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ASTM F1586-21

(Specification)

Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)

Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)

ABSTRACT
This specification covers the chemical composition, mechanical, and metallurgical requirements for wrought nitrogen strengthened 21chromium-10nickel-3manganese-2.5molybdenum stainless steel alloy bars for use in surgical implants. The alloy bars shall be furnished in the annealed, medium hard, or hard condition, and shall be finished cold-drawn, pickled, ground, ground and polished, or as specified by the purchaser.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 21chromium—10nickel—3manganese—2.5molybdenum stainless steel alloy bar for surgical implants.  
1.2 The values stated in either inch-pound units or SI units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.3 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.

General Information

Status
Published
Publication Date
14-Sep-2021
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

Refers
ASTM A484/A484M-20a - Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
Effective Date
05-May-2020

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ASTM F1586-21 - Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)ASTM F1586-21 - Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
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ASTM F1586-21 - Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
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REDLINE ASTM F1586-21 - Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)REDLINE ASTM F1586-21 - Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
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REDLINE ASTM F1586-21 - Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
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Standards Content (Sample)

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.
Designation:F1586 −21
Standard Specification for
Wrought Nitrogen Strengthened 21Chromium—10Nickel—
3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for
1
Surgical Implants (UNS S31675)
This standard is issued under the fixed designation F1586; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
1.1 This specification covers the chemical, mechanical, and
E45Test Methods for Determining the Inclusion Content of
metallurgical requirements for wrought nitrogen strengthened
Steel
21chromium—10nickel—3manganese—2.5molybdenum
E112Test Methods for Determining Average Grain Size
stainless steel alloy bar for surgical implants.
F138Specification for Wrought 18Chromium-14Nickel-
1.2 The values stated in either inch-pound units or SI units
2.5MolybdenumStainlessSteelBarandWireforSurgical
are to be regarded separately as standard. The values stated in
Implants (UNS S31673)
each system may not be exact equivalents; therefore, each
F746Test Method for Pitting or Crevice Corrosion of
system shall be used independently of the other. Combining
Metallic Surgical Implant Materials
values from the two systems may result in nonconformance
3
2.2 Aerospace Material Specifications:
with the standard.
AMS 2248Chemical CheckAnalysis Limits, Corrosion and
1.3 This international standard was developed in accor-
Heat Resistant Steels and Alloys, Maraging and Other
dance with internationally recognized principles on standard-
Highly-Alloyed Steels, and Iron Alloys
ization established in the Decision on Principles for the
4
2.3 ISO Standards:
Development of International Standards, Guides and Recom-
ISO 6892Metallic Materials Tensile Testing at Ambient
mendations issued by the World Trade Organization Technical
Temperature
Barriers to Trade (TBT) Committee.
ISO 9001Quality Management System—Requirements
2. Referenced Documents
ISO 13485 Medical Devices—Quality Management
2
Systems—Requirements for Regulatory Purposes
2.1 ASTM Standards:
2
A262Practices for Detecting Susceptibility to Intergranular
2.4 Quality Standard:
Attack in Austenitic Stainless Steels
IEEE/ASTM SI 10American National Standard for Metric
A484/A484MSpecification for General Requirements for
Practice
Stainless Steel Bars, Billets, and Forgings
5
2.5 Quality Standard:
A751Test Methods and Practices for Chemical Analysis of
ASQ C1Specification of General Requirements for a Qual-
Steel Products
ity Program
E8/E8MTest Methods for Tension Testing of Metallic Ma-
terials
3. Terminology
E10Test Method for Brinell Hardness of Metallic Materials
E18Test Methods for Rockwell Hardness of Metallic Ma- 3.1 Definitions of Terms Specific to This Standard:
terials
3.1.1 lot, n—the total number of mill products produced
from the same melt heat under the same conditions at essen-
tially the same time.
1
This specification is under the jurisdiction of ASTM Committee F04 on
MedicalandSurgicalMaterialsandDevicesandisunderthedirectresponsibilityof
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Sept. 15, 2021. Published September 2021. Originally
3
approved in 1995. Last previous edition approved in 2013 as F1586–13. DOI: Available from Society of Automotive Engineers (SAE), 400 Commonwealth
10.1520/F1586-21. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve.,
the ASTM website. 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 ----------------------
F1586−21
4. General Requirements for Delivery 7.1.2 Methods and practices relating to chemical analysis
required by this specification shall be in accordance with Test
4.1 In addition to the requirements of this specification, all
Methods, Practices, and Terminology A751.
requirements of the current edition of Specification A484/
A484M sha
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: F1586 − 13 F1586 − 21
Standard Specification for
Wrought Nitrogen Strengthened 21Chromium—10Nickel—
3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for
1
Surgical Implants (UNS S31675)
This standard is issued under the fixed designation F1586; 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 (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—The designation was editorially corrected in August 2013.
1. Scope*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened
21chromium—10nickel—3manganese—2.5molybdenum stainless steel alloy bar for surgical implants.
1.2 The values stated in either inch-pound units or SI units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformancenonconformance with the standard.
1.3 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.
2. Referenced Documents
2
2.1 ASTM Standards:
A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
A751 Test Methods and Practices for Chemical Analysis of Steel Products
E8E8/E8M Test Methods for Tension Testing of Metallic Materials [Metric] E0008_E0008M
E10 Test Method for Brinell Hardness of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E45 Test Methods for Determining the Inclusion Content of Steel
E112 Test Methods for Determining Average Grain Size
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is under the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved June 1, 2013Sept. 15, 2021. Published August 2013September 2021. Originally approved in 1995. Last previous edition approved in 20082013
as F1586 – 08.F1586 – 13. DOI: 10.1520/F1586-13E01.10.1520/F1586-21.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 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 the ASTM website.
*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 ----------------------
F1586 − 21
3
2.2 Aerospace Material Specifications:
AMS 2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys
4
2.3 ISO Standard:Standards:
ISO 6892 Metallic Materials Tensile Testing at Ambient Temperature
ISO 9001 Quality Management System—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
2
2.4 Quality Standard:
IEEE/ASTM SI 10™10 American National Standard for Use of the International System of Units (SI): The Modern Metric
SystemMetric Practice
5
2.5 Quality Standard:
ASQ C1 Specification of General Requirements for a Quality Program
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the same
time.
4. General Requirements for Delivery
4.1 In addition to the requirements of this specification, all requirements of the current edition of Specification A484/A484M shall
apply.
4.2 In cases in which a conflict exists between this specification and the standards listed in Section 2, this spe
...

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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.

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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
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.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.

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ASTM
ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
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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