1、Traditional Chinese medicine Pulse graph force transducerBS ISO 19614:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 19614:2017.The UK participation in its preparation was entrusted to Techni
2、cal Committee CH/100/1, Traditional Chinese Medicine.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The Briti
3、sh Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 86659 3ICS 11.040.55Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July
4、2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS ISO 19614:2017 ISO 2017Traditional Chinese medicine Pulse graph force transducerMdecine traditionnelle chinoise Transducteur dintensit du poulsINTERNATIONAL STANDARDISO19614First edition2017-05-15Reference number
5、ISO 19614:2017(E)BS ISO 19614:2017ISO 19614:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electroni
6、c 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 ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Ge
7、neva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 19614:2017ISO 19614:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Symbols 85 Classification 86 Test conditions and preparation 86.1 Test conditions 86.1.1 Environmental con
8、ditions . 86.1.2 Loading condition . 96.1.3 Preconditioning 96.1.4 Warm-up . 96.2 Preparation 97 Requirements .107.1 Labelling 107.1.1 Product marking .107.1.2 Technical description 107.2 Rated load (Fn) 107.3 Temperature characteristics 117.4 Geometric dimension of transducer applied plane .117.5 I
9、nput resistance (Ri) 117.6 Output resistance (Ro) .127.7 Transducer output independence . 127.8 Full scale span error (Fs) . 127.9 Terminal linearity error (L) 127.10 Hysteresis (H) . 137.11 Repeatability (R). 137.12 Creep (Cp) . 137.13 Offset stability (Zs) 147.14 Offset temperature drift (Zt) 147.
10、15 Sensitivity temperature drift (St). 147.16 Eccentricity (Sz) 157.17 Overload (Ov) 167.18 Vibration, impact and temperature influence . 167.19 Fatigue life 167.20 Biological evaluation . 17Annex A (informative) Transducer examples .18Bibliography .20 ISO 2017 All rights reserved iiiContents PageBS
11、 ISO 19614:2017ISO 19614:2017(E)ForewordISO (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 intere
12、sted 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
13、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 documen
14、ts 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
15、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
16、 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 ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT)
17、 see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.iv ISO 2017 All rights reservedBS ISO 19614:2017Traditional Chinese medicine Pulse graph force transducer1 ScopeThis document specifies the technical requi
18、rements, classification and test method for a pulse graph force transducer, hereafter referred to as transducer.It only applies to pulse graph acquisition over the patients radial artery based on TCM pulse condition requirements.2 Normative referencesThe following documents are referred to in the te
19、xt 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 d
20、evices Part 1: Evaluation and testing within a risk management processIEC 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 temperatureIEC 60068-2-27, Environmental testing Part 2-27: Tests Test Ea and g
21、uidance: Shock3 Terms and definitionsFor 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: av
22、ailable at http:/www.electropedia.org/3.1pulse graph force transducertransducer 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 acq
23、uisitionNote 1 to entry: Transducers involved in this document only refer to pressure or force transducers.3.2calibrationprocess of recording input/output data through applied standard mechanical quantities to determine the performance of transducersNote 1 to entry: The calibration unit of transduce
24、rs may be the unit of either pressure or force.INTERNATIONAL STANDARD ISO 19614:2017(E) ISO 2017 All rights reserved 1BS ISO 19614:2017ISO 19614:2017(E)3.3radial artery pulse graphpulse graphelectrical signal waveform converted from peripheral vascular pulsation at the radial artery, expressed in ti
25、me-amplitude coordinates, hereafter referred to as pulse graph3.4effective planeplane of transducers with the sensitivity during radial artery pulsation acquisitionNote 1 to entry: See Figure 1.3.5auxiliary planeplane with no sensitivity and lower than the effective plane (3.4) of transducersNote 1
26、to entry: See Figure 1.3.6applied planecontact 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 transducerKey1 effective plane2 auxiliary planeFigure 1 Effective plane, auxiliary plane of tra
27、nsducers3.7output quantityelectrical signal quantity produced by a transducer, which is a function of a measurandNote 1 to entry: See Figure 2. 2 ISO 2017 All rights reservedBS ISO 19614:2017ISO 19614:2017(E)a) Analog output with constant voltage sourceb) Analog output with constant current sourcec)
28、 Analog output with amplifierd) Frequency output e) Digital or other forms of outputKey1 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 class
29、ified 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
30、which represents a measurand in the form of discrete quantities coded in a system of notation (e.g. binary code).Figure 2 Different transducers3.8resistive bridge transducertransducer receiving excitation (3.11) from alternating or direct electrical energy, the output of which is directly proportion
