ASTM F2633-19
(Specification)Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
ABSTRACT
This specification covers the chemical, mechanical, and dimensional requirements for wrought seamless nickel-titanium shape memory alloy tubes used for the manufacture of medical devices and surgical implants. Tubes shall be furnished in the superelastic condition, and the outer surface shall have a pickled, ground, or mechanically polished finish, or as agreed upon between purchaser and supplier. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms. This specification applies precisely to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness. The mechanical properties to which the tubes shall conform are ultimate tensile strength (UTS), uniform elongation, upper plateau strength, lower plateau strength, and residual elongation.
SCOPE
1.1 This specification covers the requirements for wrought nickel-titanium shape memory alloy tube, nominally 54.5 to 57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product variables that differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F2063.
1.2 This specification applies to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner nominal wall thickness.
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses (inch-pound units) are for information only.
1.4 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.
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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:F2633 −19
Standard Specification for
Wrought Seamless Nickel-Titanium Shape Memory Alloy
1
Tube for Medical Devices and Surgical Implants
This standard is issued under the fixed designation F2633; 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* F2063 Specification for Wrought Nickel-Titanium Shape
Memory Alloys for Medical Devices and Surgical Im-
1.1 This specification covers the requirements for wrought
plants
nickel-titanium shape memory alloy tube, nominally 54.5 to
F2082 Test Method for Determination of Transformation
57.0 mass/mass (weight) % nickel, in the superelastic
Temperature of Nickel-Titanium Shape Memory Alloys
condition, used for the manufacture of medical devices and
by Bend and Free Recovery
surgical implants. Material shall conform to the applicable
F2516 Test Method for Tension Testing of Nickel-Titanium
requirements of Specification F2063. This specification ad-
Superelastic Materials
dressesthoseproductvariablesthatdifferentiatedrawnmedical
3
grade tube from the raw material and mill product forms 2.2 ISO Standard:
covered in Specification F2063. ISO 9001 Quality Management Systems—Requirements
ISO 13485 Quality Management Standard for Medical De-
1.2 This specification applies to tube with 10 mm (0.4 in.)
vices
and smaller nominal outside diameter and 2 mm (0.08 in.) and
thinner nominal wall thickness.
3. Terminology
1.3 The values stated in SI units are to be regarded as the
3.1 Definitions of Terms Specific to This Standard:
standard. The values given in parentheses (inch-pound units)
3.2 See Terminology F2005 for the definition of terms used
are for information only.
in this specification that are specific to nickel-titanium alloys.
1.4 This international standard was developed in accor-
3.3 individual wall thickness measurement, n—any one of
dance with internationally recognized principles on standard-
the wall thickness measurements taken around the circumfer-
ization established in the Decision on Principles for the
ence on any one transverse cross-section of a single sample of
Development of International Standards, Guides and Recom-
the tube.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
3.4 lot, n—the total quantity of product produced from the
same melt heat under the same conditions, at essentially the
2. Referenced Documents
same time.
2
2.1 ASTM Standards:
3.4.1 Discussion—For purposes of this specification, con-
A632 Specification for Seamless and Welded Austenitic
version from bar to tubular form by extrusion, gundrilling, or
Stainless Steel Tubing (Small-Diameter) for General Ser-
other method is included within the scope of this definition.
vice
3.5 lot average concentricity, n—the arithmetic average of
F2004 Test Method for Transformation Temperature of
the sample concentricities measured on a statistically represen-
Nickel-Titanium Alloys by Thermal Analysis
tative number of samples from the lot.
F2005 Terminology for Nickel-Titanium Shape Memory
Alloys 3.6 lot average wall thickness, n—the grand average of the
sample average wall thicknesses measured on a statistically
representative number of samples from the lot.
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
3.7 nominal outside diameter (OD), n—theoutsidediameter
Subcommittee F04.12 on Metallurgical Materials.
specified on the purchaser’s order or engineering drawing
Current edition approved Nov. 1, 2019. Published December 2019. Originally
without regard to tolerance.
approved in 2007. Last previous edition approved in 2013 as F2633–13. DOI:
10.1520/F2633-19.
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 ----------------------
F2633−19
3.8 nominal wall thickness, n—the wall thickness specified 4.1.8 Length (exact or random, see 9.4),
bythepurchaser’sordero
...
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: F2633 − 13 F2633 − 19
Standard Specification for
Wrought Seamless Nickel-Titanium Shape Memory Alloy
1
Tube for Medical Devices and Surgical Implants
This standard is issued under the fixed designation F2633; 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 nickel-titanium shape memory alloy tube, nominally 54.5 to 57.0
mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants.
Material shall conform to the applicable requirements of Specification F2063. This specification addresses those product variables
that differentiate drawn medical grade tube from the raw material and mill product forms covered in Specification F2063.
1.2 This specification applies to tube with 10 mm (0.4 in.) and smaller nominal outside diameter and 2 mm (0.08 in.) and thinner
nominal wall thickness.
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses (inch-pound units) are for
information only.
1.4 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 Standards:
A632 Specification for Seamless and Welded Austenitic Stainless Steel Tubing (Small-Diameter) for General Service
F2004 Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
F2005 Terminology for Nickel-Titanium Shape Memory Alloys
F2063 Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
F2082 Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and
Free Recovery
F2516 Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
3
2.2 ISO Standard:
ISO 9001 Quality Management Systems—Requirements
ISO 13485 Quality Management Standard for Medical Devices
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.2 See Terminology F2005 for the definition of terms used in this specification that are specific to nickel-titanium alloys.
3.3 individual wall thickness measurement, n—any one of the wall thickness measurements taken around the circumference on
any one transverse cross-section of a single sample of the tube.
3.4 lot, n—the total quantity of product produced from the same melt heat under the same conditions, at essentially the same
time.
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, 2013Nov. 1, 2019. Published November 2013December 2019. Originally approved in 2007. Last previous edition approved in 20072013
as F2633–07.–13. DOI: 10.1520/F2633-13.10.1520/F2633-19.
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 ----------------------
F2633 − 19
3.4.1 Discussion—
For purposes of this specification, conversion from bar to tubular form by extrusion, gundrilling, or other method is included within
the scope of this definition.
3.5 lot average concentricity, n—the arithmetic average of the sample concentricities measured on a statistically representative
number of samples from the lot.
3.6 lot average wall thickness, n—the grand average of the sample average wall thicknesses measured on a statistically
representative number of samples from the lot.
3.7 nominal outside diameter (OD), n—the outside diameter specified on the purchaser’s o
...
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