ASTM F1091-12
(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 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 the standard.
General Information
Relations
Buy Standard
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F1091 −12
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* 3. General Requirements for Delivery
3.1 In addition to the requirements of this specification, all
1.1 This specification covers the chemical, mechanical, and
requirements of the current editions of Specification F90 shall
metallurgical requirements for the manufacture of wrought
apply.
cobalt-20chromium-15tungsten-10nickel surgical fixation
wire. 3.2 In cases where a conflict exists between this specifica-
tion and the standards listed in Section 2, this specification
1.2 The values stated in either SI units or inch-pound units
shall take precedence.
are to be regarded separately as standard. The values stated in
each system may not be exact equivalents; therefore, each
4. Terminology
system shall be used independently of the other. Combining
4.1 Definitions of Terms Specific to This Standard:
values from the two systems may result in non-conformance
4.1.1 lot, n—the total number of mill products produced
with the standard.
from the same melt heat under the same conditions at essen-
tially the same time.
2. Referenced Documents
5. Ordering Information
2
2.1 ASTM Standards:
5.1 Inquiries and orders for material under this specification
E8 Test Methods for Tension Testing of Metallic Materials
shall include the following information:
E29 Practice for Using Significant Digits in Test Data to
5.1.1 Quantity,
Determine Conformance with Specifications
5.1.2 ASTM designation and date of issue,
F86 Practice for Surface Preparation and Marking of Metal-
5.1.3 Material requirements (see Section 6),
lic Surgical Implants
5.1.4 Mechanical properties (see Section 7),
F90 Specification for Wrought Cobalt-20Chromium-
5.1.5 Form,
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
5.1.6 Dimensional requirements, including diameter and
tions (UNS R30605)
diameter tolerance,
3
2.2 USP Standards: 5.1.7 Surface condition and handling,
Nonabsorbable Surgical Suture, U.S. Pharmacopeia 5.1.8 Special tests (if applicable), and
4 5.1.9 Other requirements.
2.3 ISO Standard:
ISO 9001 Quality Management Systems—Requirements
6. Material Requirements
6.1 The starting material used to make fixation wire must
meet Specification F90.
1
This specification is under the jurisdiction of ASTM Committee F04 on
6.2 Surgical fixation wire shall conform to the specified
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
chemical requirements of Specification F90.
Current edition approved Dec. 1, 2012. Published December 2012. Originally
approved 1991. Last previous edition approved in 2008 as F1091 – 08. DOI:
7. Mechanical Requirements
10.1520/F1091-12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
7.1 Surgical fixation wire shall conform to the appropriate
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
mechanical properties specified in Table 1.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
7.2 Perform tension tests in accordance with Test Methods
3
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
E8 using a 254-mm (10-in.) gage length and crosshead speed
MD 20852-1790, http://www.usp.org.
4
of 254 mm/min (10 in./min). Should any of the test specimens
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. not meet the specified requirements, test two additional test
*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 ----------------------
F1091−12
TABLE 1 Mechanical and Dimensional Requirements for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation
Wire
USP Diameter Tensile Strength Elong.
Range of Sizes Diameter, mm (in.)
A B ,C D E
Size Tolerance max, MPa (ksi) min, %
0.010 to under 0.020 (0.0004 to 0.0008) . 0.0015 (0.000 06) 1730 (250) 20
0.020 to under 0.030 (0.0008 to 0.0012) 10-0 0.0015 (0.000 06) 1660 (240) 20
0.030 to under 0.040 (0.0012 to 0.0016) 9-0 0.0025 (0.0001) 1590 (230) 25
0.040 to under 0.050 (0.0016 to 0.0020) 8-0 0.0025 (0.0001) 1555 (225) 30
0.050 to under 0.070 (0.0020 to 0.0028) 7-0 0.0025 (0.0001) 1520 (220) 30
0.070
...
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 − 08 F1091 − 12
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 The values stated in either SI units or inch-pound units are to be regarded separately as the standard. The inch-pound values
given 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 the standard.
2. Referenced Documents
2
2.1 ASTM Standards:
E8 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
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
3
2.2 USP Standards:
Nonabsorbable Surgical Suture, U.S. Pharmacopeia
4
2.3 ISO Standard:
ISO 9001 Quality Management Systems—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 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.
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,
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, 2008Dec. 1, 2012. Published June 2008December 2012. Originally approved 1991. Last previous edition approved in 20022008 as
F1091 – 02.F1091 – 08. DOI: 10.1520/F1091-08.10.1520/F1091-12.
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 − 12
5.1.2 ASTM designation and date of issue,
5.1.3 Material requirements (Section (see Section 6),
5.1.4 Mechanical properties ((see Section 7),
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 Specification F90.
6.2 Surgical fixation wire shall conform to the specified chemical requirements of Specification F90.
7. Mechanical Requirements
7.1 Surgical fixation wire shall conform to the appropriate mechanical properties specified in Table 1.
7.2 Perform tension tests in accordance with Test Methods E8 using a 254-mm (10-in.) gage length and crosshead speed of 254
mm/min (10 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 be cons
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.