ASTM F1350-08
(Specification)Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
ABSTRACT
This specification covers UNS S31673 chromium-nickel-molybdenum wrought annealed stainless steel surgical fixation wires. The wires should conform to the required values of tensile strength and elongation. Wire surfaces should be processed to minimize tool marks, nicks, scratches, cracks, cavities, spurs, and other imperfections that would impair wire serviceability.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought 18 chromium-14 nickel-2.5 molybdenum stainless steel in the form of surgical fixation wire.
1.2 The values stated in SI units are to be regarded as the standard. The inch-pound values in parentheses are for information only.
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Designation:F1350 −08
StandardSpecification for
Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless
1
Steel Surgical Fixation Wire (UNS S31673)
This standard is issued under the fixed designation F1350; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
5
1. Scope* 2.4 American Society for Quality Standard:
ASQ C1 Specification of General Requirements for a Qual-
1.1 This specification covers the chemical, mechanical, and
ity Program
metallurgical requirements for the manufacture of wrought 18
chromium-14 nickel-2.5 molybdenum stainless steel in the
3. General Requirements for Delivery
form of surgical fixation wire.
3.1 In addition to the requirements of this specification, all
1.2 The values stated in SI units are to be regarded as the
requirements of the current editions of Specifications A555/
standard. The inch-pound values in parentheses are for infor-
A555M and F138 apply.
mation only.
3.2 In cases where a conflict exists between this specifica-
tion and the standards listed in Section 2, this specification
2. Referenced Documents
shall take precedence.
2
2.1 ASTM Standards:
A555/A555M Specification for General Requirements for
4. Terminology
Stainless Steel Wire and Wire Rods
4.1 Definitions of Terms Specific to This Standard:
E8 Test Methods for Tension Testing of Metallic Materials
4.1.1 lot, n—the total number of mill products produced
E29 Practice for Using Significant Digits in Test Data to
from the same melt heat under the same conditions at essen-
Determine Conformance with Specifications
tially the same time.
F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
5. Ordering Information
F138 Specification for Wrought 18Chromium-14Nickel-
5.1 Inquiries and orders for material under this specification
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
shall include the following information:
Implants (UNS S31673)
5.1.1 Quantity,
F981 Practice for Assessment of Compatibility of Biomate-
5.1.2 ASTM designation and date of issue,
rials for Surgical Implants with Respect to Effect of
5.1.3 Material requirements,
Materials on Muscle and Bone
5.1.4 Mechanical properties,
3
2.2 USP Standard:
5.1.5 Form,
Nonabsorbable Surgical Suture, U.S. Pharmacopeia
5.1.6 Dimensional requirements, including diameter and
4
diameter tolerance,
2.3 ISO Standard:
5.1.7 Surface condition and handling,
ISO 9001 Quality Management System—Requirements
5.1.8 Special tests (if applicable), and
5.1.9 Other requirements.
1
This specification is under the jurisdiction of ASTM Committee F04 on
6. Material Requirements
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
6.1 The starting material used to make fixation wire must
Current edition approved May 1, 2008. Published June 2008. Originally
meet the requirements of Specification F138.
approved in 1991. Last previous edition approved in 2002 as F1350 – 02. DOI:
10.1520/F1350-08.
6.2 Surgical fixation wire shall conform to the specified
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
chemical requirements of Specification F138. Conformance
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
with this standard shall be so identified by suitable packaging,
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
labeling, or both.
3
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
MD 20852-1790, http://www.usp.org.
4
5
Available from American National Standards Institute (ANSI), 25 W. 43rd St., Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
4th Floor, New York, NY 10036, http://www.ansi.org. Milwaukee, WI 53203, http://www.asq.org.
*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
1
---------------------- Page: 1 ----------------------
F1350−08
7. Mechanical Requirements plus and minus if the total spread in size tolerance is not less
than the total spread shown in Table 1.
7.1 Surgical fixation wire shall conform to the appropriate
mechanical properties specified 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.
7.2 Perform tension tests in accordance with Test Methods
E8 using a 254 mm (10 in.) gage length and a cross-head speed
9. Surface Condition Requirements
of 254 mm/min (10 in./min). Should any of the test specimens
9.1 Surgical fixation wire is u
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F1350–02 Designation: F 1350 – 08
Standard Specification for
Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless
1
Steel Surgical Fixation Wire (UNS S31673)
This standard is issued under the fixed designation F 1350; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought 18
chromium-14 nickel-2.5 molybdenum stainless steel in the form of surgical fixation wire.
1.2 The values stated in SI units are to be regarded as the standard. The inch-pound equivalents of the SI units may be
approximate. values in parentheses are for information only.
2. Referenced Documents
2
2.1 ASTM Standards:
A555 555/A 555M Specification for General Requirements for Stainless Steel Wire and Wire Rods
E 8 Test Methods for Tension Testing of Metallic Materials
E 29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
F 86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
3
2.2 USP Standard:
Nonabsorbable Surgical Suture, U.S. Pharmacopeia
4
2.3 ISO Standard:
ISO 9001 Quality Management System—Requirements
5
2.4 American Society for Quality Standard:
ASQ C1 Specification of General Requirements for a Quality Program
3. General Requirements for Delivery
3.1 In addition to the requirements of this specification, all requirements of the current editions of SpecificationsA 555/A 555M
and F 138 apply.
3.2 In cases where a conflict exists between this specification and the standards listed in Section 2, this specification shall take
precedence.
4. Ordering Information
4.1Inquiries and orders for material under this specification shall include the following information:
4.1.1Quantity,
4.1.2ASTM designation and date of issue,
4.1.3Material requirements,
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Apr. 10, 2002. Published June 2002. Originally published as F1350–91. Last previous edition F1350–01.
Current edition approved May 1, 2008. Published June 2008. Originally approved in 1991. Last previous edition approved in 2002 as F 1350 – 02.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 01.03.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Annual Book of ASTM Standards, Vol 03.01.
3
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
4
Annual Book of ASTM Standards, Vol 13.01.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Available from U.S. Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD 20852.
5
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
*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.
1
---------------------- Page: 1 ----------------------
F1350–08
4.1.4Mechanical properties,
4.1.5Form,
4.1.6Dimensional requirements, including diameter and diameter tolerance,
4.1.7Surface condition and handling,
4.1.8Special tests (if applicable), and
4.1.9Other requirements. Terminology
4.1 Definitions of Terms Specific to This Standard:
4.1.1 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the
same time.
5. Material Requirements
5.1The starting material used to make fixation wire must meet the requirements of F138Ordering Information
5.1 Inquiries and orders for material under this specification shall include the following information:
5.1.1 Quantity,
5.1.2 ASTM designation and date of i
...
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