ISO 19614:2017

INTERNATIONAL ISO
STANDARD 19614
First edition
2017-05
Traditional Chinese medicine — Pulse
graph force transducer
Médecine traditionnelle chinoise — Transducteur d’intensité du pouls
Reference number
ISO 19614:2017(E)
©
ISO 2017

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ISO 19614:2017(E)

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© ISO 2017, Published in Switzerland
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ISO 19614:2017(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 8
5 Classification . 8
6 Test conditions and preparation. 8
6.1 Test conditions . 8
6.1.1 Environmental conditions . 8
6.1.2 Loading condition . 9
6.1.3 Preconditioning . 9
6.1.4 Warm-up . 9
6.2 Preparation . 9
7 Requirements .10
7.1 Labelling .10
7.1.1 Product marking .10
7.1.2 Technical description .10
7.2 Rated load (F ) .10
n
7.3 Temperature characteristics .11
7.4 Geometric dimension of transducer applied plane .11
7.5 Input resistance (R ) .11
i
7.6 Output resistance (R ) .12
o
7.7 Transducer output independence .12
7.8 Full scale span error (Fs) .12
7.9 Terminal linearity error (L) .12
7.10 Hysteresis (H) .13
7.11 Repeatability (R).13
7.12 Creep (Cp) .13
7.13 Offset stability (Zs).14
7.14 Offset temperature drift (Zt) .14
7.15 Sensitivity temperature drift (St).14
7.16 Eccentricity (Sz) .15
7.17 Overload (Ov) .16
7.18 Vibration, impact and temperature influence .16
7.19 Fatigue life .16
7.20 Biological evaluation .17
Annex A (informative) Transducer examples .18
Bibliography .20
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ISO 19614:2017(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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organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
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Technical Barriers to Trade (TBT) see the following URL: www . i so .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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INTERNATIONAL STANDARD ISO 19614:2017(E)
Traditional Chinese medicine — Pulse graph force
transducer
1 Scope
This document specifies the technical requirements, classification and test method for a pulse graph
force transducer, hereafter referred to as transducer.
It only applies to pulse graph acquisition over the patient’s radial artery based on TCM pulse condition
requirements.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
IEC 60068-2-6, Environmental testing — Part 2-6: Test Fc: Vibration (sinusoidal)
IEC 60068-2-14, Environmental testing — Part 2-14: Tests — Test N: Change of temperature
IEC 60068-2-27, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
pulse graph force transducer
transducer that can detect pulsation of the radial artery and its peripheral tissues as a mechanical
quantity and convert it into an electrical signal output according to a certain pattern for the purpose of
TCM pulse condition acquisition
Note 1 to entry: Transducers involved in this document only refer to pressure or force transducers.
3.2
calibration
process of recording input/output data through applied standard mechanical quantities to determine
the performance of transducers
Note 1 to entry: The calibration unit of transducers may be the unit of either pressure or force.
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ISO 19614:2017(E)

3.3
radial artery pulse graph
pulse graph
electrical signal waveform converted from peripheral vascular pulsation at the radial artery, expressed
in time-amplitude coordinates, hereafter referred to as pulse graph
3.4
effective plane
plane of transducers with the sensitivity during radial artery pulsation acquisition
Note 1 to entry: See Figure 1.
3.5
auxiliary plane
plane with no sensitivity and lower than the effective plane (3.4) of transducers
Note 1 to entry: See Figure 1.
3.6
applied plane
contact plane of transducers with patients during pulse graph acquisition, including the effective plane
(3.4) and auxiliary plane (3.5)
      a) Array transducer b) Single transducer
Key
1 effective plane
2 auxiliary plane
Figure 1 — Effective plane, auxiliary plane of transducers
3.7
output quantity
electrical signal quantity produced by a transducer, which is a function of a measurand
Note 1 to entry: See Figure 2.
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ISO 19614:2017(E)

a) Analog output with constant b) Analog output with constant c) Analog output with amplifier
voltage source current source
d) Frequency output e) Digital or other forms of output
Key
1 output+
2 input+
3 input-
4 output-
NOTE 1 The output format includes analog output (e.g. a continuous function of a measurand such as changes
in voltage amplitude, voltage ratio, and capacitance) which can be classified into amplified and unamplified.
NOTE 2 Frequency output (i.e. the number of cycles or pulses per second as a function of a measurand) and
frequency-modulated output (i.e. frequency deviation from a centre frequency) are also forms of analog output.
NOTE 3 Another output format is digital output which represents a measurand in the form of discrete
quantities coded in a system of notation (e.g. binary code).
Figure 2 — Different transducers
3.8
resistive bridge transducer
transducer receiving excitation (3.11) from alternating or direct electrical energy, the output of which is
directly proportional to the product of the applied mechanical quantities and excitation
3.9
static signal
electrical signal transferred from the applied force
Note 1 to entry: See Figure 3.
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ISO 19614:2017(E)

