ISO/TR 10993-55:2023

ISO/TC 194
Date:  2022-09-01
ISO/DTR 10993--55:2022(E)
ISO/TC 194/WG 5
Secretariat: DIN
Biological evaluation of medical devices — Part 55: Interlaboratory study on
cytotoxicity


Copyright notice
ThisFirst edition
Date: 2022-09-30

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ISO/DTR 10993-55:2022(E)
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Published in Switzerland.
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ISO/DTR 10993-55:2022(E)
Contents Page
Foreword . iii
Introduction . iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Participants . 1
5 Materials and Sample preparation . 2
6 Test procedures . 2
7 Results . 2
7.1 Neutral Red Uptake . 2
7.1.1 Sodium Lauryl Sulfate as positive control . 2
7.1.2 Test samples . 3
7.2 Colony Formation Assay . 3
7.2.1 Negative reference material . 4
7.2.2 Positive reference materials . 5
8 Assessment of results . 7
Annex A (informative) Interlaboratory study protocol for the neutral red uptake (NRU)
cytotoxicity test . 9
Annex B (informative) Interlaboratory study protocol for the colony formation cytotoxicity
test . 17
Bibliography. 24

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ISO/DTR 10993-55:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
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patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of
medical devices.
A list of all parts in the ISO 10993 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/DTR 10993-55:2022(E)
Introduction
The first versionedition of ISO 10993-5, published in 1992, allowed several different ways to assess
cytotoxicity of medical devices and gave an imprecise description of how to perform the tests. Qualitative
assays were accepted and only a small amount of guidance was given for the interpretation of the results.
Not surprisingly, the first interlaboratory study by the members of working group 5 (WG 5) of ISO/TC
194 in 2000 resulted in quite low reproducibility of results. It was therefore the consensus of WG 5 to
includeTherefore, detailed protocols were included into the standard and to evaluate in another study
the practicability of the protocols and reference materials proposed by the working group members.were
evaluated. The results of this second interlaboratory study mainly influenced the revision of the
standardISO 10993-5, which was published in 2009.
This technical report isdocument provides the historical report of the second interlaboratory study,
conducted in 2006.
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TECHNICAL REPORT ISO/DTR 10993-55:2022(E)

Biological evaluation of medical devices — Part 55:
Interlaboratory study on cytotoxicity
1 Scope
This document describes the results of an international interlaboratory study conducted in 2006 to
evaluate the performance of two different test protocols in terms of the cytotoxic effects in the biological
[2 ]
evaluation of medical devices. The results of these tests were used for the revision of ISO 10993-5 [. ].
Furthermore, the results of these tests were used to estimate the accuracy of these test systems with
living cells to define a threshold what is considered a cytotoxic effect.
NOTE The determination of cytotoxic effects has a high relevance in the biological evaluation of medical devices;
[1]
according to ISO 10993-1 it is one of the very few tests which are proposed to be performed for every kind of
device.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
4 Participants
1
Twelve laboratories participated in this study mainly from entities represented in ISO/TC 194, which is
responsible for this document. Eleven reports on a neutral red uptake (NRU) assay were received and
ten10 reports on a colony formation (CF) assay were received. Four participants were commercial test
laboratories, four participants were internal test laboratories of medical device manufacturers and four
laboratories were in research institutes.
The laboratories were located in six different countries.

1
The participating laboratories include: Deutsche Institute für Textil- und Faserforschung, Germany; Hatano Research
Institute, Food and Drug Safety Center, Japan; Medical University Vienna, Austria; National Institute of Health Sciences,
Japan; Envigo CRS GmbH, Germany; Terumo Corporation R&D, Japan; BD Technologies, United States; NAMSA, United
States; Gambro BCT, United States and three other laboratories.

