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ASTM F621-02

(Specification)

Standard Specification for Stainless Steel Forgings for Surgical Implants

Standard Specification for Stainless Steel Forgings for Surgical Implants

SCOPE
1.1 This specification covers the requirements of forged stainless steel for surgical implants when the material forged conforms to Specification F 138 (UNS S31673), Specification F 1314 (UNS S21910), or Specification F 1586 (UNS S31675).
1.2 The values stated in inch-pound units are to be regarded as the standard.

General Information

Status
Historical
Publication Date
09-Apr-2002
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 F621-97 - Standard Specification for Stainless Steel Forgings for Surgical Implants
Effective Date
10-Apr-2002
Replaced By
ASTM F621-08 - Standard Specification for Stainless Steel Forgings for Surgical Implants
Effective Date
01-Feb-2008
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
10-Apr-2002

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ASTM F621-02 - Standard Specification for Stainless Steel Forgings for Surgical ImplantsASTM F621-02 - Standard Specification for Stainless Steel Forgings for Surgical Implants
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ASTM F621-02 - Standard Specification for Stainless Steel Forgings for Surgical Implants
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 621 – 02
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.
7
1. Scope * 2.2 ISO Standards:
ISO 5832-1 Implants for Surgery—Metallic Materials Part
1.1 This specification covers the requirements of forged
1: Wrought Stainless Steel
stainless steel for surgical implants when the material forged
ISO 5832-9 Implants for Surgery—Metallic Materials Part
conforms to Specification F 138 (UNS S31673), Specification
9: Wrought High Nitrogen Stainless Steel
F 1314(UNSS21910),orSpecificationF 1586(UNSS31675).
2.3 American Society for Quality Standard:
1.2 The values stated in inch-pound units are to be regarded
Cl Specifications of General Requirements for a Quality
as the standard.
8
Control Program
2. Referenced Documents
3. Ordering Information
2.1 ASTM Standards:
3.1 Inquiries and orders for forgings under this specification
A 262 Practices for Detecting Susceptibility to Intergranu-
2
shall include the following information:
lar Attack in Austenitic Stainless Steels
2 3.1.1 Quantity,
A 473 Specification for Stainless Steel Forgings
3
3.1.2 ASTM designation and date of issue,
E 8 TestMethodsforTensionTestingofMetallicMaterials
3.1.3 ASTM material (alloy) standard and date of issue,
E 18 Test Methods for Rockwell Hardness and Rockwell
3
3.1.4 Condition,
Superficial Hardness of Metallic Materials
3
3.1.5 Mechanical properties,
E 112 Test Methods for Determining Average Grain Size
4
3.1.6 Finish,
E 165 Practice for Liquid Penetrant Examination
3.1.7 Applicable dimensions or drawing number,
E 353 Test Methods for Chemical Analysis of Stainless,
3.1.8 Special tests, if any, and
Heat-Resisting, Maraging, and Other Similar Chromium-
5
3.1.9 Other special requirements.
Nickel-Iron Alloys
F 138 Specification for Wrought-18Chromium-14Nickel-
4. General Requirements for Delivery
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
6 4.1 Material furnished to this specification shall conform to
Implants (UNS S31673)
the applicable requirements in the current edition of Specifi-
F 601 Practice for Fluorescent Penetrant Inspection of Me-
6 cation A 473.
tallic Surgical Implants
4.2 In the case where a conflict exists between this specifi-
F 1314 Specification for Wrought Nitrogen Strengthened-
cation and that listed in 4.1, this specification shall take
22Chromium-13Nickel-5Manganese-2.5Molybdenum
precedence.
Stainless Steel Alloy Bar and Wire for Surgical Implants
6
(UNS S21910)
5. Materials and Manufacture
F 1586 Specification for Wrought Nitrogen
5.1 Material for forgings shall be bars or wire fabricated in
Strengthened–21Chromium-10Nickel-3Manganese-
accordance with Specifications F 138, F 1314, or F 1586,
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
generally in the unannealed condition with a finish suitable for
6
Implants (UNS S31675)
forging.
5.2 The material shall be forged by hammering, pressing,
rolling, extruding, or upsetting, and shall be processed, if
1
This specification is under the jurisdiction of ASTM Committee F04 on practicable, so as to cause metal flow during the hot-working
Medical and Surgical Materials and Devices and is the direct responsibility of
operation to be in the most favorable direction for resisting
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Apr. 10, 2002. Published June 2002. Originally
published as F 621 – 79. Last previous edition F 621 – 97.
2
Annual Book of ASTM Standards, Vol 01.03.
3 7
Annual Book of ASTM Standards, Vol 03.01. Available from American National Standards Institute, 25 W. 43rd St., 4th
4
Annual Book of ASTM Standards, Vol 03.03. Floor, New York, NY 10036.
5 8
Annual Book of ASTM Standards, Vol 03.05. Available from American Society for Quality, 600 N. Plankinton Ave.,
6
Annual Book of ASTM Standards, Vol 13.01. Milwaukee, WI 53203.
*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 ----------------------
F 621
stresses encountered in service, as may be indicated to the 7.2 When desired, Rockwell hardness may be specified by
supplier by the purchaser. the purchaser and shall be determined in accordance with Test
Methods E 18.
5.3 Forgings shall be free of splits, scale, cracks, inequali-
7.3 The mechanical properties shall be determined in accor-
ties, flaws, and other imperfections not consistent with good
dance with Test Methods E 8
...

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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 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.  
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1.5 The values stated in SI units are to be regarded as the standard.  
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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
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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.  
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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