Clinical Biomechanics 63 (2019) 34–40

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Clinical Biomechanics
journal homepage: www.elsevier.com/locate/clinbiomech

Comparison of ISO 14243-1 to ASTM F3141 in terms of wearing of knee T

prostheses
Xiao-Hong Wanga, Hui Lib,c,d, Xiang Dongb,c,d, Feng Zhaoa,e, Cheng-Kung Chenga,e,
⁎

a
School of Biological Science and Medical Engineering, Beihang University, Beijing 100083, China
b
Naton Institute of Medical Technology, Beijing 100095, China
c
Beijing Engineering Laboratory of Functional Medical Materials and Devices, Beijing Naton Technology Group Co. Ltd., Beijing 100082, China
d
Beijing Medical Implant Engineering Research Center, Beijing Naton Technology Group Co. Ltd., Beijing 100082, China
e
Beijing Advanced Innovation Center for Biomedical Engineering, Beihang University, Beijing 100191, China

ARTICLE INFO ABSTRACT

Keywords: Background: The wear properties of knee implants need to be thoroughly evaluated prior to clinical use to ensure
ISO 14243-1 implant longevity. ISO 14243-1:2009 and ASTM F3141-17 are the two standards typically used for evaluating
ASTM F3141 wear, with the ISO standard being more common; ASTM F3141-17 was first released in 2015. The aim of this
Tibial wear study is to compare differences between these two standards in terms of wearing on a knee prosthesis.
Finite element analysis
Methods: Using finite element analysis based on Archard's law, this study evaluated anterior-posterior and in-
Knee kinematics
ternal-external motion, contact area, contact force, contact stress, volumetric wear rate, wear depth, and wear
distribution on the knee prosthesis.
Findings: The results show that simulations performed according to ASTM F3141 produced knee kinematics that
were more similar to human gait. The maximum wear depth occurred on the medial side of the tibia. However,
the region of peak contact stress did not always correspond with the region of the maximum wear depth, in-
dicating that considering the contact stress alone is not sufficient for evaluating wear as the sliding distance also
plays an important role. The resulting wear region from the ASTM F3141 simulation was smaller but deeper than
the wear region from the simulation per ISO 14243-1. However, the volumetric wear rates were very similar,
with 13.48–55.26 mm3/million for ASTM F3141 and 13.64–54.9 mm3/million for ISO 14243-1.
Interpretation: The resulting rate of wear is almost identical between ISO 14243-1 and ASTM F3141. However,
there are differences in wear contours and wear depth.

1. Introduction
Total knee arthroplasty (TKA) is a common surgical treatment for
degenerated knees to alleviate patient pain and increase knee function.
Polyethylene wear and wear-related complications, such as implant
loosening, are still a leading cause of revision (Harman et al., 2010;
Liang et al., 2018; Pinol et al., 2014; Sharkey et al., 2014). Implant
retrieval studies are the most effective way of directly analyzing wear
on the knee joint, but such studies require samples from suitable pa-
tients with a detailed assessment of individual physiological and pa-
thological conditions. In addition, it is often time consuming and costly
(Gebert de Uhlenbrock et al., 2012; Huang et al., 1999; Huang et al.,
2002; Lu et al., 2010).
Wear simulators are often used to evaluate the wear properties of
knee implants prior to clinical use, with ISO 14243-1:2009 being the
most commonly used standard governing the test methods (Accutek,
2018; Endolab, 2018; FDA, 2003; ISO, 2009). ISO 14243-1 is also re-
commended by FDA guidance documents for evaluating knee pros-
theses, with the requirement that if the thickness of the tibial bearing
(polyethelene) is below 6 mm, a wear test should be performed to de-
monstrate that the tibial bearing can survive 10 million cycles under
normal physiological loading (walking) (FDA, 2003; ISO, 2009). An-
other option is to comply with ASTM F3141-17 which has similar input
rules for knee wear simulators under walking conditions.
A reliable standard for wear performance is crucial for the devel-
opment of knee prostheses as it predicts the lifetime of the tibial
bearing. There are two control modes for wear testing during simulated
gait: displacement control according to ISO 14243-3, and load control
according to ISO 14243-1 and ASTM F3141 (ASTM, 2017; ISO, 2002;
ISO, 2009; ISO, 2014). The inputs for displacement control are anterior-
posterior (AP) displacement and internal-external (IE) angle, and the
inputs for load control are AP load and tibial rotation (TR) torque. This

