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ASTM F2181-09

(Specification)

Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

ABSTRACT
This specification covers the requirements for three compositions of wrought seamless stainless steel tubing for the manufacture of surgical implants. Materials shall be tested and shall conform to chemical composition, metallurgical requirements, and mechanical properties. Materials and manufacture are also detailed.
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 Specifications F 138, F 1314, F 1586, F 2229, or F 2581. 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 inch-pound or SI units are to be regarded separately as standard. Inch-pound units are shown in parentheses. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

General Information

Status
Historical
Publication Date
31-Jan-2009
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

Replaces
ASTM F2181-08 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
Effective Date
01-Feb-2009
Replaced By
ASTM F2181-14 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
Effective Date
01-Oct-2014
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
01-Feb-2009

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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:F2181 −09
StandardSpecification for
Wrought Seamless Stainless Steel Tubing for Surgical
1
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* 2.5Molybdenum Stainless Steel Alloy Bar for Surgical
Implants (UNS S31675)
1.1 This specification covers the requirements for five
F2229 Specification for Wrought, Nitrogen Strengthened
compositions of wrought seamless stainless steel tubing for the
23Manganese-21Chromium-1Molybdenum Low-Nickel
manufactureofsurgicalimplants.Materialshallconformtothe
Stainless Steel Alloy Bar and Wire for Surgical Implants
applicable requirements of Specifications F138, F1314, F1586,
(UNS S29108)
F2229,or F2581. This specification addresses those product
F2581 Specification for Wrought Nitrogen Strengthened
variables that differentiate wrought seamless tubing from the
11Manganese-17Chromium-3Molybdenum Low-Nickel
bar and wire product forms covered in these specifications.
Stainless Steel Alloy Bar and Wire for Surgical Implants
1.2 This specification applies to cold finished, straight
(UNS S29225)
length tubing from 3 to 34 mm (0.125 to 1.315 in.) nominal
2.2 ASTM Tubing Standards:
outside diameter (OD) and 0.5 mm (0.020 in.) and greater
A262 Practices for Detecting Susceptibility to Intergranular
nominal wall thickness.
Attack in Austenitic Stainless Steels
1.3 The specifications in 2.1 are referred to as the ASTM
A269 Specification for Seamless and Welded Austenitic
material standard(s) in this specification.
Stainless Steel Tubing for General Service
1.4 The values stated in either inch-pound or SI units are to
A632 Specification for Seamless and Welded Austenitic
beregardedseparatelyasstandard.Inch-poundunitsareshown
Stainless Steel Tubing (Small-Diameter) for General Ser-
in parentheses. The values stated in each system may not be
vice
exact equivalents; therefore, each system shall be used inde-
E29 Practice for Using Significant Digits in Test Data to
pendentlyoftheother.Combiningvaluesfromthetwosystems
Determine Conformance with Specifications
may result in non-conformance with the standard.
F2257 Specification for Wrought Seamless or Welded and
Drawn18Chromium-14Nickel-2.5MolybdenumStainless
2. Referenced Documents
Steel Small Diameter Tubing for Surgical Implants (UNS
2
2.1 ASTM Material Standards:
S31673)
F138 Specification for Wrought 18Chromium-14Nickel-
SI 10 American National Standard for Use of the Interna-
2.5Molybdenum Stainless Steel Bar andWire for Surgical
tional System of Units (SI): The Modern Metric System
Implants (UNS S31673)
3
2.3 ISO Standards:
F1314 Specification for Wrought Nitrogen Strengthened 22
ISO 5832-1 Implants for Surgery—Metallic Materials—Part
Chromium–13Nickel–5Manganese–2.5Molybdenum
1: Wrought Stainless Steel
Stainless Steel Alloy Bar and Wire for Surgical Implants
ISO 5832-9 Implants for Surgery—Metallic Materials—Part
(UNS S20910)
9: Wrought High Nitrogen Stainless Steel
F1586 Specification for Wrought Nitrogen Strengthened
ISO 9001 Quality Management System—Requirements
21Chromium—10Nickel—3Manganese—
4
2.4 ASME Standard:
ASMEY14.5.1M Mathematical Definition of Dimensioning
1
This specification is under the jurisdiction of ASTM Committee F04 on
and Tolerancing Principles
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
CurrenteditionapprovedFeb.1,2009.PublishedJuly2009.Originallyapproved
in 2002. Last previous edition approved 2008 as F2181 – 08. DOI: 10.1520/F2181-
3
09. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 4th Floor, New York, NY 10036, http://www.ansi.org.
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from American Society of Mechanical Engineers (ASME), ASME
Standards volume information, refer to the standard’s Document Summary page on International Headquarters, Three Park Ave., New York, NY 10016-5990, http://
the ASTM website. www.asme.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 ----------------------
F2181−09
3. Terminology 4.2 In addition to the requirements of this specification, all
applicable seamless tubing requirements of Specification A269
3.1 Definitions of Terms Specific to This Standard:
or Specification A632 shall apply. Flare testing is not appli-
3
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2181–08 Designation: F 2181 – 09
Standard Specification for
Wrought Seamless Stainless Steel Tubing for Surgical
1
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 (´) 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 Specifications F 138, F 1314, F 1586,
F 2229, or F 2581.This specification addresses those product variables that differentiate wrought seamless tubing from the bar and
wire product forms covered in these specifications.
1.2This 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.
1.2 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 will be referred to as the ASTM material standard(s) in this specification.
1.4The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversionstoSIunitsthatareprovidedforinformationonlyandarenotconsideredstandard.arereferredtoastheASTMmaterial
standard(s) in this specification.
1.4 The values stated in either inch-pound or SI units are to be regarded separately as standard. Inch-pound units are shown in
parentheses. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently
of the other. Combining values from the two systems may result in non-conformance with the standard.
2. Referenced Documents
2
2.1 ASTM Material Standards:
F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F 1314 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)
F 1586 Specification for Wrought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel
Alloy Bar for Surgical Implants (UNS S31675)
F 2229 Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless
SteelAlloyBarandWireforSurgicalImplants(UNSS29108)F2257SpecificationforWroughtSeamlessorWeldedandDrawn
18 Chromium-14Nickel-2.5Molybdenum Stainless Steel
Small Diameter Tubing for Surgical Implants (UNS
S31673)
F 2581 Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
2.2 ASTM Tubing Standards:
A 262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A 269 Specification for Seamless and Welded Austenitic Stainless Steel Tubing for General Service
A 632 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 Practice for Using
Significant Digits in Test Data to Determine Conformance with Specifications
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 MayFeb. 1, 2008.2009. Published June 2008.July 2009. Originally approved in 2002. Last previous edition approved 20022008as
F2181–02a.F 2181 – 08.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
1

---------------------- Page: 1 ----------------------
F2181–09
F 2257 Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Sta
...

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1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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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ASTM
ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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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