Traditional Chinese medicine -- Pulse graph force transducer

ISO 19614:2017 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.

Médecine traditionnelle chinoise -- Transducteur d'intensité du pouls

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Status
Published
Publication Date
22-May-2017
Current Stage
6060 - International Standard published
Start Date
30-Mar-2017
Completion Date
23-May-2017
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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)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

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copyright@iso.org
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ii © ISO 2017 – All rights reserved
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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

7.3 Temperature characteristics ....................................................................................................................................................11

7.4 Geometric dimension of transducer applied plane .............................................................................................11

7.5 Input resistance (R ) ........................................................................................................................................................................11

7.6 Output resistance (R ) ...................................................................................................................................................................12

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

© ISO 2017 – All rights reserved iii
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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

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

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

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any 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).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,

as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the

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.

iv © ISO 2017 – All rights reserved
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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.

© ISO 2017 – All rights reserved 1
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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.
2 © ISO 2017 – All rights reserved
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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.
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]
4 © ISO 2017 – All rights reserved
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ISO 19614:2017(E)
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)
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

© ISO 2017 – All rights reserved 7
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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
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
7 Effective plane mm
8 V Offset
off μV, mV , V , Hz , C
9 Terminal linearity error % FSS
10 Hysteresis % FSS
11 Repeatability % FSS
12 Creep % FSS
13 Eccentricity % FSS
14 Overload capacity % F
OV n
15 Offset stability % FSS
16 Offset temperature drift %/ FSS °C
17 Sensitivity temperature drift %/ FSS °C
18 Output independence %
...

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