ASTM F2819-2010(2015)e2 Standard Test Methods for Measurement of Straightness of Bar Rod Tubing and Wire to be used for Medical Devices《测量医疗器械用棒材 杆材 管材和线材的直线度的标准试验方法》.pdf

《ASTM F2819-2010(2015)e2 Standard Test Methods for Measurement of Straightness of Bar Rod Tubing and Wire to be used for Medical Devices《测量医疗器械用棒材 杆材 管材和线材的直线度的标准试验方法》.pdf》由会员分享，可在线阅读，更多相关《ASTM F2819-2010(2015)e2 Standard Test Methods for Measurement of Straightness of Bar Rod Tubing and Wire to be used for Medical Devices《测量医疗器械用棒材 杆材 管材和线材的直线度的标准试验方法》.pdf（6页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F2819 10 (Reapproved 2015)2Standard Test Methods forMeasurement of Straightness of Bar, Rod, Tubing and Wireto be used for Medical Devices1This standard is issued under the fixed designation F2819; the number immediately following the designation indicates the year oforiginal adoption o

2、r, 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.1NOTEEditorial corrections were made in June 2016.2NOTESubsection 11.1.3 was corrected edi

3、torially in September 2017.1. Scope1.1 This standard covers the various test methods to be usedfor measurement of straightness of bar, rod, tubing, and wire.These test methods apply primarily to bar, rod, tubing, and wirethat are ordered in the straightened and cut-to-length condition.They also appl

4、y to small diameter tubing and wire that hasbeen specially processed to roll off a spool in the straightenedcondition.1.2 These test methods apply to straightness of round wirethat has a diameter between 0.05 and 4.78 mm (0.002 and0.188 in.). They also apply to flatness (camber) of flat-shapedwire o

5、r ribbon with a maximum dimension between 0.05 and4.78 mm (0.002 and 0.188 in.). For flatness (camber)measurement, refer to Test Method F2754/F2754M.NOTE 1The current version of Test Method F2754/F2754M covers adifferent diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.) anddoes not include sup

6、erelastic NiTi. These exceptions would not affect thecamber measurement as conducted by Test Method F2754/F2754M.1.3 These test methods apply to straightness of round tubingthat has an outer diameter between 0.05 and 6.35 mm (0.002and 0.25 in.).1.4 These test methods apply to straightness of round r

7、odthat has a diameter between 4.78 and 6.35 mm (0.188 and 0.25in). It also applies to flatness (camber) of flat and shaped rodwith a maximum dimension between 4.78 and 6.35 mm (0.188and 0.25 in). For measurement of flatness (camber), refer toTest Method F2754/F2754M.NOTE 2The current version of Test

8、 Method F2754/F2754M covers adifferent diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.) anddoes not include superelastic NiTi. These exceptions would not affect thecamber measurement as conducted by Test Method F2754/F2754M.1.5 These test methods apply to straightness of round barthat has a d

9、iameter between 6.35 and 101.6 mm (0.25 and 4 in).It also applies to flatness (camber) of flat and shaped bar witha maximum dimension between 6.35 and 101.6 mm (0.25 and4 in). For measurement of flatness (camber), refer to TestMethod F2754/F2754M.NOTE 3The current version of Test Method F2754/F2754M

10、 covers adifferent diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.) anddoes not include superelastic NiTi. These exceptions would not affect thecamber measurement as conducted by Test Method F2754/F2754M.1.6 These test methods apply to ferrous and non-ferrousalloys including linear-elastic or

11、 superelastic nitinol. Refer toTerminology F2005 for more details on NiTi terminology.1.7 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 shall be used independently

12、 of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.1.8 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health,

13、and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of Internationa

14、l Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F2005 Terminology for Nickel-Titanium Shape MemoryAlloysF2754/F2754M Test Method for Measurement of Camber,1These test methods are und

15、er the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.15 on Material Test Methods.Current edition approved May 1, 2015. Published July 2015. Originally approvedin 2010. Last previous edition approved in 2010 as F281

16、9 10. DOI: 10.1520/F2819-10R15E02.2For 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.Copyright ASTM Internationa

17、l, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides

18、and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1Cast, Helix and Direction of Helix of Coiled Wire2.2 Other Standards:3GGG-P-463 U.S. Federal Specification: Plate, Surface(Granite)3. Terminology3.1 Fig. 1 and Fig. 2 show the physical meaning ofs

