ASTM F2181-20

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: F2181 − 14 F2181 − 20
Standard Specification for
Wrought Seamless Stainless Steel Tubing for Surgical
Implants
This standard is issued under the fixed designation F2181; 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 five compositions of wrought seamless stainless steel tubing for the
manufacture of surgical implants. Material shall conform to the applicable requirements of SpecificationsSpecification F138,
F1314, F1586, F2229, or F2581. 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 3 to 34 mm [0.125 to 1.315 in.] nominal outside
diameter (OD) and 0.5 mm [0.020 in.] and greater 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. Inch-pound units are shown
in brackets. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of
the other. Combiningother and values from the two systems may result in nonconformance with the standard.shall not be combined.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.6 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
2.1 ASTM Material Standards:
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium–13 Nickel–5 Manganese–2.5 Molybdenum Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
F1586 Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless
Steel Alloy Bar for Surgical Implants (UNS S31675)
F2229 Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
F2581 Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel
Alloy Bar and Wire for Surgical Implants (UNS S29225)
2.2 ASTM Standards:
A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A269 Specification for Seamless and Welded Austenitic Stainless Steel Tubing for General Service
A632 Specification for Seamless and Welded Austenitic Stainless Steel Tubing (Small-Diameter) for General Service
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
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, 2014June 1, 2020. Published January 2015July 2020. Originally approved in 2002. Last previous edition approved 20092014 as
F2181 – 09.F2181 – 14. DOI: 10.1520/F2181-14.10.1520/F2181-20.
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
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2181 − 20
F2257 Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small
Diameter Tubing for Surgical Implants (UNS S31673)
IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System
2.3 ISO Standards:
ISO 5832-1 Implants for Surgery—Metallic Materials—Part 1: Wrought Stainless Steel
ISO 5832-9 Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless Steel
ISO 9001 Quality Management System—Requirements
ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposesDevices—Quality
Management Systems—Requirements for Regulatory Purposes
2.4 ASME Standard:
ASME Y14.5.1M Mathematical Definition of Dimensioning and Tolerancing Principles
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 individual wall thickness measurement—any one of the wall thickness measurements taken around the circumference on
any one transverse cross section of a single sample of the tube.
3.1.2 lot—the total number of product produced from the same melt heat under the same conditions at essentially the same time.
3.1.3 lot average concentricity—the arithmetic average of the sample concentricities measured on a statistically representative
number of samples from the lot.
3.1.4 lot average wall thickness—the arithmetic average of the sample average wall thicknesses measured on a statistically
representative number of samples from the lot.
3.1.5 nominal outside diameter (OD)—the outside diameter specified on the purchaser’s order or engineering drawing without
regard to tolerance.
3.1.6 nominal wall thickness—the wall thickness specified on the purchaser’s order or engineering drawing without regard to
tolerance.
3.1.7 sample average wall thickness—the arithmetic average of all individual wall thickness measurements measured around the
circumference on any one transverse cross section of a single sample of tube.
3.1.8 sample concentricity—two times the offset between the centers of the two circles representing the outside diameter (OD)
and the inside diameter (ID) of the tube.
3.1.8.1 Discussion—
For the purposes of this specification, the sample minimum wall and the sample maximum wall measured on any one transverse
cross section of a single sample shall be used to calculate sample concentricity. The sample maximum,maximum and sample
minimum wall thickness shall be the largest and smallest respectivelysmallest, respectively, of no less than four individual wall
thickness measurements taken at uniformly spaced locations around the circumference of a single sample of the tube. Sample
concentricity shall be expressed as a percent of the wall thickness and shall be calculated using the following equation:
A 2 B
sample concentricity percent 5 23 3100
S D
A1B
where:
where:
A = sample maximum wall, and
B = sample minimum wall.
3.1.9 sample maximum wall thickness—the largest individual wall thickness measurement taken around the circumference on
any one transverse cross section of a single sample of tube.
3.1.10 sample minimum wall thickness—the smallest individual wall thickness measurement taken around the circumference on
any one transverse cross section of a single sample of tube.
4. General Requirements for Delivery
4.1 In addition to the requirements of this specification, all applicable requirements of the appropriate ASTM material standard
shall apply.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from American Society of Mechanical Engineers (ASME), ASME International Headquarters, Three Park Ave., New York, NY 10016-5990, http://
www.asme.org.
