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ASTM

ASTM F1350-91(2000)

(Specification)

Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

SCOPE
1.1 This specification covers the requirements for the manufacture of stainless steel 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-2000
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

Relations

Replaced By
ASTM F1350-01 - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
Effective Date
01-Jan-2001
Referred By
ASTM F138-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Effective Date
01-Jan-2001

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ASTM F1350-91(2000) - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)ASTM F1350-91(2000) - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
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ASTM F1350-91(2000) - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
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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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.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 1350 – 96 (Reapproved 2000)
Standard Specification for
Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless
Steel Surgical Fixation Wire (UNS S31673)
This standard is issued under the fixed designation F 1350; 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 ance shall be stated on material certification.
3.4 Surgical fixation wire shall be furnished in the bright
1.1 This specification covers the requirements for the manu-
annealed condition and finish.
facture of stainless steel surgical fixation wire.
1.2 The values stated in metric units are to be regarded as
4. Mechanical Properties
standard. The inch-pound equivalents may be approximate.
4.1 Surgical fixation wire shall conform to the appropriate
2. Referenced Documents mechanical properties specified in Table 1.
4.2 Mechanical testing shall be performed in accordance
2.1 ASTM Standards:
with Methods A 370 using a 254 mm (10 inch) gage length and
A 262 Practices for Detecting Susceptibility to Intergranu-
cross-head speed of 254 mm/min (10 inches/min).
lar Attack in Austenitic Stainless Steels
4.3 The wire shall meet the requirements of USP for
A 370 Test Methods and Definitions for Mechanical Testing
Nonabsorbable Surgical Sutures, (latest revision) when tested
of Steel Products
in accordance with 4.2.
A 555 Specification for General Requirements for Stainless
and Heat-Resisting Steel Wire and Wire Rods
5. Dimensional Requirements
E 45 Practice for Determining the Inclusion Content of
3 5.1 Surgical fixation wire shall be fabricated in accordance
Steel
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 138 Specification for Stainless Steel Bar and Wire for
4 6.1 The surface of surgical fixation wire conforming to this
Surgical Implants (Special Quality)
specification shall be free of imperfections such as toolmarks,
2.2 USP Standards:
nicks, scratches, cracks, cavities, spurs, and other defects that
Nonabsorbable Surgical Suture, U.S. Pharmacopoeia
would impair the serviceability of the wire. The surface shall
3. Materials and Manufacture be free of embedded or deposited finishing materials and other
undesirable contaminants.
3.1 Surgical fixation wire shall conform to the specified
6.2 The wire may be subjected to a passivation process if
chemical composition of Specification F 138, Grade 2 material.
requested by the customer. Such passivation process shall be
Conformance with this specification shall be so identified by
performed in accordance with Practice F 86.
suitable packaging or labeling, or both.
6.3 Surgical fixation wire shall be handled with care and
3.2 The microcleanliness of the steel as determined by
packaged adequately to prevent damage and contamination of
Practice E 45, Method A shall conform to Specification F 138.
the surface.
Microcleanliness conformance shall be stated on the material
certification.
7. General Requirements
3.3 The steel shall be capable of passing the intergranular
7.1 In addition to the requirements of this specification, all
corrosion susceptibility test in accordance with Practices
requirements of the current editions of Specifications A 555
A 262, Practice E as specified in Specification F 138. Conform-
and F 138 shall apply.
7.2 In cases of conflict between this specification and those
This specification is under the jurisdiction of ASTM Committee F04 on listed in 2.1, this specification shall take precedence.
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
8. Keywords
Current edition approved April 10, 1996. Published June 1996. Originally
8.1 fixation; mechanical properties; stainless steel; surgical
published as F 1350 – 91. Last previous edition F 1350 – 91.
Annual Book of ASTM Standards, Vol 01.03. implant; suture; tolerances; wire
Annual Book of ASTM Standards, Vol 03.01.
Annual
...

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