ASTM F1091-20
(Specification)Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
ABSTRACT
This specification covers the requirements for the manufacture of wrought cobalt-20chromium-15tungsten-10nickel surgical fixation wire. The starting material, dimensions, and tolerances shall conform to the requirements specified. The surgical fixation wire is usually furnished in the bright-annealed condition. Mechanical properties of the surgical fixation wire such as tensile strength and elongation shall be determined.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought cobalt-20chromium-15tungsten-10nickel 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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 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.
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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:F1091 −20
Standard Specification for
Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy
1
Surgical Fixation Wire (UNS R30605)
This standard is issued under the fixed designation F1091; 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* Determine Conformance with Specifications
F86 Practice for Surface Preparation and Marking of Metal-
1.1 This specification covers the chemical, mechanical, and
lic Surgical Implants
metallurgical requirements for the manufacture of wrought
F90 Specification for Wrought Cobalt-20Chromium-
cobalt-20chromium-15tungsten-10nickel surgical fixation
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
wire.
tions (UNS R30605)
1.2 Units—The values stated in either SI units or inch-
IEEE/ASTM SI 10 American National Standard for Use of
pound units are to be regarded separately as standard. The
theInternationalSystemofUnits(SI):TheModernMetric
values stated in each system are not necessarily exact equiva-
System
lents; therefore, to ensure conformance with the standard, each 3
2.2 USP Standards:
system shall be used independently of the other, and values
USP29 Nonabsorbable Surgical Suture, U.S. Pharmacopeia
from the two systems shall not be combined.
4
2.3 ISO Standards:
1.3 This standard does not purport to address all of the
ISO 9001 Quality Management Systems—Requirements
safety concerns, if any, associated with its use. It is the
ISO 13485 Medical Devices—Quality Management
responsibility of the user of this standard to establish appro-
Systems—Requirements for Regulatory Purposes
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use. 3. General Requirements for Delivery
1.4 This international standard was developed in accor-
3.1 In addition to the requirements of this specification, all
dance with internationally recognized principles on standard-
requirements of the current editions of Specification F90 shall
ization established in the Decision on Principles for the
apply.
Development of International Standards, Guides and Recom-
3.2 In cases where a conflict exists between this specifica-
mendations issued by the World Trade Organization Technical
tion and the standards listed in Section 2, this specification
Barriers to Trade (TBT) Committee.
shall take precedence.
2. Referenced Documents
4. Terminology
2
2.1 ASTM Standards:
4.1 Definitions of Terms Specific to This Standard:
A484/A484M Specification for General Requirements for
4.1.1 lot, n—the total number of mill products produced
Stainless Steel Bars, Billets, and Forgings
from the same melt heat under the same conditions at essen-
A555/A555M Specification for General Requirements for
tially the same time.
Stainless Steel Wire and Wire Rods
E8/E8M Test Methods for Tension Testing of Metallic Ma-
5. Ordering Information
terials
5.1 Inquiries and orders for material under this specification
E29 Practice for Using Significant Digits in Test Data to
shall include the following information:
5.1.1 Quantity;
1
This specification is under the jurisdiction of ASTM Committee F04 on
5.1.2 ASTM designation and date of issue;
Medical and Surgical Materials and Devices and is the direct responsibility of
5.1.3 Material requirements (see Section 6);
Subcommittee F04.12 on Metallurgical Materials.
5.1.4 Mechanical properties (see Section 7);
Current edition approved Feb. 1, 2020. Published April 2020. Originally
approved 1991. Last previous edition approved in 2012 as F1091 – 12. DOI:
10.1520/F1091-20.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM MD 20852-1790, http://www.usp.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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 ----------------------
F1091−20
5.1.5 Form (bar or wire); 7. Mechanical Requirements
5.1.6 Applicable dimension, including size, thickness,
7.1 Surgical fixation wire shall conform to the appropriate
width, and
...
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: F1091 − 12 F1091 − 20
Standard Specification for
Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy
1
Surgical Fixation Wire (UNS R30605)
This standard is issued under the fixed designation F1091; 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
cobalt-20chromium-15tungsten-10nickel 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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used
independently of the other, and values from the two systems shall not be combined.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.4 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.
2. Referenced Documents
2
2.1 ASTM Standards:
A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods
E8E8/E8M Test Methods for Tension Testing of Metallic Materials [Metric] E0008_E0008M
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
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
3
2.2 USP Standards:
Nonabsorbable Surgical Suture, USP29 Nonabsorbable Surgical Suture, U.S. Pharmacopeia
4
2.3 ISO Standard:Standards:
ISO 9001 Quality Management Systems—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
3. General Requirements for Delivery
3.1 In addition to the requirements of this specification, all requirements of the current editions of Specification F90 shall apply.
3.2 In cases where a conflict exists between this specification and the standards listed in Section 2, this specification shall take
precedence.
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 Dec. 1, 2012Feb. 1, 2020. Published December 2012April 2020. Originally approved 1991. Last previous edition approved in 20082012 as
F1091 – 08.F1091 – 12. DOI: 10.1520/F1091-12.10.1520/F1091-20.
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 ----------------------
F1091 − 20
4. 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. Ordering Information
5.1 Inquiries and orders for material under this specification shall include the following information:
5.1.1 Quantity,Quantity;
5.1.2 ASTM designation and date of issue,issue;
5.1.3 Mat
...
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