ASTM-F382 2008

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F382-99(2008) Standard Specification and Test Method for Metallic Bone Plates

Published By	Publication Date	Number of Pages
ASTM	2008	12

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify, define the geometric characteristics, and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates.

1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system.

1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application.

1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics.

1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates Annex A1.

1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates Annex A2.

1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered 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 and health practices and determine the applicability of regulatory limitations prior to use.

A2.1.1 This test method describes methods for bending fatigue testing in order to determine intrinsic, metallic bone plate structural properties. The test method may be used to determine the fatigue life at a specific or over a range of maximum bending moment levels, or to estimate the fatigue strength for a specified number of fatigue cycles of a bone plate.

A2.1.2 This test method is intended to provide a means to mechanically characterize different bone plate designs. It is not the intention of this standard to define bone plate performance levels since insufficient knowledge is available to predict the consequences of the use of a particular bone plate design.

A2.1.3 Units The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

A2.1.4 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 and health practices and to determine the applicability of regulatory limitations prior to use.

Note A2.1There is currently no ISO standard that is similar or equivalent to this test method.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology FIG. 1
3	Classification Marking, Packaging, Labeling, and Handling FIG. 2
4	Materials General Requirements and Performance Considerations Keywords A1. STANDARD TEST METHOD FOR SINGLE CYCLE BEND TESTING OF METALLIC BONE PLATES A1.1 Scope A1.2 A1.3 FIG. A1.1
5	A1.4 A1.5 FIG. A1.2 FIG. A1.3
6	A1.6 A1.7 A1.8 FIG. A1.4
7	A1.9 A1.10
8	A2. STANDARD TEST METHOD FOR DETERMINING THE BENDING FATIGUE PROPERTIES OF METALLIC BONE PLATES A2.1 Scope A2.2 Referenced Documents A2.3. Terminology A2.4 Summary of Test Method A2.5 Significance and Use FIG. A2.1
9	A2.6 Apparatus A2.7 Test Specimens and Sampling A2.8 Procedure
10	A2.9 Calculation and Interpretation of Results A2.10 Report A2.11 Precision and Bias
11	X1. RATIONALE FOR SPECIFICATION X1.1 X1.2 X1.3 X2. RATIONALE FOR ANNEX A1 X2.1 X2.2 X2.3 X2.4 X2.5
12	X3. RATIONALE FOR ANNEX A2 X3.1 X3.2 X3.3 X3.4

Additional information

Standard Title	F382-99(2008) Standard Specification and Test Method for Metallic Bone Plates
Published Code	ASTM
Publication Date	2008
Pages Count	12
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F382 2008

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