BS PD ISO TS 18339-2015 Endotherapy devices Eyepiece cap and light guide connector《内疗器械 目镜盖和导光连接器》.pdf

1、BSI Standards Publication Endotherapy devices Eyepiece cap and light guide connector PD ISO/TS 18339:2015National foreword This Published Document is the UK implementation of ISO/TS 18339:2015. The UK participation in its preparation was entrusted to Technical Committee CPW/172, Optics and Photonics

2、. 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 necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI St

3、andards Limited 2015 ISBN 978 0 580 80647 6 ICS 11.040.55 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 November 2015. Amendments/corrigenda issued since

4、 publication Date Text affected PUBLISHED DOCUMENT PD ISO/TS 18339:2015 ISO 2015 Endotherapy devices Eyepiece cap and light guide connector Dispositifs dendothrapie Bouchon doculaire et raccord de guide de lumire TECHNICAL SPECIFICATION ISO/TS 18339 Reference number ISO/TS 18339:2015(E) First editio

5、n 2015-11-01 PD ISO/TS 18339:2015 ISO/TS 18339:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, elec

6、tronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Ver

7、nier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org PD ISO/TS 18339:2015 ISO/TS 18339:2015(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Dimensions . 1 4.1 Eyepiece cap 1 4.1.1 Eyepiece cap with straight

8、 edges . 1 4.1.2 Eyepiece cap with curved edges . 2 4.2 Light guide connector . 3 ISO 2015 All rights reserved iii Contents Page PD ISO/TS 18339:2015 ISO/TS 18339:2015(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO mem

9、ber bodies). The work of preparing International Standards 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, governmen

10、tal and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance

11、 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. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention

12、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 any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/

13、or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity a

14、ssessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 5, Microscopes and endosc

15、opes.iv ISO 2015 All rights reserved PD ISO/TS 18339:2015 ISO/TS 18339:2015(E) Introduction To carry out minimal invasive diagnostic or therapy not only endoscopes are required, but also some additional components like light guide cable, light source, and video-camera. Sometimes these components are

16、 not from the same manufacturer. This Technical Specification is a recommendation to ensure the mechanical compatibility with these components. If items are not from the same manufacturer, this kind of combination might not generate best results, but it allows the user to be able to work. ISO 2015 A

17、ll rights reserved v PD ISO/TS 18339:2015 Endotherapy devices Eyepiece cap and light guide connector IMPORTANT Joint applications of different products are only permissible if the intended use and the relevant technical data are the same (working length, diameter, etc.). Injuries to the patient, use

18、r, or others, as well as damage to the products, are possible if the combination is not correct. 1 Scope This Technical Specification specifies the design of eyepiece cap and light guide connector of an endoscope to enable the combination of products from different manufacturers. The products intend

19、ed only for limited combination are out of the scope. It is a mechanical connection; it might not generate best results, but it allows the user to be able to work. This Technical Specification supports manufacturers of components in the design of interfaces. 2 Normative references The following docu

20、ments, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 2768-1, General toler

21、ances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications ISO 8600-6, Optics and photonics Medical endoscopes and endotherapy devices Part 6: Vocabulary ISO 14971, Medical devices Application of risk management to medical devices 3 T erms a nd definiti ons F

22、or the purposes of this document, the terms and definitions given in ISO 8600-6 and the following apply. 3.1 eyepiece cap part located at the proximal end to which a photographic or video camera can be attached 3.2 light guide connector part located at the proximal end which is designed to allow the

23、 connection of a light guide cable (3.3) 3.3 light guide cable part which connects the endoscope to a light source for transmitting illumination 4 Dimensions 4.1 Eyepiece cap 4.1.1 Eyepiece cap with straight edges If the proximal image output is provided in the form of an eyepiece cap, it shall be d

24、esigned in accordance to the details shown in Figure 1. These are the minimum requirements in terms of shape and design. TECHNICAL SPECIFICATION ISO/TS 18339:2015(E) ISO 2015 All rights reserved 1 PD ISO/TS 18339:2015 ISO/TS 18339:2015(E) Dimensions in millimetres 50 10 +0,1 31,75 0,1 0 Figure 1 Eye

25、piece cap with straight edges 4.1.2 Eyepiece cap with curved edges Even if the eyepiece cap is designed with a radius, it will fit into the dimensions of this Technical Specification. See Figure 2. Dimensions in millimetres R 6,477 31,75 0,1 0 3,39 50 10 10 10 10 10 50 10 R 3,3 31,75 0,1 0 0 4,7 1,7

26、7 a) Form 1 b) Form 2 NOTE This information is provided in order to assure the correct mechanical interface to any kind of camera couplers. Figure 2 Eyepiece cap with radius2 ISO 2015 All rights reserved PD ISO/TS 18339:2015 ISO/TS 18339:2015(E) 4.2 Light guide connector To assure mechanical connect

27、ion of the light guide cable to an endoscope with detachable light guide connector. The design shall be considered in accordance with Figure 3. NOTE For future light guide connectors, only the smaller thread size could be applicable. Dimensions in millimetres M 8,5 0,5 7,55 8,9 12 0,5 a Key a Nut op

28、tional. Figure 3 Light guide connector The tolerance class in Figure 3 should be in accordance with ISO 2768-1. To connect the light guide cable, it can be necessary to use manufacturer specified adapter available on the market. For safety aspects, a risk management shall be carried out in accordanc

29、e with ISO 14971. To achieve optimum light transmission, the fibre bundle diameters of the endoscope and fibre light cable shall match. The instruction manuals of the products used in conjunction with these products shall be considered. The possible consequences if the identification does not match

30、are as follows. The fibre light cables with excessively large fibre bundle diameter (cross-section) cause excessive heating at the coupling point with the endoscope. In the case of unfavourable combinations, temperature increases can occur at the coupling point or at the light exit point of the endo

31、scope. Burns of the patient, user, and others, as well as damage to endoscope, are possible. Reduce the light output or choose a fibre light cable with suitable diameter. The fibre light cables with excessively small fibre bundle diameter (cross-section) cause reduced light output. ISO 2015 All righ

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