F2181 − 20
4.2 In addition to the requirements of this specification, all applicable seamless tubing requirements of Specification A269 or
Specification A632 shall apply. Flare testing is not applicable.
4.3 If a conflict exists between this specification and those listed in Section 2, or if a conflict exists between those specifications
listed in 2.1 and those listed in 2.2 and 2.3, the following order of precedence applies: (1) this specification, (2) the ASTM material
standard referenced on the purchase order, and (3) all other referenced specifications.
5. Ordering Information
5.1 Inquiries and orders for material under this specification should include the following information:
5.1.1 Quantity (weight, total length, or number of pieces),
5.1.2 This ASTM specification and date of issue,
5.1.3 The appropriate ASTM material standard and date of issue,
5.1.4 Units to be certified—SI or inch-pound,
5.1.5 Condition (see 6.2),
5.1.6 Surface finish (see 6.3),
5.1.7 Applicable dimensions including OD and ID, OD and wall or ID and wall, length (exact, random, multiples)multiples),
or engineering drawing reference number,
5.1.8 Dimensional tolerances (see Table 1 and Table 2),
5.1.9 Condition (see 6.2),
5.1.10 Surface finish (see 6.3),
5.1.9 Special requirements or supplements, if any, and
5.1.10 Certification requirements.
6. Materials and Manufacture
6.1 Method of Manufacture:
6.1.1 Tubing shall be made by the seamless process in which the tube periphery is continuous at all stages of the process.
6.2 Condition:
6.2.1 Tubing shall be furnished, as specified, in the annealed, cold worked, medium hard, hard, or extra hard condition as
defined in the appropriate ASTM material standard.
6.3 Surface Finish:
6.3.1 The tubing outer surface shall be furnished with a pickled, cold drawn, bright annealed, ground, or polished finish. Outer
surface roughness shall be 0.8 μm [30 μin.] Ra maximum.
6.3.2 The tubing inner surface shall be furnished with a pickled, cold drawn, bright annealed, or abrasive conditioned finish.
Inner surface roughness shall be 1.5 μm [60 μin.] Ra maximum.
6.3.3 The method used to determine surface roughness shall be agreed upon between the purchaser and supplier.
7. Chemical Composition, Metallurgical Requirements, and Mechanical Properties
7.1 The chemical composition, metallurgical requirements, and mechanical properties of the finished tube shall conform to the
requirements of the appropriate ASTM material standard. Alternative mechanical properties may be agreed upon between the
purchaser and the supplier.
TABLE 1 Permissible Variation in OD Dimensions
A
Permissible Variation from Nominal
Nominal OD,
Half Standard
Standard Tolerance,
B
mm [in.]
Tolerance,
mm [in.]
mm [in.]
3.2 to 12.7 excl. ± 0.050 [0.002] ±0.025 [0.001]
[0.125 to 0.500]
12.7 to 25.4 excl. ±0.075 [0.003] ±0.038 [0.0015]
[0.500 to 1.00]
25.4 to 34 incl. ±0.100 [0.004] ±0.050 [0.002)
[1.00 to 1.315]
25.4 to 34 incl. ±0.100 [0.004] ±0.050 [0.002]
[1.00 to 1.315]
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 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 in the
table.
B
Half standard tolerance may be used when specifying tubing for use on
machining centers with tight collet clearance.
F2181 − 20
TABLE 2 Permissible Variation in ID Dimensions
Nominal ID, Permissible Variation
A
mm [in.] from Nominal, mm [in.]
Up to 12.7 excl. [0.500] ±0.050 [0.002]
12.7 to 25.4 excl. [0.500 to 1.00] ±0.075 [0.003]
25.4 and over [1.00] ±0.100 (0.004]
25.4 and over [1.00] ±0.100 [0.004]
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 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 in the
table.
7.2 If both tensile properties and hardness are specified on the purchase order, tensile properties shall be used to accept or reject
the tubing. Hardness shall be reported for information only.
8. Permissible Outer and Inner Surface Imperfections
8.1 For tubes with wall thickness greater than
...