ASTM F2527-10
(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.
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Designation:F2527 −10
StandardSpecification 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* F1058 Specification for Wrought 40Cobalt-20Chromium-
16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for
1.1 This specification covers the requirements for wrought
Surgical Implant Applications (UNS R30003 and UNS
seamless and welded and drawn cobalt alloy small diameter
R30008)
tubing used for the manufacture of surgical implants. Material
F1537 Specification for Wrought Cobalt-28Chromium-
shall conform to the applicable requirements of Specifications
6Molybdenum Alloys for Surgical Implants (UNS
F90, F562, F688, F1058 or F1537, Alloy 1. This specification
R31537, UNS R31538, and UNS R31539)
addresses those product variables that differentiate small diam-
2.2 ASTM Standards:
eter medical tubing from the bar, wire, sheet and strip product
E8 Test Methods for Tension Testing of Metallic Materials
forms covered in these specifications.
E29 Practice for Using Significant Digits in Test Data to
1.2 This specification applies to straight length tubing with
Determine Conformance with Specifications
6.3 mm [0.250 in.] and smaller nominal outside diameter (OD)
E112 Test Methods for Determining Average Grain Size
and 0.76 mm [0.030 in.] and thinner nominal wall thickness.
SI 10 American National Standard for Use of the Interna-
1.3 The specifications in 2.1 are referred to as the ASTM
tional System of Units (SI): The Modern Metric System
3
material standard(s) in this specification.
2.3 ISO Standards:
ISO 5832- 5 Implants for Surgery—Metallic Materials Part
1.4 The values stated in either SI units or inch-pound units
5: Wrought Cobalt, Chromium, Tungsten, Nickel Alloy
are to be regarded separately as standard. The values stated in
ISO 5832- 6 Implants for Surgery—Metallic Materials Part
each system may not be exact equivalents; therefore, each
6: Wrought Cobalt, Nickel, Chromium, Molybdenum
system shall be used independently of the other. Combining
Alloy
values from the two systems may result in non-conformance
ISO 5832- 7 Implants for Surgery—Metallic Materials Part
with the standard.
7: Wrought Cobalt, Chromium, Molybdenum Alloy
ISO 5832- 8 Implants for Surgery—Metallic Materials Part
2. Referenced Documents
8: Wrought Cobalt, Nickel, Chromium, Molybdenum,
2
2.1 ASTM Material Standards:
Tungsten, Iron Alloy
F90 Specification for Wrought Cobalt-20Chromium-
ISO 5832- 12 Implants for Surgery—Metallic Materials Part
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
12: Wrought Cobalt, Chromium, Molybdenum Alloy
tions (UNS R30605)
ISO 6892 Metallic Materials—Tensile Testing
F562 Specification for Wrought 35Cobalt-35Nickel-
ISO 9001 Quality Management Systems—Requirements
20Chromium-10Molybdenum Alloy for Surgical Implant
2.4 ASME Standard:
Applications (UNS R30035)
ASME Y14.5.1M 1994 (R2004) Mathematical Definition of
4
Dimensioning and Tolerancing Principles
1 3. Terminology
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
3.1 Definitions of Terms Specific to This Standard:
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2010. Published January 2011. Originally
ε1
approved in 2005. Last previous edition approved in 2005 as F2527 –05 . DOI:
3
10.1520/F2527-10. 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 service@astm.org. 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 ----------------------
F2527−10
3.1.1 average wall thickness—the arithmetic average of the and annealing operations shall be performed in such a way that
minimum wall thickness and the maximum wall thickness the weld bead and heat affected zone are virtually indistin-
measur
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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.
´1
Designation:F2527–05 Designation: F2527 – 10
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
´ NOTE—Section references in Section5 were editorially changed in April 2006.
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.
1.2This specification applies to straight length tubing with 0.250 in. (6.3 mm) and smaller nominal outside diameter (OD) and
0.030 in. (0.76 mm) and thinner nominal wall thickness.
1.3The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
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 Test Methods for Determining Average Grain Size
SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
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 Oct. 1, 2005. Published October 2005. DOI: 10.1520/F2527-05E01.
´1
Current edition approved Dec. 1, 2010. Published January 2011. Originally approved in 2005. Last previous edition approved in 2005 as F2527 –05 . DOI:
10.1520/F2527-10.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
*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 – 10
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 Surge
...
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