3.10
dynamic signal
electrical signal transferred from pulsation at the radial artery and its peripheral tissues detected
Note 1 to entry: See Figure 3.
X
2
1
0
Y
Key
X amplitude
Y time
1 static signal
2 dynamic signal
Figure 3 — Static signal and dynamic signal
3.11
excitation
external energy (voltage or current) applied to a transducer for its proper operation
3.12
measuring range
set of values for a measurand for which the error of the transducer is intended to lie within specified limits
Note 1 to entry: See Figure 4.
[SOURCE: IEC 60747-14-1:2010, 3.2.11]
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ISO 19614:2017(E)

X
4
3
1
100 %
0 2 Y
Key
X output (e.g. voltage)
Y measurand (e.g. force)
1 offset
2 measuring range
3 full scale span (FSS)
4 full scale output (FSO); FSO = FSS + offset
Figure 4 — Output-measurand relationship of a linear-output sensor with an offset
3.13
full scale span
FSS
algebraic difference between the end-points of the transducer output
Note 1 to entry: The upper limit of the transducer output over the measuring range (3.12) is called the full scale
output (FSO). This signal is the sum of the offset signal plus the full scale span.
[SOURCE: IEC 60747-14-1:2010, 3.2.4]
3.14
linearity
closeness between the calibration (3.2) curve and a specified straight line of the transducer
Note 1 to entry: This document adopts the end-point or terminal linearity. There are two methods for calculating
linearity: end-point straight line fit or a least squares best line fit. While a least squares fit gives the “best case”
linearity error, the calculations required are burdensome. Conversely, an end-point fit will give the “worst case”
error and the calculations are more straightforward for the user. The result is called the end-point or terminal
linearity.
[SOURCE: IEC 60747-14-1:2010, 3.2.7]
3.15
rated load
load value assigned to the transducer by the manufacturer
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ISO 19614:2017(E)

3.16
stability
ability of a transducer to maintain its performance characteristics for a certain period of time
Note 1 to entry: Stability is the ability of a transducer to reproduce output readings, obtained during the original
calibration, and under constant room conditions, for a specified period of time. It is typically expressed as a
percentage of FSO.
[SOURCE: IEC 60747-14-1:2010, 3.2.24]
3.17
hysteresis
maximum difference in output, at any measurand value, within the measuring range (3.12) when the
value is approached first with an increasing and then a decreasing measurand
Note 1 to entry: Hysteresis is expressed in percent of FSO during one calibration cycle.
[SOURCE: IEC 60747-14-1:2010, 3.2.5]
3.18
drift
undesired change in transducer output, which is irrelevant to the measurand, caused by temperature
change at a certain time interval
3.19
repeatability
ability of a transducer to reproduce output readings at room temperature, when the same measurand is
applied to it consecutively, under the same conditions and in the same direction
[SOURCE: IEC 60747-14-1:2010, 3.2.17]
3.20
eccentricity
consistency among measurement values of different points applied with identical mechanical quantity
on the same effective plane (3.4) of the tested transducer under the same measuring conditions
3.21
creep
change in output quantity (3.7) within a specified time when applying a measurand to the transducer
quickly and then keeping all other external conditions constant
Note 1 to entry: See Figure 5.
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ISO 19614:2017(E)

X
1
2
3
Y
0
4
Key
X output
Y time
1 positive creep
2 negative creep
3 positive creep recovery
4 negative creep recovery
Figure 5 — Creep and creep recovery
3.22
input resistance
resistance measured across the excitation (3.11) terminal of the transducer
Note 1 to entry: It is sometimes called “excitation resistance”.
3.23
output resistance
effective resistance across the output terminals of the transducer presented to the associated
external circuit
Note 1 to entry: It is sometimes called “signal resistance”.
3.24
testing mechanical quantity generator
apparatus which may generate force or pressure to test radial artery mechanical transducer
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ISO 19614:2017(E)

4 Symbols
Table 1 — Symbols
No. Letter symbol Description Unit
1 R Input resistance
i W
2 R Output resistance
o
W
3 F Rated load
n N , kPa
4 FSO Full scale output
μV, mV , V , Hz , PF
5 FSS Full scale span
μV, mV , V , Hz , PF
6 FS Full scale span error % FSS
2
7 Effective plane mm
C
8 V Offset
off μV, mV , V , Hz , C
9 Terminal linearity error % FSS
L
10 Hysteresis % FSS
H
11 Repeatability % FSS
R
12 Creep % FSS
Cp
13 Eccentricity % FSS
Sz
14 Overload capacity % F
OV n
15 Offset stability % FSS
Zs
16 Offset temperature drift %/ FSS °C
Zt
17 Sensitivity temperature drift %/ FSS °C
St
18 Output independence %
Y
...