31、al to the product of the applied mechanical quantities and excitation3.9static signalelectrical signal transferred from the applied forceNote 1 to entry: See Figure 3.3.10dynamic signalelectrical signal transferred from pulsation at the radial artery and its peripheral tissues detectedNote 1 to entr
32、y: See Figure 3. ISO 2017 All rights reserved 3BS ISO 19614:2017ISO 19614:2017(E)X12Y0KeyX amplitudeY time1 static signal2 dynamic signalFigure 3 Static signal and dynamic signal3.11excitationexternal energy (voltage or current) applied to a transducer for its proper operation3.12measuring rangeset
33、of values for a measurand for which the error of the transducer is intended to lie within specified limitsNote 1 to entry: See Figure 4.SOURCE: IEC 60747-14-1:2010, 3.2.11 4 ISO 2017 All rights reservedBS ISO 19614:2017ISO 19614:2017(E)X1324Y0100 %KeyX output (e.g. voltage)Y measurand (e.g. force)1
34、offset2 measuring range3 full scale span (FSS)4 full scale output (FSO); FSO = FSS + offsetFigure 4 Output-measurand relationship of a linear-output sensor with an offset3.13full scale spanFSSalgebraic difference between the end-points of the transducer outputNote 1 to entry: The upper limit of the
35、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, 3.2.43.14linearitycloseness between the calibration (3.2) curve and a specified straight line of the transducerNo
36、te 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. Conversel
37、y, 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, 3.2.73.15rated loadload value assigned to the transducer by the manufacturer ISO 2017 All rights rese
38、rved 5BS ISO 19614:2017ISO 19614:2017(E)3.16stabilityability of a transducer to maintain its performance characteristics for a certain period of timeNote 1 to entry: Stability is the ability of a transducer to reproduce output readings, obtained during the original calibration, and under constant ro
39、om conditions, for a specified period of time. It is typically expressed as a percentage of FSO.SOURCE: IEC 60747-14-1:2010, 3.2.243.17hysteresismaximum 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 de
40、creasing measurandNote 1 to entry: Hysteresis is expressed in percent of FSO during one calibration cycle.SOURCE: IEC 60747-14-1:2010, 3.2.53.18driftundesired change in transducer output, which is irrelevant to the measurand, caused by temperature change at a certain time interval3.19repeatabilityab
41、ility 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 directionSOURCE: IEC 60747-14-1:2010, 3.2.173.20eccentricityconsistency among measurement values of different points applied with
42、identical mechanical quantity on the same effective plane (3.4) of the tested transducer under the same measuring conditions3.21creepchange in output quantity (3.7) within a specified time when applying a measurand to the transducer quickly and then keeping all other external conditions constantNote
43、 1 to entry: See Figure 5. 6 ISO 2017 All rights reservedBS ISO 19614:2017ISO 19614:2017(E)XY12340KeyX outputY time1 positive creep2 negative creep3 positive creep recovery4 negative creep recoveryFigure 5 Creep and creep recovery3.22input resistanceresistance measured across the excitation (3.11) t
44、erminal of the transducerNote 1 to entry: It is sometimes called “excitation resistance”.3.23output resistanceeffective resistance across the output terminals of the transducer presented to the associated external circuitNote 1 to entry: It is sometimes called “signal resistance”.3.24testing mechani
45、cal quantity generatorapparatus which may generate force or pressure to test radial artery mechanical transducer ISO 2017 All rights reserved 7BS ISO 19614:2017ISO 19614:2017(E)4 SymbolsTable 1 SymbolsNo. Letter symbol Description Unit1 RiInput resistanceW2 RoOutput resistanceW3 FnRated loadN , kPa4
46、 FSO Full scale outputV, mV , V , Hz , PF5 FSS Full scale spanV, mV , V , Hz , PF6 FS Full scale span error % FSS7CEffective plane mm28 VoffOffsetV, mV , V , Hz , C9LTerminal linearity error % FSS10HHysteresis % FSS11RRepeatability % FSS12CpCreep % FSS13SzEccentricity % FSS14OVOverload capacity % Fn
47、15ZsOffset stability % FSS16ZtOffset temperature drift %/ FSS C17StSensitivity temperature drift %/ FSS C18YOutput independence %NOTE The symbols for the actual detection value during the test are formed by adding a lowercase m before the symbols specified in this table. For example, the symbol of t
48、he actual detected offset is expressed as mVoff.5 ClassificationTransducer shall be classified into two types based on the structures (see Annex A):a) Type A transducer: single transducer;b) Type B transducer: array transducer.6 Test conditions and preparation6.1 Test conditions6.1.1 Environmental c
49、onditionsTests are carried out within the range of environmental conditions specified in 6.1.1, unless otherwise specified by the manufacturer. Where ambient temperatures cannot be maintained and the test conditions are to be consequently modified, the results are adjusted accordingly:a) an ambient temperature range of 25 C 3 C;b) a relative humidity range of 30 % to 80 %, (non-condensation);8 ISO 2017 All rights reservedBS ISO 19614:2017ISO 19614:2017(E)c) an atmospheric pressure ran
