ASTM F1091-08
(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 SI units are to be regarded as the standard. The inch-pound values given in parentheses are for information only.
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Designation:F1091 −08
StandardSpecification 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
1.1 This specification covers the chemical, mechanical, and 3.1 In addition to the requirements of this specification, all
metallurgical requirements for the manufacture of wrought requirements of the current editions of Specification F90 shall
cobalt-20chromium-15tungsten-10nickel surgical fixation apply.
wire.
3.2 In cases where a conflict exists between this specifica-
1.2 The values stated in SI units are to be regarded as the tion and the standards listed in Section 2, this specification
standard. The inch-pound values given in parentheses are for shall take precedence.
information only.
4. Terminology
2. Referenced Documents
4.1 Definitions of Terms Specific to This Standard:
2
4.1.1 lot, n—the total number of mill products produced
2.1 ASTM Standards:
from the same melt heat under the same conditions at essen-
E8 Test Methods for Tension Testing of Metallic Materials
tially the same time.
E29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
5. Ordering Information
F86 Practice for Surface Preparation and Marking of Metal-
5.1 Inquiries and orders for material under this specification
lic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium- shall include the following information:
5.1.1 Quantity,
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
tions (UNS R30605) 5.1.2 ASTM designation and date of issue,
3 5.1.3 Material requirements (Section 6),
2.2 USP Standards:
5.1.4 Mechanical properties (7),
Nonabsorbable Surgical Suture, U.S. Pharmacopeia
5.1.5 Form,
4
2.3 ISO Standard:
5.1.6 Dimensional requirements, including diameter and
ISO 9001 Quality Management Systems—Requirements
diameter tolerance,
5
2.4 American Society for Quality Standard: 5.1.7 Surface condition and handling,
ASQ C1 Specification of General Requirements for a Qual- 5.1.8 Special tests (if applicable), and
ity Program 5.1.9 Other requirements.
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
Medical and Surgical Materials and Devices and is the direct responsibility of
meet Specification F90.
Subcommittee F04.12 on Metallurgical Materials.
6.2 Surgical fixation wire shall conform to the specified
Current edition approved May 1, 2008. Published June 2008. Originally
approved 1991. Last previous edition approved in 2002 as F1091 – 02. DOI:
chemical requirements of Specification F90.
10.1520/F1091-08.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
7. Mechanical Requirements
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
7.1 Surgical fixation wire shall conform to the appropriate
the ASTM website.
mechanical properties specified in Table 1.
3
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
MD 20852-1790, http://www.usp.org.
7.2 Perform tension tests in accordance with Test Methods
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
E8 using a 254-mm (10-in.) gage length and crosshead speed
4th Floor, New York, NY 10036, http://www.ansi.org.
5
of 254 mm/min (10 in./min). Should any of the test specimens
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Milwaukee, WI 53203, http://www.asq.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
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F1091−08
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
...
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:F1091–02 Designation: F 1091 – 08
Standard Specification for
Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy
1
Surgical Fixation Wire [UNS R30605](UNS R30605)
This standard is issued under the fixed designation F 1091; 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 SI units are to be regarded as the standard. The inch-pound equivalents of the SI units may be
approximate. values given in parentheses are for information only.
2. Referenced Documents
2
2.1 ASTM Standards:
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 90 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 Inadditiontotherequirementsofthisspecification,allrequirementsofthecurrenteditionsofSpecificationF 90shallapply.
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,
4.1.4Mechanical properties,
4.1.5Form,
4.1.6Dimensional requirements, including diameter and diameter tolerance,
4.1.7Surface condition and handling,
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 F1091–91. Last previous edition F1091–91 (2000).
Current edition approved May 1, 2008. Published June 2008. Originally approved 1991. Last previous edition approved in 2002 as F 1091 – 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 03.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Annual Book of ASTM Standards, Vol 13.01.
3
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
4
Available from U.S. Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD 20852.
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 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 ----------------------
F1091–08
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 Specification F90Ordering 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 (Section 6),
5.1.4 Mechanical properties (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
...
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