ASTM F139-00

Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

SCOPE
1.1 This specification covers the requirements for wrought 18 chromium-14 nickel-2.5 molybdenum stainless steel sheet and strip used for the manufacture of surgical implants.  
1.2 The values stated in inch-pound units are to be regarded as the standard.

General Information

• Status: Historical
• Publication Date: 09-Jun-2000
• 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 F139-03 - Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
• Effective Date: 10-Jun-2003
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Jun-2000
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 10-Jun-2000
• Referred By: ASTM F2257-22 - Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
• Effective Date: 10-Jun-2000
• Referred By: ASTM F452-76(2022) - Standard Specification for Preformed Cranioplasty Plates
• Effective Date: 10-Jun-2000

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 139 – 00
Standard Specification for
Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless
Steel Sheet and Strip for Surgical Implants (UNS S31673)
This standard is issued under the fixed designation F 139; 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.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope 3. General Requirements for Delivery
1.1 This specification covers the requirements for wrought 3.1 In addition to the requirements of this specification, all
18 chromium-14 nickel-2.5 molybdenum stainless steel sheet requirements of the current edition of Specification A 480/
and strip used for the manufacture of surgical implants. A 480M shall apply.
1.2 The values stated in inch-pound units are to be regarded 3.2 In the case where a conflict exists between this specifi-
as the standard. cation and those listed in 2.1 and 2.2, this specification shall
take precedence.
2. Referenced Documents
4. Ordering Information
2.1 ASTM Standards:
A 262 Practices for Detecting Susceptibility to Intergranu- 4.1 Inquiries and orders for material under this specification
lar Attack in Austenitic Stainless Steels shall include the following information:
A 480/A480M Specification for General Requirements for 4.1.1 Quantity (weight or number of pieces),
Flat-Rolled Stainless and Heat-Resisting Steel Plate, 4.1.2 ASTM designation,
Sheet, and Strip 4.1.3 Form (sheet or strip),
A 751 Test Methods, Practices, and Terminology for 4.1.4 Condition (see 5.1),
Chemical Analysis of Steel Products 4.1.5 Mechanical properties (if applicable, for special con-
E 45 Test Methods for Determining the Inclusion Content ditions),
of Steel 4.1.6 Finish (see 5.2),
E 112 Test Methods for Determining the Average Grain 4.1.7 Applicable dimensions including size, thickness,
Size width, and length (exact, random, multiples) or print number,
F 981 Practice for Assessment of Compatibility of Bioma- and
terials for Surgical Implants With Respect to Effect of 4.1.8 Special requirements.
Materials on Muscle and Bone
5. Materials and Manufacture
2.2 ISO Standard:
ISO 5832-1 Implants for Surgery-Metallic Materials—Part 5.1 Condition:
5.1.1 Sheet and strip shall be furnished as specified, in the
1: Wrought Stainless Steel
2.3 American Society for Quality Control (ASQC) Stan- annealed or cold-worked condition (see Table 1).
5.2 Finish:
dard:
C1 Specification of General Requirements for a Quality 5.2.1 Types of finish available in sheet and strip are dull
cold rolled, bright cold rolled, intermediate polished, general-
Program
purpose polished, dull satin-finished, high luster finish, mirror
finish, or as specified in the purchase order.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
6. Chemical Composition
Subcommittee F04.12 on Metallurgical Materials.
6.1 The heat analysis shall conform to the requirements as
Current edition approved June 10, 2000. Published September 2000. Originally
published as F 139 – 76. Last previous edition F 139 – 96.
to chemical composition specified in Table 2.
Annual Book of ASTM Standards, Vol 01.03.
6.1.1 The compositional requirement shall meet the follow-
Annual Book of ASTM Standards, Vol 03.01.
4 ing:
Annual Book of ASTM Standards, Vol 13.01.
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
%Cr 1 3.3 3 %Mo $ 26.0 (1)
4th Floor, New York, NY 10036.
6.1.2 Requirements for the major and minor elemental
Available from American Society for Quality Control, 161 W. Wisconsin Ave.,
Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 139
TABLE 1 Mechanical Requirements
Methods, Practices, and Terminology A 751.
Ultimate Tensile Yield Strength Elongation in 2 Rockwell
Condition Strength, min, (0.2 % Offset), in. (50 mm) Hardness,
7. Metallurgical Requirements
psi (MPa) min, psi (MPa) min, % max
7.1 The material shall contain no delta ferrite phase when it
Annealed 71 000 27 500 40 95 HRB
(490) (190)
is examined metallographically at 1003 magnification.
Cold-worked 125 000 100 000 10 .
7.2 The microcleanliness of the steel as determined by Test
(860) (690)
Methods E 45, Method A, except using Plate I-r on represen-
tative samples from the hot-rolled band from the heat shall not
exceed the following:
TABLE 2 Chemical Requirements, Heat Analysis
Inclusion A B C D
Element Composition, %
Type (Sulfide) (Alumina) (Silicate) (Globular Oxide)
Carbon 0.030 max
Thin 1.5 1.5 1.5 1.5
Manganese 2.00 max
Heavy 1.5 1.0 1.5 1.0
Phosphorus 0.025 max
Sulfur 0.010 max
8. Mechanical Properties
Silicon 0.75 max
A
Chromium 17.00 to 19.00
8.1 Material shall conform to the appropriate requirements
Nickel 13.00 to 15.00
as to mechanical properties specified in Table 1. The level of
A
Molybdenum 2.25 to 3.00
mechanical properties for material in conditions other than
Nitrogen 0.10 max
Copper 0.50 max
those included in Table 1 shall be specified in the purchase
B
Iron balance
order.
A
The compositional requirement shall meet the following:
8.2 When desired, Rockwell hardness, A scale (HRA),
% Cr + 3.3 3%Mo $ 26.0
B
Rockwell hardness, B scale (HRB) or Rockwell hardness, C
Approximately equal to the difference between 100 % and the sum percentage
of the other specified elements. The percentage iron content by difference is not
Scale (HRC), limits may be specified.
required to be reported.
9. Special Tests
constituents are listed in Table 2. Also listed are important
9.1 The steel shall be capable of passing the intergranular
residual elements. Analysis for elements not listed in Table 2 is
corrosion susceptibility test in accordance with Practices
not required to certify compliance with this specification.
A 262, Practice E.
6.2 Product Analysis— Product analysis tolerances do not
9.2 The grain size shall be five or finer when tested in
broaden the specified heat analysis requirements, but cover
accordance with Test Methods E 112.
variations
...