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ASTM F621-12(2017)

(Specification)

Standard Specification for Stainless Steel Forgings for Surgical Implants

Standard Specification for Stainless Steel Forgings for Surgical Implants

ABSTRACT
This specification covers the requirements for stainless steel forgings for surgical implants. Materials for forgings shall be bars or wire and shall be forged by hammering, pressing, rolling, extruding, or upsetting. The material shall comply with the manufacturing procedure, chemical composition, mechanical requirements, and test methods indicated in this specification. Mechanical testing includes tension, tensile, elongation, and hardness tests. Special tests shall also be done such as corrosion tests, grain size, and fluorescent penetrant inspection.
SCOPE
1.1 This specification covers the requirements of forged stainless steel for surgical implants when the material forged conforms to Specifications F138 (UNS S31673), F1314 (UNS S21910), F1586 (UNS S31675), F2229 (UNS S29108), or F2581 (UNS R56320).  
1.2 The values stated in either SI units or inch-pound 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-conformance 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
Historical
Publication Date
30-Apr-2017
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

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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F621 −12 (Reapproved 2017)
Standard Specification for
1
Stainless Steel Forgings for Surgical Implants
ThisstandardisissuedunderthefixeddesignationF621;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.
1. Scope* E165 Practice for Liquid Penetrant Examination for General
Industry
1.1 This specification covers the requirements of forged
E353 Test Methods for Chemical Analysis of Stainless,
stainless steel for surgical implants when the material forged
Heat-Resisting, Maraging, and Other Similar Chromium-
conforms to Specifications F138 (UNS S31673), F1314 (UNS
Nickel-Iron Alloys
S21910), F1586 (UNS S31675), F2229 (UNS S29108), or
F138 Specification for Wrought 18Chromium-14Nickel-
F2581 (UNS R56320).
2.5Molybdenum Stainless Steel Bar andWire for Surgical
1.2 The values stated in either SI units or inch-pound units
Implants (UNS S31673)
are to be regarded separately as standard. The values stated in
F601 Practice for Fluorescent Penetrant Inspection of Me-
each system may not be exact equivalents; therefore, each
tallic Surgical Implants
system shall be used independently of the other. Combining
F1314 Specification for Wrought Nitrogen Strengthened 22
values from the two systems may result in non-conformance
Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
with the standard.
Stainless Steel Alloy Bar and Wire for Surgical Implants
1.3 This international standard was developed in accor- (UNS S20910)
dance with internationally recognized principles on standard-
F1586 Specification for Wrought Nitrogen Strengthened
ization established in the Decision on Principles for the 21Chromium—10Nickel—3Manganese—
Development of International Standards, Guides and Recom-
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
mendations issued by the World Trade Organization Technical Implants (UNS S31675)
Barriers to Trade (TBT) Committee.
F2229 Specification for Wrought, Nitrogen Strengthened
23Manganese-21Chromium-1Molybdenum Low-Nickel
2. Referenced Documents
Stainless Steel Alloy Bar and Wire for Surgical Implants
2
(UNS S29108)
2.1 ASTM Standards:
F2581 Specification for Wrought Nitrogen Strengthened
A262 Practices for Detecting Susceptibility to Intergranular
11Manganese-17Chromium-3Molybdenum Low-Nickel
Attack in Austenitic Stainless Steels
Stainless Steel Alloy Bar and Wire for Surgical Implants
A473 Specification for Stainless Steel Forgings
(UNS S29225)
E8 Test Methods for Tension Testing of Metallic Materials
IEEE/ASTM SI 10 American National Standard for Metric
E10 Test Method for Brinell Hardness of Metallic Materials
Practice
E18 Test Methods for Rockwell Hardness of Metallic Ma-
3
terials 2.2 ISO Standards:
E29 Practice for Using Significant Digits in Test Data to ISO 5832-1 Implants for Surgery—Metallic Materials Part
Determine Conformance with Specifications 1: Wrought Stainless Steel
E92 Test Methods for Vickers Hardness and Knoop Hard- ISO 5832-9 Implants for Surgery—Metallic Materials Part
ness of Metallic Materials 9: Wrought High Nitrogen Stainless Steel
E112 Test Methods for Determining Average Grain Size ISO 9001 Quality Managements Systems—Requirements
3. Terminology
1
This specification is under the jurisdiction of ASTM Committee F04 on
3.1 Definitions of Terms Specific to This Standard:
Medical and Surgical Materials and Devices and is the direct responsibility of
3.1.1 lot—the total number of forgings produced from the
Subcommittee F04.12 on Metallurgical Materials.
same heat under the same conditions at essentially the same
Current edition approved May 1, 2017. Published June 2017. Originally
approved in 1979. Last previous edition approved in 2012 as F621 – 12. DOI:
time.
10.1520/F0621-12R17.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.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 ----------------------
F621−12 (2017)
4. Ordering Information 7. Chemical Composition
4.1 Inquiries and orders for forgings under this specification
7.1 The stainless steel forgings shall conform to the chemi-
shall include the following information:
cal requirements prescribed in the applicable alloy specifica-
4.1.1 Quantity,
tion: F138
...

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.
Designation: F621 − 12 F621 − 12 (Reapproved 2017)
Standard Specification for
1
Stainless Steel Forgings for Surgical Implants
This standard is issued under the fixed designation F621; 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. Scope*
1.1 This specification covers the requirements of forged stainless steel for surgical implants when the material forged conforms
to Specifications F138 (UNS S31673), F1314 (UNS S21910), F1586 (UNS S31675), F2229 (UNS S29108), or F2581 (UNS
R56320).
1.2 The values stated in either SI units or inch-pound 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-conformance 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
A473 Specification for Stainless Steel Forgings
E8 Test Methods for Tension Testing of Metallic Materials
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
E92 Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E112 Test Methods for Determining Average Grain Size
E165 Practice for Liquid Penetrant Examination for General Industry
E353 Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron
Alloys
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium–13 Nickel–5 Manganese–2.5 Molybdenum Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
F1586 Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless
Steel Alloy Bar for Surgical Implants (UNS S31675)
F2229 Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
F2581 Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel
Alloy Bar and Wire for Surgical Implants (UNS S29225)
IEEE/ASTM SI 10 American National Standard for Metric Practice
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2012May 1, 2017. Published October 2012June 2017. Originally approved in 1979. Last previous edition approved in 20082012 as
F621 – 08.F621 – 12. DOI: 10.1520/F0621-12.10.1520/F0621-12R17.
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 ----------------------
F621 − 12 (2017)
3
2.2 ISO Standards:
ISO 5832-1 Implants for Surgery—Metallic Materials Part 1: Wrought Stainless Steel
ISO 5832-9 Implants for Surgery—Metallic Materials Part 9: Wrought High Nitrogen Stainless Steel
ISO 9001 Quality Managements Systems—Requirements
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot—the total number of forgings produced from the same heat under the same conditions at essentially the same time.
4. Ordering Information
4.1 Inquiries and orders for forgings under this
...

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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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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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