1、Designation: F1350 08F1350 15Standard Specification forWrought 18Chromium-14Nickel-2.5Molybdenum StainlessSteel Surgical Fixation Wire (UNS S31673)1This standard is issued under the fixed designation F1350; the number immediately following the designation indicates the year oforiginal adoption or, i
2、n 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.1. Scope*1.1 This specification covers the chemical, mechanical, and metallurgical requirement
3、s for the manufacture of wrought 18chromium-14 nickel-2.5 molybdenum stainless steel in the form of surgical fixation wire.1.2 UnitsThe values stated in either SI units or inch-pound units are to be regarded separately as the standard. The inch-poundvalues in parentheses are for information only.sta
4、ted in each system may not be exact equivalents; therefore, each system shall beused independently of the other. Combining values from the two systems may result in non-conformance with this specification.2. Referenced Documents2.1 ASTM Standards:2A555/A555M Specification for General Requirements fo
5、r Stainless Steel Wire and Wire RodsE8E8/E8M Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsF86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF138 Specification for W
6、rought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneIEEE/ASTM SI 10 American National Standard for Metric Practi
7、ce2.2 USP Standard:3Nonabsorbable 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 Quality Program3. General Requirements for Delivery3.1 In addition to the
8、requirements of this specification, all requirements of the current editions of Specifications A555/A555Mand F138 apply.3.2 In cases where a conflict exists between this specification and the standards listed in Section 2, this specification shall takeprecedence.4. Terminology4.1 Definitions of Term
9、s Specific to This Standard:1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved May 1, 2008May 1, 2015. Published June 2008 June 2
10、015. Originally approved in 1991. Last previous edition approved in 20022008 asF1350 02.F1350 08. DOI: 10.1520/F1350-08.10.1520/F1350-15.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume in
11、formation, refer to the standards Document Summary page on the ASTM website.3 Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http:/www.usp.org.4 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:
12、/www.ansi.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users con
13、sult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken
14、, PA 19428-2959. United States14.1.1 lot, nthe total number of mill products produced from the same melt heat under the same conditions at essentially thesame time.5. Ordering Information5.1 Inquiries and orders for material under this specification shall include the following information:5.1.1 Quan
15、tity,5.1.2 ASTM designation 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 and diameter tolerance,5.1.7 Surface condition and handling,5.1.8 Special tests (if applicable), and5.1.9 Other requirements.6. Material
16、 Requirements6.1 The starting material used to make fixation wire must meet the requirements of Specification F138.6.2 Surgical fixation wire shall conform to the specified chemical requirements of Specification F138. Conformance with thisstandard shall be so identified by suitable packaging, labeli
17、ng, or both.7. Mechanical Requirements7.1 Surgical fixation wire shall conform to the appropriate mechanical properties specified in Table 1.7.2 Perform tension tests in accordance with Test Methods E8E8/E8M using a 254 mm (10 in.)10 in. gage length and across-head speed of 254 mm/min (10 in./min).1
18、0 in./min. Should any of the test specimens not meet the specified requirements,test two additional test pieces representative of the same lot, in the same manner, for each failed test piece. The lot shall beconsidered in compliance only if all additional test pieces meet the specified requirements.
19、7.3 Tensile test results for which any specimen fractures outside the gage length shall be considered acceptable if the elongationmeets the minimum requirements specified in Table 1. Refer to subsections 7.11.4 and 7.11.5 of Test Methods E8E8/E8M. If theelongation is less than the minimum requiremen
20、t, discard the test and retest. Retest one specimen for each specimen that did notmeet the minimum requirement.7.4 The wire shall meet the requirements of the latest version of USP for Nonabsorbable Surgical Sutures, when tested inaccordance with 7.2.8. Dimensional Requirements8.1 Surgical fixation
21、wire shall be fabricated in accordance with the dimensions and tolerances specified in Table 1.8.2 Unless otherwise specified, size tolerances are plus and minus as shown in Table 1. When required by the purchaser, roundwire tolerances may be specified all plus and nothing minus, or all minus and no
22、thing plus, or any combination of plus and minusif the total spread in size tolerance is not less than the total spread shown in Table 1.8.3 The maximum out-of-round tolerance for round wire is one-half of the size tolerance given in Table 1.8.4 Units of Measure8.4.1 SelectionThis specification requ
23、ires that the purchaser select the units (SI or inch-pound) to be used for productclarification. In the absence of a stated selection of units on the purchase order, this selection may be expressed by the purchaserin several alternate forms listed in order of precedence.8.4.1.1 If the purchaser and
