ASTM F1314-95

Standard Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22 chromium - 13 nickel - 5 manganese - 2.5 molybdenum stainless steel alloy bar and wire for surgical implants.
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents of the inch-pound units may be approximate.

General Information

• Status: Historical
• Publication Date: 09-Oct-2001
• 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

Relations

• Replaced By: ASTM F1314-01 - Standard Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2181-20 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2581-12(2017) - Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2229-21 - Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 10-Oct-2001
• Referred By: ASTM F621-12(2021)e1 - Standard Specification for Stainless Steel Forgings for Surgical Implants
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
• Effective Date: 10-Oct-2001
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 10-Oct-2001

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 1314 – 95
Standard Specification for
Wrought Nitrogen Strengthened–22 Chromium–12.5
Nickel–5 Manganese–2.5 Molybdenum Stainless Steel Bar
and Wire for Surgical Implants
This standard is issued under the fixed designation F 1314; 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. Ordering Information
1.1 This specification covers the requirements for wrought 3.1 Inquiries and orders for material under this specification
nitrogen strengthened–22 chromium–12.5 nickel–5 manga- shall include the following information:
nese–2.5 molybdenum stainless steel bar and wire (except 3.1.1 Quality (weight or number of pieces),
suture wire) used for the manufacture of surgical implants. 3.1.2 ASTM designation,
1.2 The values stated in inch-pound units are to be regarded 3.1.3 Form (bar or wire),
as the standard. The values in parentheses are for information 3.1.4 Condition (see 4.1),
only. 3.1.5 Mechanical properties (if applicable, for special con-
ditions),
2. Referenced Documents
3.1.6 Finish (see 4.2),
2.1 ASTM Standards:
3.1.7 Applicable dimensions including size, thickness,
A 262 Practices for Detecting Susceptibility to Intergranu- width, and length (exact, random or multiples) or print number,
lar Attack in Austenitic Stainless Steels
and
A 484/A 484M Specification for General Requirements for 3.1.8 Special requirements.
Stainless and Heat-Resisting Bars, Billets, and Forgings
4. Materials and Manufacture
A 555/A 555M Specification for General Requirements for
Stainless and Heat-Resisting Steel Wire and Wire Rods 4.1 Condition—Bar and wire shall be furnished to the
A 751 Test Methods, Practices, and Terminology for implant manufacturer, as specified, in the hot-worked, an-
Chemical Analysis of Steel Products nealed, or cold-worked condition.
E 45 Practice for Determining the Inclusion Content of 4.2 Finish—Types of finish available in bar and wire
Steel products are cold-drawn, pickled, ground, ground and polished,
E 112 Test Methods for Determining Average Grain Size or as specified in the implant manufacturer’s purchase order.
F 746 Test Method for Pitting and Crevice Corrosion of
5 5. Chemical Composition
Metallic Surgical Implant Materials
F 981 Practice for Assessment of Compatibility of Bioma- 5.1 The heat analysis shall conform to the requirements as
terials (Nonporous) for Surgical Implants with Respect to to chemical composition specified in Table 1.
5.2 Methods and practices relating to chemical analysis
Effect of Materials on Muscle and Bone
2.2 American Society for Quality Control (ASQC) Stan- required by this specification shall be in accordance with Test
Methods A 751.
dard:
Cl Specification of General Requirements for a Quality 5.3 Requirements for the major and minor elemental con-
stituents are listed in Table 1. Also listed are important residual
Program
elements. Analysis for elements not listed in Table 1 is not
1 required to verify compliance with this specification.
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
6. Metallurgical Requirements
F04.12 on Metallurgical Materials.
Current edition approved March 15, 1995. Published May 1995. Originally
6.1 The material shall exhibit no free ferrite phase when it is
published as F 1314 – 90. Last previous edition F 1314 – 90.
examined metallographically at 1003 magnification.
Annual Book of ASTM Standards, Vol 01.03.
Annual Book of ASTM Standards, Vol 01.05. 6.2 The microcleanliness of the steel, as determined by
Annual Book of ASTM Standards, Vol 03.01.
Practice E 45, Method A, except using Plate III and Plate I, on
Annual Book of ASTM Standards, Vol 13.01.
representative billet or bar samples from the heat shall not
Available from American Society for Quality Control, 161 West Wisconsin
exceed the following:
Ave., Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1314
TABLE 1 Chemical Requirements, Heat Analysis
7.3 When desired, hardness limits may be specified. Hard-
Element Composition, % ness determination on cold-worked material shall be made on
a product cross section, midway between the center and
Carbon 0.030 max
Manganese 4.00 to 6.00
surface, if cross section size is adequate.
Phosphorus 0.025 max
8. Special Tests
Sulfur 0.010 max
Silicon 0.75 max
8.1 The steel shall be capable of passing the intergranular
Chromium 20.50 to 23.50
Nickel 11.50 to 13.50 corrosion susceptibility test in accordance with Practices
Molybdenum 2.00 to 3.00
A 262, Practice E. The test shall be performed on a sample
Nitrogen 0.20 to 0.40
sensitized at 1250°F for 1 h.
Niobium 0.10 to 0.30
Vanadium 0.10 to 0.30 8.2 The grain size shall be five or finer when tested in
Copper 0.50 max
accordance with Test Methods E 112.
A
Iron balance
8.2.1 If grain size samples are selected after a final cold-
A
Approximately equal to the difference between 100 % and the sum percent of
working operation, transverse specimens shall be prepared.
the other specified elements. The percent iron content by difference is not required
to be reported. 8.3 Any other special requirements shal
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