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ASTM F2181-02a

(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-Nov-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

Replaces
ASTM F2181-02 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
Effective Date
10-Nov-2002
Replaced By
ASTM F2181-08 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
Effective Date
01-May-2008
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-Nov-2002

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ASTM F2181-02a - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical ImplantsASTM F2181-02a - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
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ASTM F2181-02a - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2181 – 02a
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2.3 ISO Standards:
ISO 5832-1 Implants for Surgery—Metallic Materials—
1.1 This specification covers the requirements for three
4
Part 1: Wrought Stainless Steel
compositions of wrought seamless stainless steel tubing for the
ISO 5832-9 Implants for Surgery—Metallic Materials—
manufactureofsurgicalimplants.Materialshallconformtothe
4
Part 9: Wrought High Nitrogen Stainless Steel
applicable requirements of Specifications F 138, F 1314, or
2.4 American Society for Quality Standard:
F 1586. This specification addresses those product variables
C1 Specification of General Requirements for a Quality
that differentiate wrought seamless tubing from the bar and
5
Program
wire product forms covered in these specifications.
1.2 This specification applies to cold finished, straight
3. Terminology
length tubing from 0.125 to 1.315 in. (3.18 to 33.4 mm)
3.1 Definitions of Terms Specific to This Standard:
nominal outside diameter (OD) and 0.018 in. (0.46 mm) and
3.1.1 average wall thickness—the arithmetic average of the
greater nominal wall thickness.
minimum wall thickness and the maximum wall thickness
1.3 The values stated in inch-pound units are to be regarded
measured on any one transverse cross section of the tube.
as the standard. The SI units in parentheses are approximate.
3.1.2 concentricity—two times the offset between the cen-
1.4 Thespecificationsin2.1willbereferredtoastheASTM
ters of two circles, representing outside diameter (OD) and
material standard(s) in the remainder of this specification.
inside diameter (ID) of the tube. For purposes of this specifi-
2. Referenced Documents cation, the minimum wall and the maximum wall measured on
any one transverse cross section shall be used to calculate
2.1 ASTM Material Standards:
concentricity. The percent concentricity shall be calculated
F 138 Specification for Wrought 18Chromium-14Nickel-
using the equation:
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
2
Implants (UNS S31673) maximum wall 2 minimum wall
Percent Concentricity 5 2 3 3 100
S D
maximum wall 1 minimum wall
F 1314 Specification for Wrought Nitrogen Strengthened-
22Chromium-13Nickel-5Manganese-2.5Molybdenum
3.1.3 nominal wall thickness—the wall thickness specified
Stainless Steel Bar and Wire for Surgical Implants (UNS
by the purchaser without regard to tolerance.
2
S20910)
4. General Requirements for Delivery
F 1586 Specification for Wrought Nitrogen Strengthened-
21Chromium-10Nickel-3Manganese-2.5Molybdenum
4.1 In addition to the requirements of this specification, all
2
Stainless Steel Bar for Surgical Implants (UNS S31675)
applicable requirements of the appropriate ASTM material
2.2 ASTM Tubing Standards:
standard shall apply.
A 269 Specification for Seamless and Welded Austenitic
4.2 In addition to the requirements of this specification, all
3
Stainless Steel Tubing for General Service
applicable seamless tubing requirements of Specification
A 632 Specification for Seamless and Welded Austenitic
A 269 or Specification A 632 shall apply. Flare testing is not
Stainless Steel Tubing (Small Diameter) for General
applicable.
3
Service
4.3 In the case where a conflict exists between this specifi-
cation and those listed in Section 2 or in the case where a
conflict exists between those specifications listed in 2.1 and
those listed in 2.2 and 2.3, the following order of precedence
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.
4
Current edition approved Nov. 10, 2002. Published December 2002. Originally Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
approved in 2002. Last previous edition approved 2002 as F 2181 – 02. 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.,
3
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.
1

---------------------- Page: 1 ----------------------
F 2181 – 02a
TABLE 1 Permissible Variation in OD Dimensions
applies: (1) this specification, (2) the ASTM material standard
A
referenced on the purchase order, and (3) all other referenced Permissible Var
...

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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.
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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.
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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.  
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1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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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.  
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ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

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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).  
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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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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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    English language
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