JIS-T-1303-2005-ENG.pdf
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1、JIS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association Fetal monitors ICs 11.040.55 Reference number : JIS T 1303 : 2005 (E) PROTECTED BY COPYRIGHT 12 c Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/11111110
2、01, User=Wing, Bernie Not for Resale, 03/15/2007 22:45:41 MDTNo reproduction or networking permitted without license from IHS -,-,- T 1303 2005 Foreword This translation has been made based on the original Japanese Industrial Standard revised by the Minister of Health, Labour and Welfare and the Min
3、ister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee, as the result of proposal for revision of Japanese Industrial Standard submitted by Japan Electronics and Information Technology Industries Association (JEITA)/Japanese Standards Association (J
4、SA) with the draft being attached, based on the provision of Article 12 Clause 1 of the Industrial Standardization Law applicable to the case of revision by the provision of Article 14. Consequently JIS T 1303:1994 is replaced with this Standard. The revision of this time is limited to reviewing the
5、 conformity to JIS T 0601-1 (Medical electrical equbment -Part I General requirements jor safety), because no International Standard corresponding to JIS is developed. Attention is drawn to the possibility that some parts of this Standard may conflict with a patent right, application for a patent af
6、ter opening to the public, utility model right or application for registration of utility model after 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
7、patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have the said technical properties. Date of Establishment: 1984-03-15 Date of Revision: 2005-03-25 Date of Public Notice in Official Gazette: 2005-03-25 Investig
8、ated by: Japanese Industrial Standards Committee Standards Board Technical Committee on Medical Equipment JIS T 1303 : 2005, First English edition published in 2005-08 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any do
9、ubts arising as to the contents, the original JIS is to be the final authority. O JSA 2005 All rights 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 p
10、ermission in writing from the publisher. Printed in Japan M&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 22:45:41 MDTNo reproduction or networking permitted with
11、out license from IHS -,-,- T 1303 2005 Contents Page 1 2 3 4 5 6 6.1 6.2 6.3 7 8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10 8.11 8.12 8.13 8.14 9 9.1 9.2 9.3 10 11 12 Scope 1 Normative references . 1 Definitions . 1 Safety . 2 Classification . 2 Configuration . 2 Configuration of basic monitors . 2 Co
12、nfiguration of expanded monitors 3 Additional parts . 4 Construction 4 Performance . 5 Driving frequency of ultrasonic probe . 5 Fetal heart sound converter 5 Ultrasonic doppler signal detection amplifier . 5 ECG amplifier 5 Fetal heart sound amplifier . 6 Heart rate counter . 6 Heart rate calibrato
13、r 7 External measurement labour converter . 8 Intrauterine pressure converter 8 External measurement labour amplifier . 8 Intrauterine pressure labour amplifier 8 Recorder . 8 Alarm generation function . 9 Telemeter function . 9 Test 10 Test condition 10 Safety-related test . 10 Performance-related
14、test . 11 Marking . 15 Accompanying document . 15 Environmental conditions and power supply 15 (i) 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 22:45:41 MDTNo repr
15、oduction or networking permitted without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS T 1303 2005 Fetal monitors 1 Scope This Japanese Industrial Standard specifies fetal monitors (hereafter referred to as “monitors”) that record continuously the ultrasonic doppler fetal heart rate curves
16、 and the external measurement labour curves on charts as fetal information and maternal information. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this Standard. The most recent editions of the standards (including a
17、mendments) indicated below shall be applied. JIS T 0601- 1 JIS T 1031 IEC 6 116 1 Medical electrical equipment-Part 1: General requirements for safety General rules for alarms o f medical equipment Ultrasonic power measurement in liquids in the frequency range O. 5 MHz to 25 MHz 3 (Definitions) of J
18、IS T 0601-1 and the following definitions apply. Definitions For the purposes of this Standard, the definitions given in clause 2 The terms defined in JIS T 0601-1 are bold-faced in this Standard. ultrasonic doppler method fetal heart rate equation. the method that uses the ultrasonic doppler effect
19、 the heart rate per minute of a fetus. It is obtained by the following 60 FHR= - T where, FHR fetal heart rate (heart beats/min) T : duration from any one heart beat to the next heart beat(s) transvaginal direct induction fetal ECG signal the fetal ECG signal that is acquired transvaginally via the
20、fetal lower presentation, mothers vulva, or vaginal wall abdominal wall induction fetal ECG signal via the mothers abdominal wall external measurement method the method where measurement is made by placing externally a converter on the abdominal wall of pregnant woman labour (labour pains) a mechani
21、cal change that accompanies the uterine contractions and that occurs in the abdomen of pregnant woman the fetal ECG signal that is acquired PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not f
22、or Resale, 03/15/2007 22:45:41 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 T 1303 2005 4 Safety following. The safety of monitors shall be as per the provisions of JIS T 0601-1 and the a b) C 5 Degree of protection against electric shock of the applied part The fetal
23、ECG measuring unit and the intrauterine pressure measuring unit shall be type CF applied part. Surface temperature of applied part When monitors are used at the ambient temperature of 36 O C , the surface temperature of applied part shall not exceed 41 “C. Ultrasonic output The ultrasonic output per
24、 unit area of ultrasonic probe shall be ISATA (space average, time average strength) 10 mW/cm2 or less, when monitors are tested by 9.2.1. Classification Monitors shall be classified into two types: the basic monitors and the expanded monitors. 6 Configuration 6.1 Configuration of basic monitors The
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