1、raising standards worldwide NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BSI Standards Publication BS ISO 8600-7:2012 Endoscopes Medical endoscopes and endotherapy devices Part 7: Basic requirements for medical endoscopes of water-resistant typeBS ISO 8600-7:2012 BRITISH ST
2、ANDARD National foreword This British Standard is the UK implementation of ISO 8600-7:2012. 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. T
3、his publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012 ISBN 978 0 580 71633 1 ICS 11.040.55 Compliance with a British Standard cannot co
4、nfer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2012. Amendments issued since publication Date T e x t a f f e c t e dBS ISO 8600-7:2012 ISO 2012 Endoscopes Medical endoscopes and endotherapy de
5、vices Part 7: Basic requirements for medical endoscopes of water-resistant type Endoscopes Endoscopes mdicaux et dispositifs dendothrapie Partie 7: Exigences de base pour les endoscopes mdicaux rsistants leau INTERNATIONAL STANDARD ISO 8600-7 First edition 2012-07-15 Reference number ISO 8600-7:2012
6、(E)BS ISO 8600-7:2012ISO 8600-7:2012(E) ii ISO 2012 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2012 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 m
7、icrofilm, without permission in writing 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
8、 8600-7:2012ISO 8600-7:2012(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 intere
9、sted 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
10、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 committees is to prepare International Standards. Draft International Standards adopted by the tec
11、hnical 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 possibility that some of the elements of this document may be the subject of patent rights. ISO
12、 shall not be held responsible for identifying any or all such patent rights. ISO 8600-7 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 5, Microscopes and endoscopes. ISO 8600 consists of the following parts, under the general title Endoscopes Medical endoscope
13、s and endotherapy devices 1) : 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 insertion portion Part 5: Determination of optical reso
14、lution of rigid endoscopes with optics Part 6: Vocabulary Part 7: Basic requirements for medical endoscopes of water-resistant type 1) This title will be used uniformly after the systematic review of all parts of ISO 8600. At present, Parts 1, 5 and 6 have the title Optics and photonics Medical endo
15、scopes and endotherapy devices, Parts 2 and 3 have the title Optics and optical instruments Medical endoscopes and endoscopic accessories and Part 4 has the title Optics and optical instruments Medical endoscopes and certain accessories. ISO 2012 All rights reserved iiiBS ISO 8600-7:2012BS ISO 8600-
16、7:2012Endoscopes Medical endoscopes and endotherapy devices Part 7: Basic requirements for medical endoscopes of water- resistant type 1 Scope This part of ISO 8600 specifies requirements for medical endoscopes, either flexible or rigid with a bending section, of water-resistant type. 2 Requirement
17、Endoscopes of water-resistant type shall demonstrate resistance to air leakage when a positive pressure of at least 20 kPa is applied to the inside of the endoscope enclosure. 3 Testing The endoscope of water-resistant type shall be completely submerged in water and a positive pressure applied to th
18、e inside of the endoscope enclosure as specified in Clause 4. While the endoscope is submerged in water for no less than 1 min, with a positive pressure applied to the inside of the endoscope enclosure, a steady stream of air bubbles from a single part of the endoscope enclosure or channel opening s
19、hall not be seen with the naked eye. Those air bubbles attached by surface tension to the external surface of the endoscope, or air trapped in an internal channel when the endoscope is submerged in water, should be disregarded. Endoscopes to be tested shall be placed in the water in an appropriate c
20、onfiguration such that any leaked air accumulating inside a channel tube could not be trapped in a bowed section of the channel tube and thereby escape detection. Depending on the diameter and length of the channel tube, it may be necessary to increase the pressurization time beyond 1 min in order t
21、o observe leaked air accumulating within a channel tube. When an endoscope has electric connecting points on its surface, as in the case of video endoscopes and ultrasonic endoscopes, those parts unable to ensure water-resistance alone may be tested by taking measures such as mounting water-resistan
22、t caps. 4 Test conditions The test conditions shall be as follows: a) Temperature: any temperature between 10 C and 40 C; b) Pressure difference: not less than 20 kPa; c) Immersion depth: any depth that allows complete immersion of the endoscope; d) Pressure time: not less than 1 min. INTERNATIONAL
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