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ASTM F1091-02

(Specification)

Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)

Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)

SCOPE
1.1 This specification covers the requirements for the manufacture of wrought cobalt-20 chromium-15 Tungsten-10 nickel surgical fixation wire.
1.2 The values stated in metric units are to be regarded as standard. The inch-pound equivalents may be approximate.

General Information

Status
Historical
Publication Date
09-Apr-2002
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.12 - Metallurgical Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F1091-91(2000) - Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
Effective Date
10-Apr-2002
Replaced By
ASTM F1091-08 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
Effective Date
01-May-2008
Referred By
ASTM F90-23 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
Effective Date
10-Apr-2002

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ASTM F1091-02 - Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)ASTM F1091-02 - Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
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ASTM F1091-02 - Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 1091 – 02
Standard Specification for
Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy
1
Surgical Fixation Wire [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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope * 4.1.1 Quantity,
4.1.2 ASTM designation and date of issue,
1.1 This specification covers the requirements for the manu-
4.1.3 Material requirements,
facture of wrought cobalt-20chromium-15tungsten-10nickel
4.1.4 Mechanical properties,
surgical fixation wire.
4.1.5 Form,
1.2 The values stated in SI units are to be regarded as the
4.1.6 Dimensional requirements, including diameter and
standard. The inch-pound equivalents of the SI units may be
diameter tolerance,
approximate.
4.1.7 Surface condition and handling,
2. Referenced Documents
4.1.8 Special tests (if applicable), and
4.1.9 Other requirements.
2.1 ASTM Standards:
2
E 8 Test Methods forTensionTesting of Metallic Materials
5. Material Requirements
F 86 Practice for Surface Preparation and Marking of Me-
3 5.1 The starting material used to make fixation wire must
tallic Surgical Implants
meet Specification F 90.
F 90 Specification for Wrought Cobalt-20Chromium-
5.2 Surgical fixation wire shall conform to the specified
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
3
chemical requirements of Specification F 90.
tions (UNS R30605)
4
2.2 USP Standards:
6. Mechanical Requirements
Nonabsorbable Surgical Suture, U.S. Pharmacopeia
5
6.1 Surgical fixation wire shall conform to the appropriate
2.3 American Society for Quality Standard:
mechanical properties specified in Table 1.
ASQ C1 Specification of General Requirements for a Qual-
6.2 Mechanical testing shall be performed in accordance
ity Program
with Test Methods E 8 using a 254-mm (10-in.) gage length
3. General Requirements for Delivery and crosshead speed of 254 mm/min (10 in./min).
6.3 The wire shall meet the requirements of USP for
3.1 In addition to the requirements of this specification, all
Nonabsorbable Surgical Sutures, when tested in accordance
requirements of the current editions of Specification F 90 shall
with 6.2.
apply.
3.2 In cases where a conflict exists between this specifica-
7. Dimensional Requirements
tion and the standards listed in Section 2, this specification
7.1 Surgical fixation wire shall be fabricated in accordance
shall take precedence.
with the dimensions and tolerances specified in Table 1.
4. Ordering Information 7.2 Unless otherwise specified, size tolerances are plus and
minus as shown in Table 1. When required by the purchaser,
4.1 Inquiries and orders for material under this specification
round wire tolerances may be specified all plus and nothing
shall include the following information:
minus, or all minus and nothing plus, or any combination of
plus and minus if the total spread in size tolerance is not less
1
This specification is under the jurisdiction of ASTM Committee F04 on
than the total spread shown in Table 1.
Medical and Surgical Materials and Devices and is the direct responsibility of
7.3 The maximum out-of-round tolerance for round wire is
Subcommittee F04.12 on Metallurgical Materials.
one half of the size tolerance given in Table 1.
Current edition approved Apr. 10, 2002. Published June 2002. Originally
published as F 1091 – 91. Last previous edition F 1091 – 91 (2000).
2
8. Surface Condition Requirements
Annual Book of ASTM Standards, Vol 03.01.
3
Annual Book of ASTM Standards, Vol 13.01.
8.1 Surgical fixation wire is usually furnished in the bright-
4
Available from U.S. Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD
annealed condition. Other surface finishes shall be specified as
20852.
5
Available from American Society for Quality, 600 N. Plankinton Ave., agreed to between supplier and purchaser.
Milwaukee, WI 53203.
*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 ----------------------
F 1091
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)
...

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1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off