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ASTM F2181-02

(Specification)

Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

SCOPE
1.1 This specification covers the requirements for three compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F 138, F 1314, or F 1586. This specification addresses those product variables that differentiate wrought seamless tubing from the bar and wire product forms covered in these specifications.
1.2 This specification applies to cold finished, straight length tubing from 0.125 to 1.315 in. (3.18 to 33.4 mm) nominal outside diameter (OD) and 0.018 in. (0.46 mm) and greater nominal wall thickness.
1.3 The values stated in inch-pound units are to be regarded as the standard. The SI units in parentheses are approximate.
1.4 The specifications in will be referred to as the ASTM material standard(s) in the remainder of this specification.

General Information

Status
Historical
Publication Date
09-Apr-2002
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
Current Stage
Ref Project

Relations

Replaced By
ASTM F2181-02a - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
Effective Date
10-Nov-2002
Referred By
ASTM F2257-22 - Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
Effective Date
10-Apr-2002

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ASTM F2181-02 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical ImplantsASTM F2181-02 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
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ASTM F2181-02 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2181 – 02
Standard Specification for
Wrought Seamless Stainless Steel Tubing for Surgical
Implants
This standard is issued under the fixed designation F 2181; 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 Part 1: Wrought Stainless Steel
ISO 5832-9 Implants for Surgery—Metallic Materials—
1.1 This specification covers the requirements for three
Part 9: Wrought High Nitrogen Stainless Steel
compositions of wrought seamless stainless steel tubing for the
2.4 American Society for Quality Standard:
manufacture of surgical implants. Material shall conform to the
C1 Specification of General Requirements for a Quality
applicable requirements of Specifications F 138, F 1314, or
Program
F 1586. This specification addresses those product variables
that differentiate wrought seamless tubing from the bar and
3. Terminology
wire product forms covered in these specifications.
3.1 Definitions of Terms Specific to This Standard:
1.2 This specification applies to cold finished, straight
3.1.1 average wall thickness—the arithmetic average of the
length tubing from 0.125 to 1.315 in. (3.18 to 33.4 mm)
minimum wall thickness and the maximum wall thickness
nominal outside diameter (OD) and 0.018 in. (0.46 mm) and
measured on any one transverse cross section of the tube.
greater nominal wall thickness.
3.1.2 concentricity—the offset between the centers of two
1.3 The values stated in inch-pound units are to be regarded
circles, representing outside diameter (OD) and inside diameter
as the standard. The SI units in parentheses are approximate.
(ID) of the tube. For purposes of this specification, the
1.4 The specifications in 2.1 will be referred to as the ASTM
minimum wall and the maximum wall measured on any one
material standard(s) in the remainder of this specification.
transverse cross section shall be used to calculate concentricity.
2. Referenced Documents The percent concentricity shall be calculated using the equa-
tion:
2.1 ASTM Material Standards:
F 138 Specification for Wrought 18Chromium-14Nickel- maximum wall 2 minimum wall
Percent Concentricity 5 3 100
S D
maximum wall 1 minimum wall
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
Implants (UNS S31673)
The calculated percent concentricity may be added to and
F 1314 Specification for Wrought Nitrogen Strengthened-
subtracted from the average wall thickness to express the actual
22Chromium-13Nickel-5Manganese-2.5Molybdenum
range of wall variation due to concentricity. Percent concen-
Stainless Steel Bar and Wire for Surgical Implants (UNS
tricity may also be used as a plus and minus tolerance which
S20910)
when applied to the nominal wall thickness defines the
F 1586 Specification for Wrought Nitrogen Strengthened-
allowable range of wall variation due to concentricity.
21Chromium-10Nickel-3Manganese-2.5Molybdenum
3.1.3 nominal wall thickness—the wall thickness specified
Stainless Steel Bar for Surgical Implants (UNS S31675)
by the purchaser without regard to tolerance.
2.2 ASTM Tubing Standards:
A 269 Specification for Seamless and Welded Austenitic 4. General Requirements for Delivery
Stainless Steel Tubing for General Service
4.1 In addition to the requirements of this specification, all
A 632 Specification for Seamless and Welded Austenitic
applicable requirements of the appropriate ASTM material
Stainless Steel Tubing (Small Diameter) for General
standard shall apply.
Service
4.2 In addition to the requirements of this specification, all
2.3 ISO Standards:
applicable seamless tubing requirements of Specification
ISO 5832-1 Implants for Surgery—Metallic Materials—
A 269 or Specification A 632 shall apply. Flare testing is not
applicable.
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. Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Current edition approved Apr. 10, 2002. Published June 2002. 4th Floor, New York, NY 10036.
2 5
Annual Book of ASTM Standards, Vol 13.01. Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Annual Book of ASTM Standards, Vol 01.01. Milwaukee, MI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 2181
TABLE 1 Permissible Variation in OD Dimensions
4.3 In the case where a conflict exists between this specifi-
A
cation and those listed in Section 2 or in the case where a Permissible Variation from Nominal
Nominal OD,
B
Standard Tolerance, ⁄2 Standard Tolerance,
conflict exists between those specifications listed in 2.1 and
in. (mm)
in. (mm) in. (mm)
those listed in 2.2 and 2.3, the following order of precedence
0.125 to 0.500 excl. 60.002 (0.051) 60.001 (0.025)
applies: (1) this specification, (2) the ASTM material standard (3.2 to 12.7)
0.500 to 1.00 excl. 60.003 (0.076) 60.0015 (0.038)
referenced on the purchase order, and (3) all other referenced
(12.7 to 25.4)
specifications.
1.00 to 1.315 incl. 60.004 (0.102) 60.002 (0.051)
(25.4 to 33.4)
5. Ordering Information
A
Unless otherwise specified, size tolerances are plus and minus as shown in
the table. When required by the purchaser, tolerances may be specified all plus
5.1 Inquiries and orders for material under this specification
and nothing minus, or all minus and nothing plus, or any combination of plus and
should include the following information:
minus if the total spread in size tolerance is not less than the total spread shown
5.1.1 Quantity (weight, total length or number of pieces), in the table.
B
⁄2 standard tolerance may be used when specifying tubing for use on
5.1.2 This ASTM designation and date of issue,
machining centers with tight collet clearance.
5.1.3 ASTM material standard and date of issue,
5.1.4 Condition (see 6.1.2),
TABLE 2 Permissible Variation in ID Dimensions
5.1.5 Surface finish (see 6.2),
Nominal ID, Permissible Variation
5.1.6 Applicable dimensions including OD and ID, OD and
A
in. (mm) from Nominal, in. (mm)
wall or ID and wall, length (exact, random, multiples) or
Up to 0.500 excl. (3.18 to 12.7) 60.002 (0.051)
engineering drawing reference number,
0.500 to 1.00 excl. (12.7 to 25.4) 60.003 (0.076)
5.1.7 Dimensional tolerances (see Tables 1 and 2),
1.00 (and over) (25.4) 60.004 (0.102)
A
5.1.8 Certification requirements, and
Unless otherwise specified, size tolerances are plus and minus as shown in
the table. When required by the purchaser, tolerances may be specified all plus
5.1.9 Special requirements or supplements, if any.
and nothing minus, or all minus and nothing plus, or any combination of plus and
minus if the total spread in size tolerance is not less than the total spread shown
6. Materials and Manufacture
in the table.
6.1 Method of Manufacture:
6.1.1 Tubing shall be made by a seamless process in which
8.2.2 Concentricity shall no
...

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