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ISO/DTR 10993-55:2022(E)
: one each in Austria, France and the Netherlands, and three each in Germany, Japan and the United
States.
5 Materials and sample preparation
The following materials were used for the study:
a) reference material-C [RM-C; Hatano Research Institute (HRI):)]: high density polyethylene sheet.;
b) RM-A (HRI): segmented polyurethane film containing 0,1 % zinc diethyldithiocarbamate (ZDEC));
c) RM-B (HRI): segmented polyurethane film containing 0,25 % zinc dibutyldithiocarbamate (ZDBC)).
RM-C (HRI), RM-A (HRI) and RM-B (HRI) have been widely used as reference materials for cytotoxicity
tests of medical devices. The Food and Drug Safety Center of the Hatano Research Institute (HRI) (Ochiai
729-5, Hadanoshi, Kanagawa 257-8523, Japan) has certified these materials and offers them for sale.
HRI agreed to provide them for the interlaboratory study. Test samples were cut (2 mm x × 15 mm) and
sterilized with ethylene oxide (EO) and were distributed from HRI to the participants. Extraction was
then performed in the participating laboratories according to the protocols.
6 Test procedures
Two test protocols were chosen by the working group developing the tests for cytotoxicity in vitro:
neutral red uptake (NRU) and colony formation (CF). The NRU assay protocol is based on the protocol,
which was used in a validation study of Interagency Coordinating Committee on the Validation of
[4]
Alternative Methods (ICCVAM) .). The CF assay protocol is based on the cytotoxicity test of the Japanese
[5]
guidelines for basic biological tests of medical materials and devices. These original protocols were
modified to meet the requirements of this specific study (see Annexes A and ).B). The protocols were sent
to the participants together with the test materials.
7 Results
7.1 Neutral red uptake
7.1.1 General
Eleven laboratories participated in this study. All test samples were extracted once as described in
.Annex A. Each concentration of the dilution series was tested in six replicates. The mean values were
used to calculate the concentration producing a 50 % inhibition of cell viability (IC ) values.
50
7.1.17.1.2 Sodium lauryl sulfate as positive control
The laboratories were usingused different internal reference materials as positive controls. It was
therefore decided that all participants use the same common chemical substance as positive control and
® 2
sodium lauryl sulfate (SLS, CAS #Registry Number 151-21-3 ) was selected for this purpose. is a
summary ofTable 1 summarizes the results.
Table 1 — IC -values of SLS in the NRU assay
50

2
®
CAS Registry Number is a trademark of CAS corporation. This information is given for the convenience of users of this
document and does not constitute an endorsement by ISO of the product named. Equivalent products may be used if they
can be shown to lead to the same results.
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ISO/DTR 10993-55:2022(E)
Laboratory LaboratoryIC
50

µg/ml
1 34,0
2 83,0
1 2 5 6 7 8 9 10 11
3 62,4 Deleted Cells
34,0 83,0 85,9 75,6 67,8 47,8 49,8 62,1 22,0 Deleted Cells
IC
50
62,4 77,0
Deleted Cells
µg/ml
Deleted Cells
5 85,9
Deleted Cells
6 75,6
Deleted Cells
7 67,8
Deleted Cells
8 47,8
Deleted Cells
9 49,8
Deleted Cells
10 62,1
Deleted Cells
11 22,0
The variation of the IC was from 22,0 µg/ml to 85,9 µg/ml, the mean IC was (60,7 ± ± 20,4) µg/ml.
50 50
In Annex A, an IC –-value between 70 µg/ml and 116 µg/ml was requested as acceptance criterion. This
50
was an error in the 2009 version of ISO 10993-5:2009 and will be removed in the next versionedition.
Historical IC –-values are typical for a specific laboratory but cannot be compared between
50
laboratories.
7.1.27.1.3 Test samples
The three different test samples RM-A, RM-B and RM-C were extracted as described in Annex A and the
extracts were diluted as defined. The cell viabilities at different extract concentrations were determined
as described in .Annex A. The IC was determined from the concentration-response. This was done by
50
using validated software, which is available in public, see Reference .[6]. The results of the eleven11
participants are summarized in Table 2 and illustrated in .Figure 1. Initially, the testing was conducted
using the following concentrations of the RM-A extract: 0,25 %, 0,5 %, 1,0 %, 2,0 %, 3,0 %,% and 4,0 %.
Unexpectedly, IC –-values were higher than expected from the colony formation assay, because the
50
neutral red assay is less sensitive probably due to the shorter exposure time. Therefore, the laboratories
repeated the test with the following concentrations of the RM-A extract: 5 %, 10 %, 20 %, 30 %, 40 %,%
Merged Cells
and 50 %.
Deleted Cells
Table 2 — IC -values of sample extracts in the NRU assay
50
Deleted Cells
Laboratory LaboratoryIC Deleted Cells
50

