ASTM-F384 2012

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F384-12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Published By	Publication Date	Number of Pages
ASTM	2012	11

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

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Description

1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This 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 angled devices.

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

1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application.

Note 1This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate.

1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:

1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1).

1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see Annex A2).

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

Note 2There is currently no ISO standard that is either similar to equivalent to this standard.

PDF Catalog

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

Additional information

Standard Title	F384-12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Published Code	ASTM
Publication Date	2012
Pages Count	11
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F384 2012

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