BS ISO 14835-1-2016 Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Measurement and evaluation of finger skin temperature《机.pdf

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1、BSI Standards PublicationBS ISO 14835-1:2016Mechanical vibration and shock Cold provocation tests forthe assessment of peripheralvascular functionPart 1: Measurement and evaluation offinger skin temperatureBS ISO 14835-1:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implement

2、ation of ISO 14835-1:2016.It supersedes BS ISO 14835-1:2005 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee GME/21/6, Mechanical vibration, shock and conditionmonitoring - Human exposure to mechanical vibration and shock.A list of organizations represen

3、ted on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 9225

4、1 0ICS 13.160Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 29 February 2016.Amendments issued since publicationDate Text affectedBS ISO 14835-1:2016 ISO 2016Mech

5、anical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Part 1: Measurement and evaluation of finger skin temperatureVibrations et chocs mcaniques Essais de provocation froid pour lvaluation de la fonction vasculaire priphrique Partie 1: Mesurage et valua

6、tion de la temprature de la peau des doigtsINTERNATIONAL STANDARDISO14835-1Second edition 2016-02-15Reference numberISO 14835-1:2016(E)BS ISO 14835-1:2016ISO 14835-1:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless other

7、wise 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 b

8、elow or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 14835-1:2016ISO 14835-1:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative referen

9、ces 13 Measurement equipment 13.1 General . 13.2 Thermometry . 23.2.1 General 23.2.2 Sensors . 23.2.3 Recorders . 23.2.4 Calibration . 23.3 Thermography . 23.3.1 General 23.3.2 Remote-sensing techniques . 23.3.3 Data processing . 23.3.4 Calibration . 34 Measurement procedure 34.1 Quantity to be meas

10、ured 34.2 Conditions of examination 34.2.1 General 34.2.2 Examination room 34.2.3 Time 34.2.4 Subject preparation . 44.3 Cold provocation . 44.3.1 Cold-water bath 44.3.2 Water temperature and duration of immersion . 54.3.3 Choice of test hands and fingers . 54.3.4 Waterproof covering . 54.4 Conduct

11、of the test . 54.4.1 General 54.4.2 Placement of sensors . 64.4.3 Measurement periods . 65 Safety aspects . 75.1 General . 75.2 Electrical safety 75.3 Contraindications . 75.4 Informed consent 75.5 Examiner and medical supervision . 76 Data reporting . 76.1 General . 76.2 Examination conditions 86.2

12、.1 Test conditions. 86.2.2 Subject conditions 86.2.3 Temperature measurement 86.2.4 Hand cooling 86.3 Subject characteristics 86.4 Symptoms and signs during examination 86.5 Results 87 Assessment of normative values and limits . 8Bibliography 9 ISO 2016 All rights reserved iiiContents PageBS ISO 148

13、35-1:2016ISO 14835-1:2016(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 interested

14、 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 Comm

15、ission (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 s

16、hould 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

17、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 con

18、venience 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 WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Forewor

19、d - Supplementary informationThe committee responsible for this document is ISO/TC 108, Mechanical vibration, shock and condition monitoring, Subcommittee SC 4, Human exposure to mechanical vibration and shock.This second edition cancels and replaces the first edition (ISO 14835-1:2005), of which it

20、 constitutes a minor technical revision. The main change is the specification of additional test conditions in 4.3.2.ISO 14835 consists of the following parts, under the general title Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function: Part 1: Me

21、asurement and evaluation of finger skin temperature Part 2: Measurement and evaluation of finger systolic blood pressureiv ISO 2016 All rights reservedBS ISO 14835-1:2016ISO 14835-1:2016(E)IntroductionFinger skin temperature (FST) is related indirectly to finger blood flow and reflects the contribut

22、ion of feed capillaries, nutritive capillaries and arteries. Mechanical, physiologic and pharmacologic effects at any of these levels may affect FST.Assessing FST over a sufficient observation time can identify the presence and extent of finger vasoconstriction in response to cold provocation produc

23、ed by appropriate hand cooling.The changes in FST during hand cooling normally reflect the degree of vasoconstriction and resistance to blood flow caused by cold provocation, and possibly also alterations of this physiological process. The changes in FST after cold provocation reflect different neur

24、ovascular processes that control recovery from cold exposure and the return to steady-state circulatory conditions. The measurement of FST during cold provocation is carried out in a well-controlled environment.FST indicates intra- and inter-individual variability to some extent. The test results of

25、 cold provocation are interpreted together with subjective symptoms, signs and history, including vibration exposure.After having gained experience with the use of ISO 14835-1:2005 over several years, it turned out that cold provocation tests are carried out in some countries using slightly differen

26、t test parameters. In particular, the test conditions 12 C water temperature and 5-min immersion duration are not generally used. A survey of ISO/TC 108/SC 4 revealing the current measurement practice of four countries constitutes the background for the development of this second edition of this par

27、t of ISO 14835.The intention is to open the possibility to undertake the tests with specified different test parameters (in particular water temperature and immersion duration) in a clearly defined way in order to make the test results nevertheless comparable. Finally, the overall usage of this Inte