⁎
Corresponding author at: School of Biological Science and Medical Engineering, Beihang University, No.37, XueYuan Road, HaiDian District, Beijing, China.
E-mail address: ckcheng2009@gmail.com (C.-K. Cheng).

https://doi.org/10.1016/j.clinbiomech.2019.02.008
Received 10 September 2018; Accepted 13 February 2019
0268-0033/ © 2019 Elsevier Ltd. All rights reserved.
X.-H. Wang, et al. Clinical Biomechanics 63 (2019) 34–40

study focuses on load control according to ISO 14243-1 and ASTM of wearing of knee prostheses. The aim of this study is to quantitatively
F3141, as there is only a load control mode defined in the ASTM compare differences between ISO 14243-1 and ASTM F3141 in terms of
standard. Given its longer history, ISO 14243-1 is more common and wearing of knee prostheses. The hyposthesis is that there are differences
established in industry than ASTM F3141. ASTM F3141 was first re- in wear rates because of different input conditions, in particular the AP
leased in 2015 and then revised in 2017. ISO 14243-1 is still re- load as shown in Fig. 1.
commended for use by FDA guidance documents as well as a number of
multinational research organizations (Accutek, 2018; Endolab, 2018;
2. Methods
FDA, 2003). ASTM F3141 is based on studies by Bergmann et al.
(Bergmann et al., 2014; Bergmann and Graichen, 2014), while ISO
Finite element analysis (FEA) models of the femoral component and
14243-1 is based on decades of data (Bergmann et al., 2014). However,
tibial insert were developed in Abaqus® 2017 (Abaqus, SIMULIA, East
the differences between ISO 14243-1 and ASTM F3141 are still unclear
Providence, USA) using 3D scans of a PFC implant (Size two, PFC,
in terms of wearing of knee prostheses. Comparing the current revision
Depuy Synthes, Salt Lake, Utah, USA) (Figs. 2 & 3). Geometrical dif-
of ISO 14243-1:2009 with the previous 2002 revision, the definition of
ferences in the articular surface between the model and physical im-
soft tissue constraints has changed, but the definition of input curves
plant were controlled to be < 0.1 mm. The tibial insert was modeled as
remains the same (ISO, 2002; ISO, 2009). The definition of input curves
a deformable polyethylene (Gur 1050) material. The contact region of
in ASTM F3141 has not changed from its initial publication through to
the insert was meshed using hexahedron 8-noded elements C3D8R, and
its revision in 2017 (ASTM, 2017).
tetrahedron 10-noded elements C3D10M were used for all other regions
There are four inputs to the knee simulator required by ISO 14243-
(Fig. 3). Based on convergence testing (< 2% difference) of maximum
1: 2009 and ASTM F3141-17; flexion, axial load, internal-external (IE)
contact stress, an element size of around 1 mm was chosen for the
torque and anterior-posterior (AP) load. The flexion, axial load and IE
contact region and 1.6 mm was chosen for all other regions. The fe-
torque are similar between the two standards, but the definition of AP
moral component was modeled as a rigid body to save computational
load is different. For illustration, variations in these four inputs against
time. The coefficient of friction between the tibia and femur was 0.04
gait cycles are plotted in Fig. 1 for both standards.
(Grupp et al., 2009).
In a healthy knee joint, when the knee flexes between 5° and 60°, the
The boundary conditions were set according to the ISO and ASTM
tibia moves anteriorly. This is due to the fact that knee flexion and
standards (ISO, 2009; ASTM, 2017). The axial loading axis was offset to
femoral rollback occur simultaneously (Bergmann et al., 2014;
the medial side by a distance 0.07 times the width of tibia. Three of the
Dimitriou et al., 2016; Iwaki et al., 2000; Reinschmidt et al., 1997). As
loading curves (axial load, AP load and IE torque, Fig. 1B, C & D) were
seen in Fig. 1A, knee flexion noticeably increases in the range of 40% to
applied to the tibia and the flexion angle curve (Fig. 1A) was applied to
70% of the gait cycle. ASTM F3141 correctly gives the AP load for the
the femur. The tibia insert was constrained in flexion but free to move
tibia in the anterior direction while ISO 14243-1 states a posterior di-
in all other directions; medial-lateral, AP, superior-inferior, valgus
rection.
varus and rotation. The femoral component was only permitted to move
To the best of our knowledge, no studies have been conducted so far
in flexion during the gait simulation. The flexion axis was defined as a
to evaluate differences between ISO 14243-1 and ASTM F3141 in terms
line connecting the lateral femoral center and medial femoral center

Fig. 1. Four inputs from ISO 14243-1: 2009 and ASTM F3141:2017. (A) Flexion angle; (B) axial load; (C) internal-external (IE) torque; (D) anterior-posterior (AP)
load.