19、traightness. Fig. 3 shows the definition of wobble in a straightwire or tube as it is being rotated.3.2 Definitions of Terms Specific to This Standard:3.2.1 straightnessDeviation of an axis or surface elementfrom linearity over a unit length in the unloaded (force andmoment free) condition.Aperfectl

20、y straight condition is shownin Fig. 1. A non-straight condition is shown in Fig. 2.3.2.2 wobbleElliptical rotation observed in a small diam-eter wire or tube as it is being rotated around a central axis asis shown in Fig. 3.4. Summary of Test Method4.1 For bar, rod, tube, and wire, the deviation fr

21、om thecondition of resting flat on a smooth surface can be measuredby using a quantitative or qualitative test method. Two quan-titative and two qualitative methods are the gap and TIR (TotalIndicator Readout) and inclined flat plate and finger roll tests,respectively4.2 Inclined Flat Plate Test (qu

22、alitative test method that canbe made quantitative)Acommon method for measurement ofstraightness of wire or tubing with a diameter less than 4.78mm (0.188 in.) is the inclined flat plate test. In this method, asectioned piece of material is allowed to roll down an inclinedtable as is illustrated by

23、Fig. 4 and Fig. 5. The material passesthe test if it rolls freely down the table without stopping as isshown by Fig. 5.4.3 Finger-Roll Test (qualitative test method)A secondcommon method for measurement of straightness that is usedfor wire and tubing with a diameter less than 0.25 mm (0.010in.) is t

24、he finger-roll test. In this test, a cut length of wire ortubing is laid on a flat surface. A finger, pencil, pen, or plasticcard is used to rotate the center of the sample back and forth onthe flat surface. The opposite ends of the sample should rotatesmoothly without wobble as is defined in 3.2.2

25、of these testmethods.4.4 Gap Test (quantitative test method)A common quan-titative method for measurement of straightness of wire with adiameter less than 4.78 mm (0.188 in.) is the gap test. It canalso be used for rod with a diameter between 4.78 and 6.35 mm(0.188 and 0.25 in.), tubing with diamete

26、r 0.05 to 6.35 mm(0.0002 to 0.25 in.) or bar with a diameter between 6.35 to101.7 mm (0.25 to 4 in.), the gap test can be used to measurestraightness. The gap test can also be used for flat or shapedwire and ribbon. In this method, a thickness gauge equal to thegap must not fit between the rod, tubi

27、ng, or bar and flat surfaceat any point along its length when rolled or rotated 360. Thegap defines the straightness of the rod, tubing, or bar.4.5 Total Indicator Readout (TIR) test (quantitative testmethod)In this method, a round rod with a diameter between4.78 and 6.35 mm (0.188 and 0.25 in.) or

28、round bar with adiameter between 6.35 to 101.7 mm (0.25 to 4 in.), is placed ontwo or more V-blocks. The test specimen is then rotated onerevolution between two or more V-blocks that are a fixeddistance (d) apart while measuring in the center with anindicator. Total Indicator Readout (TIR) in the te

29、st specimen isthen calculated.5. Significance and Use5.1 SignificanceWith the birth of minimally invasive sur-gery in the 1960s, there has been a requirement for guide wires.The guide wires serve as the access line by which procedureslike balloon angioplasty and stent placement are conducted. Aguide

30、 wire typically consists of a mandrel, coil and in somecases a safety wire is used. The market for guide wirescontinues to grow as the number of procedures increases. Forsuccessful manufacturing of guide wires, linearity or straight-ness of 304 stainless steel and nitinol wire that is used for thema

31、nufacture of guide wire mandrels is critical to their end useperformance. Users of guide wires require that they mustnavigate a tortuous anatomy.5.1.1 A second part of minimally invasive surgery is the useof machined or formed wire, tube, or rod. In this case,straightness of rod, tube, and wire that

32、 is going to be machined3Available from IHS, 321 Inverness Drive South Englewood, CO 80112,http:/.FIG. 1 Definition of a “Straight” ConditionF2819 10 (2015)22or subjected to a forming practice such as bending needs to bevery linear or straight so it is accurately fed into the equipmentthat is used f

33、or the machining or forming practice. Lasermachining is an example of a machining operation that requiresa wobble-free piece of rod, tubing, or wire so that it can beproperly fed into the alignment bushings of the laser. Wireforming equipment also requires wobble-free material for thesame reason.5.2

34、 UseThese test methods can be used by users andproducers of medical grade bar, rod, tubing, and wire to specifyrequirements to evaluate and confirm the straightness ofmaterial. Depending upon the type of material and its metal-lurgical condition, it may be possible to reprocess the materialto reduce

