ASTM F2527-05

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)

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 F 90, F 562, F 688, F 1058 or F 1537, 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 0.250 in. (6.3 mm) and smaller nominal outside diameter (OD) and 0.030 in. (0.76 mm) and thinner nominal wall thickness.
1.3 The 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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2005
• 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

• Replaced By: ASTM F2527-05e1 - 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-Oct-2005

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2527 – 05
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)
This standard is issued under the fixed designation F 2527; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope Chromium-10MolybdenumAlloyPlate,SheetandFoilfor
Surgical Implants (UNS R30035)
1.1 This specification covers the requirements for wrought
F 1058 Specification for Wrought 40Cobalt-20Chromium-
seamless and welded and drawn cobalt alloy small diameter
16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for
tubing used for the manufacture of surgical implants. Material
Surgical Implant Application (UNS R30003 and UNS
shall conform to the applicable requirements of Specifications
R30008)
F90, F 562, F 688, F 1058 or F 1537, Alloy 1. This specifica-
F 1537 Specification for Wrought Cobalt-28Chromium-
tion addresses those product variables that differentiate small
6Molybdenum Alloys for Surgical Implants (UNS
diameter medical tubing from the bar, wire, sheet and strip
R31537, UNS R31538, and UNS R31539)
product forms covered in these specifications.
2.2 ASTM Standards:
1.2 This specification applies to straight length tubing with
A 632 Specification for Seamless and Welded Austenitic
0.250 in. (6.3 mm) and smaller nominal outside diameter (OD)
Stainless Steel Tubing (Small-Diameter) for General Ser-
and 0.030 in. (0.76 mm) and thinner nominal wall thickness.
vice
1.3 The values stated in inch-pound units are to be regarded
E8 Test Methods for Tension Testing of Metallic Materials
as standard. The values given in parentheses are mathematical
E45 TestMethodsforDeterminingtheInclusionContentof
conversions to SI units that are provided for information only
Steel
and are not considered standard.
E112 Test Method for Determining Average Grain Size
2. Referenced Documents 2.3 ISO Standards:
ISO 5832- 5 Implants for Surgery—Metallic Materials Part
2.1 ASTM Material Standards:
5: Wrought Cobalt, Chromium, Tungsten, Nickel Alloy
F90 Specification for Wrought Cobalt-20Chromium-
ISO 5832- 6 Implants for Surgery—Metallic Materials Part
15Tungsten-10Nickel Alloy for Surgical Implants (UNS
6: Wrought Cobalt, Nickel, Chromium, Molybdenum
R30605)
Alloy
F 562 Specification for Wrought 35Cobalt-35Nickel-
ISO 5832- 7 Implants for Surgery—Metallic Materials Part
20Chromium-10MolybdenumAlloy for Surgical Implants
7: Wrought Cobalt, Chromium, Molybdenum Alloy
(UNS R30035)
ISO 5832- 8 Implants for Surgery—Metallic Materials Part
F 688 Specification for Wrought Cobalt-35 Nickel-20
8: Wrought Cobalt, Nickel, Chromium, Molybdenum,
Tungsten, Iron Alloy
This specification is under the jurisdiction of ASTM Committee F04 on ISO 5832- 12 Implants for Surgery—Metallic Materials
Medical and Surgical Materials and Devices and is the direct responsibility of
Part 12: Wrought Cobalt, Chromium, Molybdenum Alloy
Subcommittee F04.12 on Metallurgical Materials.
ISO 6892 Metallic Materials—Tensile Testing
Current edition approved Oct. 1, 2005. Published October 2005.
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 Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
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F2527–05
TABLE 1 Permissible Variation in OD and ID Dimensions
2.4 American Society for Quality Standard:
ASQ C1 Specification of General Requirements for a Qual- Permissible Variation
Nominal OD or ID
A
4 from Nominal
ity Program
in. (mm)
in. (mm)
Less than 0.060 (1.54) 60.0005 (0.013)
3. Terminology
0.060 to 0.250 (1.54 to 6.30) incl. 60.001 (0.025)
3.1 Definitions of Terms Specific to This Standard:
A
Unless otherwise specified, size tolerances are plus and minus as shown in
3.1.1 average wall thickness—the arithmetic average of the
the table. When required by the purchaser, tolerances may be specified all plus
and nothing minus, or all minus and nothing plus, or any combination of plus and
minimum wall thickness and the maximum wall thickness
minus if the total range of size tolerance is not less than the total range shown in
measured on any one transverse cross section of the tube.
the table.
3.1.2 concentricity—two times the offset between the cen-
ters of two circles, representing the outside diameter (OD) and
5.1.7 Applicable dimensions including OD and ID, OD and
the inside diameter (ID) of the tube.
wall or ID and wall, length (exact, random, multiples) or
3.1.2.1 Discussion—For purposes of this specification, the
engineering drawing reference number,
minimum wall and the maximum wall measured on any one
5.1.8 Dimensional tolerances (see Table 2),
transversecrosssectionshallbeusedtocalculateconcentricity.
5.1.9 Certification requirements, and
