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: F2063 − 18

Standard Specification for

Wrought Nickel-Titanium Shape Memory Alloys for Medical
Devices and Surgical Implants1
This standard is issued under the fixed designation F2063; 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* E112 Test Methods for Determining Average Grain Size

1.1 This specification covers the chemical, physical, E1019 Test Methods for Determination of Carbon, Sulfur,
mechanical, and metallurgical requirements for wrought Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt
nickel-titanium bar, flat rolled products, and tubes containing Alloys by Various Combustion and Inert Gas Fusion
nominally 54.5- to 57.0-weight percent nickel and used for the Techniques
manufacture of medical devices and surgical implants. E1097 Guide for Determination of Various Elements by
Direct Current Plasma Atomic Emission Spectrometry
1.2 Requirements are for mill product, measuring 5.50 to E1172 Practice for Describing and Specifying a Wavelength
94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill Dispersive X-Ray Spectrometer
product is not intended to have the final shape, final surface E1245 Practice for Determining the Inclusion or Second-
finish, or final properties of the medical device, implant, or Phase Constituent Content of Metals by Automatic Image
their components. Finished NiTi cold-worked tube should be Analysis
considered under Specification F2633. E1409 Test Method for Determination of Oxygen and Nitro-
1.3 The values stated in either SI units or inch-pound units gen in Titanium and Titanium Alloys by Inert Gas Fusion
are to be regarded separately as standard. The values stated in E1447 Test Method for Determination of Hydrogen in Tita-
each system may not be exact equivalents; therefore, each nium and Titanium Alloys by Inert Gas Fusion Thermal
system shall be used independently of the other. Combining Conductivity/Infrared Detection Method
values from the two systems may result in non-conformance E1479 Practice for Describing and Specifying Inductively
with the standard. Coupled Plasma Atomic Emission Spectrometers
1.4 This international standard was developed in accor- E1941 Test Method for Determination of Carbon in Refrac-
dance with internationally recognized principles on standard- tory and Reactive Metals and Their Alloys by Combustion
ization established in the Decision on Principles for the Analysis
Development of International Standards, Guides and Recom- E2465 Test Method for Analysis of Ni-Base Alloys by
mendations issued by the World Trade Organization Technical Wavelength Dispersive X-Ray Fluorescence Spectrometry
Barriers to Trade (TBT) Committee. F1710 Test Method for Trace Metallic Impurities in Elec-
tronic Grade Titanium by High Mass-Resolution Glow
2. Referenced Documents Discharge Mass Spectrometer
2.1 ASTM Standards:2 F2004 Test Method for Transformation Temperature of
E4 Practices for Force Verification of Testing Machines Nickel-Titanium Alloys by Thermal Analysis
E8/E8M Test Methods for Tension Testing of Metallic Ma- F2005 Terminology for Nickel-Titanium Shape Memory
terials Alloys
E29 Practice for Using Significant Digits in Test Data to F2082 Test Method for Determination of Transformation
Determine Conformance with Specifications Temperature of Nickel-Titanium Shape Memory Alloys
by Bend and Free Recovery
F2633 Specification for Wrought Seamless Nickel-Titanium
1
This specification is under the jurisdiction of ASTM Committee F04 on Shape Memory Alloy Tube for Medical Devices and
Medical and Surgical Materials and Devices and is the direct responsibility of
Surgical Implants
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Aug. 1, 2018. Published August 2018. Originally IEEE/ASTM SI 10 American National Standard for Metric
approved in 2000. Last previous edition approved in 2012 as F2063 – 12. DOI: Practice
10.1520/F2063–18.
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.