35
X.-H. Wang, et al.
Fig. 2. Geometrical differences on the articular surface between the model and physical implant were controlled to be < 0.1 mm.
Fig. 3. FEA model; (A) AP and IE constraints, (B) wear region of tibial insert.
(ISO, 2009).
Nonlinear constraints were applied to simulate the integrative effect
of all ligaments, tendons and muscles according to ISO 14243-1 in the
AP and IE directions (ISO, 2009). In the AP direction, the soft tissue
restraint stiffness was set as 9.3 N/mm if displacement exceeded
2.5 mm, but was zero if < 2.5 mm. In IE rotation, the restraint stiffness
was set as 130 Nmm/° if angular rotation exceeded 6° (including in-
ternal and external rotation), but was zero if within 6° (including in-
ternal and external rotation).
The restraints identified above were validated. As shown in Fig. 4,
the two curves in each plot reached their peak values simultaneously at
approximately 58% of the gait cycle; refer to Table 1 for peak values
recorded. The stiffness could then be calculated from these peak values:
stiffness = force / (displacement - 2.5 mm), or stiffness = torque / (ro-
tation angle - 6°). The results corresponded with the theoretical values
(9.3 N/mm or 130 Nmm/°).
The tibial insert was evaluated in terms of wear depth, volumetric
wear rate and volumetric wear. The wear depth was estimated by
Archard's wear law (Archard, 1953):
36
Clinical Biomechanics 63 (2019) 34–40
H = KPS (1)
where H is wear depth (mm), K is wear coefficient (mm3/Nm), P is the
contact pressure, and S is the sliding distance of the tibia relative to the
femur (mm). Values for K from literature vary from 2.64 ∗ 10−7 mm3/
Nm to 10.656 ∗ 10−7 mm3/Nm (Barnett et al., 2002; Ding et al., 2018;
Knight et al., 2007; Wang et al., 2017; Willing and Kim, 2009). This
study presents all wear results based on both 2.64 ∗ 10−7 mm3/Nm and
10.656 ∗ 10−7 mm3/Nm.
Using the user-defined subroutine UMESHMOTION in Abaqus 2017,
the wear depth at each node on the articular surface could be calculated
using Archard's law. According to the calculated wear depth, each node
on the surface was then moved in the direction normal to the articular
surface. An adaptive remeshing procedure was employed to simulate
the progression of surface wear and was calculated for 5 million cycles
according to ISO 14243-1. The mesh on the surface of the tibial insert
was updated every 500,000 cycles (1 step), which has been shown to
produce results with a difference of only 2.75% to 4.8% with a step size
of 125,000 cycles (Knight et al., 2007; Wang et al., 2017).
The wear rate was calculated as the average wear volume per
X.-H. Wang, et al. Clinical Biomechanics 63 (2019) 34–40

Fig. 4. Curves for Load-Displacement and Rotation-Torque in the AP and IE directions, respectively.

Table 1 plots, there was a negative AP translation of −1.53 mm.

Maximum values obtained from the curves plotted in Fig. 4.
AP constraint IE constraint
3.2. Contact area, contact force and contact stress
Max AP displacement (mm) Max AP load Max rotation (°) Max torque
(N) (Nmm) The contact areas, total contact forces, maximum contact stress and
contact stress distribution on the tibia insert are shown in Figs. 6, 7 and
11.51 83.80 11.38° 699.40
8. The points of maximum contact stresses in Fig. 7 are labeled A, B, C
and D and their respective locations on the insert are presented in the
million cycles (mm3/million cycles). This approach was developed and Fig. 8; A, C, D are located on the medial side, and B is on the lateral
validated in previous studies on TKA in our laboratory (Ding et al., side. During the stance phase of the gait cycle (0–60%), both models
2018; Wang et al., 2017). showed large contact areas (Fig. 6A) and high contact stresses (Fig. 7).
All finite element models and analyses were setup and performed in The overall maximum contact stress from ASTM F3141 was greater
accordance with the journal requirements for finite element studies than from ISO 14243-1. For both ASTM and ISO standards, the total
(Viceconti et al., 2005). contact force on the insert had a similar magnitude to the contact force
in the axial direction in Fig. 6B. The contact forces in the axial direction
were larger than the contact forces in AP and ML direction in Fig. 6B.
3. Results

