ASTM F621-12(2021)e1

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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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: Published
• 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

Relations

• Refers: ASTM E8/E8M-24 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Jan-2024
• Refers: ASTM F138-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• Effective Date: 01-Dec-2019
• Refers: ASTM A473-18a - Standard Specification for Stainless Steel Forgings
• Effective Date: 01-Nov-2018
• Refers: ASTM E18-18 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2018
• Refers: ASTM A473-18 - Standard Specification for Stainless Steel Forgings
• Effective Date: 01-May-2018
• Refers: 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
• Refers: ASTM A473-17a - Standard Specification for Stainless Steel Forgings
• Effective Date: 01-Sep-2017
• Refers: ASTM E18-17 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2017
• Refers: ASTM A473-17 - Standard Specification for Stainless Steel Forgings
• Effective Date: 01-May-2017
• Refers: ASTM E8/E8M-16 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 15-Jul-2016
• Refers: ASTM A473-16 - Standard Specification for Stainless Steel Forgings
• Effective Date: 01-May-2016
• Refers: ASTM A473-15 - Standard Specification for Stainless Steel Forgings
• Effective Date: 01-May-2015
• Refers: ASTM E8/E8M-15 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Feb-2015
• Refers: ASTM E353-14 - Standard Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys
• Effective Date: 15-Sep-2014
• Refers: ASTM E10-14 - Standard Test Method for Brinell Hardness of Metallic Materials
• Effective Date: 01-May-2014

Overview

ASTM F621-12(2021)e1 is an international standard developed by ASTM for specifying the requirements of stainless steel forgings intended for surgical implants. This specification is applicable to forgings made from specific stainless steel alloys, as defined in corresponding ASTM standards, ensuring material suitability for use in human implant applications. The standard encompasses criteria related to manufacturing processes, chemical composition, mechanical properties, testing methods, and quality assurance, contributing to safety and consistency in surgical device production.

Key Topics

• Material Scope: Covers stainless steel forgings produced from bar or wire in accordance with ASTM specifications F138, F1314, F1586, F2229, or F2581.
• Manufacturing Methods: Allows for forging by hammering, pressing, rolling, extruding, or upsetting, intended to optimize material flow and mechanical performance in service.
• Quality and Finish: Forgings must be free from detrimental imperfections like splits, cracks, or scale. Optional identification marks and surface finishes can be specified by purchasers.
• Testing Requirements:
  • Mechanical Testing: Includes tension, tensile strength, elongation, and hardness tests to verify material integrity.
  • Special Tests: Requires corrosion resistance evaluation (intergranular corrosion), average grain size observation, and fluorescent penetrant inspection to detect surface flaws.
• Units of Measurement: Accepts both SI and inch-pound units; these cannot be intermixed on a single certification.
• Certification and Documentation: Suppliers must provide certificates of compliance and detailed test reports with each shipment.

Applications

This standard is directly relevant to manufacturers and suppliers of surgical implants, particularly those utilizing high-performance stainless steel forgings. Key applications include:

• Orthopedic Implants: Hip, knee, and other joint replacements
• Dental Implants: Structural components requiring biocompatibility and corrosion resistance
• Trauma Devices: Screws, plates, and rods for bone fracture fixation
• Custom Surgical Hardware: Where specific material characteristics and mechanical properties are critical for patient safety

Widespread implementation of ASTM F621 ensures that stainless steel forgings for surgical use meet globally recognized safety, quality, and performance requirements. The standard supports both regulatory compliance and harmonization with international trade practices, making it essential for medical device manufacturers seeking worldwide market access.

Related Standards

ASTM F621 references and complements several key standards, including:

• ASTM F138: Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel for Surgical Implants
• ASTM F1314: Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire
• ASTM F1586, F2229, F2581: Various high-nitrogen and low-nickel stainless steel alloys for surgical use
• ASTM A473: General Stainless Steel Forgings requirements
• ISO 5832-1 & ISO 5832-9: International standards for wrought stainless steel for surgical implants
• ASTM E8/E8M, E10, E18, E92, E112, E165, E353: Test methods for mechanical, hardness, and microstructure evaluation
• ISO 9001: Quality management systems

Compliance with ASTM F621 and these referenced standards is vital for ensuring material reliability, patient safety, and acceptance by both regulators and the global healthcare market.

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Keywords: ASTM F621, stainless steel forgings, surgical implants, medical device materials, mechanical testing, corrosion resistance, grain size, biocompatibility, implant standards, orthopedic hardware

Standards Content (Sample)

