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ASTM F1314-13ae1

(Specification)

Standard 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)

Standard 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)

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22 chromium – 13 nickel – 5 manganese – 2.5 molybdenum stainless steel alloy bar and wire for surgical implants.  
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.

General Information

Status
Historical
Publication Date
30-Sep-2013
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 F1314-13 - Standard 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)
Effective Date
01-Oct-2013
Replaced By
ASTM F1314-18 - Standard 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)
Effective Date
01-Feb-2018
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-Oct-2013
Referred By
ASTM F2181-20 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
Effective Date
01-Oct-2013
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
01-Oct-2013
Referred By
ASTM F2229-21 - Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
Effective Date
01-Oct-2013
Referred By
ASTM F621-12(2021)e1 - Standard Specification for Stainless Steel Forgings for Surgical Implants
Effective Date
01-Oct-2013
Referred By
ASTM F2581-12(2017) - Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
Effective Date
01-Oct-2013
Referred By
ASTM F2180-17 - Standard Specification for Metallic Implantable Strands and Cables
Effective Date
01-Oct-2013
Referred By
ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
Effective Date
01-Oct-2013

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ASTM F1314-13ae1 - Standard 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)ASTM F1314-13ae1 - Standard 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)
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ASTM F1314-13ae1 - Standard 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)
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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
´1
Designation:F1314 −13a
Standard Specification for
Wrought Nitrogen Strengthened 22 Chromium–13 Nickel–5
Manganese–2.5 Molybdenum Stainless Steel Alloy Bar and
1
Wire for Surgical Implants (UNS S20910)
This standard is issued under the fixed designation F1314; 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
ε NOTE—The designation was corrected editorially in December 2013.
1. Scope* E45Test Methods for Determining the Inclusion Content of
Steel
1.1 This specification covers the chemical, mechanical, and
E112Test Methods for Determining Average Grain Size
metallurgical requirements for wrought nitrogen strengthened
E354 Test Methods for Chemical Analysis of High-
22 chromium – 13 nickel – 5 manganese – 2.5 molybdenum
Temperature,Electrical,Magnetic,andOtherSimilarIron,
stainless steel alloy bar and wire for surgical implants.
Nickel, and Cobalt Alloys
1.2 The values stated in either SI units or inch-pound units
E407Practice for Microetching Metals and Alloys
are to be regarded separately as standard. The values stated in
F138Specification for Wrought 18Chromium-14Nickel-
each system may not be exact equivalents; therefore, each
2.5MolybdenumStainlessSteelBarandWireforSurgical
system shall be used independently of the other. Combining
Implants (UNS S31673)
values from the two systems may result in non-conformance
F746Test Method for Pitting or Crevice Corrosion of
with the standard.
Metallic Surgical Implant Materials
IEEE/ASTM SI 10American National Standard for Metric
2. Referenced Documents
Practice
2
2.1 ASTM Standards:
3
2.2 Aerospace Materials Specification:
A262Practices for Detecting Susceptibility to Intergranular
AMS 2248Chemical CheckAnalysis Limits, Corrosion and
Attack in Austenitic Stainless Steels
Heat Resistant Steels and Alloys, Maraging and Other
A484/A484MSpecification for General Requirements for
Highly-Alloyed Steels, and Iron Alloys
Stainless Steel Bars, Billets, and Forgings
AMS 2630Inspection, Ultrasonic Product Over 0.5 inch
A555/A555MSpecification for General Requirements for
(12.7 mm) Thick
Stainless Steel Wire and Wire Rods
AMS 2632Ultrasonic Inspection of Thin Materials
A751Test Methods, Practices, and Terminology for Chemi-
4
2.3 ISO Standards:
cal Analysis of Steel Products
ISO 6892Metallic Materials Tensile Testing at Ambient
E8/E8MTest Methods for Tension Testing of Metallic Ma-
Temperature
terials
ISO 9001Quality Management Systems—Requirements
E10Test Method for Brinell Hardness of Metallic Materials
E18Test Methods for Rockwell Hardness of Metallic Ma-
3. Terminology
terials
E29Practice for Using Significant Digits in Test Data to 3.1 Definitions of Terms Specific to This Standard:
Determine Conformance with Specifications 3.1.1 bar,n—roundbarsandflatsfrom0.1875in.[4.75mm]
to 4.00 in. [101.60 mm] in diameter or thickness (other sizes
and shapes by special order).
1
This specification is under the jurisdiction of ASTM Committee F04 on
3.1.2 forging bar, n—as described in 3.1.2 used for produc-
Medical and Surgical Materials and Devicesand is the direct responsibility of
tion of forgings, may be furnished in the hot rolled condition.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Oct. 1, 2013. Published November 2013. Originally
approved in 1990. Last previous edition approved in 2013 as F1314–13. DOI:
10.1520/F1314-13AE01.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Society of Automotive Engineers (SAE), 400 Commonwealth
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Dr., Warrendale, PA 15096-0001, http://www.sae.org.
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.
*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 ----------------------
´1
F1314−13a
3.1.3 lot, n—the total number mill products produced under 6.1.2 Methods and practices relating to chemical analysis
thesamemeltheatunderthesameconditionsatessentiallythe required by this specification shall be in accordance with Test
same time. Methods A751.
3.1.4 wire, n—rounds less than 0.1875 in. [4.75 mm] in
6.2 Product Analysis—The product analysis is either for the
diameter.
purpose of verifying the composition of a heat or manufactur-
inglotortodeterminevariationsinthecompositionwithi
...

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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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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.
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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 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.

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