ASTM F1091-2008 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)《轧制钴-铬合金外科固定金属线的标准规范(UNS R30605)》.pdf

1、Designation: F 1091 08Standard Specification forWrought Cobalt-20Chromium-15Tungsten-10Nickel AlloySurgical Fixation Wire (UNS R30605)1This standard is issued under the fixed designation F 1091; the number immediately following the designation indicates the year oforiginal adoption or, in the case o

2、f 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 covers the chemical, mechanical, andmetallurgical requirements for the man

3、ufacture of wroughtcobalt-20chromium-15tungsten-10nickel surgical fixationwire.1.2 The values stated in SI units are to be regarded as thestandard. The inch-pound values given in parentheses are forinformation only.2. Referenced Documents2.1 ASTM Standards:2E8 Test Methods for Tension Testing of Met

4、allic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsF86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions

5、 (UNS R30605)2.2 USP Standards:3Nonabsorbable Surgical Suture, U.S. Pharmacopeia2.3 ISO Standard:4ISO 9001 Quality Management SystemsRequirements2.4 American Society for Quality Standard:5ASQ C1 Specification of General Requirements for a Qual-ity Program3. General Requirements for Delivery3.1 In ad

6、dition to the requirements of this specification, allrequirements of the current editions of Specification F90shallapply.3.2 In cases where a conflict exists between this specifica-tion and the standards listed in Section 2, this specificationshall take precedence.4. Terminology4.1 Definitions of Te

7、rms Specific to This Standard:4.1.1 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.5. Ordering Information5.1 Inquiries and orders for material under this specificationshall include the following information:5.1.1 Quant

8、ity,5.1.2 ASTM designation and date of issue,5.1.3 Material requirements (Section 6),5.1.4 Mechanical properties (7),5.1.5 Form,5.1.6 Dimensional requirements, including diameter anddiameter tolerance,5.1.7 Surface condition and handling,5.1.8 Special tests (if applicable), and5.1.9 Other requiremen

9、ts.6. Material Requirements6.1 The starting material used to make fixation wire mustmeet Specification F90.6.2 Surgical fixation wire shall conform to the specifiedchemical requirements of Specification F90.7. Mechanical Requirements7.1 Surgical fixation wire shall conform to the appropriatemechanic

10、al properties specified in Table 1.7.2 Perform tension tests in accordance with Test MethodsE8using a 254-mm (10-in.) gage length and crosshead speedof 254 mm/min (10 in./min). Should any of the test specimens1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical

11、Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved May 1, 2008. Published June 2008. Originallyapproved 1991. Last previous edition approved in 2002 as F 1091 02.2For referenced ASTM standards, visit the ASTM website, www.

12、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 U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.4Available fro

13、m American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.1*A Summary of Changes section appears at the end of this standard.Copyri

14、ght ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.not meet the specified requirements, test two additional testpieces representative of the same lot, in the same manner, foreach failed test piece. The lot shall be considered in complianceonly

15、 if all additional test pieces meet the specified require-ments.7.3 Tensile test results for which any specimen fracturesoutside the gage length shall be considered acceptable if theelongation meets the minimum requirements specified in Table1. Refer to subsections 7.11.4 and 7.11.5 of Test Methods

16、E8.If the elongation is less than the minimum requirement, discardthe test and retest. Retest one specimen for each specimen thatdid not meet the minimum requirement.7.4 The wire shall meet the requirements of USP forNonabsorbable Surgical Sutures, when tested in accordancewith 7.2.8. Dimensional Re

17、quirements8.1 Surgical fixation wire shall be fabricated in accordancewith the dimensions and tolerances specified in Table 1.8.2 Unless otherwise specified, size tolerances are plus andminus as shown in Table 1. When required by the purchaser,round wire tolerances may be specified all plus and noth

18、ingminus, or all minus and nothing plus, or any combination ofplus and minus if the total spread in size tolerance is not lessthan the total spread shown in Table 1.8.3 The maximum out-of-round tolerance for round wireshall be one-half of the size tolerance given in Table 1.9. Surface Condition Requ

19、irements9.1 Surgical fixation wire is usually furnished in the bright-annealed condition. Other surface finishes shall be specified asagreed to between supplier and purchaser.9.2 The surface of surgical fixation wire conforming to thisspecification shall be processed to minimize imperfectionssuch as

20、 tool marks, nicks, scratches, cracks, cavities, spurs, andother defects that would impair the serviceability of the wire.The surfaces shall be cleaned to minimize the presence offoreign material.9.3 The wire may be subjected to a passivation process ifrequested by the purchaser. Such passivation pr

21、ocess shall beperformed in accordance with Practice F86.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limitsan observed or calculated value shall be rounded to the nearestunit in the last right

