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ASTM F2181-14

(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 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. 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 nonconformance with the standard.

General Information

Status
Historical
Publication Date
30-Sep-2014
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 F2181-09 - 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-Oct-2014

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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 −14
Standard Specification 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* Stainless Steel Alloy Bar and Wire for Surgical Implants
(UNS S20910)
1.1 This specification covers the requirements for five
F1586 Specification for Wrought Nitrogen Strengthened
compositions of wrought seamless stainless steel tubing for the
21Chromium—10Nickel—3Manganese—
manufactureofsurgicalimplants.Materialshallconformtothe
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
applicable requirements of Specifications F138, F1314, F1586,
Implants (UNS S31675)
F2229,or F2581. This specification addresses those product
F2229 Specification for Wrought, Nitrogen Strengthened
variables that differentiate wrought seamless tubing from the
23Manganese-21Chromium-1Molybdenum 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 S29108)
length tubing from 3 to 34 mm [0.125 to 1.315 in.] nominal
F2581 Specification for Wrought Nitrogen Strengthened
outside diameter (OD) and 0.5 mm [0.020 in.] and greater
11Manganese-17Chromium-3Molybdenum Low-Nickel
nominal wall thickness.
Stainless Steel Alloy Bar and Wire for Surgical Implants
(UNS S29225)
1.3 The specifications in 2.1 are referred to as the ASTM
material standard(s) in this specification. 2.2 ASTM Standards:
A262 Practices for Detecting Susceptibility to Intergranular
1.4 The values stated in either SI units or inch-pound units
Attack in Austenitic Stainless Steels
are to be regarded separately as standard. The values stated in
A269 Specification for Seamless and Welded Austenitic
each system may not be exact equivalents; therefore, each
Stainless Steel Tubing for General Service
system shall be used independently of the other. Combining
A632 Specification for Seamless and Welded Austenitic
values from the two systems may result in nonconformance
Stainless Steel Tubing (Small-Diameter) for General Ser-
with the standard.
vice
E29 Practice for Using Significant Digits in Test Data to
2. Referenced Documents
Determine Conformance with Specifications
2
2.1 ASTM Material Standards:
F2257 Specification for Wrought Seamless or Welded and
F138 Specification for Wrought 18Chromium-14Nickel-
Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless
2.5Molybdenum Stainless Steel Bar andWire for Surgical
Steel Small Diameter Tubing for Surgical Implants (UNS
Implants (UNS S31673)
S31673)
F1314 Specification for Wrought Nitrogen Strengthened 22
IEEE/ASTM SI 10 American National Standard for Use of
Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
theInternationalSystemofUnits(SI):TheModernMetric
System
3
1
This specification is under the jurisdiction of ASTM Committee F04 on
2.3 ISO Standards:
Medical and Surgical Materials and Devices and is the direct responsibility of
ISO 5832-1 Implants for Surgery—Metallic Materials—Part
Subcommittee F04.12 on Metallurgical Materials.
1: Wrought Stainless Steel
Current edition approved Oct. 1, 2014. Published January 2015. Originally
ISO 5832-9 Implants for Surgery—Metallic Materials—Part
approved in 2002. Last previous edition approved 2009 as F2181 – 09. DOI:
10.1520/F2181-14.
9: Wrought High Nitrogen Stainless Steel
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
3
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, http://www.ansi.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 ----------------------
F2181−14
ISO 9001 Quality Management System—Requirements 3.1.9 sample maximum wall thickness—the largest indi-
ISO13485 Medicaldevices-Qualitymanagementsystems- vidual wall thickness measurement taken around the circum-
Requirements for regulatory purposes ference on any one transverse cross section of a single sample
4
of tube.
2.4 ASME Standard:
ASMEY14.5.1M Mathematical Definition of Dimensioning
3.1.10 sample minimum wall thickness—the smallest indi-
and Tolerancing Principles
vidual wall thickness measurement taken around the circum-
ference on any one transverse cross se
...

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 − 09 F2181 − 14
Standard Specification 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*
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 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[0.125 to 1.315 in.)in.] nominal
outside diameter (OD) and 0.5 mm (0.020 in.)[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 or inch-pound 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-conformancenonconformance with the
standard.
2. Referenced Documents
2
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 Tubing 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
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
3
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
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 Feb. 1, 2009Oct. 1, 2014. Published July 2009January 2015. Originally approved in 2002. Last previous edition approved 20082009 as
F2181 – 08.F2181 – 09. DOI: 10.1520/F2181-09.10.1520/F2181-14.
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.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 − 14
ISO 9001 Quality Management System—Requirements
ISO 13485 Medical devices - Quality management systems - Requir
...

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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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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
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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