Results are presented for AP translation, IE rotation, contact area,
contact force, contact stress, volumetric wear rate, wear depth and wear
distribution.
3.1. AP and IE kinematics
Results for AP translation and IE rotation according to ISO 14243-1
and ASTM F3141 are shown in Fig. 5. As detailed previously in Fig. 1A,
there was an obvious increase in knee flexion between 40% and 70% of
the gait cycle. Referring to the ASTM plots in Fig. 5, between 40% and
70% of the gait cycle, there was a corresponding increase in AP
translation (Fig. 5A), signifying femoral rollback, and also a noticeable
increase in internal rotation of the tibia (Fig. 5B). However, for the ISO
3.3. Volumetric wear rate, depth and distribution
The predicted wear rate, volumetric wear and wear depth are listed
in Table 2. For both K values, the wear rate and volumetric wear were
similar for ASTM F3141 and ISO 14243-1. However there was a great
difference in the calculated wear depth between the two standards,
possibly due to the different knee kinematics and contact stresses. Also,
increasing the K value from 2.64 ∗ 10−7 to 10.656 ∗ 10−7 resulted in an
almost four-fold increase in volumetric wear rate and wear depth.
Fig. 9 shows the wear depth on the tibial insert for both standards.
The wear region is smaller but deeper for the ASTM standard, while the
region is more dispersed for the ISO model. The maximum depth is
present on the medial side of the insert for both models.

Fig. 5. Plot of (A) AP translation and (B) IE rotation.

37
X.-H. Wang, et al.
Fig. 6. Contact areas and contact forces from ASTM and ISO standards. (A) Contact areas; (B) contact forces.
Fig. 7. Peaks of maximum contact stress labeled as A, B, C and D.
4. Discussion
The most important finding of this study is that whether ASTM
F3141 or ISO 14243-1 is used for simulating wear on the tibial insert,
the resulting volumetric rate of wear is almost identical. However, there
are differences in wear contours and wear depth between the two
standards.
The wear region was smaller but deeper for the ASTM model, but
the two standards had an almost identical volumetric wear rate. This
can be attributed to several causes. Firstly, for the ISO 14243-1 model,
the AP load acted on both the posterior and anterior region of the tibia
(Fig. 1D), which resulted in not only femoral rollback but also anterior
femoral translation, which is opposite to normal knee motion. This
caused a more dispersed wear region for the ISO model (Fig. 5). Sec-
ondly, the IE torque and mean axial load from the ASTM standard are
greater (Fig. 1B and C), which resulted in more IE rotation and greater
contact stresses (Figs. 5 and 7). Therefore, the wear depth was deeper in
the ASTM model. Thirdly, the wear rate for a volume is calculated by
integrating the wear area and wear depth per million cycles. Therefore,
almost equivalent volumetric wear rates were calculated for both
standards.
The accuracy of the FEA models in this study was confirmed by the
following aspects: (i) The wear region from the ISO 14243-1 model was
similar to that reported by Morra and Postak (1999), in which shallow
wearing was found in the anterior region but deeper wearing in the
posterior region. (ii) The calculated volumetric wear rates in this study
(13.64 mm3/million to 54.9 mm3/million from ISO 14243-1 with
38
Clinical Biomechanics 63 (2019) 34–40
different K values) are comparable to in vitro experimental studies by
Barnett et al. (18.1 mm3/million on average with a standard deviation
of 3 mm3/million, and 41 mm3/million on average with a standard
deviation of 14 mm3/million) (Barnett et al., 2001; Barnett et al., 2002)
and McEwen et al. (22.12 mm3/million on average with a standard
deviation of 6.02 mm3/million) (McEwen et al., 2001). (iii) The wear
algorithm and calculations were confirmed by experimental results
published in previous research from our laboratory (Ding et al., 2018;
Wang et al., 2017). (iv) The FEA method and model was validated
according to the experimental results (Supporting file).
From the results presented in Fig. 5, ASTM F3141 can be considered
to more closely represent normal gait. During knee flexion, the tibia
rotates internally and the femur rolls back (Bergmann et al., 2014;
Dimitriou et al., 2016; Iwaki et al., 2000; Reinschmidt et al., 1997).
Variations in the contact area, total contact forces, and contact
stress (Figs. 6 and 7) show a similar pattern to the axial load inputs from
the ASTM and ISO standards in Fig. 1B, and the locations of maximum
depth can be seen on the medial side of the tibial insert. These results
could be anticipated as the axial load dominates over other loading
forces, such AP or ML loads. As a consequence, the total contact force
appears to be primarily influenced by the axial load. The loading points
on the tibia and femur were offset by a distance 0.07 times the width of
tibia to the medial side according to ISO 14243-1, which resulted in the
medial side bearing a greater load (ISO, 2009).
The locations of peak contact stresses (Fig. 8A, B, C, D) did not
necessary correspond with the location of maximum wear depth
(Fig. 9). This indicates that considering contact stress alone is not suf-
ficient for evaluating wear as the sliding distance also plays an im-
portant role for estimating the wear depth and volume (Liau et al.,
2002; Simpson et al., 2008).
There are some limitations to this study that should be noted.
Firstly, Archard's law does not account for pitting, delamination and
third body wear modes and has a limited ability for predicting abra-
sive/adhesive wear (Pal et al., 2008). Secondly, neither the effect of
creep nor cross-shear was considered in this study. Thirdly, the geo-
metrical models and material properties were not sourced directly from
the manufacturer, but the accuracy of the model in this study was
confirmed to be within 0.1 mm of the physical implant. Despite these
limitations, the current study provides insights into the differences
between ISO 14243-1 and ASTM F3141 and the variability in wear
calculations.
5. Conclusion
The resulting wear region is smaller but deeper when simulated
according to ASTM F3141. However, the calculated volumetric wear
rates were very similar for both standards. The results show that knee
kinematics simulated according to ASTM F3141 are also more similar to
X.-H. Wang, et al. Clinical Biomechanics 63 (2019) 34–40

