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ASTM F745-07

(Specification)

Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)

Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)

ABSTRACT
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. This material is known to be paramagnetic. The product casting and casting alloy shall conform to the prescribed chemical requirements, tensile strength, yield strength, elongation and minimum reduction of area.
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.
WITHDRAWN RATIONALE
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. This material is known to be paramagnetic.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in September 2012 due to lack of use.

General Information

Status
Withdrawn
Publication Date
31-Jan-2007
Withdrawal Date
31-Aug-2012
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 F745-00 - Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
Effective Date
01-Feb-2007
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis
Effective Date
01-Feb-2007
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
01-Feb-2007

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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)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)
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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)
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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: F745 – 07
Standard Specification for
18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for
1
Cast and Solution-Annealed Surgical Implant Applications
ThisstandardisissuedunderthefixeddesignationF745;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
5
1. Scope* 2.4 American Society for Quality (ASQ) Standard:
ASQ C1 Specification of General Requirements for a Qual-
1.1 This specification covers the requirements for
ity Program
18chromium-12.5nickel-2.5molybdenum stainless steel alloy
shot, bar, or ingot used for the manufacture of cast and
3. Terminology
solution-annealed surgical implants. This material is known to
3.1 Definitions of Terms Specific to This Standard:
be paramagnetic.
3.1.1 investment casting, n—a metal casting that is pro-
1.2 The values stated in inch-pound units are to be regarded
duced in a mold obtained by investing (surrounding) an
as the standard. The SI equivalents in parentheses are for
expendable pattern with a ceramic slurry that is allowed to
information only.
solidify.Theexpendablepatternmayconsistofwax,plastic,or
2. Referenced Documents other material and is removed prior to filling the mold with
2
liquid metal.
2.1 ASTM Standards:
3.1.2 master heat, n—a quantity of metal processed in a
A800/A800M Practice for Steel Casting, Austenitic Alloy,
single furnace or refining vessel at one time in such a manner
Estimating Ferrite Content Thereof
as to produce the desired composition and properties.
A957 Specification for Investment Castings, Steel and Al-
3.1.3 sub-heat, n—a portion of a master heat remelted
loy, Common Requirements, for General Industrial Use
without additional processing for pouring into castings. Syn-
E8 Test Methods for Tension Testing of Metallic Materials
onyms: melt, production heat.
E29 Practice for Using Significant Digits in Test Data to
3.1.3.1 Discussion—TerminologysectiontakenfromSpeci-
Determine Conformance with Specifications
fication A957.
E353 Test Methods for Chemical Analysis of Stainless,
Heat-Resisting, Maraging, and Other Similar Chromium-
4. Ordering Information
Nickel-Iron Alloys
3 4.1 Inquiries and orders for material under this specification
2.2 Aerospace Material Specifications:
shall include the following information:
AMS 2248 Chemical CheckAnalysis Limits, Corrosion and
4.1.1 Quantity (weight),
Heat Resistant Steels and Alloys, Maraging and Other
4.1.2 ASTM designation and date of issue,
Highly-Alloyed Steels, and Iron Alloys
4 4.1.3 Form (Section 5.1),
2.3 ISO Standards:
4.1.4 Special tests, and
ISO 6892 Metallic Materials Tensile Testing at Ambient
4.1.5 Other requirements.
Temperature
ISO 9001 Quality Management Systems—Requirements
5. Materials and Manufacture
5.1 Themasterheatfurnishedtothesupplierforpurposesof
casting surgical implants shall be supplied in the form of bar,
1
This specification is under the jurisdiction of ASTM Committee F04 on
shot, or ingot.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
6. Chemical Composition
Current edition approved Feb. 1, 2007. Published February 2007. Originally
approved in 1981. Last previous edition approved in 2000 as F745 – 00. DOI:
6.1 The product castings and casting alloy shall conform to
10.1520/F0745-07.
2 the chemical requirements prescribed in Table 1. The supplier
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
shall not ship material that is outside the limits specified in
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
Table 1.
the ASTM website.
3
Available from Society of Automotive Engineers (SAE), 400 Commonwealth
Dr., Warrendale, PA 15096-0001, http://www.sae.org.
4 5
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
4th Floor, New York, NY 10036, http://www.ansi.org. Milwaukee, WI 53203, http://www.asq.org.
*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 ----------------------
F745 – 07
TABLE 1 Chemical Requirements (Master and Sub Heat TABLE 3 Mechanical Property Requirements (As-Cast and
Analysis) Solution-Annealed)
Composition, % mass/mass Property Requirement
Element
min max Tensile strength, min, psi (MPa) 70000 (483)
Yield strength (0.2 % offset), min, psi (MPa) 30000 (207)
Carbon . 0.06
A
Elongation
...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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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.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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.  
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Standard Guide for Total Knee Replacement Loading Profiles

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4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
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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  • Guide
    34 pages
    English language
    sale 15% off