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ASTM F2091-01(2006)

(Specification)

Standard Specification for Acetabular Prostheses

Standard Specification for Acetabular Prostheses

ABSTRACT
This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. Acetabular prostheses included within the scope of this specification are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement or through biological fixation. Acetabular prostheses shall be classified as: Type I and Type II. The following test methods shall be performed: mechanical strength; corrosion resistance; biocompatibility; structural requirements; metal and ceramic coating or surface texture integrity; component disassociation; fixation failure; device fracture; and articular surface wear.
SCOPE
1.1 This standard describes acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur.
1.2 This standard is intended to provide basic descriptions of materials and device geometry. Additionally, those characteristics determined to be important to in vivo performance of the device are defined.
1.3 Acetabular prostheses included within the scope of this standard are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement or through biological fixation.
1.4 Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this standard.
1.5 This standard does not cover the details for quality assurance, design control, production control contained in 21 CFR 820 (Quality System Regulation) and ISO 9001.

General Information

Status
Historical
Publication Date
28-Feb-2006
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Replaces
ASTM F2091-01 - Standard Specification for Acetabular Prostheses
Effective Date
01-Mar-2006
Replaced By
ASTM F2091-01(2012) - Standard Specification for Acetabular Prostheses
Effective Date
15-Jan-2012
Referred By
ASTM F2582-20 - Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
Effective Date
01-Mar-2006
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
01-Mar-2006

