ASTM F367-81(1991)
(Specification)Specification for Holes and Slots for Inch Cortical Bone Screws (Withdrawn 1997)
Specification for Holes and Slots for Inch Cortical Bone Screws (Withdrawn 1997)
General Information
Standards Content (Sample)
ASTM F3b7 81 m 0759530 0509797 2Lb -
Designation: F 367 - 61 (Reapproved 1991)
#lb
Standard Specification for
Holes and Slots for Inch Cortical Bone Screws’
This standard is issued under the fixed designation F 367; 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 reapprovaf. A
superscript epsilon (0 indicates an editorial change since the last revision or reapprovaf.
are provided for information purposes only.
1. Scope
1.1 This specification covers the basic dimensions of
2. Referenced Document
screw holes and slots in surgical implants with regard to cor-
tical bone screws in accordance with Table 1 of Specification
2.1 ASTM Standard:
F 543.
F 543 Specification for Cortical Bone Screws’
1.2 The values stated in inch-pound units are to be re-
garded as the standard. SI units are given in parentheses and
3. Dimensions
3.1 Screw holes and screw slots shall be in accordance
with the dimensions listed in Table 1 and illustrated in Fig. 1.
’ This specification is under the jurisdiction of ASTM Committee F-4 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee FO4.03 on Orthopedics.
Current edition approved Dec. 28, I98 I. Published March 1982. 2 Annual Book of ASTM Standards, Vol 13.0 I,
Dimensions for Hole Diamewrs and Slot Wiis
TABLE 1
Screw Size
Dinwwion A, Hole Diiter or Slot Wiitb, in. (mm)
Class A, No. 4M 0.116/0.132 (3.OP.l)
Class B, No. 6M 0.147/0.152 (3.7P.9)
Uaea C, No. 6.5M 0.150/6.156 (3.6l4.0)
Class D, No. 7M 0.160/0.166 (4.114.2)
claeaE.No.6M 0.166;0.176 (4.3/4.5j
0.010 in. (0.25mm) min
Dimension A
See Table I
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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.
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1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.
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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.
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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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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.
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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.
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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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