*A Summary of Changes section appears at the end of this standard

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 F2063 − 18
2.2 ISO Standard:3 6.4 The product surface condition may be oxidized,
ISO 9001 Quality Management Systems—Requirements descaled, pickled, blasted, machined, ground, mechanically
polished, or electropolished.
3. Terminology
7. Chemical Composition Requirements
3.1 The terminology describing the physical and thermal
properties of these alloys shall be as defined in Terminology 7.1 The ingot analysis shall conform to the requirements of
F2005. Table 1. Ingot analysis may be used for reporting all chemical
requirements except hydrogen. Samples for hydrogen analysis
3.2 See also Practice E4 (General Terminology). shall be taken from the finished product (see Section 4) or as
3.3 Definitions: agreed upon between the customer and supplier. The supplier
3.3.1 ingot, n—quantity of metal cast into a shape suitable shall not ship material that is outside the limits specified in
for subsequent processing to various mill products. Table 1.
3.3.2 mill product, n—any finished or semi-finished product 7.1.1 Requirements for major and minor elements are listed
from a mill. Product may be straight or coiled. Product types in Table 1. Important residual elements are also listed. Analysis
include hot-worked, hot-worked and cold-finished, and hot- for elements not listed in Table 1 is not required to verify
worked and cold-worked, with or without a final heat treat- compliance with this specification.
ment. 7.2 Product Analysis:
7.2.1 Product analysis limits shall be as specified in Table 2.
4. Product Classification Product analysis tolerances do not broaden the specification
4.1 Bar—Round bars and flats from 5.50 to 94.0 mm [0.218 ingot analysis requirements, but cover variation between labo-
to 3.70 in.] in diameter or thickness (other sizes or shapes by ratories in the measurement of chemical content. The manu-
special order). facturer shall not ship material that is outside the limits
specified in Table 1.
4.2 Plate—Any product 5.50 up to 94.0 mm [0.218 to 3.70 7.2.2 The product analysis is either for the purpose of
in.] in thickness, with a width equal to or greater than five times verifying the composition of an ingot or manufacturing lot or
the thickness. to determine variations in the composition within the ingot.
4.3 Tube—Hollow cylindrical shapes from 5.50 up to 94.0 7.2.3 Acceptance or rejection of an ingot or manufacturing
mm [0.218 to 3.70 in.] in outer diameter. lot of material may be made by the purchaser on the basis of
this product analysis. Product analysis may be conducted by a
5. Ordering Information third party if agreed upon by the supplier and the purchaser.
5.1 Inquiries and orders for material under this specification 7.2.4 Major elements shall be analyzed by direct current
shall include the following information: plasma spectrometry according to Guide E1097; atomic
5.1.1 Quantity—weight, length, or number of pieces. absorption, inductively coupled plasma spectrometry accord-
5.1.2 Alloy formulation, in terms of transformation tempera- ing to Practice E1479; X-ray spectrometer according to Prac-
ture parameter (see Section 8). tice E1172; glow discharge mass spectrometry according to
5.1.3 Form—bar, plate, or tube (see Section 4). Test Method F1710; or an equivalent method. Carbon shall be
5.1.4 Condition—(see 3.3). measured by combustion according to Test MethodS E1019 or
5.1.5 Mechanical Properties—if applicable for special con- E1941 or wavelength dispersive X-ray fluorescence spectrom-
ditions (see Section 10). etry according to Test Method E2465. Hydrogen shall be
5.1.6 Surface Condition—(see Section 6.4). measured by inert gas fusion or vacuum hot extraction.
5.1.7 Applicable Dimensions, including diameter, thickness, Hydrogen shall be measured by inert gas fusion or vacuum hot
width, and length (exact, random, multiples) or print number. extraction according to Test Method E1447. Nitrogen and
5.1.8 Special Tests—for example, chemical analysis on the oxygen shall be measured by inert gas fusion according to Test
finished mill product. Method E1409.
5.1.9 Special Requirements—(see Section 13).
TABLE 1 Chemical Composition Requirements
Element % (mass/mass)
6. Materials and Manufacture Nickel 54.5 to 57.0
6.1 The material shall be made from ingot made from nickel Carbon, maximum 0.040
Cobalt, maximum 0.050
and titanium with no other intentional alloy additions. Copper, maximum 0.010
Chromium, maximum 0.010
6.2 The material shall be vacuum or inert atmosphere Hydrogen, maximum 0.005
melted to control metallurgical cleanliness and alloy chemistry. Iron, maximum 0.050
Niobium, maximum 0.025
6.3 The product shall be supplied as specified in the Nitrogen, maximum 0.005
purchase order. Oxygen, maximum 0.040
TitaniumA Balance
A
Approximately equal to the difference between 100 % and the sum percentage
of the other specified elements. The percentage titanium content by difference is
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., not required to be reported.
4th Floor, New York, NY 10036, http://www.ansi.org.

