ASTM F1091-2002 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)《外科固定线采用煅制钴-20铬-15钨-10镍合金(UNS R30605)标准规范》.pdf

1、Designation: F 1091 02Standard Specification forWrought Cobalt-20Chromium-15Tungsten-10Nickel AlloySurgical Fixation Wire UNS R306051This standard is issued under the fixed designation F 1091; the number immediately following the designation indicates the year oforiginal adoption or, in the case of

2、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. Scope *1.1 This specification covers the requirements for the manu-facture of wrought cobalt-20chromium-

3、15tungsten-10nickelsurgical fixation wire.1.2 The values stated in SI units are to be regarded as thestandard. The inch-pound equivalents of the SI units may beapproximate.2. Referenced Documents2.1 ASTM Standards:E 8 Test Methods for Tension Testing of Metallic Materials2F 86 Practice for Surface P

4、reparation and Marking of Me-tallic Surgical Implants3F 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)32.2 USP Standards:4Nonabsorbable Surgical Suture, U.S. Pharmacopeia2.3 American Society for Quality Standard:5ASQ C1 Specif

5、ication of General Requirements for a Qual-ity Program3. General Requirements for Delivery3.1 In addition to the requirements of this specification, allrequirements of the current editions of Specification F 90 shallapply.3.2 In cases where a conflict exists between this specifica-tion and the stand

6、ards listed in Section 2, this specificationshall take precedence.4. Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information:4.1.1 Quantity,4.1.2 ASTM designation and date of issue,4.1.3 Material requirements,4.1.4 Mechanical properti

7、es,4.1.5 Form,4.1.6 Dimensional requirements, including diameter anddiameter tolerance,4.1.7 Surface condition and handling,4.1.8 Special tests (if applicable), and4.1.9 Other requirements.5. Material Requirements5.1 The starting material used to make fixation wire mustmeet Specification F 90.5.2 Su

8、rgical fixation wire shall conform to the specifiedchemical requirements of Specification F 90.6. Mechanical Requirements6.1 Surgical fixation wire shall conform to the appropriatemechanical properties specified in Table 1.6.2 Mechanical testing shall be performed in accordancewith Test Methods E 8

9、using a 254-mm (10-in.) gage lengthand crosshead speed of 254 mm/min (10 in./min).6.3 The wire shall meet the requirements of USP forNonabsorbable Surgical Sutures, when tested in accordancewith 6.2.7. Dimensional Requirements7.1 Surgical fixation wire shall be fabricated in accordancewith the dimen

10、sions and tolerances specified in Table 1.7.2 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 nothingminus, or all minus and nothing plus, or any combination ofplus and minus if the

11、total spread in size tolerance is not lessthan the total spread shown in Table 1.7.3 The maximum out-of-round tolerance for round wire isone half of the size tolerance given in Table 1.8. Surface Condition Requirements8.1 Surgical fixation wire is usually furnished in the bright-annealed condition.

12、Other surface finishes shall be specified asagreed to between supplier and purchaser.1This 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 edition appr

13、oved Apr. 10, 2002. Published June 2002. Originallypublished as F 1091 91. Last previous edition F 1091 91 (2000).2Annual Book of ASTM Standards, Vol 03.01.3Annual Book of ASTM Standards, Vol 13.01.4Available from U.S. Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD20852.5Available from American

14、Society for Quality, 600 N. Plankinton Ave.,Milwaukee, WI 53203.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.8.2 The surface of surgical fixation wire conforming to

15、 thisspecification shall be processed to minimize imperfectionssuch as 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.8.3 The wire may be subjected to a

16、 passivation process ifrequested by the purchaser. Such passivation process shall beperformed in accordance with F 86.9. Quality Program Requirements9.1 The surgical wire producer and any processors shallmaintain a quality program such as that which is defined inASQ C1.10. Certification10.1 Certific

17、ation shall be provided by the supplier that thematerial meets the requirements of this specification. A reportof the test results shall be furnished at the time of shipment.11. Keywords11.1 fixation; L-605 alloy; mechanical properties; surgicalimplant; suture; tolerances; wire; wrought cobalt-chrom

18、ium-tungsten-nickel alloyAPPENDIXES(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 surgicalfixation wire.X1.2 Surgical fixation wire shall be handled

19、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.TABLE 1 Mechanical and Dimensional Requirements for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixati

20、onWireRange of Sizes Diameter, mm (in.)USPSizeADiameterToleranceB,CTensile Strengthmax, MPa (ksi)DElong.min, %E0.010 to under 0.020 (0.0004 to 0.0008) . 0.0015 (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)

21、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 0.0025 (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 0.00

22、50 (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 (0.0003) 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

23、) 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 (185) 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) 4

24、50.600 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 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

25、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 purposes only (U.S. Pharmacopeia).BDiameter tolerances are over and under as given in this table. When required by the purchaser, round wire tolerances

26、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 not less than the total spread shown in this table.CThe maximum out-of-round tolerance for round wire is one half of the total size tolerance given

27、 in this table.DMaximum tensile strength in ksi (1 ksi = 1000 psi) is specified to assure proper wire-handling characteristics.EMinimum elongation for spooled wire is six percentage points lower than values given in this table.F 10912X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this spe

28、cificationhas 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 materia

29、lreferred 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 91 (2

30、000) that may impact the use of this standard.(1) The responsibility for this specification was transferredfrom Subcommittee F04.21 to Subcommittee F04.12.(2) The specification was modified to incorporate the standardformat (template) used by Subcommittee F04.12.ASTM International takes no position

31、respecting the validity of any patent rights asserted in 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.Th

32、is standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM Int

33、ernational Headquarters. Your comments will receive careful 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

34、 below.This standard is copyrighted by ASTM International, 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).F 10913