Deleted Cells
%
Deleted Cells
RM- RM- RM-C
Deleted Cells
A B
Deleted Cells
1 16,5 32,0 —
Deleted Cells
2 26,4 54,0 —
Deleted Cells
1 2 4 8 9 10 11
3 18,5 693,2 7—
Deleted Cells
R 16,5% 18, 24,3 15,1 11,7 6,7% 16,7%
15,6%
26, 2056, Deleted Cells
15,3
M- 5% % % %
4% —
% 6%
A Deleted Cells
Deleted Cells
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ISO/DTR 10993-55:2022(E)
5 20,6 79,6 —
R 32, 54, 93, 43,3 38,2 89,4 33,6%
Deleted Cells
93,3%
7915, 45,6
M- 0% 0% 2% 56,6% % % %
—
6% %
Deleted Cells
B
none none none none non no no no
none Deleted Cells
none2 none9
RM-C7 e ne ne ne
4,3 3,3 —
Deleted Cells
Deleted Cells
8 15,1 43,3 —
Deleted Cells
9 11,7 38,2 —
Deleted Cells
10 6,7 89,4 —
Deleted Cells
11 16,7 33,6 —
Deleted Cells
Results for RM-A varied from 6,7 % to 26,4 %, mean IC was (17,0 ± 5,5) %. Results for RM-B varied
50
Deleted Cells
from 32,0 % to 93,3 %, %, the mean IC was (59,9 ± 24,4) %.
50 Deleted Cells
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Deleted Cells
Deleted Cells
Deleted Cells
Deleted Cells
Deleted Cells


Key
X Laboratory number
Y IC
50
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Reference material A
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Reference material B
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ISO/DTR 10993-55:2022(E)
X laboratory number reference material A

Y IC reference material B
50

Figure 1 — Comparison of IC -values of sample extracts in the NRU assay
50
7.2 Colony formation assay
7.2.1 General
The test samples RM-A, RM-B and RM-C were those materials, which were already recommended to be
used as reference materials in the Japanese Guidelines for the colony formation assay. For the study only
these materials were used by the laboratories, to assess the differences between individual laboratories.
The test samples were extracted as described in Annex B and the extracts were diluted as proposed. The
cell viabilities at different extract concentrations were determined by counting the colonies formed
[plating efficiency (PE)]. IC was calculated as the dose with 50 % PE which was calculated from the line
50
which passed through a dose with higher PE and a dose with lower PE than 50 %.
Ten of the twelve12 participants in the NRU study also participated in the CF assay and communicated
their results. All test samples were extracted once as described in .Annex B. Each concentration of the
dilution series was tested in triplicate. The mean values were used to calculate IC -values.
50
The plating efficiency of the controls in the different labslaboratories is listed in .Table 3.
Table 3 — Control PE of the CF assay in the participating labslaboratories
Laboratory Plating efficiency
Inserted Cells
%
1 68,0
1 3 4 5 7 9 10 12
Deleted Cells
2 62,8
Deleted Cells
3 75,7
Deleted Cells
4 101,5
Deleted Cells
5 92,2
Deleted Cells
7 71,2
Deleted Cells
8 108,7
Deleted Cells
9 85,0
Deleted Cells
62,8% 75,7% 101,5% 92,2% 71,2% 108,7% 85,0% 106,3%
68,0%10 75,0% Deleted Cells
Deleted Cells
12 106,3
Deleted Cells
The PE in the controls varied from 62,8 % to 108,7 %, mean value was (84,6 ± 15,8) %.
Deleted Cells
7.2.17.2.2 Negative reference material
Deleted Cells
Deleted Cells
The test sample RM-C is certified not to give any positive response in the test. Nevertheless, the extract
of RM-C was used in this study to detect the variation of results in this biological system. The results of
Deleted Cells
the 10 participants are summarized in Table 4 and illustrated in .Figure 2.
Deleted Cells
Table 4 — Plating efficiencies of RM-C in the CF assay
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ISO/DTR 10993-55:2022(E)
LaboratoryPlating efficiency
Concentration
%
of RM-C
%
Lab 1 Lab 2 Lab 3 Lab 4 Lab 5 Lab 7 Lab 8 Lab 9 Lab 10 Lab 12
0 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0%
25 112,0% 96,8% 100,0% 100,2% 93,3% 97,8% 85,3% 102,4% 98,7% 101,9%
50 94,0% 87,1% 81,5% 100,5% 103,1% 92,6% 101,8% 94,9% 79,6% 99,4%
75 110,0% 92,9% 96,0% 97,5% 92,9% 98,2% 96,6% 98,5% 85,3% 98,4%
100 106,0% 94,8% 110,1% 97,2% 95,1% 91,2% 92,0% 96,1% 77,8% 98,1%


