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1、JIS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS T 4206:2005 Clinical thermometers, mercury-in-glass, with maximum device ICs 11.040.55 Reference number : JIS T 4206 : 2005 (E) PROTECTED BY COPYRIGHT 13 S Copyright Japanese Standards Association Provide
2、d by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:40:31 MDTNo reproduction or networking permitted without license from IHS -,-,- T 4206 : 2005 Foreword This translation has been made based on the original Japanese Industrial Standard r
3、evised by the Minister of Health, Labour and Welfare and the Minister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee in accordance with the Industrial Standardization Law. Consequently JIS T 4206 : 1989 is replaced with this Standard. This Standar
4、d has been made based on OIML R7 : 1976 Clinical thermometers (mercuq-in-glass, with mmimum device) for the purposes of making it easier to compare this Standard with International Standard; to prepare Japanese Industrial Standard conforming with International Standard; and to propose a draft of an
5、International Standard which is based on Japanese Industrial Standard. Attention is drawn to the possibility that some parts of this Standard may conflict with a patent right, application for a patent after opening to the public, utility model right or application for registration of utility model a
6、fter opening to the public which have technical properties. The relevant Ministers and the Japanese Industrial Standards Committee are not responsible for identifying the patent right, application for a patent after opening to the public, utility model right or application for registration of utilit
7、y model after opening to the public which have the said technical properties. Date of Establishment: 1989-06-15 Date of Revision: 2005-03-25 Date of Public Notice in Official Gazette: 2005-03-25 Investigated by: Japanese Industrial Standards Committee Standards Board Technical Committee on Medical E
8、quipment JIS T 4206 : 2005, First English edition published in 2005-06 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2003 All ri
9、ghts reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. Printed in Japan M b) sealing mercury inside, with retai
10、ning point; c measuring unit of temperature is the degree Celsius (“C). Remarks : The International Standard corresponding to this Standard is as follows. In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (ident
11、ical), MOD (modified) and NEQ (not equivalent) according to ISOPIEC Guide 21. OIML R7 : 1976 Clinical tlwrmometers (mercury-in-glass, with rnuximum evice) (MOD) 2 Normative reference The following standard contains provisions which, through reference in this Standard, constitute provisions of this S
12、tandard. The most recent edition of the standard (including amendments) indicated below shall be applied. JIS Z 8103 3 Definitions and the following definitions apply. a retaining point glossa of terms used in measurement For the purpose of this Standard, the definitions given in JIS Z 8103 a part o
13、f capillary tube made narrow so as the mercury column is maintained at the position of the measured maximum temperature, even though PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resa
14、le, 03/15/2007 21:40:31 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 T 4206 : 2005 Classification Enclosed-scale type Solid-stem type 4 Construction Capillary tube and scale strip are sealed in an outer tube (see figure i). Capillary tube is directly graduated (see fip
15、ure 2). the temperature is lowered capillary tube mercury column the mercury in a capillary tube cut mercury the condition where the mercury column is cut and becomes discontinuous due to bubbles or the like scale spacing the distance between centres of neighboring graduation lines scale interval (1
16、 Note (l) a fine glass tube in which sealed mercury rises or falls the size of measured quantity corresponding to scale spacing The scale interval may sometimes be called the reading of one scale division. OV value a fundamental index for basal body temperature used in medical field and a value of a
17、 range from 35.5 “C to 38 “C divided equally by 50 (O ov to 50 ov) (Ovulation index) Classification Clinical thermometers shall be classified as given in table 1 and table 2 according to the construction and uses. Table 1 Classification according to construction Table 2 Classification according to u
18、ses I Classification I Use I To be used for measuring body temperature for ordinary purpose. General use Retaining Minimum Scale CaPilla1“y Maximum Bulb Point scale face tube scale Outer tube Figure 1 Enclosed-scale type PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS
19、 under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:40:31 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 T 4206 : 2005 Retaining Minimum Maximum Bulb point scale Stem scale Coloured glass axis Figure 2 Solid-stem type
20、 5 Performance 5.1 Maximum permissible instrumental error When instrumental error test specified in 7.2.1 is performed on a clinical thermometer, the maximum permissible instrumental error .shai!not.exce.e.bsc.ale.inteval.ofth.esaid.c!i.nica!.thermometer. 5.2 After a clinical thermometer is raised t
21、o an arbitrary temperature from 37C or over up to and including the maximum scale, it is left at an ordinary temperature. After the clinical thermometer itself has become an ordinary temperature, the swing down test specified in 7.2.2 shall be performed, and then the mercury column shall lower to th
22、e minimum scale or below. 5.3 Materials Rigidity of retaining point 5.3.1 Glass a Glass used for clinical thermometers shall be resistant to ageing. b) For glass used for clinical thermometers, when the alkali elution test specified in 7.2.3 is performed, the quantity of alkali eluate shall be 0.7 m
23、g or less per 2.5 g of powdered sample of the glass. For glass used for clinical thermometers, when the test to determine variation of zero point indication is performed as specified in 7.2.4, the variation of zero point indication shall not exceed 0.07 “C. c 5.3.2 functioning of the clinical thermo
24、meter. 5.3.3 _ _ _ _ _ Celsius degree (OC) c) Symbol to identify the clinical thermometer 9.2 Markings on package a) Name of manufacturer b) In the case of clinical thermometers for use by women, indication of it 10 Accompanying documents General clinical thermometers shall be accompanied with the d
25、ocuments specified in laws or instruction manual and corresponding documents. As many of the following items as possible shall be described on the thermometer in a manner easy to understand, but items not relevant may be omitted. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provid
