ASTM F2257-22

Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)

ABSTRACT
This specification covers the requirements for wrought seamless or welded and drawn 18chromium-14nickel-2.5molybdenum stainless steel small diameter tubing for surgical implants. Manufacturing method shall be seamless or welded and drawn process. Tubing shall conform to chemical composition, dimensions, and mechanical properties of this specification. Mechanical properties include ultimate tensile strength, yield strength, and elongation. Outside and inside diameter, wall thickness, length and straightness shall conform to the permissible limits of this specification.
SCOPE
1.1 This specification covers the requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel tubing used for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specification F138 (for seamless) or Specification F139 (for welded and drawn). This specification addresses those product variables that differentiate small-diameter medical grade tubing from the bar, wire, sheet, and strip product forms covered in these specifications.  
1.2 This specification applies to cold finished straight length tubing with 3 mm [0.125 in.] and smaller nominal outside diameter (OD) and 0.5 mm [0.020 in.] and thinner nominal wall thickness.  
1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. Inch-pound units are shown in brackets. 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.  
1.5 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.  
1.6 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-Sep-2022
• 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

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.
Designation:F2257 −22
Standard Specification for
Wrought Seamless or Welded and Drawn 18Chromium-
14Nickel-2.5Molybdenum Stainless Steel Small Diameter
1
Tubing for Surgical Implants (UNS S31673)
This standard is issued under the fixed designation F2257; 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* Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This specification covers the requirements for wrought
Barriers to Trade (TBT) Committee.
18chromium-14nickel-2.5molybdenum stainless steel tubing
used for the manufacture of surgical implants. Material shall
2. Referenced Documents
conform to the applicable requirements of Specification F138
2
2.1 ASTM Material Standards:
(for seamless) or Specification F139 (for welded and drawn).
F138Specification for Wrought 18Chromium-14Nickel-
This specification addresses those product variables that dif-
2.5MolybdenumStainlessSteelBarandWireforSurgical
ferentiate small-diameter medical grade tubing from the bar,
Implants (UNS S31673)
wire, sheet, and strip product forms covered in these specifi-
F139Specification for Wrought 18Chromium-14Nickel-
cations.
2.5Molybdenum Stainless Steel Sheet and Strip for Sur-
1.2 Thisspecificationappliestocoldfinishedstraightlength
gical Implants (UNS S31673)
tubing with 3 mm [0.125 in.] and smaller nominal outside
2
2.2 ASTM Standards:
diameter (OD) and 0.5 mm [0.020 in.] and thinner nominal
A632Specification for Seamless and Welded Austenitic
wall thickness.
Stainless Steel Tubing (Small-Diameter) for General Ser-
1.3 The specifications in 2.1 are referred to as the ASTM
vice
material standard(s) in this specification.
E8/E8MTest Methods for Tension Testing of Metallic Ma-
terials
1.4 The values stated in either SI units or inch-pound units
E29Practice for Using Significant Digits in Test Data to
are to be regarded separately as standard. Inch-pound units are
Determine Conformance with Specifications
shown in brackets. The values stated in each system are not
E112Test Methods for Determining Average Grain Size
necessarilyexactequivalents;therefore,toensureconformance
F2181Specification for Wrought Seamless Stainless Steel
with the standard, each system shall be used independently of
Tubing for Surgical Implants
the other and values from the two systems shall not be
IEEE/ASTM SI10American National Standard for Metric
combined.
Practice
1.5 This standard does not purport to address all of the
3
2.3 ISO Standards:
safety concerns, if any, associated with its use. It is the
ISO 5832-1Implants for Surgery—Metallic Materials Part
responsibility of the user of this standard to establish appro-
1: Wrought Stainless Steel
priate safety, health, and environmental practices and deter-
ISO 6892Metallic Materials—Tensile Testing
mine the applicability of regulatory limitations prior to use.
ISO9001Quality Management Systems—Requirements
1.6 This international standard was developed in accor-
ISO 13485 Medical Devices—Quality Management
dance with internationally recognized principles on standard-
Systems—Requirements for Regulatory Purposes
ization established in the Decision on Principles for the
1 2
This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Subcommittee F04.12 on Metallurgical Materials. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Oct. 1, 2022. Published October 2022. Originally the ASTM website.
3
approved in 2003. Last previous edition approved in 2014 as F2257–14. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2257-22. 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 ----------------------
F2257−22
4
2.4 ASME Standards: 3.1.10 sample minimum wall thickness—the smallest indi-
ASMEY14.5.1MMathematical Definition of Dimensioning vidual wall thickness measurement taken around the circum-
and Tolerancing Principles ference on any one transverse cross section
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2257 − 14 F2257 − 22
Standard Specification for
Wrought Seamless or Welded and Drawn 18 Chromium-
14Nickel-2.5Molybdenum 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Small Diameter Tubing for
1
Surgical Implants (UNS S31673)
This standard is issued under the fixed designation F2257; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This specification covers the requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel tubing used for
the manufacture of surgical implants. Material shall conform to the applicable requirements of Specification F138 (for seamless)
or Specification F139 (for welded and drawn). This specification addresses those product variables that differentiate small-diameter
medical grade tubing from the bar, wire, sheet, and strip product forms covered in these specifications.
1.2 This specification applies to cold finished straight length tubing with 3 mm [0.125 in.] and smaller nominal outside diameter
(OD) and 0.5 mm [0.020 in.] and thinner nominal wall thickness.
1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification.
1.4 The values stated in either inch-pound or SI units or inch-pound units are to be regarded separately as standard. Inch-pound
units are shown in parentheses.brackets. The values stated in each system mayare not benecessarily exact equivalents; therefore,
to ensure conformance with the standard, each system shall be used independently of the other. Combiningother and values from
the two systems may result in non-conformance with the standard.shall not be combined.
1.5 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.
1.6 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.
2. Referenced Documents
2
2.1 ASTM Material Standards:
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Nov. 1, 2014Oct. 1, 2022. Published February 2015October 2022. Originally approved in 2003. Last previous edition approved in 20092014 as
F2257 – 09.F2257 – 14. DOI: 10.1520/F2257-14.10.1520/F2257-22.
2
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 the ASTM website.
*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 ----------------------
F2257 − 22
F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants
(UNS S31673)
2
2.2 ASTM Standards:
A632 Specification for Seamless and Welded Austenitic Stainless Steel Tubing (Small-Diameter) for General Service
E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
F2181 Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric
SystemMetric Practice
3
2.3 ISO Standards:
ISO 5832-1 Implants for Surgery—Metallic Materials Part 1: Wrought Stainless Steel
ISO 6892 Metallic Materials — Tensile Materials—Tensile Testing
ISO 9001 Quality Management Systems — RequirementsSystems—Requirements
ISO 13485 Medical devices
...