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ASTM F763-99

(Practice)

Standard Practice for Short-Term Screening of Implant Materials

Standard Practice for Short-Term Screening of Implant Materials

SCOPE
1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted.  
1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.  
1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material.  
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.

General Information

Status
Historical
Publication Date
09-May-1999
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.16 - Biocompatibility Test Methods
Current Stage
Ref Project

Relations

Replaced By
ASTM F763-99(2003) - Standard Practice for Short-Term Screening of Implant Materials
Effective Date
01-Nov-2003

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ASTM F763-99 - Standard Practice for Short-Term Screening of Implant Materials
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 763 – 99
Standard Practice for
1
Short-Term Screening of Implant Materials
This standard is issued under the fixed designation F 763; 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 (ε) indicates an editorial change since the last revision or reapproval.
1. Scope F 563 Specification for Wrought Cobalt-Nickel-Chromium-
Molybdenum-Tungsten-Iron Alloy for Surgical Implant
1.1 This practice provides guidelines for short-term testing
2
Applications
or screening of candidate materials, both porous and dense, as
F 603 Specification for High-Purity Dense Aluminum Ox-
to the effects of the material on animal tissue in which it is
2
ide for Surgical Implant Application
implanted. This is a rapid screening prodedure for determining
F 648 Specification for Ultra-High-Molecular-Weight Poly-
acceptability of candidate materials.
ethlene Powder and Fabricated Form for Surgical Im-
1.2 This practice, along with other appropriate biological
2
plants
tests (including other appropriateASTM tests) may be used in
F 748 Practice for Selecting Generic Biological Test Meth-
the biocompatibility assessment of the candidate materials for
2
ods for Materials and Devices
use in the fabrication of devices for clinical application.
F 981 Practice for Assessment of Compatibility of Bioma-
1.3 This experimental protocol is not designed to provide a
terials for Surgical Implants with Respect to Effect of
comprehensive assessment of the systemic toxicity, carcinoge-
2
Materials on Muscle and Bone
nicity, teratogenicity, or mutagenicity of the material since
other standards deal with these issues.
3. Terminology
1.4 This practice is one of several developed for the
3.1 Description of a Term Specific to this Standard:
assessment of the biocompatibility of materials. Practice F 748
3.1.1 biocompatibility assay—a comparison of the tissue
provides guidance for the selection of appropriate methods for
response produced through the close association of the im-
testing materials for a specific application.
planted candidate material to its implant site within the host
2. Referenced Documents animal to that tissue response recognized and established as
suitable with control materials.
2.1 ASTM Standards:
F 75 Specification for Cast Cobalt-Chromium Molybdenum
4. Summary of Practice
2
Alloy for Surgical Implant Applications
4.1 Under aseptic conditions, test specimens of the candi-
F 86 Practice for Surface Preparation and Marking of Me-
date material and of controls are inserted into a muscle or
2
tallic Surgical Implants
group of muscles of the animal host.After a period of time the
F 90 Specification for Wrought Cobalt-Chromium-
animals are euthanized. The tissue reactions to implants of the
2
Tungsten-Nickel Alloy for Surgical Implant Applications
candidate material during the acute to subchronic time period
F 136 Specification for Wrought Titanium- 6 Aluminum–4
of healing are compared with tissue reactions to control
Vanadium 4V ELI (Extra Low Interstiitial) Alloy (UNS
materials which have a well characterized response. The
2
R56401) for Surgical Implant Applications
implants are not subject to major stress while in situ.
F 138 Specification for Wrought 18 Chromium–14
Nickel–2.5 Molybdenum Stainless Steel Bar and Wire for
5. Significance and Use
2
Surgical Implants (UNS S31673)
5.1 The use of in vivo implantation techniques for charac-
F 562 Specification for Wrought Cobalt-35 Nickel-20
terizing the biocompatibility of materials to be utilized in
Chromium-10 Molybdenum Alloy for Surgical Implant
various medical applications provides a unique assessment of
2
Applications
such materials not achieved by other procedures. Physical
characteristics (that is, form, density, hardness, surface finish)
1
can influence the character of the tissue response to the test
This practice is under the jurisdiction ofASTM Committee F-4 on Medical and
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
materials.
F04.16 on Biocompatibility.
5.2 This practice is intended as a rapid screening procedure
Current edition approved May 10, 1999. Published August 1999. Originally
ε1 for determining the acceptability of candidate materials. It
published as F 763 – 82. Last previous edition F 763 – 87(1993) .
2
would be invoked prior to using the long-term tests described
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 763
in Practice F 981. It is understood that for some applications 7.3.1 The insertion of all implants into any one animal s
...

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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 ...

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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.
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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.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
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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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Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
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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1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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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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