The percent concentricity shall be calculated using the equa-
5.1.10 Specialrequirementsorsupplementaryrequirements,
tion:
if any.
maximum wall – minimum wall
Percent Concentricity 5 2 3 3 100
S D
maximum wall 1 minimum wall
6. Materials and Manufacture
(1)
6.1 Method of Manufacture:
3.1.3 nominal outside diameter (OD)—the outside diameter
6.1.1 Seamless tubing shall be made from bar, hollow bar,
specifiedonthecustomerorderorengineeringdrawingwithout
rod, or hollow rod raw material forms that meet the chemical
regard to tolerance.
requirements of the appropriate material specification.
3.1.4 nominal wall thickness—the wall thickness specified
6.1.1.1 Seamless tubing shall be made by a process consis-
onthecustomerorderorengineeringdrawingwithoutregardto
tent with the definition in 3.1.5.
tolerance.
6.1.2 Welded and drawn tubing shall be made from strip or
3.1.5 seamless tubing—tubing made by a process in which
sheet raw material forms that meet the chemical requirements
the tube periphery is continuous at all stages of the process.
of the appropriate material specification.
3.1.6 welded and drawn tubing—tubing fabricated from
6.1.2.1 Weldedanddrawntubingshallbemadebyaprocess
strip or sheet using welding, drawing, and annealing opera-
consistent with the definition in 3.1.6.
tions.
6.2 Condition—Tubing shall be furnished, as specified, in
3.1.6.1 Discussion—Welding shall be performed using a
the annealed, solution annealed, warm worked or cold worked
liquid phase weld process with no filler metal. Typical weld
and aged condition as defined in the appropriate ASTM
processes are tungsten inert gas (TIG) and laser. The drawing
material standard.
and annealing operations shall be performed in such a way that
6.3 Surface Finish:
the weld bead and heat affected zone are virtually indistin-
6.3.1 The tubing outer surface shall be furnished with a
guishable microstructurally and dimensionally from the parent
cold-drawn, bright annealed, ground or polished finish. Outer
metal when examined per 11.3.
surfaceroughnessshallbeamaximumof25µin.(0.63µm)Ra.
6.3.2 The tubing inner surface shall be furnished with an
4. General Requirements for Delivery
as-drawn finish, bright annealed or conditioned finish. Inner
4.1 In addition to the requirements of this specification, all
surfaceroughnessshallbeamaximumof30µin.(0.75µm)Ra.
applicable requirements of the appropriate ASTM material
6.3.3 The method used to determine surface roughness shall
standard shall apply.
be agreed upon between purchaser and supplier.
5. Ordering Information
7. Chemical Composition
5.1 Inquiries and orders for material under this specification
7.1 The heat analysis limits and product analysis tolerances
should include the following information:
of the appropriate ASTM material specification shall apply.
5.1.1 Quantity (weight, total length, or number of pieces),
5.1.2 This ASTM designation and date of issue,
TABLE 2 Maximum Allowable Inclusion Rating
5.1.3 ASTM material standard and date of issue,
NOTE—The inclusion type description in parentheses is not intended to
5.1.4 Method of manufacture (seamless or welded and
represent the chemistry of the rated inclusion. The inclusion type will be
drawn; see 6.1),
determined by choosing the inclusion morphology on chart 1-r that most
5.1.5 Condition (see Table 1),
closely matches the rated inclusion.
5.1.6 Surface finish (see 6.2),
Inclusion A B C D
Type (Sulfides) (Alumina) (Silicate) (Globular Oxide)
Thin 1.5 1.5 1.5 1.5
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Heavy 1.0 1.0 1.0 1.0
Milwaukee, WI 53203.
F2527–05
7.2 Alternative chemistries with more restrictive limits than 9.3.1 For exact length orders, length variation on all lengths
those in theASTM material specifications may be specified as up to and including 24 ft (7.3 m) shall be plus or minus 0.125
agreed upon by purchaser and supplier. in. (3 mm).
9.3.2 For random length orders, a maximum and minimum
8. Mechanical Properties
length shall be specified by the purchaser. Up to 5 % of the
8.1 The required mechanical properties shall be selected
order may ship short of the minimum length specified. No
from the tables for similar product forms in the appropriate
length shall be less than 2 ft (0.6 m), unless permitted by the
material specification. Where bar or wire data is presented, the
purchaser.
mechanical properties listed for bar or wire of similar OD size
9.4 Straightness—The deviation from straightness shall not
shall apply. Where sheet or strip data is presented, the
exceed0.012in.perfoot(0.30mmper300mm)oftubelength.
mechanical properties for sheet or strip with thickness similar
The method of measuring straightness shall be negotiated
to the tubing wall thickness shall apply.Tensile testing shall be
between purchaser and supplier.Alternative requirements may
inaccordancewithTestMethodsE8usingunmachinedtubular
be agreed upon between purchaser and supplier.
specimens. Alternative mechanical properties may be agreed
10. Permissible Outer and Inner Surface Imperfections
upon between purchaser and supplier.
8.2 In the event that both tensile properties and hardness are 10.1 Outer surface imperfection shall not exceed 10 % of
specified on
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