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ASTM

ASTM F787-82(1991)

(Specification)

Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)

Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)

General Information

Status
Withdrawn
Withdrawal Date
09-Oct-1998
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.21 - Osteosynthesis
Current Stage
Ref Project

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ASTM F787-82(1991) - Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)ASTM F787-82(1991) - Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)
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ASTM F787-82(1991) - Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)
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Standards Content (Sample)

ASTM F?8? 82 = 0?595l10 0509823 138
Designation: F 787 - 82 (Reapproved 1991)
Standard Specification for
Metallic Nail-Plate Appliances’
This standard is issued under the fixed designation F 787; the number immediately following the designation indicates the year of
o&al adoption or, in the case of revision, the year of last revision. A number in parenthesa iadicates the year of last reapproval. A
superscript epaiioa (e) indicates an editorid sina the iast revision or reapproval.
.
3. Materials and Manufacture
1. scope
3.1 Nail plates shaii be fabricated from material con-
1.1 This specification covers functional dimensidns, toler-
forming to one of the following ASTM Specifications: F 55,
ances and materials for nad-plates used in the treatment of
F 56, F 67, F 75, F 90, F 136, F 138, and F 139.
fractures.
3.1.1 Nail plates of forged Specification F 136 shali meet
1:2 The values stated in inch-pound units are to be
the requirements of Specification F 620.
regarded as the standard.
3.1.2 Nail plates of forged Specification F 55 or specifica-
tion F 138 shall meet the requirements of Specification F 62 1.
2. Referenced Documents 2
4. Períormance Considerations
2.1 ASTM Standards:
4.1 Nail plates may be tested using Practice F 384.
F 55 Specification for Stainless Steel Bar and Wire for
4.2 Factors considered to be important, but for which
Surgid impiants’
values and test methods have not been established, are bend-
F 56 Specification for Stainless Steel Sheet and Strip for
ing strength, fatigue strength, ductiüty, and bending rigidity.
Surgid Impiants2
5. Dimensions, Mass, and Permissible Variations
F 67 Specification for Unalloyed Titanium for Surgical
Implant Applications’
5.1 Nail plates shail be fabricated in accordance with the
F 75 Specification for Cast Colbalt-Chromium-Molybde
dimensions and tolerances shown in Figs. 1, 2, 3, 4, and 5.
num Alloy for Surgid Implant Applications*
Notes for Fig. 1 apply to Figs. 3 and 4, also.
F 86 Practice for Surface Preparation and Marking of 5.2 Nail plates shall have no sharp exterior edges, except
Metallic Surgid Implants’ where a sharp edge provides a functional purpose.
F 90 Specification for Wrought Cobalt-Chromium-Tung- 5.3 Nail plates shail have surfaces prepared and shall be
sten-Nickel Alloy for Surgid Implant Applications’ marked using a method specified in accordance with Practice
F 136 Specification for Wrought Titanium 6Al-4V ELI F 86.
Alloy for Surgid Implant Applications’ 5.3.1 Markings on the nail plate shall identis. the manu-
F 138 Specification for Stainless Steel Bars and Wire for facturer or distributor and shali be near the ends of the plate
and away from the most highly stressed area, where possible.
Surgical Implants (Special Quality)’
5.4 Dimensions and tolerances for screw holes and screw
F 139 Specification for Stainless Steel Sheet and Strip for
slots in nail plates shali conform to Practice F 367, for use
Surgid Implants (Special Quality?
with bone screws conforming to Specification F 543, Table 1.
F 367 Specification for Holes and Slots for Inch Cortid
Bone Screws’
6. Packaging and Labeling
F 384 Practice for Static Bend Testing of Nail Plates’
6.1 Packaging shail be adequate to protect the nail plate
F 543 Specification for Cortical Bone Screws’
during shipment.
F 565 Practice for Care and Handling of Orthopedic
6.2 Labeling for nail plates shall include:
Implants and Instruments’
6.2.1 Product name,
F 620 Specification for Titanium 6A1-4V ELI Alloy
6.2.2 Size, on the immediate container,
Forgings for Surgical Implants’
6.2.2.1 Plate length
F 621 Specification for Stainless Steel Forgings for Sur-
6.2.2.2 Plate width,
gid impiants’
6.2.2.3 Plate thickness,
6.2.2.4 Nail length,
6.2.2.5 Number of screw holes,
I This specification is under the jurisdiction of ASTM Committee F-4 on
Medical and Surgical Materials and Devices and is the direct responsibility of
6.2.2.6 Size of screw holes, and
Subcommittee Fû4.03 on orthopaedics.
*
6.2.3 ASTM Material Specification Designation Number.
Current edition approved Aug. 27, 1982. Published January, 1983. Onginally
6.3 Nail plates shall be med for and handled in accord-
published as F 787 - 82. Last previous edition F 787 - 82.
* Annual Book of ASTA4 Sthrak, Vol 13.0 I. ance with Practice F 565.
284

---------------------- Page: 1 ----------------------
ASTM F787 82 = 0759530 O509824 074 W
@ F787
.350 (8.89mm) DIA C'BORE MIN TO 7SOAFULL LAND MIN
1/4-20 UNC-28 MOD THREAD
.265(674mm) DEEP MIN
.221(5.61mm)MINOR DIA MOO MAX
.5i O{ 12.95 m m ) DIA
y .480 (1219mm)
.625(Iá88mm) MI
.lO9(277mm)DlA MIN
CANNULATION (OPTTIONAL)
JUNCTION .120( 3.05 mm) R MIN
SEE NOTE 2
- 1/16 (1.59mm)
J
SEE NOTE I
SECTION c-c
.750(19.05mrn) TO 1.000(25.4Omm) ~.010(0.25mm) TYPICAL
\
SEE FlG.2 FOR SECTION 8-B
SEE FIG5 FOR SECTION A-A
NOTE l-End of plate may opaonaiiy have a full radius or radiused come*i.
NOTE 2-Locatlo
...

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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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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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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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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 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 ...

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