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ASTM F621-97

(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

Replaced By
ASTM F621-02 - Standard Specification for Stainless Steel Forgings for Surgical Implants
Effective Date
10-Apr-2002
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 F621-97 - Standard Specification for Stainless Steel Forgings for Surgical ImplantsASTM F621-97 - Standard Specification for Stainless Steel Forgings for Surgical Implants
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Technical specification
ASTM F621-97 - Standard Specification for Stainless Steel Forgings for Surgical Implants
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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 621 – 97
Standard Specification for
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 Cl Specifications of General Requirements for a Quality
Control Program
1.1 This specification covers the requirements of forged
stainless steel for surgical implants when the material forged
3. Ordering Information
conforms to F 138 (R31673), F 1314 (S21910), or F 1586.
3.1 Inquiries and orders for forgings under this specification
1.2 The values stated in inch-pound units are to be regarded
shall include the following information:
as the standard.
3.1.1 Quality; number of pieces,
2. Referenced Documents 3.1.2 ASTM designation; material grade,
3.1.3 Condition,
2.1 ASTM Standards:
3.1.4 Mechanical properties (other than those specified
A 262 Practices for Detecting Susceptibility to Intergranu-
2 herein),
lar Attack in Austenitic Stainless Steels
3.1.5 Finish,
A 370 Test Methods and Definitions for Mechanical Testing
2 3.1.6 Applicable dimensions or print number,
of Steel Products
3.1.7 Special tests, and
A 473 Specification for Stainless and Heat-Resisting Steel
3 3.1.8 Special requirements.
Forgings
E 18 Test Methods for Rockwell Hardness and Rockwell
4. General Requirements for Delivery
Superficial Hardness of Metallic Materials
4 4.1 Material furnished to this specification shall conform to
E 112 Test Methods for Determining Average Grain Size
5 the applicable requirements in the current edition of Specifi-
E 165 Practice for Liquid Penetrant Inspection Method
cation A 473.
E 353 Test Methods for Chemical Analysis of Stainless,
4.2 In the case where a conflict exists between this specifi-
Heat-Resisting, Maraging, and Other Similar Chromium-
6 cation and that listed in 4.1, this specification shall take
Nickel-Iron Alloys
precedence.
F 138 Specification for Stainless Steel Bars and Wire for
Surgical Implants (Special Quality)
5. Materials and Manufacture
F 601 Practice for Fluorescent Penetrant Inspection of Me-
7 5.1 Material for forgings shall be bars or wire fabricated in
tallic Surgical Implants
accordance with Specification F 138, F 1314, or F 1586, gen-
F 1314 Specification for Wrought Nitrogen
erally in the unannealed condition with a finish suitable for
Strengthened-22 Chromium-12.5 Nickel-5 Manganese-2.5
forging.
Molybdenum Stainless Steel Bar and Wire for Surgical
5.2 The material shall be forged by hammering, pressing,
Implants
rolling, extruding, or upsetting, and shall be processed, if
F 1586 Specification for Wrought Nitrogen Strength-
practicable, so as to cause metal flow during the hot-working
ened–21 Chromium-10 Nickel-3 Manganese-2.5 Molybde-
7 operation in the direction most favorable for resisting stresses
num Stainless Steel Bar for Surgical Implants
encountered in service, as may be indicated to the fabricator by
2.2 ASQC Standard:
the implant manufacturer.
5.3 Forgings shall be free of splits, scale, cracks, inequali-
ties, flaws, and other imperfections not consistent with good
commercial practice (see Note 1). Offset or mismatch allow-
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
ance, dependent upon part size and configuration, shall be
F04.12 on Metallurgical Materials.
within standard forging tolerances.
Current edition approved April 10, 1997. Published March 1998. Originally
published as F 621 – 79. Last previous edition F 621 – 92.
NOTE 1—Compliance to these requirements may be verified by Prac-
Annual Book of ASTM Standards, Vol 01.03.
tices E 165 or F 601 or other suitable methods.
Annual Book of ASTM Standards, Vol 01.05.
Annual Book of ASTM Standards, Vol 03.01.
Annual Book of ASTM Standards, Vol 03.03.
Annual Book of ASTM Standards, Vol 03.05.
Available from American Society for Quality Control, 161 W. Wisconsin Ave.,
Annual Book of ASTM Standards, Vol 13.01.
Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 621
5.4 After all hot working-operations, the forgings shall 7.5 The mechanical properties shall be determined in accor-
receive an annealing treatment, when necessary, by heating the dance with Test Methods A 370.
parts to an appropriate elevated temperature for a specified
dwell time followed by rapid cooling to meet the applicable 8. Special Requirements
metallurgical requirements specified herein.
8.1 Corrosion Tests— Forgings furnished to this specifica-
5.5 Optional identification marks, including the manufactur-
tion shall be capable of passing the test for intergranular
er’s logo, material designation, heat code
...

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