ASTM F3141-15

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F3141 −15
Standard Guide for
1
Total Knee Replacement Loading Profiles
This standard is issued under the fixed designation F3141; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope walking, turning navigational movements, stair climbing, stair
descent, and squatting. The kinetic and kinematic test condi-
1.1 Motion path, load history and loading modalities all
tions are expressed as reference waveforms used to drive the
contribute to the wear, degradation and damage of implanted
relevant simulator machine actuators. These waveforms repre-
prosthetics. Simulating a variety of functional activities prom-
sent motion, as in the case of flexion extension, or kinetic
ises more realistic testing for wear and damage mode evalua-
signals representing the forces and moments resulting from
tion. Such activities are often called activities of daily living
body dynamics, gravitation and the active musculature acting
(ADLs).ADLs identified in the literature include walking, stair
across the knee.
ascent and decent, sit-to-stand, stand-to-sit, squatting,
kneeling, cross-legged sitting, into bath, out of bath, turning 1.6 This document does not address the assessment or
2
and cutting motions (1-7). Activities other than walking gait measurement of damage modes, or wear or failure of the
often involve an extended range of motion and higher imposed prosthetic device.
loading conditions which have the ability to cause damage and
1.7 This document is a guide.As defined byASTM in their
modes of failure other than normal wear (8-10).
“Form and Style forASTM Standards” book in section C15.2,
1.2 This document provides guidance for functional simu- “Astandard guide is a compendium of information or series of
lation to evaluate the durability of knee prosthetic devices
options that does not recommend a specific course of action.
under force control. Guides are intended to increase the awareness of information
and approaches in a given subject area. Guides may propose a
1.3 Function simulation is defined as the reproduction of
series of options or instructions that offer direction without
loads and motions that might be encountered in activities of
recommending a definite course of action. The purpose of this
daily living but it does not necessarily cover every possible
type of standard is to offer guidance based on a consensus of
type of loading. Functional simulation differs from typical
viewpoints but not to establish a standard practice to follow in
wear testing in that it attempts to exercise the prosthetic device
allcases.”Theintentofthisguideistoprovideloadingprofiles
through a variety of loading and motion conditions such as
and test procedures to develop testing that might be used for
might be encountered in situ in the human body in order to
wear, durability or other types of testing of total knee replace-
reveal various damage modes and damage mechanisms that
ments.Asnotedinthisdefinition,aguideprovidesguidanceon
might be encountered throughout the life of the prosthetic
testing,butdoesnotrequirespecifictesting.Thus,forexample,
device.
if a user is unable to control one mode of force control given
1.4 Force control is defined as the mode of control of the
in the load profiles, that user is not required to perform that
testmachinethatacceptsaforcelevelasthesetpointinputand
mode of loading.
which utilizes a force feedback signal in a control loop to
1.8 This standard does not purport to address all of the
achieve that set point input. For knee simulation, the flexion
safety concerns, if any, associated with its use. It is the
motion is placed under angular displacement control, internal
responsibility of the user of this standard to establish appro-
and external rotation is placed under torque control, and axial
priate safety and health practices and determine the applica-
load, anterior posterior shear and medial lateral shear are
bility of regulatory limitations prior to use.
placed under force control.
1.5 This document establishes kinetic and kinematic test
2. Referenced Documents
conditions for several activities of daily living, including
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2.1 ASTM Standards:
E74 Practice of Calibration of Force-Measuring Instruments
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
3
Current edition approved Dec. 15, 2015. Published February 2016. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/F3141–15. contact ASTM Customer Service at service@astm.org.
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