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 F2063 − 18
TABLE 2 Product Analysis ToleranceA 8.3 Section size, location, evaluation method, and results
Element Tolerance Under the Minimum Limit shall be reported on the product certification report provided to
or Over the Maximum Limit,
% (mass/mass)B
the purchaser.
Carbon 0.002
Cobalt 0.001 9. Metallurgical Structure
Copper 0.001
Chromium 0.001 9.1 Microstructure:
Hydrogen 0.0005 9.1.1 Microstructure shall be evaluated only in the hot-
Iron 0.01
Nickel 0.2 under min; 0.2 over max
worked or annealed condition. Such evaluations shall take
Niobium 0.004 place at a section size not larger than 94.0 mm [3.70 in.] and
Nitrogen 0.001 not smaller than 5.50 mm [0.218 in.] in diameter, thickness,
Oxygen 0.004
width, height, wall thickness, or other maximum dimension.
A
Product analysis tolerance limits are based on analytical capabilities that have
been demonstrated for this composition.
Evaluation may take place on in-process product that will be
B
Under minimum limit not applicable for elements where only a maximum utilized to create the final product form. Condition, section
percentage is indicated. size, location, and evaluation method shall be reported on the
product certification report provided to the purchaser.
9.1.2 For all product evaluated as stated in 9.1.1, the product
shall have an average grain size number (G) of 4 or larger as
7.2.5 The titanium content of these alloys shall be deter- measured by Test Method E112. Results shall be reported on
mined by difference and need not be analyzed. the product certification report provided to the purchaser.
9.2 Microcleanliness:
8. Transformation Temperature 9.2.1 Porosity and nonmetallic inclusions shall be evaluated
8.1 The nickel and titanium contents of nickel-titanium only in the hot-worked, or for cold-worked mill product in the
shape memory alloys cannot be measured to a precision annealed condition, or as agreed between the supplier and
required to guarantee shape memory or superelastic properties. purchaser. Such evaluations shall take place at a section size
Calorimetry or an equivalent thermomechanical test method not larger than 94.0 mm [3.70 in.] and not smaller than 5.50
shall be used to ensure the alloy formulation in terms of mm [0.218 in.] in diameter, thickness, width, height, wall
transformation temperature. Testing shall be performed on thickness, or other maximum dimension. Evaluation may take
material in the fully annealed condition. place on in-process product that will be utilized to create the
final product form. Condition, section size, location, and
8.2 Product alloy formulation shall be specified in terms of evaluation method shall be reported on the product certification
the transformation temperature parameter(s) required by the report provided to the purchaser.
purchase order. This parameter shall be one of the following: 9.2.2 For product with As less than or equal to 30°C, the
Mf, Mp, Ms, As, Ap, Af as defined in Terminology F2005 and as maximum allowable dimension of porosity and nonmetallic
measured on the product in accordance with Test Method inclusions such as Ti4Ni2Ox and TiC particles shall be 39.0 µm
F2004, or as measured in accordance with another appropriate [0.0015 in.]. The maximum dimension shall be the maximum
thermomechanical test method, such as Test Method F2082. length of all contiguous particles and voids, including particles
Test Method F2004 shall be used to determine transformation separated by voids. Furthermore, porosity and nonmetallic
temperatures unless otherwise agreed between the supplier and inclusions shall not constitute more than 2.8 % (area percent)
purchaser. of the structure as viewed at 400× to 500× in any field of view.
8.2.1 When measured in accordance with Test Method 9.2.3 For product with As greater than 30°C, the maximum
F2004 for transformation temperature by thermal analysis, the allowable dimensions of porosity and nonmetallic inclusions
As shall be uniform on the purchased product to within the such as Ti4Ni2Ox and TiC particles shall be agreed upon by the
ranges in Table 3 or as agreed upon by the purchaser and purchaser and supplier
supplier. 9.2.4 Measurements shall be made in accordance with
8.2.2 Table 3 tolerances are for As only. Tolerances for Mf, Practice E1245 or an equivalent method with longitudinal
Mp, Ms, Ap, and Af are as agreed upon by the purchaser and samples parallel to the working direction. The supplier and
supplier. purchaser shall agree upon the size of the product when
8.2.3 Transformation temperature parameters are normally sampled, the number and location of samples in the product,
specified in the wrought product as defined in Terminology the sample preparation, the number of fields of view, and the
F2005. Other conditions for the certification of alloy transfor- measurement technique. These shall be reported on the product
mation temperature shall be considered a special requirement. certification report provided to the purchaser.

