ASTM F1350-15
(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 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with this specification.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F1350 −15
Standard Specification 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.
4
1. Scope* 2.3 ISO Standard:
ISO 9001 Quality Management System—Requirements
1.1 This specification covers the chemical, mechanical, and
metallurgical requirements for the manufacture of wrought 18
3. General Requirements for Delivery
chromium-14 nickel-2.5 molybdenum stainless steel in the
3.1 In addition to the requirements of this specification, all
form of surgical fixation wire.
requirements of the current editions of Specifications A555/
1.2 Units—The values stated in either SI units or inch-
A555M and F138 apply.
pound units are to be regarded separately as standard. The
3.2 In cases where a conflict exists between this specifica-
values stated in each system may not be exact equivalents;
therefore,eachsystemshallbeusedindependentlyoftheother. tion and the standards listed in Section 2, this specification
Combining values from the two systems may result in non- shall take precedence.
conformance with this specification.
4. Terminology
2. Referenced Documents
4.1 Definitions of Terms Specific to This Standard:
2
2.1 ASTM Standards:
4.1.1 lot, n—the total number of mill products produced
A555/A555M Specification for General Requirements for
from the same melt heat under the same conditions at essen-
Stainless Steel Wire and Wire Rods
tially the same time.
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials
5. Ordering Information
E29 Practice for Using Significant Digits in Test Data to
5.1 Inquiries and orders for material under this specification
Determine Conformance with Specifications
shall include the following information:
F86 Practice for Surface Preparation and Marking of Metal-
5.1.1 Quantity,
lic Surgical Implants
5.1.2 ASTM designation and date of issue,
F138 Specification for Wrought 18Chromium-14Nickel-
5.1.3 Material requirements,
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
5.1.4 Mechanical properties,
Implants (UNS S31673)
5.1.5 Form,
F981 Practice for Assessment of Compatibility of Biomate-
5.1.6 Dimensional requirements, including diameter and
rials for Surgical Implants with Respect to Effect of
diameter tolerance,
Materials on Muscle and Bone
5.1.7 Surface condition and handling,
IEEE/ASTM SI 10 American National Standard for Metric
5.1.8 Special tests (if applicable), and
Practice
5.1.9 Other requirements.
3
2.2 USP Standard:
Nonabsorbable Surgical Suture, U.S. Pharmacopeia
6. Material Requirements
6.1 The starting material used to make fixation wire must
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of meet the requirements of Specification F138.
Subcommittee F04.12 on Metallurgical Materials.
6.2 Surgical fixation wire shall conform to the specified
Current edition approved May 1, 2015. Published June 2015. Originally
approved in 1991. Last previous edition approved in 2008 as F1350 – 08. DOI: chemical requirements of Specification F138. Conformance
10.1520/F1350-15.
with this standard shall be so identified by suitable packaging,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
labeling, or both.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
MD 20852-1790, http://www.usp.org. 4th Floor, New York, NY 10036, http://www.ansi.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 ----------------------
F1350−15
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/
...
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. 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 − 08 F1350 − 15
Standard Specification 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.
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 Units—The values stated in either SI units or inch-pound units are to be regarded separately as the standard. The inch-pound
values in parentheses are for information only.stated in each system may not be exact equivalents; therefore, each system shall be
used independently of the other. Combining values from the two systems may result in non-conformance with this specification.
2. Referenced Documents
2
2.1 ASTM Standards:
A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods
E8E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F138 Specification for Wrought 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 on
Muscle and Bone
IEEE/ASTM SI 10 American National Standard for Metric Practice
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 Specifications A555/A555M
and F138 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. Terminology
4.1 Definitions of Terms 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 Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved May 1, 2008May 1, 2015. Published June 2008 June 2015. Originally approved in 1991. Last previous edition approved in 20022008 as
F1350 – 02.F1350 – 08. DOI: 10.1520/F1350-08.10.1520/F1350-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s 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://www.ansi.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 − 15
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. Ordering 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 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), and
5.1.9 Other requirements.
6. Material Requirements
6.1 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 this
standard shall be so identified by suitable packaging, labeling, or both.
7. Mechanical Requirements
7.1 Surgical fixation
...
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F1350 − 15
Standard Specification 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.
4
1. Scope* 2.3 ISO Standard:
ISO 9001 Quality Management System—Requirements
1.1 This specification covers the chemical, mechanical, and
metallurgical requirements for the manufacture of wrought 18
3. General Requirements for Delivery
chromium-14 nickel-2.5 molybdenum stainless steel in the
3.1 In addition to the requirements of this specification, all
form of surgical fixation wire.
requirements of the current editions of Specifications A555/
1.2 Units—The values stated in either SI units or inch-
A555M and F138 apply.
pound units are to be regarded separately as standard. The
values stated in each system may not be exact equivalents; 3.2 In cases where a conflict exists between this specifica-
therefore, each system shall be used independently of the other. tion and the standards listed in Section 2, this specification
Combining values from the two systems may result in non- shall take precedence.
conformance with this specification.
4. Terminology
2. Referenced Documents
4.1 Definitions of Terms Specific to This Standard:
2
2.1 ASTM Standards:
4.1.1 lot, n—the total number of mill products produced
A555/A555M Specification for General Requirements for
from the same melt heat under the same conditions at essen-
Stainless Steel Wire and Wire Rods
tially the same time.
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials
5. Ordering Information
E29 Practice for Using Significant Digits in Test Data to
5.1 Inquiries and orders for material under this specification
Determine Conformance with Specifications
shall include the following information:
F86 Practice for Surface Preparation and Marking of Metal-
5.1.1 Quantity,
lic Surgical Implants
5.1.2 ASTM designation and date of issue,
F138 Specification for Wrought 18Chromium-14Nickel-
5.1.3 Material requirements,
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
5.1.4 Mechanical properties,
Implants (UNS S31673)
5.1.5 Form,
F981 Practice for Assessment of Compatibility of Biomate-
5.1.6 Dimensional requirements, including diameter and
rials for Surgical Implants with Respect to Effect of
diameter tolerance,
Materials on Muscle and Bone
5.1.7 Surface condition and handling,
IEEE/ASTM SI 10 American National Standard for Metric
5.1.8 Special tests (if applicable), and
Practice
5.1.9 Other requirements.
3
2.2 USP Standard:
Nonabsorbable Surgical Suture, U.S. Pharmacopeia
6. Material Requirements
1 6.1 The starting material used to make fixation wire must
This specification is under the jurisdiction of ASTM Committee F04 on
meet the requirements of Specification F138.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
6.2 Surgical fixation wire shall conform to the specified
Current edition approved May 1, 2015. Published June 2015. Originally
chemical requirements of Specification F138. Conformance
approved in 1991. Last previous edition approved in 2008 as F1350 – 08. DOI:
10.1520/F1350-15.
with this standard shall be so identified by suitable packaging,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
labeling, or both.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
MD 20852-1790, http://www.usp.org. 4th Floor, New York, NY 10036, http://www.ansi.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 − 15
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/E8M using a 254 mm [10 in.] gage length and a cross-head
8.4 Units of Measure—
speed of 254 mm/min [10 in./min]. Shoul
...
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