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ASTM F361-80

(Practice)

Practice for Assessment of Compatibility of Metallic Materials for Surgical Implants With Respect to Effect of Materials on Tissue (Withdrawn 1987)

Practice for Assessment of Compatibility of Metallic Materials for Surgical Implants With Respect to Effect of Materials on Tissue (Withdrawn 1987)

General Information

Status
Withdrawn
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.02 - Division II - Orthopaedic Devices
Current Stage
Ref Project

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ASTM F361-80 - Practice for Assessment of Compatibility of Metallic Materials for Surgical Implants With Respect to Effect of Materials on Tissue (Withdrawn 1987)ASTM F361-80 - Practice for Assessment of Compatibility of Metallic Materials for Surgical Implants With Respect to Effect of Materials on Tissue (Withdrawn 1987)
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ASTM F361-80 - Practice for Assessment of Compatibility of Metallic Materials for Surgical Implants With Respect to Effect of Materials on Tissue (Withdrawn 1987)
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Standards Content (Sample)

~
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= 9009276 0038302 bo5
ANSI/ASTM F 381 - 80
AMERICAN SOCILTV FOR TLSTINQ LN0 MATERIALS
1916 Rica St. Phliadolphii* Pi: 19103
Raprintd from tho Annual Book of ASTM Stmndudr, CopVrlght ASTM
If not Ilrtd In tho Curront cornbind lnôrx. WIN r~9wr In tho next dition.
Standard Practice for
ASSESSMENT OF COMPATIBILITY OF METALLIC
MATERIALS FOR SURGICAL IMPLANTS WITH RESPECT
TO EFFECT OF MATERIALS ON TISSUE'
This siandard ir issued under ihr fired designation F 361; ihc number immcáiaicly following ihc drsi4naiion indicaies ihr
year of oriEini1 adupiion or. in ihr C8K Of revuim the year of lui revision. A number in parentheses indicaies the year of last
reapprov1l.
1. scope
and Wire for Surgical Implants (Special
1.1 This practice provides a series of exper- Quality)'
2.2 Oih.er Documents:
imental protocols for biological assays of tissue
Guidejbr the Care und Use of Laborator)
reaction to metallic materials for surgical im-
Animals, Department of Health, Education
plants. It assesses the effects of the material on
and Welfare Publication No. 711-23 (197~~
animal tissue in which it is 'implanted. The
experimental protocol is not designed to pro-
3. Summary of Practice
vide a comprehensive assessment of the sys-
3.1 This practice describes the preparation
temic toxicity, carcinogenicity, teratogenicity,
of implants, the number of implants and test
or mutagenicity of the material. It applies only
hosts, test sites, exposure schedule, implant ster-
to materials with projected applications in hu-
ilization techniques, and methods of implant
man subjects where the materials will reside in
retrieval and tissue examination of each test
skeletal or sol\ tissue for time ;tcriocîs in excess
site.
30 days and will remain functional. Cardio-
of
vascular applications and applications in other
4. Significance
organ systems or tissues for which these proto-
4.1 This is a test protocol for comparing the
cols may be inappropriate are excluded. Con-
local tissue response evoked by metallic mate-
trol materials will consist of-any one of the
from which surgical devices might ulti-
rials,
metal alloys in Specifications F 67. F 75, F 90,
mately bt. fabricated, with the local tissue re-
or F 138.
sponse clkitcd by control materiais currently
2. Applicable Documents
accepted r!r the fabrication of surgical devices.
Currently' accepted materials are the metais
2. I ASTM Standards:
(and metal alloys, see Section 2) which were
F 67 Specification for Unalloyed Titanium
standardized on the basis of acceptable long-
for Surgical Implant Applications'
term clinical experience. These metal controls
F 75 Specification for Cast Cobalt-Chro-
consistently producc cellular reaction and scar
mium-Molybdenum Alloy for Surgical
Implant Applications'
F 86 Recommended Practice for Surface
Preparation and Marking,of Metallic Sur-
gicai Implants'
F 90 Specification for Wrought Cobalt-
Chromium-Tungrten-Nickel Alloy for
Surgid Implant Applidons*
F 138 Specification for Stknlcss Steel Ban
k-9

---------------------- Page: 1 ----------------------
F 361
to u degree that has ken found to,be acceptable
ical cons!raints, such should be rcprted in
to thc host. This practice provides methods for
accordance with 8.1.
assaying candidate metallic matefials based on
6.4 Numbers of Test and Control Implants:
a comparison with the tissue reaction produced
6.4.1 In each rat there shall be two implants.
by the current standard metals.
one on each side of the spine. Animals shall be
alternately designated to receive test or refer-
5. Test liosts nnd Sites
ence material implants.
5.1 Rats (strains in which the. incidence of 6.4.2 In each rabbit, there shall be two im-
tumors are low), New Zealand rabbits, and
plants in the muscle on each side of the spine
dogs shall be used as test hosts for soft tissue or in each femur. Animals shall receive test or
implants. Rabbits and dogs shall be used as test reference material implants.
6.4.3 In each dog. there shall be six implants
hosts for bone implants.
5.2 The sacro-spinalis muscle .pr femur can on each side of the spine or in each femur.
serve as the test site for implants. However, the Animals shall receive test or reference material
implants.
same site must be used for all the implants in
all the animal species. 6.5 Conciif ioning:
5.3 Twenty rats. I2 rabbits, and 8 dogs shall 6.5.1 Remove all surface contaminants with
be used for studies utilizing intramuscular im- appropriate solvents and rinse all test and con-
plants. Twelve rabbits and 8 dogs shall be used trol implants in distilled water prior to sterili-
for bone implants. zat ion.
5.4 A suggested schedule for the sacrifice of 6.5.2 Package and sterilize all implants in
animals is given in Table 1. the same way as is used for human implanta-
tion.
6. Iniplnnt Specimens
6.5.3 After final preparation and steriliza-
tion, handle the test and control impla
...

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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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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
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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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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.  
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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
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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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