Fig. 8. The respective locations of the peaks of maximum contact stress: A, B, C, and D.

Table 2
Predicted wear rate, volumetric wear and wear depth for ASTM and ISO standards.
ASTM F3141 ISO 14243-1

−7 3 3
K = 2.64 ∗ 10 mm /Nm Wear rate (mm /million) 13.48 13.64
Volumetric wear (mm3) 67.4 68.2
Wear depth (mm) 1.137 0.538
K = 10.656 ∗ 10–7 mm3/Nm Wear rate (mm3/million) 55.26 54.9
Volumetric wear (mm3) 276.3 274.5
Wear depth (mm) 4.606 2.171

Fig. 9. Wear contours.

human gait. For both ISO 14243-1 and ASTM F3141, the trends of maximum wear depth.
contact area, total contact forces, and contact stress curves were similar
to the axial load inputs. The location of maximum depth occurred on Declarations of interest
the medial side of the tibia for both standards, and the region of peak
contact stress did not always correspond with the region of the None.

39
X.-H. Wang, et al.
CRediT authorship contribution statement
Xiao-Hong Wang: Conceptualization, Data curation, Formal
analysis, Investigation, Methodology, Project administration,
Software, Validation, Supervision, Visualization, Writing - original
draft, Writing - review & editing. Hui Li: Methodology, Software,
Validation, Writing - review & editing. Xiang Dong: Methodology,
Software, Validation, Writing - review & editing. Feng Zhao:
Methodology, Software, Validation, Writing - review & editing.
Cheng-Kung Cheng: Conceptualization, Formal analysis,
Investigation, Methodology, Project administration, Software,
Validation, Supervision, Visualization, Writing - original draft,
Writing - review & editing, Funding acquisition, Resources.
Acknowledgement
This study was supported by a Grant from the Chinese National
Science and Technology Program (National Key Research and
Development Plan) (Grant number: 210YBXM2016110002), and a
grant from National Natural Science Foundation of China (Grant
number: 81572180). The authors would like to thank Mr. Colin
McClean for his assistance with proofreading this manuscript, and Prof.
Chuan Li at the National Yang Ming University for his support and
advice through numerous communications.
Appendix A. Supplementary data
Supplementary data to this article can be found online at https://
doi.org/10.1016/j.clinbiomech.2019.02.008.
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