DOI: 10.1520/F2633-07.10.1520/F2633-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards

12、 Document Summary page on the ASTM website.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes

13、 have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official

14、 document.*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 States1For purposes of this specification, conversion from bar to tubular form by extrusion, gundrilling, or other met

15、hod is included withinthe scope of this definition.3.5 lot average concentricity, nthe arithmetic average of the sample concentricities measured on a statistically representativenumber of samples from the lot.3.6 lot average wall thickness, nthe grand average of the sample average wall thicknesses m

16、easured on a statisticallyrepresentative number of samples from the lot.3.7 nominal outside diameter (OD), nthe outside diameter specified by the purchaser on the purchasers order or engineeringdrawing without regard to tolerance.3.8 nominal wall thickness, nthe wall thickness specified by the purch

17、aser purchasers order or engineering drawing withoutregard to tolerance.3.9 sample average wall thickness, nthe arithmetic average of all individual wall thickness measurements measured on asingle sample.3.10 sample concentricity, ntwo times the offset between the centers of the two circles represen

18、ting the outside diameter (OD)and the inside diameter (ID) of the tube. For purposes of this specification, the sample minimum wall and the sample maximumwall measured on any one transverse cross section of a single sample shall be used to calculate concentricity. Also, for purposesof this specifica

19、tion, sample concentricity shall be expressed as a percent and shall be calculated using the following equation:Sample concentricity percent523FA2BA1B G 3100where:A = sample maximum wall, andB = sample minimum wall.3.10.1 DiscussionFor purposes of this specification, the sample minimum wall and the

20、sample maximum wall measured on any one transverse crosssection of a single sample shall be used to calculate concentricity. Also, for purposes of this specification, sample concentricityshall be expressed as a percent and shall be calculated using the following equation:Sample concentricity percent

21、523FA2BA1B G 3100where:A = sample maximum wall, andB = sample minimum wall.3.11 sample maximum wall thickness, nthe largest individual wall thickness measurement taken around the circumference onany one transverse cross section of a single sample of tube.3.11.1 DiscussionIn practice, the sample maxi

22、mum wall thickness may be the largest of no less than four individual wall thickness measurementstaken at uniformly spaced locations around the circumference of a single sample of the tube.3.12 sample minimum wall thickness, nthe smallest individual wall thickness measurement taken around the circum

23、ferenceon any one transverse cross section of a single sample of tube.3.12.1 DiscussionIn practice, the sample minimum wall thickness may be the smallest of no less than four individual wall thickness measurementstaken at uniformly spaced locations around the circumference of a single sample of the

24、tube.4. Ordering Information4.1 Inquiries and orders for material under this specification may 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 Active Austenite Finish Temperature (see

25、7.27.3),F2633 1324.1.5 Mechanical Properties (see Table 1),4.1.6 Surface Finish (see 5.3),4.1.7 Nominal Dimensions including either OD and ID, OD and wall, or ID and wall, or engineering drawing number,4.1.8 Length (exact or random, see 9.4),4.1.9 Dimensional Tolerances (see Table 2 and Table 3),4.1

26、.10 Certification 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, or tube raw material forms that meet the requirements of SpecificationF2

27、063.5.1.2 Seamless tube shall be made by a process in which the tube periphery is continuous at all stages of the process.5.2 ConditionTube shall be furnished in the superelastic condition or as agreed upon between purchaser and supplier.5.3 Surface Finish:5.3.1 The tube outer surface shall be furni

28、shed, as specified by the purchaser, with a uniform, adherent oxide of any color,pickled, chemically etched, ground, or mechanically polished finish. Other finishes may be agreed upon between purchaser andsupplier.5.3.2 The tube inner surface shall be furnished, as specified by the purchaser, with a

29、 uniform, adherent oxide of any color,pickled, chemically etched, or mechanically conditioned finish.5.3.3 Inner and outer surface roughness and the method of measurement shall be as agreed upon between the purchaser andsupplier.6. Chemical Composition6.1 Seamless tube shall be made from bar, hollow

30、 bar, or tube raw material forms that meet the chemical compositionrequirements of Specification F2063.NOTE 1Non-metallic inclusions shall be rated and reported on the starting bar, hollow bar, or tube raw material forms by the raw material supplierper Specification F2063. Alternate non-metallic inc

31、lusion requirements and rating methods may be agreed upon between purchaser and supplier.6.2 Hydrogen content shall be analyzed and reported when required by the purchaser. The analysis shall be made on the finishedtube.7. Austenite Finish Transformation Temperature7.1 The austenite finish raw mater

32、ial manufacturer shall measure the ingot transformation temperature of the raw material (ingotAf) shall be measured on fully annealed raw material by the raw material manufacturer samples per Test Method F2004 or TestMethod F2082as required in Specification F2063. The raw material supplier shall rep

33、ort the ingot austenite finish (ingot Af)transformation temperature as well as any of ingot Martensite finish (Mf), Martensite peak (Mp), Martensite start (Ms), Austenitestart (As), or Austenite peak Ap transformation temperatures as required by the raw material purchaser. Each ingot transformationt

