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ASTM F1350-02

(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 wrought 18 chromium-14 nickel-2.5 molybdenum stainless steel in the form of 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.

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 F1350-01 - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
Effective Date
10-Apr-2002
Replaced By
ASTM F1350-08 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
Effective Date
01-May-2008
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
10-Apr-2002

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ASTM F1350-02 - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)ASTM F1350-02 - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
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ASTM F1350-02 - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 1350 – 02
Standard Specification for
Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless
1
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 * 3.2 In cases where a conflict exists between this specifica-
tion and the standards listed in Section 2, this specification
1.1 This specification covers the requirements for the manu-
shall take precedence.
facture of wrought 18 chromium-14 nickel-2.5 molybdenum
stainless steel in the form of surgical fixation wire.
4. Ordering Information
1.2 The values stated in SI units are to be regarded as the
4.1 Inquiries and orders for material under this specification
standard. The inch-pound equivalents of the SI units may be
shall include the following information:
approximate.
4.1.1 Quantity,
2. Referenced Documents 4.1.2 ASTM designation and date of issue,
4.1.3 Material requirements,
2.1 ASTM Standards:
4.1.4 Mechanical properties,
A 555 Specification for General Requirements for Stainless
2
4.1.5 Form,
Steel Wire and Wire Rods
3
4.1.6 Dimensional requirements, including diameter and
E 8 Test Methods forTensionTesting of Metallic Materials
diameter tolerance,
F 86 Practice for Surface Preparation and Marking of Me-
4
4.1.7 Surface condition and handling,
tallic Surgical Implants
4.1.8 Special tests (if applicable), and
F 138 Specification for Wrought 18Chromium-14Nickel-
4.1.9 Other requirements.
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
4
Implants (UNS S31673)
5. Material Requirements
F 981 Practice for Assessment of Compatibility of Bioma-
5.1 The starting material used to make fixation wire must
terials for Surgical Implants with Respect to Effect of
4 meet the requirements of F 138.
Materials on Muscle and Bone
5 5.2 Surgical fixation wire shall conform to the specified
2.2 USP Standard:
chemical requirements of Specification F 138. Conformance
Nonabsorbable Surgical Suture, U.S. Pharmacopeia
6 with this standard shall be so identified by suitable packaging
2.3 American Society for Quality Standard:
or labeling or both.
ASQ C1 Specification of General Requirements for a Qual-
ity Program
6. Mechanical Requirements
6.1 Surgical fixation wire shall conform to the appropriate
3. General Requirements for Delivery
mechanical properties specified in Table 1.
3.1 In addition to the requirements of this specification, all
6.2 Mechanical testing shall be performed in accordance
requirements of the current editions of Specifications A 555
with Methods E 8 using a 254 mm (10 in.) gage length and a
and F 138 apply.
cross-head speed of 254 mm/min (10 in./min).
6.3 The wire shall meet the requirements of the latest
1
This specification is under the jurisdiction of ASTM Committee F04 on
version of USP for Nonabsorbable Surgical Sutures, when
Medical and Surgical Materials and Devices and is the direct responsibility of
tested in accordance with 6.2.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Apr. 10, 2002. Published June 2002. Originally
7. Dimensional Requirements
published as F 1350 – 91. Last previous edition F 1350 – 01.
2
Annual Book of ASTM Standards, Vol 01.03.
7.1 Surgical fixation wire shall be fabricated in accordance
3
Annual Book of ASTM Standards, Vol 03.01.
4
with the dimensions and tolerances specified in Table 1.
Annual Book of ASTM Standards, Vol 13.01.
5
Available from U.S. Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD
7.2 Unless otherwise specified, size tolerances are plus and
20852.
minus as shown in Table 1. When required by the purchaser,
6
Available from American Society for Quality, 600 N. Plankinton Ave.,
round wire tolerances may be specified all plus and nothing
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 1350
TABLE 1 Mechanical and Dimensional Requirements for Wrought Annealed 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel
Surgical Fixation Wire
Diameter Tensile Strength Elong.
A
Range of Sizes Diameter, mm (in.) USP Size
BC D E
Tolerance max, MPa (ksi) min %
0.010 to under 0.020 (0.0004 to 0.0008) . 0.0015 (0.000 06) 1380 (200) 15
0.020 to under 0.030 (0.0008 to 0.0012) 10–0 0.0015 (0.000 06) 1240 (180) 15
0.030 to under 0.040 (0.0012 to 0.0016) 9–0 0.0025 (0.0001) 1100 (160) 20
0.040 to under 0.050 (0.0016 to 0.0020) 8–0 0.0025 (0.0001) 1100 (160) 20
0.050 to under 0.
...

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SCOPE
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1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.

  • Guide
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    English language
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  • Guide
    8 pages
    English language
    sale 15% off