ASTM F2527-24

Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)

ABSTRACT
This specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms are addressed. This specification applies to straight length tubing of specified diameters and thickness. Seamless tubing shall be made from bar, hollow bar, rod, or hollow rod raw material forms through a prescribed process. Welded and drawn tubing shall be made from strip or sheet raw material forms that meet the specified chemical requirements. The tubing shall be subject to tensile testing.
SCOPE
1.1 This specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F90, F562, F688, F1058 or F1537, Alloy 1. This specification addresses those product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms covered in these specifications.  
1.2 This specification applies to straight length tubing with 6.3 mm [0.250 in.] and smaller nominal outside diameter (OD) and 0.76 mm [0.030 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. 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: 31-Dec-2023
• 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

• Replaces: ASTM F2527-16 - Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
• Effective Date: 01-Jan-2024

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: F2527 − 24
Standard Specification for
Wrought Seamless and Welded and Drawn Cobalt Alloy
Small Diameter Tubing for Surgical Implants (UNS R30003,
1
UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
This standard is issued under the fixed designation F2527; 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* mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This specification covers the requirements for wrought
seamless and welded and drawn cobalt alloy small diameter
2. Referenced Documents
tubing used for the manufacture of surgical implants. Material
2
shall conform to the applicable requirements of Specifications
2.1 ASTM Material Standards:
F90, F562, F688, F1058 or F1537, Alloy 1. This specification
F90 Specification for Wrought Cobalt-20Chromium-
addresses those product variables that differentiate small diam-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
eter medical tubing from the bar, wire, sheet, and strip product
tions (UNS R30605)
forms covered in these specifications.
F562 Specification for Wrought 35Cobalt-35Nickel-
20Chromium-10Molybdenum Alloy for Surgical Implant
1.2 This specification applies to straight length tubing with
Applications (UNS R30035)
6.3 mm [0.250 in.] and smaller nominal outside diameter (OD)
F688 Specification for Wrought Cobalt-35Nickel-
and 0.76 mm [0.030 in.] and thinner nominal wall thickness.
20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil
1.3 The specifications in 2.1 are referred to as the ASTM
for Surgical Implants (UNS R30035)
material standard(s) in this specification.
F1058 Specification for Wrought 40Cobalt-20Chromium-
16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and
1.4 The values stated in either SI units or inch-pound units
Strip Bar for Surgical Implant Applications (UNS R30003
are to be regarded separately as standard. The values stated in
and UNS R30008)
each system are not necessarily exact equivalents; therefore, to
F1537 Specification for Wrought Cobalt-28Chromium-
ensure conformance with the standard, each system shall be
6Molybdenum Alloys for Surgical Implants (UNS
used independently of the other, and values from the two
R31537, UNS R31538, and UNS R31539)
systems shall not be combined.
2.2 ASTM Standards:
1.5 This standard does not purport to address all of the
A632 Specification for Seamless and Welded Austenitic
safety concerns, if any, associated with its use. It is the
Stainless Steel Tubing (Small-Diameter) for General Ser-
responsibility of the user of this standard to establish appro-
vice
priate safety, health, and environmental practices and deter-
E8/E8M Test Methods for Tension Testing of Metallic Ma-
mine the applicability of regulatory limitations prior to use.
terials
1.6 This international standard was developed in accor-
E29 Practice for Using Significant Digits in Test Data to
dance with internationally recognized principles on standard-
Determine Conformance with Specifications
ization established in the Decision on Principles for the
E45 Test Methods for Determining the Inclusion Content of
Development of International Standards, Guides and Recom-
Steel
E112 Test Methods for Determining Average Grain Size
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.12 on Metallurgical Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Jan. 1, 2024. Published January 2024. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2005. Last previous edition approved in 2016 as F2527 – 16. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2527-24. 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 ----------------------
F2527 − 24
F2819 Test Methods for Measurement of Straightness of 3.1.8 sample average wall thickness—the arithmetic aver-
Bar, Rod, Tubing and Wire to be used for Medical Devices age of all individual wall thickness measurements measured on
IEEE/ASTM SI 10 American National Standard for Metric a single sample.
Practice
3.1.9 sample concentricity—two times t
...

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: F2527 − 16 F2527 − 24
Standard Specification for
Wrought Seamless and Welded and Drawn Cobalt Alloy
Small Diameter Tubing for Surgical Implants (UNS R30003,
1
UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
This standard is issued under the fixed designation F2527; 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 seamless and welded and drawn cobalt alloy small diameter tubing used
for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F90, F562, F688,
F1058 or F1537, Alloy 1. This specification addresses those product variables that differentiate small diameter medical tubing from
the bar, wire, sheet, and strip product forms covered in these specifications.
1.2 This specification applies to straight length tubing with 6.3 mm [0.250 in.] and smaller nominal outside diameter (OD) and
0.76 mm [0.030 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. The values stated in each
system may not beare not necessarily 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:
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
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 April 1, 2016Jan. 1, 2024. Published May 2016January 2024. Originally approved in 2005. Last previous edition approved in 20102016 as
F2527 – 10.F2527 – 16. DOI: 10.1520/F2527-16.10.1520/F2527-24.
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 ----------------------
F2527 − 24
F688 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical
Implants (UNS R30035)
F1058 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for
Surgical Implant Applications (UNS R30003 and UNS R30008)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
2.2 ASTM Standards:
A632 Specification for Seamless and Welded Austenitic Stainless Steel Tubing (Small-Diameter) for General Service
E8E8/E8M Test Methods for Tension Testing of Metallic Materials [Metric] E0008_E0008M
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E45 Test Methods for Determining the Inclusion Content of Steel
E112 Test Methods for Determining Average Grain Size
F2819 Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be u
...