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.
´1
Designation: F621 −12 (Reapproved 2021)
Standard Specification for
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.
ε NOTE—X2.2 was updated editorially in August 2021.
1. Scope E92 Test Methods for Vickers Hardness and Knoop Hard-
ness of Metallic Materials
1.1 This specification covers the requirements of forged
E112 Test Methods for Determining Average Grain Size
stainless steel for surgical implants when the material forged
E165 Practice for Liquid Penetrant Testing for General
conforms to Specifications F138 (UNS S31673), F1314 (UNS
Industry
S21910), F1586 (UNS S31675), F2229 (UNS S29108), or
E353 Test Methods for Chemical Analysis of Stainless,
F2581 (UNS R56320).
Heat-Resisting, Maraging, and Other Similar Chromium-
1.2 The values stated in either SI units or inch-pound units
Nickel-Iron Alloys
are to be regarded separately as standard. The values stated in
F138 Specification for Wrought 18Chromium-14Nickel-
each system are not necessarily exact equivalents; therefore, to
2.5Molybdenum Stainless Steel Bar andWire for Surgical
ensure conformance with the standard, each system shall be
Implants (UNS S31673)
used independently of the other, and values from the two
F601 Practice for Fluorescent Penetrant Inspection of Me-
systems shall not be combined.
tallic Surgical Implants
1.3 This international standard was developed in accor-
F1314 Specification for Wrought Nitrogen Strengthened 22
dance with internationally recognized principles on standard-
Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
ization established in the Decision on Principles for the
Stainless Steel Alloy Bar and Wire for Surgical Implants
Development of International Standards, Guides and Recom-
(UNS S20910)
mendations issued by the World Trade Organization Technical
F1586 Specification for Wrought Nitrogen Strengthened
Barriers to Trade (TBT) Committee.
21Chromium—10Nickel—3Manganese—
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
2. Referenced Documents
Implants (UNS S31675)
2.1 ASTM Standards:
F2229 Specification for Wrought, Nitrogen Strengthened
A262 Practices for Detecting Susceptibility to Intergranular
23Manganese-21Chromium-1Molybdenum Low-Nickel
Attack in Austenitic Stainless Steels
Stainless Steel Alloy Bar and Wire for Surgical Implants
A473 Specification for Stainless Steel Forgings
(UNS S29108)
E8/E8M Test Methods for Tension Testing of Metallic Ma-
F2581 Specification for Wrought Nitrogen Strengthened
terials
11Manganese-17Chromium-3Molybdenum Low-Nickel
E10 Test Method for Brinell Hardness of Metallic Materials
Stainless Steel Alloy Bar and Wire for Surgical Implants
E18 Test Methods for Rockwell Hardness of Metallic Ma-
(UNS S29225)
terials
IEEE/ASTM SI 10 American National Standard for Metric
E29 Practice for Using Significant Digits in Test Data to
Practice
Determine Conformance with Specifications
2.2 ISO Standards:
ISO 5832-1 Implants for Surgery—Metallic Materials Part
1 1: Wrought Stainless Steel
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
ISO 5832-9 Implants for Surgery—Metallic Materials Part
Subcommittee F04.12 on Metallurgical Materials.
9: Wrought High Nitrogen Stainless Steel
Current edition approved Aug. 15, 2021. Published August 2021. Originally
ISO 9001 Quality Managements Systems—Requirements
approved in 1979. Last previous edition approved in 2017 as F621 – 12 (2017).
DOI: 10.1520/F0621-12R21E01.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F621 − 12 (2021)
3. Terminology To avoid this effect during processing, heating cycles shall be
kept as short as possible.
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot—the total number of forgings produced from the 6.6 Optional identification marks, including the purchaser’s
same heat under the same conditions at essentially the same logo, material designation, heat code number, and impression
time. number, may be placed upon each forging, the method and
location of which shall be as specified by the purchaser.
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, F1314, F1586, F2229,or F2581, as applicable.
4.1.2 ASTM designation and date of issue,
4.1.3 ASTM material (alloy) standard and date of issue,
7.2 For referee purposes, Test Methods E353 shall be used.
4.1.4 Condition,
4.1.5 Mechanical properties, 8. Mechanical Requirements
4.1.6 Finish,
8.1 The mechanical properties of forgings shall be tested by
4.1.7 Applicable dimensions or drawing number,
the forger and shall comply with the minimum mechanical
4.1.8 Special tests (if any), and
properties as specified in Specification F138, F1314, F1586,
4.1.9 Other special requirements.
F2229,or F2581, as applicable.
8.1.1 Test specimens shall be taken from a representative
5. General Requirements for Delivery
forging if possible. A representative test bar may only be used
if the configuration is such that a test bar cannot be obtained.
5.1 Material furnished to this specification shall conform to
Any specially forged test bar shall be in the same condition as
the applicable requirements in the current edition of Specifi-
the forgings it represents.
cation A473.
8.2 When desired, hardness may be specified on the pur-
5.2 In the case where a conflict exists between this specifi-
chase order or drawing and shall be determined in accordance
cation and that listed in 5.1, this specification shall take
with Test Method E10, E18,or E92.
precedence.
8.3 The mechanical properties shall be determined in accor-
6. Materials and Manufacture
dance with Test Methods E8/E8M.
6.1 Material for forgings shall be bars or wire fabricated in
8.4 Number of Tests:
accordance with Specification F138, F1314, F1586, F2229,or
8.4.1 Perform at least one tension test from each lot in the
F2581, generally in the unannealed condition with a finish
longitudinal direction, or as indicated on the part drawing.
suitable for forging.
Should this test result not meet the specified requirements, test
two additional test pieces representative of the same lot, in the
6.2 The material shall be forged by hammering, pressing,
same manner, for each failed test piece. The lot shall be
rolling, extruding, or upsetting, and shall be processed, if
considered in compliance only if both additional test pieces
practicable, so as to cause metal flow during the hot-working
meet the specified requirements.
operation to be in the most favorable direction for resisting
8.4.2 Tensile tests results for which any specimen fractures
stresses encountered in service, as may be indicated to the
outside the gage length shall be considered acceptable if both
supplier by the purchaser.
the elongation and reduction of area meet the minimum
6.3 Forgings shall be free of splits, scale, cracks, flaws, and
requirements specified. Refer to Test Methods E8/E8M, sec-
other imperfections not consistent w
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