28、rnational Standard needs to be promoted. ISO 2016 All rights reserved vBS ISO 14835-1:2016BS ISO 14835-1:2016Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Part 1: Measurement and evaluation of finger skin temperature1 ScopeThis part of ISO 1

29、4835 specifiesa) the methods for measuring the finger skin temperature (FST),b) the procedures for conducting the measurements (including the performance of cold provocation tests), andc) how to report the measurement results.The methods specified in this part of ISO 14835 are designed to assist in

30、the collection of basic data for a quantitative evaluation of vascular response to cold provocation, and to enable specification of normative figures.This part of ISO 14835 is applicable to the measurement of FST in response to cold provocation for the assessment of various peripheral vascular disor

31、ders in persons exposed to hand-arm vibration, and is intended to be used together with a battery of tests for diagnosing hand-arm vibration syndrome.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its applicat

32、ion. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 5349-1, Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements

33、IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance3 Measurement equipment3.1 GeneralSeveral types of transducers are available for the measurement of FST. Thermocouples and thermistors (point transducers) are often used. They are simple

34、to use and practical for following up. Thermal imaging devices have also been used, sometimes with infrared sensors. These devices, however, tend to be expensive and difficult to calibrate accurately compared with point transducers.It is recommended that all equipment be checked for correct operatio

35、n before and after use.INTERNATIONAL STANDARD ISO 14835-1:2016(E) ISO 2016 All rights reserved 1BS ISO 14835-1:2016ISO 14835-1:2016(E)3.2 Thermometry3.2.1 GeneralThe advantage of contact thermometry and non-contact point thermometry using infrared in the field of vascular assessment methods is that

36、the apparatus is less expensive and easier to maintain than thermography. Although FST is usually measured at one fixed point for each finger, depending on how many hands are being measured at once, an alternative is to measure on the distal phalanx of all fingers and the middle and proximal phalang

37、es when measuring just one hand.3.2.2 SensorsIt is important that sensors do not influence temperature changes at the measurement location and do not provide thermal insulation from the exterior environment or cold provocation. The sensors should be highly sensitive and accurate, with a maximum ther

38、mal discrimination of 0,1 C within the physiological temperature range (5 C to 40 C).3.2.3 RecordersAll FST data obtained during the test shall be recorded, and data storage on a computer may be performed. The time interval between temperature measurements of each finger shall not exceed 1 min. Duri

39、ng recording, the temperatures may be displayed in real time. The recorded data, as numerically stored in the recorder, may be transferred to a computer for further processing, either manually after printing on paper, or directly through an electronic interface. A recorder with an integrated keyboar

40、d may permit control and digital display of the recording parameters.3.2.4 CalibrationCalibration of the temperature sensors should be carried out by inserting a calibrated reference thermometer and all sensors into the cold-water bath. The sensors should be within 0,2 C of the reference thermometer

41、. The range of temperatures registered using the sensors should not exceed 0,1 C.3.3 Thermography3.3.1 GeneralThe advantage of non-contact thermography in the field of vascular assessment methods is that, during the cold provocation test, the skin temperature of more than one point on a single finge

42、r may be measured and registered. Non-contact thermography methods show thermal images of whole hands. In this way, peripheral blood circulation disturbances in local parts of the hands and fingers may be detected and may indicate the severity of impairment to health.3.3.2 Remote-sensing techniquesR

43、emote-sensing systems involve infrared radiation. They usually consist of a high-resolution sensor unit (i.e. plane array sensor with at least 250 pixels per line and 250 lines per image), cooling system, operating unit, digital image recorder, digital computer, colour monitor and colour printer for

44、 reproduction of the thermogram. The maximum range of temperature to be measured shall be at least from 5 C to 40 C, but shall be variable within different steps. The maximum thermal discrimination shall be 0,1 C within the mentioned temperature range.3.3.3 Data processingData are recorded as an ima

45、ge of the hand with the FST coded as a colour map. Images should be recorded at possible maximum intervals not exceeding 1 min. The times at which cold provocation begins and ends should be recorded with the image. The relationship between colour and FST should be recorded for quantitative interpret

46、ation of results.2 ISO 2016 All rights reservedBS ISO 14835-1:2016ISO 14835-1:2016(E)3.3.4 CalibrationCalibration may be accomplished in different ways. A cavity radiator as a black body may be used for calibration. Internal reference data for automatic comparison during measurement interruption may

47、 serve for testing the stability of measurements.4 Measurement procedure4.1 Quantity to be measuredFST is the quantity to be measured. It is expressed in degrees Celsius (C).4.2 Conditions of examination4.2.1 GeneralTo obtain precise data, the test conditions and procedures shall be sufficiently con

48、trolled. Measurement of FST should be carried out in a well-controlled environment.4.2.2 Examination roomFST is strongly affected by room temperature. The room temperature shall be maintained at (22 1) C over the whole length of the body, for the duration of the test.The environment shall be control

49、led to prevent extraneous conditions that might influence examination results.Atmospheric temperature during the test should be strictly controlled. It is necessary to control room temperature at different vertical levels to prevent temperature differences at different parts of the body. The atmospheric temperature around the entire body should be maintained within the allowable range by mild air circulation. Stronger air circulation can increase skin cooling and alter the effective ambient room temperature.4.2.3 Time4.2.