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1、BRITISH STANDARD BS ISO 14835-1:2005 Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Part 1: Measurement and evaluation of finger skin temperature ICS 13.160 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Unc
2、ontrolled Copy, (c) BSI BS ISO 14835-1:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 5 September 2005 BSI 5 September 2005 ISBN 0 580 46519 5 National foreword This British Standard reproduces verbatim ISO 14835-1:2005 and implements i
3、t as the UK national standard. The UK participation in its preparation was entrusted by Technical Committee GME/21, Mechanical vibration and shock, to Subcommittee GME/21/6, Human exposure to mechanical vibration and shock, which has the responsibility to: A list of organizations represented on this
4、 subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Sear
5、ch” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal ob
6、ligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of
7、 pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 10, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publica
8、tion Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 14835-1:2005(E) INTERNATIONAL STANDARD ISO 14835-1 First edition 2005-07-01 Mechanical vibration and shock Cold provocation tests for the assessm
9、ent of peripheral vascular function Part 1: Measurement and evaluation of finger skin temperature Vibrations et chocs mcaniques Essais de provocation froid pour lvaluation de la fonction vasculaire priphrique Partie 1: Mesurage et valuation de la temprature de la peau des doigts BS ISO 14835-1:2005
10、Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1
11、3 Measurement equipment . 1 3.1 General. 1 3.2 Thermometry. 2 3.3 Thermography. 2 4 Measurement procedure 3 4.1 Quantity to be measured 3 4.2 Conditions of examination. 3 4.3 Cold provocation 4 4.4 Conduct of the test. 5 5 Safety aspects. 6 5.1 General. 6 5.2 Electrical safety. 7 5.3 Contraindicatio
12、ns . 7 5.4 Informed consent 7 5.5 Examiner and medical supervision. 7 6 Data reporting . 7 6.1 General. 7 6.2 Examination conditions . 7 6.3 Subject characteristics. 8 6.4 Symptoms and signs during examination . 8 6.5 Results. 8 7 Assessment of normative values and limits 8 Bibliography. 9 BS ISO 14
13、835-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International S
14、tandards 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, als
15、o take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committe
16、es is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possi
17、bility 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. ISO 14835-1 was prepared by Technical Committee ISO/TC 108, Mechanical vibration and shock, Subcommittee SC 4, Human exposure to mec
18、hanical vibration and shock. 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: Measurement and evaluation of finger skin temperature Part 2: Measurement and evaluation o
19、f finger systolic blood pressure BS ISO 14835-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction Finger skin temperature (FST) is related indirectly to finger blood flow and reflects the contribution of feed capillaries, n
20、utritive capillaries and arteries. Mechanical, physiologic or 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 produced by appropriate hand coo
21、ling. 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 neurovascular processes that
22、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 cold provocation are in
23、terpreted together with subjective symptoms, signs and history, including vibration exposure. BS ISO 14835-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00
24、 2006, Uncontrolled Copy, (c) BSI 1 Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Part 1: Measurement and evaluation of finger skin temperature 1 Scope This part of ISO 14835 specifies a) the methods for measuring the finger skin temperature
25、 (FST), b) the procedures for conducting the measurements (including the performance of cold provocation tests), and c) how to report the measurement results. The methods specified in this part of ISO 14835 are designed to assist in the collection of basic data for a quantitative evaluation of vascu
26、lar 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 disorders in persons exposed to hand-arm vibration, and is intended to
27、be used together with a battery of tests for diagnosing hand-arm vibration syndrome. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of t
28、he 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 IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety 3 Measurement equipmen
29、t 3.1 General Several types of transducers are available for the measurement of FST. Thermocouples and thermistors (point transducers) are often used. They are simple to use and practical for following up. Thermal imaging devices have also been used, sometimes with infrared sensors. These devices, h
30、owever, tend to be expensive and difficult to calibrate accurately compared to point transducers. It is recommended that all equipment be checked for correct operation before and after use. BS ISO 14835-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Uncontroll
31、ed Copy, (c) BSI 2 3.2 Thermometry 3.2.1 General The advantage of contact thermometry and non-contact point thermometry using infrared in the field of vascular assessment methods is that the apparatus is less expensive and easier to maintain than thermography. Although FST is usually measured at one
32、 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 phalanges when measuring just one hand. 3.2.2 Sensors It is important that sensors do not influence temperature changes
33、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 thermal discrimination of 0,1 C within the physiological temperature range (5 C to 40 C). 3.2.3 Recorders All FST d
34、ata 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. During recording, the temperatures may be displayed in real time. The recorded data, as numerically stored in the
35、 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 keyboard may permit control and digital display of the recording parameters. 3.2.4 Calibration Calibration of the te
36、mperature 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. The range of temperatures registered using the sensors should not exceed 0,1 C. 3.3 Thermography 3.3.1 Ge
37、neral The 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 finger may be measured and registered. Non-contact thermography methods show thermal images of whole hands. I
38、n 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 techniques Remote-sensing systems involve infrared radiation. They usually consist of a high-resolution sensor uni
39、t (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 reproduction of the thermogram. The maximum range of temperature to be measured shall be at least fro
40、m 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 processing Data are recorded as an image of the hand with the FST coded as a colour map. Images should be recorded at possible maximum int
41、ervals 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 interpretation of results. BS ISO 14835-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:4
42、0 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 3.3.4 Calibration Calibration 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 serve for testing the stability of m
43、easurements. 4 Measurement procedure 4.1 Quantity to be measured FST is the quantity to be measured. It is expressed in degrees Celsius (C). 4.2 Conditions of examination 4.2.1 General To obtain precise data, the test conditions and procedures shall be sufficiently controlled. Measurement of FST sho
44、uld be carried out in a well-controlled environment. 4.2.2 Examination room FST is strongly affected by room temperature. The room temperature should be maintained at (21 1) C over the whole length of the body, for the duration of the test. Any deviations outside this range should be reported. The e
45、nvironment shall be controlled 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 pa
46、rts 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 Time 4.2.3.1 Time of year Because the season can aff
47、ect the measurement, it is desirable to make measurements in the cold season. If periodic examination at two or more times per year is required for follow-up in addition to the examination in the cold season, a test may be conducted in the autumn or summer. 4.2.3.2 Time of day With respect to circad
48、ian biorhythm, examination between 9:00 and 18:00 is recommended. NOTE It has been reported that the time of day has an influence on FSTs, but it is unknown whether these daily variations have a significant effect on the FST response to cold provocation. 4.2.3.3 Time lag between previous test(s)/exa
49、mination(s) A delay of 3 h between cold provocation tests, including test described in ISO 14835-2, and FST measurements is recommended so as to avoid the effects of prior cold exposure. This includes a cold provocation that has been aborted after cold provocation has begun. BS ISO 14835-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 03:43:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 4.2.4 Subject preparation 4.2.4.1 Recommendations to subject prior t
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