ASTM F1091-91(2000)

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: 31-Dec-1999
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Replaced By: ASTM F1091-02 - Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
• Effective Date: 10-Apr-2002
• Referred By: ASTM F90-23 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
• Effective Date: 01-Jan-2000

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1091 – 91 (Reapproved 2000)
Standard Specification for
Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy
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 mechanical properties specified in Table 1.
4.2 Mechanical testing shall be performed in accordance
1.1 This specification covers the requirements for the manu-
with Test Methods E 8 using a 254-mm (10-in.) gage length
facture of wrought cobalt-20 chromium-15 tungsten-10 nickel
and crosshead speed of 254 mm/min (10 in./min).
surgical fixation wire.
4.3 The wire shall meet the requirements of USP for
1.2 The values stated in metric units are to be regarded as
Nonabsorbable Surgical Sutures, (latest version) when tested in
standard. The inch-pound equivalents may be approximate.
accordance with 4.2.
2. Referenced Documents
5. Dimensional Requirements
2.1 ASTM Standards:
2 5.1 Surgical fixation wire shall be fabricated in accordance
E 8 Test Methods for Tension Testing of Metallic Materials
with the dimensions and tolerances specified in Table 1.
F 86 Practice for Surface Preparation and Marking of Me-
tallic Surgical Implants
6. Surface Condition and Handling
F 90 Specification for Wrought Cobalt-20 Chromium-15
6.1 The surface of surgical fixation wire conforming to this
Tungsten-10 Nickel Alloy for Surgical Implant Applica-
3 specification shall be free of imperfections such as toolmarks,
tions (UNS R30605)
4 nicks, scratches, cracks, cavities, spurs, and other defects that
2.2 USP Standards:
would impair the serviceability of the wire. The surface shall
Nonabsorbable Surgical Suture, U.S. Pharmacopoeia
be free of embedded or deposited finishing materials and other
3. Material Requirements undesirable contaminants.
6.2 The wire may be subjected to a passivation process if
3.1 Surgical fixation wire shall conform to the specified
requested by the customer. Such passivation process shall be
chemical composition of Specification F 90. Conformance
performed in accordance with Practice F 86.
with this standard shall be so identified by suitable packaging
6.3 Surgical fixation wire shall be handled with care and
or labeling, or both.
packaged adequately to prevent damage and contamination of
3.2 Surgical fixation wire shall be furnished in the bright
the surface.
annealed condition and finish.
7. General Requirements
4. Mechanical Requirements
7.1 In addition to the requirements of this specification, all
4.1 Surgical fixation wire shall conform to the appropriate
requirements of the current edition of Specification F 90 shall
apply.
1 7.2 In cases of conflict between this standard and those
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of listed in 2.1, this standard shall take precedence.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Feb. 22, 1991. Published June 1991.
8. Keywords
Annual Book of ASTM Standards, Vol 03.01.
8.1 fixation; mechanical properties; surgical implant; suture;
Annual Book of ASTM Standards, Vol 13.01.
U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852. tolerances; wire; wrought cobalt-chromium alloy
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F 1091
TABLE 1 Mechanical and Dimensional Requirements for Wrought Cobalt-Chromium 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) 1
...