1、Designation: F 1350 08Standard 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 () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for t
3、he manufacture of wrought 18chromium-14 nickel-2.5 molybdenum stainless steel in theform of surgical fixation wire.1.2 The values stated in SI units are to be regarded as thestandard. The inch-pound values in parentheses are for infor-mation only.2. Referenced Documents2.1 ASTM Standards:2A 555/A 55
4、5M Specification for General Requirements forStainless Steel Wire and Wire RodsE8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsF86 Practice for Surface Preparation and Marking of Me-tallic Surg
5、ical ImplantsF 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 USP Standard:3No
6、nabsorbable Surgical Suture, U.S. Pharmacopeia2.3 ISO Standard:4ISO 9001 Quality Management SystemRequirements2.4 American Society for Quality Standard:5ASQ C1 Specification of General Requirements for a Qual-ity Program3. General Requirements for Delivery3.1 In addition to the requirements of this
7、specification, allrequirements of the current editions of Specifications A 555/A 555M and F 138 apply.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 Terms Specific to Thi
8、s 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 Quantity,5.1.2 ASTM desi
9、gnation and date of issue,5.1.3 Material requirements,5.1.4 Mechanical properties,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 requirements.6. Material Requirements6.1 The
10、starting material used to make fixation wire mustmeet the requirements of Specification F 138.6.2 Surgical fixation wire shall conform to the specifiedchemical requirements of Specification F 138. Conformancewith this standard shall be so identified by suitable packaging,labeling, or both.1This spec
11、ification 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 approved May 1, 2008. Published June 2008. Originallyapproved in 1991. Last previous edition approv
12、ed in 2002 as F 1350 02.2For 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.3Available from U.S. Pharmacopeia (US
13、P), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.4Available from 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:/w
14、ww.asq.org.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.7. Mechanical Requirements7.1 Surgical fixation wire shall conform to the appropriatemechanical properties s
15、pecified in Table 1.7.2 Perform tension tests in accordance with Test MethodsE8using a 254 mm (10 in.) gage length and a cross-head speedof 254 mm/min (10 in./min). Should any of the test specimensnot meet the specified requirements, test two additional testpieces representative of the same lot, in
16、the same manner, foreach failed test piece. The lot shall be considered in complianceonly 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
17、requirements specified in Table1. Refer to subsections 7.11.4 and 7.11.5 of Test Methods 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 t
18、he latestversion of USP for Nonabsorbable Surgical Sutures, whentested in accordance with 7.2.8. Dimensional Requirements8.1 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 andmin
19、us 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 total spread in size tolerance is not lessthan the total spread shown in Table 1.8.3 The maximum out-of-r
20、ound tolerance for round wire isone-half of the size tolerance given in Table 1.9. Surface Condition Requirements9.1 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 s
21、urgical 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 serviceability of the wire.The surfaces shall be cleaned to minimize the presence offoreign material
22、9.3 The wire may be subjected to a passivation process ifrequested by the purchaser. Such passivation process 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 conform
23、ance to these limits,an observed or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.11. Certification11.1 The supplier shall provide a certification that thematerial was
24、 manufactured and tested in accordance with thisspecification. A report of the test results shall be furnished tothe 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.TABLE 1 Mechan
25、ical and Dimensional Requirements for Wrought Annealed 18 Chromium-14 Nickel-2.5 Molybdenum Stainless SteelSurgical 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 (
26、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 0.0016) 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) 250.0
27、70 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 0.0050 (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 0.30
28、0 (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 (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 0.019
29、7) 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 under 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
30、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 (0.0394 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 a
31、re 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 not less than the total spread shown in this table.
32、CThe maximum out-of-round tolerance for round wire is 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 for spooled wire is 6 percentage points lower than values
33、 given in this table.F135008213. Keywords13.1 fixation; mechanical properties; stainless steel; surgicalimplant; suture; tolerances; wire; wrought iron-chromium-nickel-molybdenum alloy; 316L alloyAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to specify th
34、erequirements 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, SI units are re
35、garded 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 of biological re
36、sponse 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 specification, ho
37、wever, 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 1350 02) that may impact the use of this standar
38、d. (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 connection with any item mentionedin this s
39、tandard. 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 responsible technical committee and must be re
40、viewed 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 will receive careful consideration at a meeting of therespons
41、ible 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 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).F1350083
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