10. Mechanical Property Requirements

TABLE 3 Typical Tolerances 10.1 Final product shall be tensile tested in the fully
As (°C) Tolerance Range (°C) annealed condition. Tensile testing shall be conducted in
$70 ±7 accordance with Test Methods E8/E8M.
–50 < As < 70 ± 10
# –50 ± 15 10.1.1 Tension test samples from the final product shall be
annealed so that the material reaches a minimum temperature

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 F2063 − 18
of 800°C [1470°F] for a minimum time of 15 min followed by significant digits should be observed when performing this
rapid cooling by water quenching, gas quenching, or air conversion. IEEE/ASTM SI 10 provides guidelines for the use
cooling. of SI units. Annex A provides conversion tables and Annex B
10.1.2 Tensile properties shall be determined using a strain provides rules for conversion and significant digits.
rate of 0.003 to 0.1 mm/mm/min [in./in./min]. Tensile proper-
ties shall meet the requirements listed in Table 4 using the 12. Significance of Numerical Limits
appropriate gauge length for the product size being tested. 12.1 The following applies to all specified numerical limits
NOTE 1—Annealed product should be tested at 5 to 10°C above Af.
in this specification. To determine conformance to these limits,
an observed or calculated value shall be rounded to the nearest
10.1.3 Specimens for tension tests from product above 50.0 unit in the last right-hand digit used in expressing the specifi-
mm [1.97 in.] in diameter or thickness may be taken from plate cation limit, in accordance with the rounding method of
or strip rolled from the product. For product 50.0 mm [1.97 in.] Practice E29.
or less in diameter or thickness, specimens shall be made from
the product. 13. Special Requirements
10.1.4 Tensile properties shall be measured in the longitu- 13.1 Size variation and out-of-round tolerance shall be
dinal direction with respect to the final fabrication of the specified in the purchase order.
sample. Transverse tensile properties for wide flat products
shall be as agreed upon between the customer and the supplier. 13.2 Special transformation temperature requirements in
Specimen size and condition shall be reported on the product terms of product form, test location or heat treatment shall be
certification report provided to the purchaser. specified on the purchase order.
10.2 Other special mechanical tests shall be as specified on 13.3 Surface roughness shall be specified on the purchase
the purchase order. order.