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Key
X extract concentration in %
Y platting efficiency in % of the control
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Lab 1
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Lab 2
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Lab 3
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Lab 4
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Lab 5
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ISO/DTR 10993-55:2022(E)
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Lab 7
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Lab 8
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Lab 9
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Lab 12
X extract concentration, % laboratory 5

Y platting efficiency of the control, % laboratory 7

laboratory 1 laboratory 8

laboratory 2 laboratory 9

laboratory 3 laboratory 10

laboratory 4 laboratory 12

Figure 2 — Plating efficiencies of RM-C in the CF assay
7.2.27.2.3 Positive reference materials
Extracts of the test samples RM-A and RM-B were applied in the CF assay as indicated in .Annex B. The
results of the ten10 participants are summarized in Table 5 and Table 6 and illustrated in Figure 3 and
.Figure 4.
Table 5 — Plating efficiencies of RM-A in the CF assay
LaboratoryPlating efficiency
Concentration
%
of RM-A
%
Lab 1 Lab 2 Lab 3 Lab 4 Lab 5 Lab 7 Lab 8 Lab 9 Lab 10 Lab 12
0,00 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0%
0,25 100,0% 93,5% 90,6% 99,5% 0,0% 92,2% 71,8% 105,1% 100,9% 101,9%
0,50 101,0% 108,3% 0,7% 96,9% 0,0% 102,9% 15,6% 105,5% 58,6% 102,5%
1,00 0,0% 91,3% 0,0% 14,4% 0,0% 85,2% 0,0% 32,1% 0,4% 61,1%
2,00 0,0% 17,0% 0,0% 1,0% 0,0% 16,3% 0,0% 0,0% 0,0% 0,0%
4,00 0,0% 1,1% 0,0% 0,3% 0,0% 0,9% 0,0% 0,0% 0,0% 0,0%
8,00 0,0% 0,5% 0,0% 0,0% 0,0% 0,5% 0,0% 0,0% 0,0% 0,0%
Concentration of RM-A
%

Lab 1 Lab 2 Lab 3 Lab 4 Lab 5 Lab 7 Lab 8 Lab 9 Lab 10 Lab 12
IC
0,75 1,56 0,36 0,78 n.d.— 1,51 0,35 0,88 0,55 1,13
50
The IC of RM-A concentrations ranged from 0,35 % to 1,56 %, mean IC was (0,87 ± 0,42) %.
50 50
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ISO/DTR 10993-55:2022(E)
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Key
X extract concentration in %
Y platting efficiency in % of the control
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Lab 1
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Lab 2
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Lab 3
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Lab 4
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Lab 5
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Lab 7
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Lab 8
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Lab 9
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Lab 10
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Lab 12
Split Cells
Figure — Plating efficiencies of RM-A in the CF assay
Inserted Cells
Inserted Cells
Table — Plating efficiencies of RM-B in the CF assay
Deleted Cells
Concent
Laboratoryextract concentration, % laboratory 5 Deleted Cells
ration

