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ASTM F745-00

(Specification)

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

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
Current Stage
Ref Project

Relations

Replaces
ASTM F745-95 - 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
Replaced By
ASTM F745-07 - Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)
Effective Date
01-Feb-2007
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ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)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

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ASTM F745-00 - Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsASTM F745-00 - Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
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ASTM F745-00 - Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
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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 745 – 00
Standard Specification for
18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for
1
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 3.1.5 Special requirements.
1.1 This specification covers the requirements for
4. Materials and Manufacture
18chromium-12.5nickel-2.5molybdenum stainless steel alloy
4.1 The base material furnished to the implant manufacturer
shot, bar, or ingot used for the manufacture of cast and
for purposes of casting surgical implants shall be supplied in
solution-annealed surgical implants.
the form of bar, shot, or ingot.
1.2 The values stated in inch-pound units are to be regarded
as the standard.
5. Chemical Composition
1.3 This standard does not purport to address all of the
5.1 The heat analysis shall conform to the chemical com-
safety concerns, if any, associated with its use. It is the
position listed in Table 1. The manufacturer shall not ship
responsibility of the user of this standard to establish appro-
material that is outside the limits specified in Table 1.
priate safety and health practices and determine the applica-
5.1.1 Requirements for the major and minor elemental
bility of regulatory limitations prior to use.
constituents are listed in Table 1. Also listed are important
residual elements.Analysis for elements not listed inTable 1 is
2. Referenced Documents
not required to verify compliance with this specification.
2.1 ASTM Standards:
5.2 Product Analysis—The product analysis is either for the
A 744/A 774M Specification for Castings, Iron-Chromium-
2
purpose of verifying the composition of a heat or lot or to
Nickel, Corrosion Resistant, for Severe Service
3 determine variations in the composition within the heat.
E 8 Test Methods forTensionTesting of Metallic Materials
5.2.1 Acceptance or rejection of a heat or lot of material
E 353 Test Methods for Chemical Analysis of Stainless,
may be made by the purchaser on the basis of this product
Heat-Resisting, Maraging, and Other Similar Chromium-
4 analysis.
Nickel-Iron Alloys
5 5.2.2 Product analysis tolerances do not broaden the speci-
2.2 American Society for Quality (ASQ) Standard:
fied heat analysis requirements but cover variation between
ASQC 1 Specification of General Requirements for a Qual-
laboratories in the measurement of chemical content. Product
ity Program
analysis limits shall be as specified in Table 2.
3. Ordering Information 5.3 For referee purposes, Test Methods E 353 shall be used.
3.1 Inquiries and orders for material under this specification
6. Mechanical Properties
shall include the following information:
6.1 The material shall conform to the mechanical property
3.1.1 Quantity (weight or number of pieces),
requirements prescribed in Table 3.
3.1.2 ASTM Designation,
6.2 Specimens for tension tests shall be cast from remelted
3.1.3 Form (Section 4.1),
material from each master heat by the same general procedures
3.1.4 Special tests, and
used in casting surgical implants.
6.2.1 Specimens may be cast, ground, or machined to final
1
This specification is under the jurisdiction of ASTM Committee F04 on dimensions in accordance with the 0.25 in. (6.35 mm) diameter
Medical and Surgical Materials and Devices and is the direct responsibility of
specimen in Fig. 8 of Test Methods E 8.
Subcommittee F04.12 on Metallurgical Materials.
6.2.2 Specimens shall be solution annealed using the same
Current edition approved Nov. 10, 2000. Published February 2001. Originally
procedures used to solution anneal surgical implants.
published as F 745 – 81. Last previous edition F 745 – 95.
2
Annual Book of ASTM Standards, Vol 01.02.
6.3 Aminimum of two tension specimens shall be tested. If
3
Annual Book of ASTM Standards, Vol 03.01.
one specimen fails below the specified mechanical require-
4
Annual Book of ASTM Standards, Vol 03.05.
ments, two additional specimens shall be tested and both must
5
Available from American Society for Quality Control, 161 West Wisconsin
pass.
Ave., Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F745–00
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
...

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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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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. 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.  
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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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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.  
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A1.1 Significance and Use
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1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off