11. Units of Measure 14. Certification

11.1 Selection—This specification requires that the pur- 14.1 The supplier shall provide at the time of shipment at
chaser selects the units (SI or inch-pound) to be used for least one copy of the report certifying that the material was
product certification. In the absence of a stated selection of manufactured, inspected, sampled, and tested in accordance
units on the purchase order, this selection may be expressed by with the requirements of this specification. The certification
the purchaser in several alternate forms listed in order of report shall include results of all chemical analyses, transfor-
precedence. mation temperature, metallurgical structure, direction of met-
11.1.1 If the purchaser and supplier have a history of using allurgical structural analysis, and mechanical properties (see
specific units, these units shall continue to be certified until Sections 7, 8, 9, and 10) and any additional requirements
expressly changed by the purchaser. agreed upon by the supplier and purchaser. The report shall
11.1.2 In the absence of historic precedence, if the units include the material size sampled, location, condition, and
used to define the product on the purchaser’s PO, specification, method(s) used for each test. For microcleanliness (see 9.2),
and engineering drawing are consistent, these units shall be the certification shall include the size of the product when
used by the supplier for product certification. sampled, the number and location of samples in the product,
11.1.3 If the purchaser’s selection of units is unclear, the the orientation of the field of view with respect to the working
units of measure shall be agreed upon between purchaser and direction, the sample preparation, the number of fields of view,
supplier. and the measurement technique. The report shall include the
melt method(s) used to produce the ingot and the manufactur-
11.2 Conversion of Units—If the supplier’s test equipment
ing method (for example, hot rolled, forged, extruded, or cold
does not report in the selected units, the test equipment units
worked) as agreed between the supplier and purchaser.
may be converted to the selected units for certification pur-
poses. Accurate arithmetic conversion and proper use of 15. Quality Program
15.1 The supplier shall maintain a quality program such as
TABLE 4 Annealed Mechanical PropertiesA
ISO 9001 or similar quality program.
Diameter or Distance Tensile Strength MPa, Elongation in 50.0 mm [1.97
Between Parallel Sides, Minimum in.] or 4 D, % MinimumB
mm 16. Keywords
Up to 50.0 [1.97 in.] 551 (79.9 KSI) 15
Over 50.0 [1.97 in.] 551 (79.9 KSI) 10
16.1 cardiac devices; metals; NiTi; TiNi; nitinol; nickel-
A
titanium alloys; titanium-nickel alloys; orthopaedic medical
Tested at ambient temperature of 20.0 to 24.0°C [68.0 to 75.2°F].
B
4D indicates 4 times diameter. devices; vascular devices; shape memory alloys; stents; super-
elastic alloys; surgical implants

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 F2063 − 18
APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 The purpose of this specification is to characterize the X1.6 Transformation temperature uniformity refers to the
chemical, physical, thermomechanical and metallurgical prop- range of As measured on an alloy formulation tested by a single
erties of wrought nominally 54.5 to 57.0 % nickel-titanium laboratory working to Test Method F2004.
alloys to be used in the manufacture of medical devices and
surgical implants. X1.7 The elements carbon, cobalt, copper, hydrogen, iron,
niobium, and oxygen are residual elements in these alloys (see
X1.2 The purchaser’s choice of shape memory alloy trans- Table 1). They are controlled to special limits in order to ensure
formation temperature and mechanical properties is dependent good shape memory, physical and mechanical properties. The
upon the design and application of the medical device. product analysis tolerance limits are based upon the analytical
X1.3 Thermo-mechanical process history, particularly cold capabilities that have been demonstrated for these composi-
work and heat treatment, affects the transformation tempera- tions.
ture and other physical and mechanical properties of nickel-
titanium shape memory alloys. The annealed condition stipu- X1.8 Units of Measure:
lated in Sections 8.2.3 and 10.1 are for the test samples only. X1.8.1 ASTM Policy—ASTM is promoting the use of ratio-
Final product may be purchased in the hot-worked, hot-worked nalized IEEE/ASTM SI 10 (metric) units in their standards.
and cold-finished, or hot-worked and cold-worked, with or The F12.04 Committee has modified this specification to
without a final heat treatment. facilitate the transition by the medical materials industry to SI
between now and 2018. In the first phase of this transition,
X1.4 Ingot chemical analysis can be affected by subsequent
thermo-mechanical and chemical processing. For example, running to 2013, the specifications will be structured to allow
pickling can result in hydrogen pick up. Therefore, hydrogen is the use of either SI or inch-pound units. The choice of primary
specified for the finished mill product (see Section 7.2). units in each specification will be determined by the industry
using the specification. The change to SI units during this
X1.5 The nickel-titanium alloys covered by this standard period may be initiated by the purchaser through his purchase
are commonly called nitinol alloys. Nitinol is not a single documentation. In the second phase of this transition the
alloy; it is a family of alloys each designated by a transforma- specifications will be written with SI as the primary units.
tion temperature measured under controlled conditions and Harmonization with corresponding ISO documents should be
after a specified thermo-mechanical history. considered when assigning the SI values.