24、supplier have a history of using specific units, these units shall continue to be certified untilexpressly changed by the purchaser.8.4.1.2 In the absence of historic precedence, if the units used to define the product on the purchasers purchase order (PO) areconsistent with the specification and en
25、gineering drawing, then these units shall be used by the supplier for product certification.8.4.1.3 If the purchasers selection of units is unclear, the units of measure shall be agreed upon between the purchaser andsupplier.8.4.2 Conversion of UnitsIf the suppliers test equipment does not report in
26、 the selected units, the test equipment units maybe converted to the selected units for certification purposes. Accurate arithmetic conversion and proper use of significant digitsshould be observed when performing this conversion. IEEE/ASTM SI 10 provides guidelines for the use of SI units. Annex A
27、ofIEEE/ASTM SI 10 provides conversion tables and Annex B of IEEE/ASTM SI 10 provides rules for conversion and significance.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
28、supplier and purchaser.F1350 1529.2 The surface of surgical fixation wire conforming to this specification shall be processed to minimize imperfections such astool marks, nicks, scratches, cracks, cavities, spurs, and other defects that would impair the serviceability of the wire. The surfacesshall
29、be cleaned to minimize the presence of foreign material.9.3 The wire may be subjected to a passivation process if requested 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 num
30、erical limits in this specification. To determine conformance to these limits, anobserved or calculated value shall be rounded to the nearest unit in the last right hand digit used in expressing the specificationlimit, in accordance with the rounding method of Practice E29.TABLE 1 Mechanical and Dim
31、ensional Requirements for Wrought Annealed 18 Chromium-14 Nickel-2.5 Molybdenum Stainless SteelSurgical Fixation WireRange of Sizes Diameter, mm (in.) USP SizeA DiameterToleranceBC Tensile Strengthmax, MPa (ksi)D Elong.min %E0.010 to under 0.020 (0.0004 to 0.0008) . 0.0015 (0.000 06) 1380 (200) 150.
32、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) 250.070 to und
33、er 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 0.300 (0.0098
34、 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 0.0197) 1 0.01
35、00 (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 (0.0008) 76
36、0 (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) 40TABLE 1 Mechanical and Dimensional Requirements for Wrought Annealed 18 Chromium
37、-14 Nickel-2.5 Molybdenum Stainless SteelSurgical Fixation WireRange of Sizes Diameter, mm in. USP SizeA DiameterToleranceBC Tensile Strengthmax, MPa ksiD Elong.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
38、 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 960 140 250.070 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 0.00
39、59 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 0.300 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 860 125 300.340 to un
40、der 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 under 0.700 0.0236 to 0.0276 3 and 4 0.0130 0
41、.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 0.0394 to 0.0433 . 0.0200 0.0008 690 100 401.100 to under 1.600 0.0433
42、to 0.0630 . 0.0250 0.0010 690 100 40A For reference purposes only (U.S. Pharmacopeia).B Diameter 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, orall minus and nothing plus, or any combination o
43、f plus and minus if the total spread in size tolerance is not less than the total spread shown in this table.C The maximum out-of-round tolerance for round wire is one-half of the total size tolerance given in this table.D Maximum tensile strength in ksi (1 ksi = 1000 psi) is specified to assure pro
44、per wire-handling characteristics.E Minimum elongation for spooled wire is 6 percentage points lower than values given in this table.F1350 15311. Certification11.1 The supplier shall provide a certification that the material was manufactured and tested in accordance with thisspecification. specifica
45、tion and met all requirements. A report of the test results shall be furnished to the purchaser at the time ofshipment.12. Quality Program Requirements12.1 The supplier shall maintain a quality program such as that defined in ASQ C1, ISO 9001, or similar.13. Keywords13.1 fixation; mechanical propert
46、ies; stainless steel; surgical implant; suture; tolerances; wire; wrought iron-chromium-nickel-molybdenum alloy; 316L alloyAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to specify the requirements for the manufacture of wrought 18 chromium-14 nickel-2.5mo
47、lybdenum stainless steel in the form of surgical fixation wire.X1.2 Surgical fixation wire shall be handled with care and adequately packaged to prevent damage and contamination of thesurface.X1.3 For this product, SI units are regarded as the standard historic means of size measurement.X2. BIOCOMPA
48、TIBILITYX2.1 The alloy composition covered by this specification has been employed successfully in human implant applications incontact with soft tissue and bone for over a decade. Due to the well-characterized level of biological response exhibited by thisalloy, it has been used as a control materi
49、al in Practice F981.X2.2 No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body.Long-term clinical experience of the use of the material referred to in this specification, however, has shown that an acceptablelevel of biological response can be expected, if the material is used in appropriate applications.SUMMARY OF CHANGESCommittee F04 has identified the