35、 its non-linearity.6. Apparatus6.1 For the inclined flat plate test, a flat table preferablymade of granite that can be precisely inclined is required. Theflat table should have an inspection grade; grade A, flatness asset forth by Federal Specification GGG-P-463. A precisemeasurement device and a p

36、rotractor are also required. Ex-amples of precise measurement devices that can be used areFIG. 2 Definition of a “Non-straight” ConditionFIG. 3 Definition of Wobble in a Small Diameter Tube or Wire as it is Being RotatedFIG. 4 Example of a Table and Granite Parallel Used to Measure Straightness by t

37、he Roll TestFIG. 5 Example of Inclined Surface Table and Protractor Used to Measure Straightness by the Roll Test MethodF2819 10 (2015)23thickness gauges, gauge pins, a micrometer, and a linear scale.Fig. 4 and Fig. 5 show the equipment used for the roll test.NOTE 4A parallel can be used but it is o

38、ptional.6.2 For the finger roll test, a precision flat surface such as abench or table is required. The surface of the bench or tableshould not be pitted, gouged, cracked, and so forth, but be ingood condition.6.3 For the gap test, a precision flat surface such as a benchor table is required. For he

39、avy test specimens such as bar, thefloor can be used. The surface of the bench, table, or floorshould not be pitted, gouged, cracked, and so forth, but be ingood condition. A measurement device such as a thicknessgauge, gauge pin, micrometer, optical comparator, or a linearscale may be used to deter

40、mine the gap. The deviation fromflatness of the flat surface shall be at least one order ofmagnitude less than the straightness requirement of bar, rod,wire, or tubing that is going to be inspected.6.4 For the TIR test, a dial indicator and two or moreV-blocks are required.7. Hazards7.1 Ends of cut

41、bar, rod, tube, and wire can be sharp. Cutpieces of material need to be handled with care. It may benecessary to wear gloves in order to avoid being injured.7.2 A pinch point exists between the inclined table andparallel. Caution and safety precautions are required in order toavoid pinch point injur

42、ies.7.3 Safety glasses and proper cutting techniques should beused when creating the test sample. Cutters should be in thesharpened condition.8. Sampling, Test Specimens, and Test Units8.1 The test sample for the finger roll and inclined flat platetests shall consist of a minimum of 0.25 m (10 in.)

43、cut piece oftubing or wire. The test sample for the gap and TIR tests shallconsist of a 0.25 6 0.02 m (10 6 1 in.) cut piece of rod ortubing, bars, or wire.8.2 The number of test specimens shall be agreed uponbetween the customer and supplier.8.3 Whether or not the test specimens are cut from the sa

44、meor separate pieces of straightened and cut to length rod, tube, orwire or spools, shall be agreed upon between the customer andsupplier.8.4 For small diameter wire and tubing, the straightened-to-length wire, tubing or spool, the test sample shall be sectionedfrom the lot by using a sharp cutter t

45、o ensure a burr-free edgeafter the cutting process. For larger diameter rod, tubing, andwire, an abrasive cut off or diamond blade saw shall be used toensure a burr-free edge and that the edge was not permanentlydeformed during the cutting process.8.5 For superelastic NiTi wire, tube, or rod, the st

46、raightnessshould be measured when the material is in the fully super-elastic condition. If the austenite finish temperature (Af)ofthetest sample is greater than the temperature of the environment,the sample should be preheated to a temperature greater thanthe austenite finish temperature (Af)9. Prep

47、aration of Apparatus9.1 For the inclined flat plate test, the surfaces of the plateand parallel shall be clean and not damaged. For the finger rolland gap tests, the flat surface used for the inspection shall beclean and not damaged. For the TIR test, the V-blocks shouldbe clean and in good conditio

48、n.10. Calibration and Standardization10.1 All measurement devices used in the test procedureincluding precision surface plates, parallels, protractors, thick-ness gauges, gauge pins, micrometers, or linear scales, shouldbe in calibration as defined by company quality assurancepolicy.11. Procedure11.

49、1 Inclined Flat Plate Test (qualitative test method):11.1.1 Ensure that the plate is clean, free of debris, and freeof damage. Optional: if a parallel is used, ensure that it is clean,free of debris, and free of damage.11.1.2 OptionalIf a parallel is used, place parallel on thetable and elevate it to a height above the table that is equal tothe rod, tube, or wire diameter plus an acceptable maximumtolerance to be agreed upon by the customer or supplier. Thiscan be done using gauge pins, thickness gauges, a micrometer,or linear scale (see