X2. BIOCOMPATIBILITY

X2.1 Biocompatibility can be influenced by the intended SMST-97 Proceedings of the Second International Conference
use, design, and fabrication of the device. on Shape Memory and Superelastic Technologies, Pelton, A et
al., (eds.), SMST, Santa Clara, CA, 1997, pp. 383–388.
X2.2 The material compositions covered by this specifica- Wever, D.J., et al., “Cytotoxic, Allergic and Genotoxic
tion have been employed successfully in human implants, Activity of a Nickel-Titanium Alloy,” Biomaterials, Vol. 18,
exhibiting a well-characterized level of local biological re- No. 16, 1997, pp. 1115–1120.
sponse since 1972. References are as follows: Trepanier, C. et al., “Effect of the Modification of the Oxide
Castleman, L. S., et al., “Biocompatability of Nitinol Alloy Layer on NiTi Stent Corrosion Resistance,” J. Biomedical
as an Implant Material,” J. Biomedical Materials Research, Vol Materials Research, Vol. 43, 1998, pp. 433–440.
10, 1976, pp. 695–731. Ryhanen, J., “Biocompatibility of Nitinol,” Minimally Inva-
Ryhanen, J., et al., “Biocompatability of Nickel Titanium sive Therapy and Allied Technology, Vol. 9, No. 2, 2000, pp.
Shape Memory Metal and its Corrosion Behavior in Human 99-105.
Cell Cultures,” J. Biomedical Materials Research, Vol. 35, Venugopalan, R. and Trepanier, C., “Assessing the Corro-
1997, pp. 451–457. sion Behavior of Nitinol for Minimally Invasive Device
Trigwell, S. and Selvaduray, G., “Effects of Surface Finish Design,” Minimally Invasive Therapy and Allied Technology,
on the Corrosion of NiTi Alloy for Biomedical Applications,” Vol. 9, No. 2, 2000, pp. 67-73.

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 F2063 − 18
Thierry, B., et al., “Nitinol versus Stainless Steel Stents: X2.3 No known surgical implant has ever been shown to be
Acute Thrombogenicity Study in an Ex-Vivo Porcine Model,” completely free of adverse reaction in the human body. Long
Biomaterials, Vol. 23, 2002, pp. 2997-3005. term clinical experience in the use of the materials referred to
Zhu, L., et al., “Oxidation of Nitinol and its Effect on in this specification, however, has shown that an acceptable
Corrosion Resistance,” S. Shrivastava, Proceedings from the level of biological response can be expected, if the material is
Materials & Processes for Medical Devices Conference, 8-10 used in an appropriate application.
Sept. 2003, Anaheim, CA, ASM International, 2004, pp.
156–161.

SUMMARY OF CHANGES

The following is a summary of selected changes to this standard since the last issue (F2063 – 12) that may
impact the use of this standard. (Approved Aug. 1, 2018.)

(1) Defined the term ingot. (5) Restricted microstructure and inclusion assessment to hot-
(2) Standardized use of the term ingot in place of heat and/or worked product, prior to any cold processing or fully annealed
ingot. condition on cold-worked product.
(3) Updated chemistry requirements of C, N, and O. Split (6) Added additional certification reporting requirements
oxygen and nitrogen (see Table 1). throughout.
(4) Added references to Test Methods E2465 and F2082 to
Section 2.1, and 7.2.4 and 8.2, respectively.

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