34、emperature reported will be clearly labeled by transformation type.7.2 The ingot Af and any other appropriate ingot transformation temperature reported by the raw material supplier may bereported on the finished tube certification as the ingot transformation temperature when required by the finish t

35、ube purchaser. Eachingot transformation temperature reported will be clearly labeled by the transformation type.7.3 The austeniteAustenite finish temperature of the finished tube (active Af) with outer diameter in the range of 0.3 to 3.0 mm(0.012 to 0.12 in.) shall be measured by the supplier on rep

36、resentative full round tube sample(s) using the bend and free recoverymethod described in Test Method F2082 when required by the purchaser.7.4 Alternate transformation temperatures and alternate measurement methods may be agreed upon between purchaser andsupplier.TABLE 1 Mechanical PropertiesUTS Uni

37、form Elongation Upper Plateau Strength Lower Plateau Strength Residual ElongationCondition Min MPa (ksi) Min % in 50 mm (2 in.) or4DMin MPa (ksi) at 3 %strainMin MPa (ksi) at 2.5 %strainMax % after 6 % strainSuperelasticA 1000 (145) 10 380 (55) B 0.3 %ASuperelastic properties are measured per Test M

38、ethod F2516 at room temperature.BLower plateau strength value may be measured and reported for information only.F2633 1338. Mechanical Properties8.1 Tensile testing of superelastic material shall be performed per Test Method F2516 using full round tube specimens with noreduced center section. Mechan

39、ical properties are listed in Table 1 for the superelastic condition tested at room temperature.Alternate test methods, conditions, test temperatures, and mechanical properties may be agreed upon between purchaser andsupplier.9. Permissible Variation in Dimensions9.1 OD or ID:9.1.1 Permissible varia

40、tions of OD or ID are listed in Table 2. Alternate tolerances may be agreed upon between purchaser andsupplier.9.1.2 OD may be measured by hand micrometer, dial indicator, linear variable displacement transducer (LVDT), coordinatemeasuring machine (CMM), or laser micrometer or other non-contact meth

41、od.9.2 Wall Thickness:9.2.1 The wall thickness variation throughout the lot shall be as shown in Table 3, or as agreed upon between purchaser andsupplier. All individual wall thickness readings shall fall within the indicated range.9.2.2 Wall thickness measurement may be made directly with a hand mi

42、crometer, dial indicator, LVDT, or CMM. Alternately,wall thickness may be measured optically on a transverse metallographic cross section, or by some other appropriate method. Themethod of wall thickness measurement shall be agreed upon between purchaser and supplier.9.3 Concentricity:9.3.1 Concentr

43、icity shall be measured and reported when specified by the purchaser.9.3.1.1 For wall thickness of 0.2 mm (0.008 in.) or greater and OD/W ratio of 15 or less, all sample concentricities shall be lessthan or equal to 10 %. For tube with nominal wall thickness less than 0.2 mm (0.008 in.) or OD/W rati

44、o greater than 15,concentricity shall be agreed upon between purchaser and supplier.9.3.2 This concentricity requirement does not apply to tube specified as OD and ID unless agreed upon between purchaser andsupplier.9.3.3 Alternate means of calculating and reporting concentricity may be agreed upon

45、between purchaser and supplier.9.4 Length:9.4.1 For exact length orders, nominal length and length variation shall be agreed upon between purchaser and supplier.9.4.2 For random length orders, a maximum and minimum length shall be agreed upon between purchaser and supplier.9.5 Straightness:9.5.1 Str

46、aightness shall be measured and reported when specified by the purchaser.9.5.2 The deviation from straightness shall not exceed 0.50 mm per 300 mm (0.020 in. per 12 in.) of tube length.9.5.3 Alternate straightness requirements and measurement methods may be agreed upon between purchaser and supplier

47、.10. Permissible Outer and Inner Surface Imperfections10.1 Outer and inner surface imperfections on tubes with nominal wall thickness greater than 0.2 mm (0.008 in.) shall be nodeeper than 10 % of the nominal wall thickness. Imperfection depths on thinner wall thickness may be agreed upon by purchas

48、erand supplier.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) 0.025 (0.001)1.5 to 6.5 (0.059 to 0.256) incl 0.050 (0.002)6.5 to 10 (0.256 to 1.2) incl 0.075 (0.003)TABLE 3 Permissible Var

49、iation in Wall Thickness DimensionsNominal Wall Thickness Permissible WallThickness VariationLess than 0.2 mm (0.008 in.) 0.025 mm (0.010 in.)from nominal wall thicknessLess than 0.2 mm (0.008 in.) 0.025 mm (0.001 in.)from nominal wall thicknessGreater than or equal to 0.2 mm(0.008 in.)12 % ofnominal wall thicknessAAThe 12 % tolerance for a particular nominal wall thickness may be converted toa decimal by multiplying 0.12 times the nominal wall thickness and rounding to theappropriate decimal place.F2633 13410.2 The method of detecting and measuring s