ASTM F2257-14

Standard Specification for Wrought Seamless or Welded and Drawn 18 Chromium-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 inch-pound or SI units are to be regarded separately as standard. Inch-pound units are shown in parentheses. 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: 31-Oct-2014
• 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)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F2257 −14
Standard Specification for
Wrought Seamless or Welded and Drawn 18 Chromium-
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* gical Implants (UNS S31673)
2
2.2 ASTM Standards:
1.1 This specification covers the requirements for wrought
A632Specification for Seamless and Welded Austenitic
18chromium-14nickel-2.5molybdenum stainless steel tubing
Stainless Steel Tubing (Small-Diameter) for General Ser-
used for the manufacture of surgical implants. Material shall
vice
conform to the applicable requirements of Specification F138
E8/E8MTest Methods for Tension Testing of Metallic Ma-
(for seamless) or Specification F139 (for welded and drawn).
terials
This specification addresses those product variables that dif-
E29Practice for Using Significant Digits in Test Data to
ferentiate small-diameter medical grade tubing from the bar,
Determine Conformance with Specifications
wire, sheet, and strip product forms covered in these specifi-
E112Test Methods for Determining Average Grain Size
cations.
F2181Specification for Wrought Seamless Stainless Steel
1.2 Thisspecificationappliestocoldfinishedstraightlength
Tubing for Surgical Implants
tubing with 3 mm [0.125 in.] and smaller nominal outside
IEEE/ASTM SI10American National Standard for Use of
diameter (OD) and 0.5 mm [0.020 in.] and thinner nominal
theInternationalSystemofUnits(SI):TheModernMetric
wall thickness.
System
3
1.3 The specifications in 2.1 are referred to as the ASTM
2.3 ISO Standards:
material standard(s) in this specification.
ISO 5832-1Implants for Surgery—Metallic Materials Part
1: Wrought Stainless Steel
1.4 The values stated in either inch-pound or SI units are to
ISO 6892Metallic Materials — Tensile Testing
beregardedseparatelyasstandard.Inch-poundunitsareshown
ISO9001Quality Management Systems — Requirements
in parentheses. The values stated in each system may not be
ISO13485Medicaldevices—Qualitymanagementsystems
exact equivalents; therefore, each system shall be used inde-
— Requirements for regulatory purposes
pendentlyoftheother.Combiningvaluesfromthetwosystems
4
2.4 ASME Standards:
may result in non-conformance with the standard.
ASMEY14.5.1MMathematical Definition of Dimensioning
2. Referenced Documents
and Tolerancing Principles
2
2.1 ASTM Material Standards:
3. Terminology
F138Specification for Wrought 18Chromium-14Nickel-
3.1 Definitions of Terms Specific to This Standard:
2.5MolybdenumStainlessSteelBarandWireforSurgical
3.1.1 individual wall thickness measurement— any one of
Implants (UNS S31673)
the wall thickness measurements taken around the circumfer-
F139Specification for Wrought 18Chromium-14Nickel-
ence on any one transverse cross section of a single sample of
2.5Molybdenum Stainless Steel Sheet and Strip for Sur-
the tube.
3.1.2 lot—the total number of product produced from the
1
This specification is under the jurisdiction of ASTM Committee F04 on
same melt heat under the same conditions at essentially the
Medical and Surgical Materials and Devices and is the direct responsibility of
same time.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 1, 2014. Published February 2015. Originally
approved in 2003. Last previous edition approved in 2009 as F2257–09. DOI:
3
10.1520/F2257-14. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 4th Floor, New York, NY 10036, http://www.ansi.org.
4
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Available from American Society of Mechanical Engineers (ASME), ASME
Standards volume information, refer to the standard’s Document Summary page on International Headquarters, Three Park Ave., New York, NY 10016-5990, http://
the ASTM website. www.asme.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 ----------------------
F2257−14
3.1.3 lot average concentricity—the arithmetic average of 3.1.11 seamless tubing—tubing made by a process in which
thesampleconcentricitiesmeasuredonastatisticallyrepresen- the tube periphery is continuous at all stages of the process.
tative number of samples from the lot.
3.1.12 welded and drawn tubing—tubing fabricated from
3.1.4 lot average wall thickness—the arithmetic average
...

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 − 09 F2257 − 14
Standard Specification for
Wrought Seamless or Welded and Drawn 18 Chromium-
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. 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.)[0.125 in.] and smaller nominal
outside diameter (OD) and 0.5 mm (0.020 in.)[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 are to be regarded separately as standard. Inch-pound units are shown in
parentheses. 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.
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)
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 System
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 — Quality management systems — Requirements for regulatory purposes
4
2.4 ASME Standards:
ASME Y14.5.1M Mathematical Definition of Dimensioning and Tolerancing Principles
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 Feb. 1, 2009Nov. 1, 2014. Published July 2009February 2015. Originally approved in 2003. Last previous edition approved in 20032009 as
F2257 – 03.F2257 – 09. DOI: 10.1520/F2257-09.10.1520/F2257-14.
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from American Society of Mechanical Engineers (ASME), ASME International Headquarters, Three Park Ave., New York, NY 10016-5990, http://
www.asme.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 − 14
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 individual wall thickness measurement— any one of the wall thickness measurements taken around the circumference on
any one transverse cross section of a single sample of the tube.
3.1.2 lot—the total number of mill products product pr
...