Deleted Cells
RM-B
[%]X
Deleted Cells
Y 1platting efficiency of the control, % 345la  boratory 7 8 9 1 1
Deleted Cells
0 2
2
Deleted Cells

Deleted Cells
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ISO/DTR 10993-55:2022(E)
1 1 1 1 1
0 0 0 0 0
0 0 0 0 0
0 100,0% 100,0% 100,0% 100,0% 100,0%
, , , , ,
0 0 0 0 0
% % % % %
1 1
8 7 9
0 0
8 0 0
1 4
20 0,0% 100,4% 96,9% 100,8% 52,1% , , ,
, ,
0 2 6
5 1
% % %
% %
099, 8 3 9 1 1
73,laboratory 1% 39,laboratory 8%
Deleted Cells
,8% 3, 4, 0, 0 0
40 84,1%
Deleted Cells
0 3 7 6 2, 3,

% % % % 2 1
Deleted Cells
% %
Deleted Cells
7 4 8 8 9
9 2 7 2 2
Deleted Cells
50 0,0% 88,2% 5,7% 27,6% 43,4% , , , , ,
6 6 9 8 2 Deleted Cells
% % % % %
Deleted Cells
0, 9 0, 6112
laboratory 2,0% 74,laboratory 9%
Deleted Cells
0 2, 0 5278
6 45,9
% 9 % ,,,,
Deleted Cells
0 %
% 2361

%%%%  Deleted Cells
0,00, 0, 0,00
0,0%laboratory 3 0,0%laboratory 10
Deleted Cells
0 , 0 0 0 , ,
80 49,9%
Deleted Cells
% 0% % % 06

% %%
Deleted Cells
0,0 7,laboratory 4% 0,0%laboratory 12 0, 00, 0, 0, 0,
Deleted Cells
% 0 ,0 0 0 0
100 0,0%
% 0% % % %
Deleted Cells

%
Deleted Cells
6 3 5 5 6
4 3 5 5 6 Deleted Cells
IC n.d. 79,95 43,43 46,04 23,41 , , , , ,
50
Deleted Cells
6 9 3 9 7
6 6 9 4 0 Deleted Cells
Deleted Cells
Figure 3 — Plating efficiencies of RM-A in the CF assay
Deleted Cells
Deleted Cells
Table 6 — Plating efficiencies of RM-B in the CF assay
Deleted Cells
Plating efficiency
Concentration
%
of RM-B
%
Lab 1 Lab 2 Lab 3 Lab 4 Lab 5 Lab 7 Lab 8 Lab 9 Lab 10 Lab 12
0 100,0 100,0 100,0 100,0 100,0 100,0 100,0 100,0 100,0 100,0
20 0,0 100,4 96,9 100,8 52,1 88,0 70,2 101,5 90,6 104,1
40 0,0 99,8 73,1 84,1 39,8 83,3 34,7 90,6 102,2 103,1
50 0,0 88,2 5,7 27,6 43,4 79,6 42,6 87,9 82,8 92,2
60 0,0 92,9 0,0 2,0 45,9 65,2 12,3 17,6 28,1 74,9
80 0,0 49,9 0,0 0,0 0,0 0,0 0,0 0,0 0,0 0,6
100 0,0 7,4 0,0 0,0 0,0 0,0 0,0 0,0 0,0 0,0
Concentration of RM-B
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ISO/DTR 10993-55:2022(E)
%
Lab 1 Lab 2 Lab 3 Lab 4 Lab 5 Lab 7 Lab 8 Lab 9 Lab 10 Lab 12
IC
— 79,95 43,43 46,04 23,41 64,66 33,96 55,39 55,94 66,70
50
The IC of RM-B concentrations ranged from 23,41 % to 79,95 %, mean IC was (52,2 ± 16,5) %.
50 50
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Key
X extract concentration in %
Y platting efficiency in % of the control
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Lab 1
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Lab 2
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Lab 3
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Lab 4
The linked image cannot be displayed. The file may have been moved, renamed, or deleted. Verify that the link points to the correct file and location.
Lab 5
The linked image cannot be displayed. The file may have been moved, renamed, or deleted. Verify that the link points to the correct file and location.
Lab 7
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