ASTM F745-95

Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications

SCOPE
1.1 This specification covers the requirements for 18chromium-12.5nickel-2.5molybdenum stainless steel alloy shot, bar, or ingot used for the manufacture of cast and solution-annealed surgical implants.
1.2 The values stated in inch-pound units are to be regarded as the standard.
1.3 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-Nov-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 F745-00 - Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
• Effective Date: 10-Nov-2000
• Referred By: ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
• Effective Date: 10-Nov-2000
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 10-Nov-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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.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 745 – 95
Standard Specification for
18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel
for Cast and Solution-Annealed Surgical Implant
Applications
This standard is issued under the fixed designation F 745; 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 Effect of Materials on Muscle and Bone
2.2 American Society for Quality Control (ASQC) Stan-
1.1 This specification covers the requirements for 18
dard:
chromium-12.5 nickel-2.5 molybdenum stainless steel alloy,
ASQC C1 Specification of General Requirements for a
shot, bar, or ingot used for the manufacture of cast and
Quality Program
solution-annealed surgical implants.
1.2 This material has been subjected to animal implant
3. Ordering Information
studies and has been shown to produce a well-characterized
3.1 Inquiries and orders for material under this specification
level of biological response which is equal to or less than that
shall include the following information:
produced by the reference material when tested by the proce-
3.1.1 Quantity (weight or number of pieces),
dures of Practice F 981, or equivalent. This material has been
3 3.1.2 ASTM Designation,
used clinically.
3.1.3 Form (Section 4.1),
1.3 The values stated in inch-pound units are to be regarded
3.1.4 Special tests, and
as the standard. The inch-pound units given in parentheses are
3.1.5 Special requirements.
for information only.
4. Materials and Manufacture
2. Referenced Documents
4.1 The base material, furnished to the implant manufac-
2.1 ASTM Standards:
4 turer for purposes of casting surgical implants, shall be
E 8 Methods of Tension Testing of Metallic Materials
supplied in the form of bar, shot, or ingot.
E 353 Methods for Chemical Analysis of Stainless, Heat-
Resisting, Maraging, and Other Similar Chromium-Nickel-
5. Chemical Composition
Iron Alloys
5.1 The heat analysis shall conform to the chemical com-
F 55 Specification for Stainless Steel Bar and Wire for
6 position listed in Table 1.
Surgical Implants
5.2 The chemical composition shall conform to the chemi-
F 75 Specification for Cast Cobalt-Chromium-Molybdenum
6 cal requirements in Table 1 with product analysis tolerances
Alloy for Surgical Implant Applications
shown in Table 2.
F 138 Specification for Stainless Steel Bar and Wire for
6 5.3 For referee purposes, Method E 353 shall be used.
Surgical Implants (Special Quality)
5.4 Requirements for the major and minor elemental con-
F 981 Practice for Assessment of Compatibility of Bioma-
stituents are listed in Table 1. Also listed are important residual
terials (Nonporous) for Surgical Implants with Respect to
elements. Analysis for elements not listed in Table 1 is not
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. Mechanical Requirements
F04.12 on Metallurgical Materials.
6.1 The material shall conform to the mechanical property
Current edition approved Feb. 15, 1995. Published April 1995. Originally
published as F 745 – 81. Last previous edition F 745 – 81 (1988)e .
requirements prescribed in Table 3.
Report No. NV-5410 dated July 31, 1975, by Northview Laboratories, Inc.,
6.2 Mechanical properties shall be determined in accor-
Northbrook, Illinois, to Richards Manufacturing Co., titled,“ Comparative Intramus-
dance with Methods E 8.
cular Implant Test with Cast 316SS and ASTM F55, Type A316SS.” Copies
available, upon request, from ASTM Headquarters, 1916 Race St., Philadelphia, PA 6.3 Mechanical test specimens shall be produced, (melted,
19103. Request RR: F04-1004.
cast, and solution-annealed) from the metal under test by the
Bechtol, C. O.; Failure of Femoral Implant Components in Total Hip Replace-
same general procedures used in casting surgical implants and
ment Operations; Orthopedic Review; Vol. IV, Number XI, p. 23–29, November,
1975.
Annual Book of ASTM Standards, Vol 03.01.
5 7
Annual Book of ASTM Standards, Vol 03.05. Available from American Society for Quality Control, 161 West Wisconsin
Annual Book of ASTM Standards, Vol 13.01. Ave., Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 745
TABLE 1 Chemical Requirements (Heat Analysis) TABLE 3 Mechanical Property Requirements (As-Cast and
Solution-Annealed)
Composition, %
Element
Property Requirement
min max
Tensile strength, min, psi (MPa) 70000 (483)
Carbon . 0.06
Yield strength (0.2 % offset), min, psi (MPa) 30000 (207)
Manganese . 2.0
Elongation (in 43 diameter), 30
Phosphorus . 0.045
min, %
Sulfur . 0.030
Reduction of area, min,% 50
Silicon . 1.0
Chromium 17.00 19.00
Nickel 11.00 14.00
Molybdenum 2.00 3.00
Iron balance balance
purchaser and the vendor.
8. Special Requirements
TABLE 2 Product Analysis Tolerances
8.1 Special requirements shall be specified on the purchase
NOTE 1—Tolerances are over the maximum limit or under the mini-
order by the purchaser.
mum limit.
Element Tolerance, %
9. Certification
Carbon 0.01
9.1 Upon request of the purchaser in the contract or order a
Manganese 0.04
manufacturer’s certification that the material was manufactured
Phosphorus 0.010
Sulfur 0.005
and tested in accordance with this specification together with a
Silicon 0.05
report of the test results requested shall be furnished at the time
Chromium 0.20
of shipment.
Nickel 0.15
Molybdenum 0.10
10. Quality Program Requirements
10.1 The producer shall maintain a quality program, such
shall be in accordance with the ⁄4 in. (6.35-m
...