22、 hand digit used in expressing thespecification limit, in accordance with the rounding of PracticeE29.11. Certification11.1 The supplier shall provide a certification that thematerial was manufactured and tested in accordance with thisspecification. A report of the test results shall be furnished to

23、the purchaser at the time of shipment.12. Quality Program Requirements12.1 The supplier shall maintain a quality program such asthat defined in ASQ C1, ISO 9001, or similar.13. Keywords13.1 fixation; L-605 alloy; mechanical properties; surgicalimplant; suture; tolerances; wire; wrought cobalt-chromi

24、um-tungsten-nickel alloyTABLE 1 Mechanical and Dimensional Requirements for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical FixationWireRange of Sizes Diameter, mm (in.)USPSizeADiameterToleranceB,CTensile Strengthmax, MPa (ksi)DElong.min, %E0.010 to under 0.020 (0.0004 to 0.0008) . 0

25、.0015 (0.000 06) 1730 (250) 200.020 to under 0.030 (0.0008 to 0.0012) 10-0 0.0015 (0.000 06) 1660 (240) 200.030 to under 0.040 (0.0012 to 0.0016) 9-0 0.0025 (0.0001) 1590 (230) 250.040 to under 0.050 (0.0016 to 0.0020) 8-0 0.0025 (0.0001) 1555 (225) 300.050 to under 0.070 (0.0020 to 0.0028) 7-0 0.00

26、25 (0.0001) 1520 (220) 300.070 to under 0.100 (0.0028 to 0.0039) 6-0 0.0025 (0.0001) 1385 (215) 350.100 to under 0.150 (0.0039 to 0.0059) 5-0 0.0050 (0.0002) 1450 (210) 350.150 to under 0.200 (0.0059 to 0.0079) 4-0 0.0050 (0.0002) 1415 (205) 350.200 to under 0.250 (0.0079 to 0.0098) 3-0 0.0075 (0.00

27、03) 1380 (200) 400.250 to under 0.300 (0.0098 to 0.0118) . 0.0075 (0.0003) 1380 (200) 400.300 to under 0.340 (0.0118 to 0.0134) 2-0 0.0100 (0.0004) 1310 (190) 400.340 to under 0.350 (0.0134 to 0.0138) . 0.0100 (0.0004) 1310 (190) 400.350 to under 0.400 (0.0138 to 0.0158) 1-0 0.0100 (0.0004) 1275 (18

28、5) 400.400 to under 0.500 (0.0158 to 0.0197) 1 0.0100 (0.0004) 1275 (185) 400.500 to under 0.600 (0.0197 to 0.0236) 2 0.0100 (0.0004) 1275 (185) 450.600 to under 0.700 (0.0236 to 0.0276) 3 and 4 0.0130 (0.0005) 1240 (180) 450.700 to under 0.800 (0.0276 to 0.0315) 5 0.0130 (0.0005) 1240 (180) 450.800

29、 to under 0.900 (0.0315 to 0.0354) 6 0.0200 (0.0008) 1240 (180) 450.900 to under 1.000 (0.0354 to 0.0394) 7 0.0200 (0.0008) 1170 (170) 451.000 to under 1.100 (0.0394 to 0.0433) . 0.0200 (0.0008) 1170 (170) 451.100 to under 1.600 (0.0433 to 0.0630) . 0.0250 (0.0010) 1140 (165) 45AFor reference purpos

30、es only (U.S. Pharmacopeia).BDiameter tolerances are over and under as given in this table. When required by the purchaser, round wire tolerances may be specified all plus and nothing minus,or all minus and nothing plus, or any combination of plus and minus if the total spread in size tolerance is n

31、ot less than the total spread shown in this table.CThe maximum out-of-round tolerance for round wire shall be one-half of the total size tolerance given in this table.DMaximum tensile strength in ksi (1 ksi = 1000 psi) is specified to assure proper wire-handling characteristics.EMinimum elongation f

32、or spooled wire is six percentage points lower than values given in this table.F1091082APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to specify therequirements for the manufacture of wrought cobalt-20chromium-15tungsten-10nickel alloy in the form of surgi

33、calfixation wire.X1.2 Surgical fixation wire shall be handled with care andadequately packaged to prevent damage and contamination ofthe surface.X1.3 For this product, SI units are regarded as the standardhistoric means of size measurement.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by th

34、is specificationhas been employed successfully in human implant applicationsin contact with soft tissue and bone for over a decade.X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. Long-term clinical experience of the use of the m

35、aterialreferred to in this specification, however, has shown that anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue(F 1091

36、 02) that may impact the use of this standard. (Approved May 1, 2008.)(1) Editorial corrections have been made in order to meetterminology and formatting guidelines established for implantmaterial standards.ASTM International takes no position respecting the validity of any patent rights asserted in

37、 connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the re

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39、ful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM Internationa

40、l, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F1091083