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ASTM F621-08

(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 F 138 (UNS S31673), F 1314 (UNS S21910), F 1586 (UNS S31675), F 2229 (UNS S29108), or F 2581 (UNS R56320).
1.2 The values stated in inch-pound units are to be regarded as the standard.

General Information

Status
Historical
Publication Date
31-Jan-2008
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 F621-02 - Standard Specification for Stainless Steel Forgings for Surgical Implants
Effective Date
01-Feb-2008
Replaced By
ASTM F621-12 - Standard Specification for Stainless Steel Forgings for Surgical Implants
Effective Date
01-Oct-2012
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
01-Feb-2008

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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 −08
StandardSpecification 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* tallic Surgical Implants
F1314 Specification for Wrought Nitrogen Strengthened 22
1.1 This specification covers the requirements of forged
Chromium–13Nickel–5Manganese–2.5Molybdenum
stainless steel for surgical implants when the material forged
Stainless Steel Alloy Bar and Wire for Surgical Implants
conforms to Specifications F138 (UNS S31673), F1314 (UNS
(UNS S20910)
S21910), F1586 (UNS S31675), F2229 (UNS S29108), or
F1586 Specification for Wrought Nitrogen Strengthened
F2581 (UNS R56320).
21Chromium—10Nickel—3Manganese—
1.2 The values stated in inch-pound units are to be regarded
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
as the standard.
Implants (UNS S31675)
F2229 Specification for Wrought, Nitrogen Strengthened
2. Referenced Documents
23Manganese-21Chromium-1Molybdenum Low-Nickel
2
2.1 ASTM Standards:
Stainless Steel Alloy Bar and Wire for Surgical Implants
A262 Practices for Detecting Susceptibility to Intergranular
(UNS S29108)
Attack in Austenitic Stainless Steels
F2581 Specification for Wrought Nitrogen Strengthened
A473 Specification for Stainless Steel Forgings
11Manganese-17Chromium-3Molybdenum Low-Nickel
E8 Test Methods for Tension Testing of Metallic Materials
Stainless Steel Alloy Bar and Wire for Surgical Implants
E10 Test Method for Brinell Hardness of Metallic Materials
(UNS S29225)
4
E18 Test Methods for Rockwell Hardness of Metallic Ma-
2.2 ISO Standards:
terials
ISO 5832-1 Implants for Surgery—Metallic Materials Part
E29 Practice for Using Significant Digits in Test Data to
1: Wrought Stainless Steel
Determine Conformance with Specifications
ISO 5832-9 Implants for Surgery—Metallic Materials Part
E92 Test Method forVickers Hardness of Metallic Materials
9: Wrought High Nitrogen Stainless Steel
3
(Withdrawn 2010)
ISO 9001 Quality Managements Systems—Requirements
5
E112 Test Methods for Determining Average Grain Size
2.3 American Society for Quality Standard:
E165 Practice for Liquid Penetrant Examination for General
ASQ C1 Specifications of General Requirements for a Qual-
Industry
ity Control Program
E353 Test Methods for Chemical Analysis of Stainless,
Heat-Resisting, Maraging, and Other Similar Chromium- 3. Terminology
Nickel-Iron Alloys
3.1 Definitions of Terms Specific to This Standard:
F138 Specification for Wrought 18Chromium-14Nickel-
3.1.1 lot—the total number of forgings produced from the
2.5Molybdenum Stainless Steel Bar andWire for Surgical
same heat under the same conditions at essentially the same
Implants (UNS S31673)
time.
F601 Practice for Fluorescent Penetrant Inspection of Me-
4. Ordering Information
4.1 Inquiries and orders for forgings under this specification
1
This specification is under the jurisdiction of ASTM Committee F04 on
shall include the following information:
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
4.1.1 Quantity,
Current edition approved Feb. 1, 2008. Published February 2008. Originally
4.1.2 ASTM designation and date of issue,
approved in 1979. Last previous edition approved in 2002 as F621 – 02. DOI:
4.1.3 ASTM material (alloy) standard and date of issue,
10.1520/F0621-08.
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
4
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.
3 5
The last approved version of this historical standard is referenced on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
www.astm.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 ----------------------
F621 − 08
4.1.4 Condition, 8. Mechanical Requirements
4.1.5 Mechanical properties,
8.1 The mechanical properties of forgings shall be tested by
4.1.6 Finish,
the forger and shall comply with the minimum mechanical
4.1.7 Applicable dimensions or drawing number,
properties as specified in Specifications F138, F1314, F1586,
4.1.8 Special tests, if any, and
F2229,or F2581, as applicable.
4.1.9 Other specia
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F621–02 Designation: F 621 – 08
Standard Specification for
1
Stainless Steel Forgings for Surgical Implants
This standard is issued under the fixed designation F 621; 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*
1.1 This specification covers the requirements of forged stainless steel for surgical implants when the material forged conforms
toSpecificationsF 138(UNSS31673),SpecificationF 1314(UNSS21910),orSpecificationF1586F 1586(UNSS31675),F 2229
(UNS S31675). S29108), or F 2581 (UNS R56320).
1.2 The values stated in inch-pound units are to be regarded as the standard.
2. Referenced Documents
2
2.1 ASTM Standards:
A 262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A 473 Specification for Stainless Steel Forgings
E 8 Test Methods for Tension Testing of Metallic Materials
3
E18Test Methods for Rockwell Hardness and Rockwell Superficial Hardness of Metallic Materials 10 Test Method for Brinell
Hardness of Metallic Materials
3
E112Test Methods for Determining Average Grain Size 18 Test Methods for Rockwell Hardness of Metallic Materials
E165Practice for Liquid Penetrant Examination 29 Practice for Using Significant Digits in Test Data to Determine
Conformance with Specifications
E 92 Test Method for Vickers Hardness of Metallic Materials
E 112 Test Methods for Determining Average Grain Size
E 165 Test Method for Liquid Penetrant Examination
E 353 Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron
Alloys
F 138 Specification for Wrought- 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F 601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F1314 Specification for Wrought Nitrogen Strengthened-22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel
6
Alloy Bar and Wire for Surgical Implants (UNS S21910)
1314 Specification forWrought Nitrogen Strengthened 22 Chromium 13 Nickel 5 Manganese 2.5 Molybdenum Stainless Steel
Alloy Bar and Wire for Surgical Implants (UNS S20910)
F 1586Specification for Wrought Nitrogen Strengthened–21Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel
6
Alloy Bar for Surgical Implants (UNS S31675)
2.2 Specification for Wrought Nitrogen Strengthened 21 Chromium10 Nickel3 Manganese2.5 Molybdenum Stainless SteelAlloy
Bar for Surgical Implants (UNS S31675)
F 2229 Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
F 2581 Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
2.2 ISO Standards:
ISO 5832-1Implants for Surgery—Metallic Materials Part 1: Wrought Stainless Steel
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 Apr. 10, 2002. Published June 2002. Originally published as F621–79. Last previous edition F621–97.
Current edition approved Feb. 1, 2008. Published February 2008. Originally approved in 1979. Last previous edition approved in 2002 as F 621 – 02.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 01.03.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 ----------------------
F621–08
3
ISO 5832-9Implants for Surgery—Metallic Materials Part 9: Wrought High Nitrogen Stainless Steel
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
4
2.3 American Society for Quality Standard:
ClASQ C1 Specifications of General Requirements for a Quality Control Program
3. Ordering Infor
...

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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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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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.

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