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ASTM F1636-95e2

(Specification)

Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)

Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)

SCOPE
1.1 This specification covers the functional dimensions and tolerances for tapered cones of proximal femoral stems and the bores of mating ceramic and metal heads.  
1.2 This specification does not cover the dimensions of proximal femoral stems other than the cone portion, nor does it cover the dimensions of the ceramic/metal femoral heads, other than the inside tapers.  
1.3 The dimensions stated in SI units are to be regarded as the standard.  
1.4 The purpose of this specification is to codify matching bore and cone combinations for easy identification. Nonetheless, components from different manufacturers should not be mixed because the combinations of tolerances within the family, surface finish, and configuration from the different manufacturers may not have been validated through axial load strengths or fatigue strength.  
1.5 The codification described in this specification represents the most current state of the art at the time of balloting. Future additions can be made but because of the time required to revise the specification, it is recommended that the manufacturer of new combinations label their components with at least the angles until such time that new code letters can be established in accordance with future revisions of this specification.

General Information

Status
Withdrawn
Publication Date
31-Dec-1994
Withdrawal Date
09-Jul-2001
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ASTM F1636-95e1 - Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)
Effective Date
01-Jan-1995
Referred By
ASTM F1875-98(2022) - Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
Effective Date
01-Jan-1995

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ASTM F1636-95e2 - Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)ASTM F1636-95e2 - Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)
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ASTM F1636-95e2 - Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)
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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e2
Designation: F 1636 – 95
Standard Specification for
1
Bores and Cones for Modular Femoral Heads
This standard is issued under the fixed designation F 1636; 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
e NOTE—Editorial changes were made throughout in December 1996.
2
e NOTE—Tables 1 and 2 were editorially corrected in May 2001.
2
1. Scope Alloy for Surgical Implant Applications
F 138 Specification for Stainless Steel Bar and Wire for
1.1 This specification covers the functional dimensions and
2
Surgical Implants (Special Quality)
tolerances for tapered cones of proximal femoral stems and the
F 562 Specification for Wrought Cobalt-Nickel-Chromium-
bores of mating ceramic and metal heads.
2
Molybdenum Alloy for Surgical Implant Applications
1.2 This specification does not cover the dimensions of
F 563 Specification for Wrought Cobalt-Nickel-Chromium-
proximal femoral stems other than the cone portion, nor does it
Molybdenum-Tungsten-Iron Alloy for Surgical Implant
cover the dimensions of the ceramic/metal femoral heads, other
2
Applications
than the inside tapers.
F 603 Specification for High-Purity Dense Aluminum Ox-
1.3 The dimensions stated in SI units are to be regarded as
2
ide for Surgical Implant Application
the standard.
F 620 Specification for Titanium 6Al, 4V ELI Alloy Forg-
1.4 The purpose of this specification is to codify matching
2
ings for Surgical Implants
bore and cone combinations for easy identification. Nonethe-
F 621 Specification for Stainless Steel Forgings for Surgical
less, components from different manufacturers should not be
2
Implants
mixed because the combinations of tolerances within the
F 799 Specification for Thermomechanically Processed
family, surface finish, and configuration from the different
Cobalt-Chromium-Molybdenum Alloy Forgings for Surgi-
manufacturers may not have been validated through axial load
2
cal Applications
strengths or fatigue strength. Information supplied by the
F 961 Specification for Cobalt-Nickel-Chromium-
manufacturer with the implants should include a precaution
Molybdenum Alloy Forgings for Surgical Implant Appli-
statement that informs the user (surgeon) that bores and cones
2
cations
with the same code letter from different manufacturers should
F 1108 Specification for Ti-6Al, 4V Alloy Castings for
not be used without first consulting the supplier of the femoral
2
Surgical Implants
components.
1.5 The codification described in this specification repre-
3. Terminology
sents the most current state of the art at the time of balloting.
3.1 Definitions:
Future additions can be made but because of the time required
3.1.1 nominal neck length—the distance, K, parallel to the
to revise the specification, it is recommended that the manu-
taper axis, between the theoretical gage point and the horizon-
facturer of new combinations label their components with at
tal plane through the center of the head; this distance does not
least the angles until such time that new code letters can be
include standard variants used to adjust for resection level, leg
established in accordance with future revisions of this specifi-
length, and so forth. The K dimension may be plus or minus
cation.
(proximal or distal to the location of the theoretical gage Point
2. Referenced Documents G).
3.1.2 residual or free length—the distance, A, parallel to the
2.1 ASTM Standards:
cone axis, between the end of the cone and the theoretical gage
F 75 Specification for Cast-Cobalt-ChromiumMolybdenum
2 point.
Alloy for Surgical Implant Applications
3.1.3 theoretical gage point—the diameter, G, at nominal
F 136 Specification for Wrought Titanium 6A1, 4V ELI
tolerance, where the stem cone (external taper) theoretically
engages the femoral head bore (internal taper).
1
This specification is under the jurisdiction of ASTM Committee F04 on
4. Materials
Medical and Surgical Materials and Devices and is under the direct responsibility of
Subcommittee F04.22 on Arthroplasty.
4.1 The cones may be made from any of the implantable
Current edition approved Dec. 10, 1995. Published June 1996.
2
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 1636
TABLE 1 Cones
grade materials used for femoral stems including: Specifica-
tions F 75, F 136, F 138, F 562, F 563, F 620, F 621, F 799, G—Diameter, A—Dimension,
a° Size
mm mm
F 961, and F 1108.
2° 508 309, 6509 A 12.8 1.0
4.2 The ceramic heads may be made from Specification
3° 48 09, 668 B 10.98 2.54
F 603 or a material det
...

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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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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.  
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Standard Guide for Total Knee Replacement Loading Profiles

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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.
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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 ...

  • Guide
    34 pages
    English language
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  • Guide
    34 pages
    English language
    sale 15% off