ASTM F2527-16
(Specification)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)
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 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
Relations
Buy Standard
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 −16
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* F688 Specification for Wrought Cobalt-35Nickel-
20Chromium-10MolybdenumAlloy Plate, Sheet, and Foil
1.1 This specification covers the requirements for wrought
for Surgical Implants (UNS R30035)
seamless and welded and drawn cobalt alloy small diameter
F1058 Specification for Wrought 40Cobalt-20Chromium-
tubing used for the manufacture of surgical implants. Material
16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for
shall conform to the applicable requirements of Specifications
Surgical Implant Applications (UNS R30003 and UNS
F90, F562, F688, F1058 or F1537, Alloy 1. This specification
R30008)
addresses those product variables that differentiate small diam-
F1537 Specification for Wrought Cobalt-28Chromium-
eter medical tubing from the bar, wire, sheet and strip product
6Molybdenum Alloys for Surgical Implants (UNS
forms covered in these specifications.
R31537, UNS R31538, and UNS R31539)
1.2 This specification applies to straight length tubing with
2.2 ASTM Standards:
6.3 mm [0.250 in.] and smaller nominal outside diameter (OD)
A632 Specification for Seamless and Welded Austenitic
and 0.76 mm [0.030 in.] and thinner nominal 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 Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to
1.4 The values stated in either SI units or inch-pound units
Determine Conformance with Specifications
are to be regarded separately as standard. The values stated in
E45 Test Methods for Determining the Inclusion Content of
each system may not be exact equivalents; therefore, each
Steel
system shall be used independently of the other. Combining
E112 Test Methods for Determining Average Grain Size
values from the two systems may result in non-conformance
F2819 Test Methods for Measurement of Straightness of
with the standard.
Bar,Rod,TubingandWiretobeusedforMedicalDevices
SI 10 American National Standard for Use of the Interna-
2. Referenced Documents
tional System of Units (SI): The Modern Metric System
2
3
2.1 ASTM Material Standards: 2.3 ISO Standards:
F90 Specification for Wrought Cobalt-20Chromium-
ISO 5832- 5 Implants for Surgery—Metallic Materials Part
15Tungsten-10NickelAlloy for Surgical ImplantApplica- 5: Wrought Cobalt, Chromium, Tungsten, Nickel Alloy
tions (UNS R30605)
ISO 5832- 6 Implants for Surgery—Metallic Materials Part
F562 Specification for Wrought 35Cobalt-35Nickel- 6: Wrought Cobalt, Nickel, Chromium, Molybdenum
20Chromium-10Molybdenum Alloy for Surgical Implant
Alloy
Applications (UNS R30035)
ISO 5832- 7 Implants for Surgery—Metallic Materials Part
7: Wrought Cobalt, Chromium, Molybdenum Alloy
ISO 5832- 8 Implants for Surgery—Metallic Materials Part
8: Wrought Cobalt, Nickel, Chromium, Molybdenum,
1
This specification is under the jurisdiction of ASTM Committee F04 on
Tungsten, Iron Alloy
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
ISO 5832- 12 Implants for Surgery—Metallic Materials Part
Current edition approved April 1, 2016. Published May 2016. Originally
12: Wrought Cobalt, Chromium, Molybdenum Alloy
approved in 2005. Last previous edition approved in 2010 as F2527 – 10. DOI:
ISO 6892 Metallic Materials—Tensile Testing
10.1520/F2527-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
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.
*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 ----------------------
F2527−16
ISO 9001 Medical Devices—Quality Management where:
Systems—Requireme
...
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 − 10 F2527 − 16
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 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:
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)
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 and Strip 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
E8 Test Methods for Tension Testing of Metallic Materials
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 used for Medical Devices
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- 5 Implants for Surgery—Metallic Materials Part 5: Wrought Cobalt, Chromium, Tungsten, Nickel Alloy
ISO 5832- 6 Implants for Surgery—Metallic Materials Part 6: Wrought Cobalt, Nickel, Chromium, Molybdenum Alloy
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 Dec. 1, 2010April 1, 2016. Published January 2011May 2016. Originally approved in 2005. Last previous edition approved in 20052010 as
ε1
F2527F2527 – 10. –05 . DOI: 10.1520/F2527-10.10.1520/F2527-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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.
*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 − 16
ISO 5832- 7 Implants for Surgery—Metallic Materials Part 7: Wrought Cobalt, Chromium, Molybdenum Alloy
ISO 5832- 8 Implants for Surgery—Metallic Materials Part 8: Wrought Cobalt, Nickel, Chromium, Molybdenum, Tungsten, Iron
Alloy
ISO 5832- 12 Implant
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.