1、BSI Standards Publication BS ISO 8600-4:2014 Endoscopes Medical endoscopes and endotherapy devices Part 4: Determination of maximum width of insertion portionBS ISO 8600-4:2014 BRITISH STANDARD National foreword This British Standard is the UK implementation of ISO 8600-4:2014. It supersedes BS ISO
2、8600-4:1997 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CPW/172, Optics and Photonics. 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 necessar
3、y provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 81117 3 ICS 11.040.55 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard
4、was published under the authority of the Standards Policy and Strategy Committee on 31 March 2014. Amendments issued since publication Date Text affectedBS ISO 8600-4:2014 ISO 2014 Endoscopes Medical endoscopes and endotherapy devices Part 4: Determination of maximum width of insertion portion Endos
5、copes Endoscopes mdicaux et dispositifs dendothrapie Partie 4: Dtermination de la largeur maximale de la partie insre INTERNATIONAL STANDARD ISO 8600-4 Second edition 2014-03-15 Reference number ISO 8600-4:2014(E)BS ISO 8600-4:2014ISO 8600-4:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED
6、 DOCUMENT ISO 2014 All rights reserved. Unless otherwise 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. Permissi
7、on can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in SwitzerlandBS ISO 8600-4:2014ISO 8600
8、-4:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv 1 Scope . 1 2 Test conditions . 1 2.1 Test environments . 1 2.2 Accuracy of measuring instruments . 1 3 Method of measurement 1 3.1 General . 1 3.2 Millimetre indication . 1 3.3 French size indication . 2BS ISO 8600-4:2014ISO 8600
9、-4:2014(E) Foreword ISO (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 in a subject fo
10、r 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 Commission (IEC) on
11、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 should be noted.
12、 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 identifying an
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15、ntary information The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 5, Microscopes and endoscopes. This second edition cancels and replaces the first edition (ISO 8600-4:1997), of which it constitutes a minor revision. ISO 8600 consists of the following
16、 parts, under the general title Endoscopes Medical endoscopes and endotherapy devices: Part 1: General requirements Part 2: Particular requirements for rigid bronchoscopes Part 3: Determination of field of view and direction of view of endoscopes with optics Part 4: Determination of maximum width of
17、 insertion portion Part 5: Determination of optical resolution of rigid endoscopes with optics Part 6: Vocabulary Part 7: Basic requirements for medical endoscopes of water-resistant typeiv ISO 2014 All rights reservedBS ISO 8600-4:2014INTERNATIONAL ST ANDARD ISO 8600-4:2014(E) Endoscopes Medical en
18、doscopes and endotherapy devices Part 4: Determination of maximum width of insertion portion 1 Scope This International Standard specifies a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories. 2 Test conditions 2.1 Test environments
19、The test environment conditions shall be as follows: a) temperature: from 15 C to 35 C; b) relative humidity: from 45 % to 75 %; c) atmospheric pressure: from 86 kPa to 106 kPa. 2.2 Accuracy of measuring instruments Measuring instruments with a minimum accuracy of 0,05 mm shall be used (e.g. by a ve
20、rnier caliper). For measurement of the peripheral length, in French size, measuring instruments with a minimum accuracy of 0,5 mm shall be used (e.g. by a tape measure or a similar tool). 3 Method of measurement 3.1 General For measurement of the millimetre indication, the maximum diameter of a circ
21、umscribed circle perpendicular to the nominal axis of the insertion portion shall be measured refer to Figure 1a) and Figure 1b). This maximum diameter is defined as the largest diameter measured in all sections perpendicular to the nominal axis along the length of the insertion portion. For measure
22、ment of the French size indication, the maximum peripheral length of a section perpendicular to the nominal axis of the insertion portion shall be measured. The maximum peripheral length is defined as the largest peripheral length measured in all sections perpendicular to the nominal axis along the
23、length of the insertion portion. Flexible endoscopes shall be measured with the insertion portion straight. 3.2 Millimetre indication To obtain millimetre indication: a) measure the maximum diameter of a circumscribed circle; ISO 2014 All rights reserved 1BS ISO 8600-4:2014ISO 8600-4:2014(E) b) if a
24、n endoscope utilizes a detachable hood, measure the maximum diameter of the endoscope both with and without the detachable hood refer to Figure 1a) and Figure 1b); c) the unit of measurement shall be millimetres. 3.3 French size indication To obtain the French size indication: a) if the section of t
25、he insertion portion is circular, the French size is calculated by multiplying the measured diameter by three; b) if the section of the insertion portion is noncircular (refer to Figure 2) measure the minimum length (U) of the circumscribed curve and calculate the French size, Fr, utilizing the foll
26、owing formula: 3 (1) where U is the minimum length of the circumscribed curve, in millimetres. a) without detachable hood b) with hood Figure 1 Examples of measurement of maximum diameter of a flexible endoscope Figure 2 Examples of non-circular insertion portion sections2 ISO 2014 All rights reserv
27、edBS ISO 8600-4:2014BS ISO 8600-4:2014ISO 8600-4:2014(E) ISO 2014 All rights reserved ICS 11.040.55 Price based on 2 pagesThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services. BSI is i
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