26、ed by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:40:31 MDTNo reproduction or networking permitted without license from IHS -,-,- 8 T 4206 : 2005 a) Date of being prepared or revised b) Necessary information specified by laws c) Sales
27、name, abbreviation or nickname, etc. Name that may fill the users with confusion in identification of products shall not be included. d) Warning notices shall be described in red including item titles, in red frame. e) Objects and application methods which are outside the responsibility of the manuf
28、acturer, including contraindication, prohibitions, design limit and improper use of the clinical thermometer, shall be described. They shall be described including item titles in red frame, but the letters shall not be written in red. f) Shape, construction, etc. g) Performance, purposes of use, pos
29、itive effect or effectiveness h) Guaranteed measuring accuracy i) Measuring temperature range j) Explanation of OV value for clinical thermometer for use by women k) Operation method or usage method, etc. 1) Required time and correct measuring method for temperature measuring m) Cautions for use n)
30、Defects and adverse events o) p) Storage conditions Storage method and period of service 1 The clinical thermometer that may be subject to breakdown due to expansion of mercury shall not be stored at places where temperature rises to 42 “C or higher for general use and 38 “C or higher for use by wom
31、en. The thermometers shall not be placed close to heaters or under direct sunlight. 2) q) Precautions for handling i) Matters about maintenance and inspection, and necessary measures for re-use such as sterilization Precautions on cleaning, cleansing, disinfection and sterilization 2) r) Packages sh
32、all bear the number of clinical thermometers contained. When there are plural units of packages, the number of thermometers per product shall be indicated. s) As for the main literary documents and the contacts, the major documents to support the description of each item shall be given, and the cont
33、acts shall include name, address and telephone number. Name and address of manufacturer or importer t) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:40:31 MDTNo
34、reproduction or networking permitted without license from IHS -,-,- 9 T 4206 : 2005 Annex 1 (normative) Clinical thermometers, mercury-in- glass, with maximum device under Measurement Law Introduction This annex was developed to specify the technical references and test methods concerning constructi
35、on and performance, from among the requirements for clinical thermometers, mercury-in-glass as specific measuring instruments under Measurement Law. Clinical thermometers complying with this annex shall not be deemed to have passed the verification specified in Measurement Law. 1 Scope This annex sp
36、ecifies the construction and performance of clinical thermometers, mercury-in-glass under Measurement Law from among those included in b) of clause 1 in the text. Definitions retaining point capillary This is in accordance with b) of clause 3 in the text. mercury column This is in accordance with c)
37、 of clause 3 in the text. mercury cut measured value instruments graduation sign related value analogue indicating mechanism value continuously scale spacing the distance between centres of two neighboring graduation signs in analogue indicating mechanism instrumental error value obtained by subtrac
38、ting the corresponding true value from the measured value instrumental error test to measure instrumental error of a thermometer to determine whether the clinical thermometer complies with the technical references related with construction specified in Measurement Law verification inspection of spec
39、ific measuring instruments specified by Measurement Law Information : The bodies to perform the verification are specified to be the prefectural governors, designated verification bodies, National Research Institute and Japan Electric Meters Inspection Corpo- This is in accordance with a) of clause
40、3 in the text. This is in accordance with d) of clause 3 in the text. quantity value of material phenomenon shown by measuring figures, points, lines or other signs to indicate measured value or a set of graduation signs to indicate measured PROTECTED BY COPYRIGHT Copyright Japanese Standards Associ
41、ation Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/15/2007 21:40:31 MDTNo reproduction or networking permitted without license from IHS -,-,- 10 T 4206 : 2005 ration for each specific measuring instrument by Measurement Law. 1) verific
42、ation tolerance permissible value of instrumental error at verification m) working tolerance permissible value of instrumental error at inspection in service n) scale interval the difference of quantity of material phenomenon indicated by each graduation sign lying side-by-side o) marking of type ap
43、proval the mark to show that the clinical thermometer belongs to the approved type of specific measuring instruments specified in Measuring Law 3 Performance 3.1 scale spacing of the said thermometer. 3.2 Rigidity of retaining point with 5.2 in the text. Verification tolerance Verification tolerance
44、 of clinical thermometer shall be the The rigidity of retaining point shall be in accordance 3.3 Materials 3.3.1 3.3.2 Glass Mercury Mercury shall be in accordance with 5.3.2 in the text. The materials of glass shall be in accordance with 5.3.1 in the text. 4 Construction 4.1 Graduation The graduati
45、on of clinical thermometers shall be in accordance with 6.1 in the text and the following. However, b) and g) of 6.1, OV value and conditional note of h) in the text are excluded. The range of scale graduation shall be 32 “C or over to and including 43 “C. 4.2 Appearance 6.2 in the text and the foll
46、owing. However, a), c) and g) of 6.2 in the text are excluded. a) The shape of clinical thermometers shall be straight. b) The thermometer shall not have more than one capillary tubes filled with temperature sensing liquid. The appearance of clinical thermometers shall be in accordance with 5 Tests
47、5.1 Types of test a) Instrumental error test b) Swing-down test c) Alkali elution test d) Test of variation of zero point indication PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resa
48、le, 03/15/2007 21:40:31 MDTNo reproduction or networking permitted without license from IHS -,-,- 11 T 4206 : 2005 5.2 Test methods 5.2.1 the text. Instrumental error test The test method shall be in accordance with 7.2.1 in 5.2.2 Swing-down test The test method shall be in accordance with 7.2.2 in the text. 5.2.3 Alkali elution test The test method shall be in accordance with 7.2.3 in the text. 5.2.4 with 7.2.4 in the text. Test of variation of zero point indication The test method shall be in accordance 6 Marking Marking on clinical thermometers shall be in accordance with 9.1 in t