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ASTM F2091-01(2006) - Standard Specification for Acetabular Prostheses
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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: F2091 – 01 (Reapproved 2006)
Standard Specification for
Acetabular Prostheses
This standard is issued under the fixed designation F2091; 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 F138 Specification for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
1.1 This specification covers acetabular resurfacing devices
Implants (UNS S31673)
used to provide a functioning articulation between the bones of
F562 Specification for Wrought 35Cobalt-35Nickel-
the acetabulum and the femur.
20Chromium-10Molybdenum Alloy for Surgical Implant
1.2 This specification is intended to provide basic descrip-
Applications (UNS R30035)
tions of materials and device geometry. Additionally, those
F563 Specification for Wrought Cobalt-20Nickel-
characteristics determined to be important to in vivo perfor-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
mance of the device are defined.
for Surgical Implant Applications (UNS R30563)
1.3 Acetabular prostheses included within the scope of this
F601 Practice for Fluorescent Penetrant Inspection of Me-
specification are intended for mechanical fixation between the
tallic Surgical Implants
prosthesis and host bone, by the use of bone cement or through
F603 Specification for High-Purity DenseAluminum Oxide
biological fixation.
for Medical Application
1.4 Custom (designed explicitly for a single patient), revi-
F629 Practice for Radiography of Cast Metallic Surgical
sion, or constrained acetabular prostheses are not covered
Implants
within the scope of this specification.
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.5 This specification does not cover the details for quality
ethylene Powder and Fabricated Form for Surgical Im-
assurance, design control, production control contained in 21
plants
CFR 820 (Quality System Regulation) and ISO 9001.
F745 Specification for 18Chromium-12.5Nickel-
2. Referenced Documents 2.5Molybdenum Stainless Steel for Cast and Solution-
Annealed Surgical Implant Applications
2.1 ASTM Standards:
F746 Test Method for Pitting or Crevice Corrosion of
F67 Specification for Unalloyed Titanium, for Surgical
Metallic Surgical Implant Materials
Implant Applications (UNS R50250, UNS R50400, UNS
F748 Practice for Selecting Generic Biological Test Meth-
R50550, UNS R50700)
ods for Materials and Devices
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
F799 Specification for Cobalt-28Chromium-6Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
Alloy Forgings for Surgical Implants (UNS R31537,
(UNS R30075)
R31538, R31539)
F86 Practice for Surface Preparation and Marking of Me-
F981 Practice forAssessment of Compatibility of Biomate-
tallic Surgical Implants
rials for Surgical Implants with Respect to Effect of
F90 Specification for Wrought Cobalt-20Chromium-
Materials on Muscle and Bone
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
F983 Practice for Permanent Marking of Orthopaedic Im-
tions (UNS R30605)
plant Components
F136 Specification for Wrought Titanium-6Aluminum-
F1044 Test Method for ShearTesting of Calcium Phosphate
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
Coatings and Metallic Coatings
Implant Applications (UNS R56401)
F1108 Specification for Titanium-6Aluminum-4Vanadium
Alloy Castings for Surgical Implants (UNS R56406)
This specification is under the jurisdiction of ASTM Committee F04 on
F1147 Test Method for Tension Testing of Calcium Phos-
Medical and Surgical Materials and Devices and is the direct responsibility of
phate and Metallic Coatings
Subcommittee F04.22 on Arthroplasty.
F1160 Test Method for Shear and Bending Fatigue Testing
Current edition approved March 1, 2006. Published April 2006. Originally
of Calcium Phosphate and Metallic Medical and Compos-
approved in 2001. Last previous edition approved in 2001 as F2091 – 01. DOI:
10.1520/F2091-01R06.
ite Calcium Phosphate/Metallic Coatings
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.
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2091 – 01 (2006)
F1185 SpecificationforCompositionofHydroxylapatitefor 3.1.4 flange, n—rim extending from the entry diameter of
Surgical Implants bearing element.
F1377 Specification for Cobalt-28Chromium- 3.1.5 porous coating, n—a region on the exterior surface of
6Molybdenum Powder for Coating of Orthopedic Implants the shell characterized by interconnecting subsurface pores,
(UNS R30075) generally with volume porosity between 30 to 70 %, average
F1472 Specification for Wrought Titanium-6Aluminum- pore size between 100 to 1000 µm, and a thickness between
4Vanadium Alloy for Surgical Implant Applications (UNS 500 to 1500 µm. This porous layer may be manufactured
R56400) directly into the device by casting or by various electro/
F1501 Test Method for Tension Testing of Calcium Phos- chemical/thermal/mechanical means, or applied as a coating of
phate Coatings (Discontinued 2000) particles, beads, or mesh by processes such as sintering or
F1537 Specification for Wrought Cobalt-28Chromium- plasma spray.
6MolybdenumAlloysforSurgicalImplants(UNSR31537, 3.1.6 radiographic marker, n—nonstructural, generally thin
UNS R31538, and UNS R31539) wire, designed to be apparent on X-rays taken after placement
F1580 Specification for Titanium and Titanium-6 of implants that otherwise would be unapparent on such
Aluminum-4 Vanadium Alloy Powders for Coatings of X-rays.
Surgical Implants 3.1.7 retention element, n—any ring, taper, wire, or other
F1714 Guide for Gravimetric Wear Assessment of Pros- protrusion or cavity from the interior surface of the shell or the
thetic Hip Designs in Simulator Devices exterior surface of the bearing element that is intended to affix
F1820 Test Method for Determining theAxial Disassembly the bearing element to the shell.
Force of a Modular Acetabular Device 3.1.8 shell, n—metal structure supporting the articulating
F1978 Test Method for Measuring Abrasion Resistance of surface material, and which may be fixed rigidly to the
Metallic Thermal Spray Coatings by Using the Taber articulating surface or fixed such that it allows the articulating
Abraser surface to rotate or translate.
F2033 Specification for Total Hip Joint Prosthesis and Hip 3.1.9 surface texturing, n—repetitive or random deviations
Endoprosthesis Bearing Surfaces Made of Metallic, Ce- from the nominal surface that forms the three dimensional
ramic, and Polymeric Materials topography of the surface.
2.2 ISO Standards: 3.2 Dimensions of acetabular prostheses should be desig-
ISO 5832 Implants for surgery—Metallic materials for sur- nated in accordance with Figs. 1-3 or by an equally acceptable
gical implants and detailed method.
ISO 5834 Implants for surgery—Ultra high molecular
NOTE 1—Figs. 1-3 are intended to be illustrative of typical acetabular
weight polyethylene
prostheses and to designate dimensions, but representation of the compo-
ISO 6474 Implants for surgery—Ceramic materials based
nents does not otherwise form part of the standard.
on alumina
4. Types
ISO 9001 Quality systems—Model for quality assurance in
design/development, production, installation, and servic-
4.1 Acetabular prostheses falling within the scope of this
ing
specification are of two types, as defined below. There are no
2.3 Code of Federal Regulations:
distinguishing features (for example, augmentation or lack
21 CFR 820 Quality System Regulation
thereof,holes,andsoforth)thatwouldexemptanydevicefrom
any requirement of this specification.
3. Terminology
4.1.1 Type I—Single-piece acetabular prostheses.
3.1 Definitions:
NOTE 2—Specifications to both bearing elements and shell may apply.
3.1.1 bearing element, n—articulating surface element be-
4.1.2 Type II—Multipiece, modular structure prostheses.
tween the femoral head and shell or bonding agent (bone
cement).
5. Material
3.1.2 cavity, n—any slot, cut, hole, or other feature within
5.1 The choice of materials is understood to be a necessary,
the shell intended to accommodate modular adjunct fixation
but not sufficient, assurance of function of the device made
elements; instruments for insertion, extraction, and so forth; or
fromthem.Alldevicesconformingtothisspecificationshallbe
for manufacturing purposes.
fabricated from materials with adequate mechanical strength
3.1.3 fixation element, n—any peg, spike, threadform, or
and durability, corrosion resistance, and biocompatibility.
other protrusion from the exterior surface of the shell intended
5.1.1 Mechanical Strength—Various components of ac-
toincreasethesurfacecontactormechanicalinterlockbetween
etabular prostheses have been successfully fabricated from the
thecomponent,thebondingagent,orthenaturalacetabulumor
following materials: See Specifications F67, F75, F90, F136,
a combination thereof.
F90, F138, F136, F562, F563, F603, F648, F745, F799, F1108,
F1185, F1377, F1472, F1537, F1580; F1580 and ISO 5832,
ISO 5834 and ISO 6474. However, not all of these materials
Available from International Organization for Standardization, 1 Rue de
may possess sufficient mechanical strength for critical highly
Varembé, Case Postale 56, CH-1211, Geneva 20, Switzerland.
stressed components nor for articulating surfaces. Associated
AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
Robbins Ave, Philadelphia, PA 19111-5094, Attn: NPODS. standards include Practices F601 and F629.
F2091 – 01 (2006)
Key:
SD1 Diameter of spherical socket SR Retention element distance from SD2
SD2 Retentive or nonretentive entry diameter SH Overall height
SD3 Effective spherical external diameter SV Angle from shell face to SC1 center
SC1 Dome cavity diameter (when present) SP1 Fixation element width or diameter
SC2 Ap
...

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Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

SIGNIFICANCE AND USE
4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.
SCOPE
1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648, or USP polyethylene negative control.  
1.2 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this standard.  
1.3 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.  
1.4 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 F3140-23(Test Method)
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

SIGNIFICANCE AND USE
4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles.  
4.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial tray designs, when tested under similar conditions.  
4.3 In order for fatigue data on tibial trays to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
SCOPE
1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.  
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.  
1.3 This test method may require modifications to accommodate other tibial tray designs.  
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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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  • Standard
    6 pages
    English language
    sale 15% off