1、Designation: F 1350 02Standard Specification forWrought 18Chromium-14Nickel-2.5Molybdenum StainlessSteel Surgical Fixation Wire (UNS S31673)1This standard is issued under the fixed designation F 1350; the number immediately following the designation indicates the year oforiginal adoption or, in the
2、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. Scope *1.1 This specification covers the requirements for the manu-facture of wrought 18 chromiu
3、m-14 nickel-2.5 molybdenumstainless steel in the form of surgical 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:A 555 Specification for General Requirements for
4、 StainlessSteel Wire and Wire Rods2E 8 Test Methods for Tension Testing of Metallic Materials3F 86 Practice for Surface Preparation and Marking of Me-tallic Surgical Implants4F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S316
5、73)4F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone42.2 USP Standard:5Nonabsorbable Surgical Suture, U.S. Pharmacopeia2.3 American Society for Quality Standard:6ASQ C1 Specification of General Requirements fo
6、r a Qual-ity Program3. General Requirements for Delivery3.1 In addition to the requirements of this specification, allrequirements of the current editions of Specifications A 555and F 138 apply.3.2 In cases where a conflict exists between this specifica-tion and the standards listed in Section 2, th
7、is 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 properties,4.1.5 Form,4.1.6 Dimensio
8、nal 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 the requirements of F 138.5.2 Surgical fixation wire
9、shall conform to the specifiedchemical requirements of Specification F 138. Conformancewith this standard shall be so identified by suitable packagingor labeling or both.6. Mechanical Requirements6.1 Surgical fixation wire shall conform to the appropriatemechanical properties specified in Table 1.6.
10、2 Mechanical testing shall be performed in accordancewith Methods E 8 using a 254 mm (10 in.) gage length and across-head speed of 254 mm/min (10 in./min).6.3 The wire shall meet the requirements of the latestversion of USP for Nonabsorbable Surgical Sutures, whentested in accordance with 6.2.7. Dim
11、ensional Requirements7.1 Surgical fixation wire shall be fabricated in accordancewith the dimensions 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 pl
12、us and nothingminus, or all minus and nothing plus, or any combination ofplus and minus if the total spread in size tolerance is not less1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F0
13、4.12 on Metallurgical Materials.Current edition approved Apr. 10, 2002. Published June 2002. Originallypublished as F 1350 91. Last previous edition F 1350 01.2Annual Book of ASTM Standards, Vol 01.03.3Annual Book of ASTM Standards, Vol 03.01.4Annual Book of ASTM Standards, Vol 13.01.5Available from
14、 U.S. Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD20852.6Available from American 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 Conshohocke
15、n, PA 19428-2959, United States.than 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. Other surf
16、ace finishes shall be specified asagreed to between supplier and purchaser.8.2 The surface of surgical fixation wire conforming to thisspecification shall be processed to minimize imperfectionssuch as tool marks, nicks, scratches, cracks, cavities, spurs, andother defects that would impair the servi
17、ceability of the wire.The surfaces shall be cleaned to minimize the presence offoreign material.8.3 The wire may be subjected to a passivation process ifrequested by the purchaser. Such passivation process shall beperformed in accordance with F 86.9. Quality Program Requirements9.1 The surgical wire
18、 producer and any processors shallmaintain a quality program such as that which is defined inASQ C1.10. Certification10.1 Certification 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 shipm
19、ent.11. Keywords11.1 fixation; mechanical properties; stainless steel; surgicalimplant; suture; tolerances; wire; wrought iron-chromium-nickel-molybdenum alloy; 316L alloyTABLE 1 Mechanical and Dimensional Requirements for Wrought Annealed 18 Chromium-14 Nickel-2.5 Molybdenum Stainless SteelSurgical
20、 Fixation WireRange of Sizes Diameter, mm (in.) USP SizeADiameterToleranceBCTensile Strengthmax, MPa (ksi)DElong.min %E0.010 to under 0.020 (0.0004 to 0.0008) . 0.0015 (0.000 06) 1380 (200) 150.020 to under 0.030 (0.0008 to 0.0012) 100 0.0015 (0.000 06) 1240 (180) 150.030 to under 0.040 (0.0012 to 0
21、.0016) 90 0.0025 (0.0001) 1100 (160) 200.040 to under 0.050 (0.0016 to 0.0020) 80 0.0025 (0.0001) 1100 (160) 200.050 to under 0.070 (0.0020 to 0.0028) 70 0.0025 (0.0001) 960 (140) 250.070 to under 0.100 (0.0028 to 0.0039) 60 0.0025 (0.0001) 965 (140) 250.100 to under 0.150 (0.0039 to 0.0059) 50 0.00
22、50 (0.0002) 895 (130) 300.150 to under 0.200 (0.0059 to 0.0079) 40 0.0050 (0.0002) 895 (130) 300.200 to under 0.250 (0.0079 to 0.0098) 30 0.0075 (0.0003) 860 (125) 300.250 to under 0.300 (0.0098 to 0.0118) . 0.0075 (0.0003) 860 (125) 300.300 to under 0.340 (0.0118 to 0.0134) 20 0.0100 (0.0004) 860 (
23、125) 300.340 to under 0.350 (0.0134 to 0.0138) . 0.0100 (0.0004) 860 (125) 300.350 to under 0.400 (0.0138 to 0.0158) 10 0.0100 (0.0004) 825 (120) 350.400 to under 0.500 (0.0158 to 0.0197) 1 0.0100 (0.0004) 825 (120) 350.500 to under 0.600 (0.0196 to 0.0236) 2 0.0100 (0.0004) 790 (115) 350.600 to und
24、er 0.700 (0.0236 to 0.0276) 3 and 4 0.0130 (0.0005) 790 (115) 350.700 to under 0.800 (0.0276 to 0.0315) 5 0.0130 (0.0005) 760 (110) 350.800 to under 0.900 (0.0315 to 0.0354) 6 0.0200 (0.0008) 760 (110) 350.900 to under 1.000 (0.0354 to 0.0394) 7 0.0200 (0.0008) 760 (110) 401.000 to under 1.100 (0.03
25、94 to 0.0433) . 0.0200 (0.0008) 690 (100) 401.100 to under 1.600 (0.0433 to 0.0630) . 0.0250 (0.0010) 690 (100) 40AFor 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 may be specified al
26、l 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 in this table.DMax
27、imum tensile strength in ksi (1 ksi = 1000 psi) is specified to assure proper wire-handling characteristics.EMinimum elongation for spooled wire is 6 percentage points lower than values given in this table.F 13502APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification
28、 is to specify therequirements for the manufacture of wrought 18 chromium-14nickel-2.5 molybdenum stainless steel in the form of surgicalfixation 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
29、, SI units are regarded as the standardhistoric means of size measurement.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been employed successfully in human implant applicationsin contact with soft tissue and bone for over a decade. Due tothe well-characterized level
30、 of biological response exhibited bythis alloy, it has been used as a control material in PracticeF 981.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 materialreferred to in this
31、specification, however, has shown that anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.SUMMARY OF CHANGESCommmittee F04 has identified the location of selected changes to this standard since the last issue(F 1350 01) that may impact the u
32、se 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 F04.12.ASTM International takes no position respecting the validity of any patent r
33、ights 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.This standard is subject to revision at a
34、ny 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 International Headquarters. Your comments
35、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 below.This standard is copyrighted by
36、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 13503
