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ASTM F2229-07

(Specification)

Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)

Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought, nitrogen strengthened manganese-chromium-molybdenum low-nickel stainless steel alloy bars and wires used for surgical implants. All bars and wires should be furnished as specified in either annealed or cold-worked condition and in cold-drawn, pickled, ground and polished, ground, or any other specified finish. The products should conform to the required chemical composition, microcleanliness, purity, surface finish, tensile properties, and hardness and should pass the intergranular corrosion susceptibility test. Both wires and bars must have a homogenous microstructure and with grain sizes within the specified range.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 23manganese-21chromium-1molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents of the inch-pound units may be approximate.

General Information

Status
Historical
Publication Date
31-Jul-2007
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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ASTM F2229-07 - Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)ASTM F2229-07 - Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
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ASTM F2229-07 - Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
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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:F2229 −07
StandardSpecification for
Wrought, Nitrogen Strengthened 23Manganese-
21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy
1
Bar and Wire for Surgical Implants (UNS S29108)
This standard is issued under the fixed designation F2229; 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* E407Practice for Microetching Metals and Alloys
F138Specification for Wrought 18Chromium-14Nickel-
1.1 This specification covers the chemical, mechanical, and
2.5MolybdenumStainlessSteelBarandWireforSurgical
metallurgical requirements for wrought nitrogen strengthened
Implants (UNS S31673)
23manganese-21chromium-1molybdenum low-nickel stainless
F746Test Method for Pitting or Crevice Corrosion of
steel alloy bar and wire for surgical implants.
Metallic Surgical Implant Materials
1.2 Thevaluesstatedininch-poundunitsaretoberegarded
F748PracticeforSelectingGenericBiologicalTestMethods
asthestandard.TheSIequivalentsoftheinch-poundunitsmay
for Materials and Devices
be approximate.
F1314Specification for Wrought Nitrogen Strengthened 22
Chromium–13Nickel–5Manganese–2.5Molybdenum
2. Referenced Documents
Stainless Steel Alloy Bar and Wire for Surgical Implants
2
2.1 ASTM Standards:
(UNS S20910)
A262Practices for Detecting Susceptibility to Intergranular
F1586Specification for Wrought Nitrogen Strengthened
Attack in Austenitic Stainless Steels
21Chromium—10Nickel—3Manganese—
A484/A484MSpecification for General Requirements for
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
Stainless Steel Bars, Billets, and Forgings
Implants (UNS S31675)
A555/A555MSpecification for General Requirements for
3
2.2 Aerospace Material Specification:
Stainless Steel Wire and Wire Rods
AMS2248Chemical CheckAnalysis Limits, Corrosion and
A751Test Methods, Practices, and Terminology for Chemi-
Heat Resistant Steels and Alloys, Maraging and Other
cal Analysis of Steel Products
Highly-Alloyed Steels, and Iron Alloys
E8Test Methods for Tension Testing of Metallic Materials
4
2.3 ISO Standards:
E10Test Method for Brinell Hardness of Metallic Materials
ISO6892Metallic Materials Tensile Testing at Ambient
E18Test Methods for Rockwell Hardness of Metallic Ma-
Temperature
terials
ISO9001Quality Management Systems—Requirements
E29Practice for Using Significant Digits in Test Data to
5
Determine Conformance with Specifications
2.4 American Society for Quality Standard:
E45Test Methods for Determining the Inclusion Content of
ASQC1Specification of General Requirements for a Qual-
Steel
ity Program
E112Test Methods for Determining Average Grain Size
E354 Test Methods for Chemical Analysis of High-
3. Terminology
Temperature,Electrical,Magnetic,andOtherSimilarIron,
3.1 Definitions of Terms Specific to This Standard:
Nickel, and Cobalt Alloys
3.1.1 bar—roundbarandflatsfrom0.1875in.(4.75mm)to
4.00 in. (101.60 mm) in diameter or thickness (other sizes and
1 shaped by special order).
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Aug. 1, 2007. Published August 2007. Originally
3
approved in 2002. Last previous edition approved in 2002 as F2229–02. DOI: Available from Society of Automotive Engineers (SAE), 400 Commonwealth
10.1520/F2229-07. 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 ----------------------
F2229−07
3.1.2 forging bar—asdescribedinsection3.1.1usedforthe 6.1.1 Requirements for the major and minor elemental
production of forgings, may be furnished in the hot rolled constituents are listed in Table 1. Also listed are important
condition. residualelements.AnalysisforelementsnotlistedinTable1is
not required to verify compliance with this specification.
3.1.3 lot—the total number of mill products produced from
6.1.2 Methods and practices relating to chemical analysis
th
...

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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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A1.1 Significance and Use
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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.

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