BS PD ISO TS 18340-2015 Endoscopes Trocar pins trocar sleeves and endotherapy devices for use with trocar sleeves《内窥镜 与套管针套一起使用的套管针针头 套管针套和内疗器械》.pdf

1、BSI Standards Publication Endoscopes Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves PD ISO/TS 18340:2015National foreword This Published Document is the UK implementation of ISO/TS 18340:2015. The UK participation in its preparation was entrusted to Technical Committ

2、ee 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 necessary provisions of a contract. Users are responsible for its correct application. The British Standards Insti

3、tution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 80648 3 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 31 October 2015. Ame

4、ndments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TS 18340:2015 ISO 2015 Endoscopes Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves Endoscopes Mandrins de trocart, fourreaux de trocart et dispositifs dendothrapie utiliser avec de

5、s fourreaux de trocart TECHNICAL SPECIFICATION ISO/TS 18340 Reference number ISO/TS 18340:2015(E) First edition 2015-10-15 PD ISO/TS 18340:2015ISO/TS 18340:2015(E) ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise sp

6、ecified, 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. Permission can be requested from either ISO at the address below or

7、 ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Te l . + 4 1 2 2 7 4 9 0 1 1 1 Fax +41 22 749 09 47 copyrightiso.org www.iso.org PD ISO/TS 18340:2015 ISO/TS 18340:2015(E)Foreword iv Introduction v 1 Scope . 1 2 N

8、ormative references 1 3 T erms and definitions . 1 4 Dimensions . 2 4.1 General . 2 4.2 Trocar pin and trocar sleeve . 2 4.3 Endotherapy device for use through a trocar sleeve 4 4.4 Endotherapy device with spring handle for use through a trocar sleeve 6 5 Material 7 6 Finish 7 7 Marking 7 Bibliograp

9、hy 8 ISO 2015 All rights reserved iii Contents Page PD ISO/TS 18340:2015ISO/TS 18340:2015(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

10、 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO

11、 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 are described in the ISO/IEC Directives, Part 1. In particular the different

12、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 www.iso.org/directives. Attention is drawn to the possibility that some of the elements of this document may be the su

13、bject 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/or on the ISO list of patent declarations received www.iso.org/patents. Any trade na

14、me 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 assessment, as well as information about ISOs adherence to the WTO principles in the Techni

15、cal 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 endoscopes. iv ISO 2015 All rights reserved PD ISO/TS 18340:2015 ISO/TS 18340:2015(E) Introduc

16、tion This Technical Specification is intended to help manufacturers to produce universal interchangeable reusable trocar sleeves and trocar pins and endotherapy devices which are inserted through these trocar sleeves. ISO 2015 All rights reserved v PD ISO/TS 18340:2015 Endoscopes Trocar pins, trocar

17、 sleeves and endotherapy devices for use with trocar sleeves 1 Scope This Technical Specification specifies the design, testing and labelling of universal interchangeable and reusable trocar sleeves and trocar pins and of endotherapy devices which are inserted through these trocar sleeves. This Tech

18、nical Specification represents the minimum requirements for the production of the products mentioned. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cit

19、ed applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8600-1:2013, Endoscopes Medical endoscopes and endotherapy devices Part 1: General requirements ISO 8600-6, Optics and photonics Medical endoscopes and endotherapy devices Part 6

20、: Vocabulary 3 T erms a nd definiti ons For the purposes of this document, the terms and definitions given in ISO 8600-6 and the following apply. 3.1 trocar endotherapy device consisting of two elements: trocar pin and trocar sleeve to gain internal access and perform endoscopy 3.2 trocar pin endosc

21、opic element with a sharp pyramidal or conical point used to puncture body cavities Note 1 to entry: It is typically assembled and used together with a compatible trocar sleeve filling its lumen, allowing the introduction of this assembly. Following puncture the trocar pin is withdrawn providing a w

22、orking channel into the cavity. 3.3 trocar sleeve endoscopic element used together with trocar pin to create an artificial orifice for puncturing body cavities Note 1 to entry: The trocar sleeve can be made with or without screw thread. 3.4 puncture point tip of a trocar pin Note 1 to entry: Punctur

23、e points can occur in varying designs: conical or pyramidal, sharp or blunt or spiral shape driven. TECHNICAL SPECIFICATION ISO/TS 18340:2015(E) ISO 2015 All rights reserved 1 PD ISO/TS 18340:2015ISO/TS 18340:2015(E) 3.5 distal part different kind of movable jaw parts at the end of an endoscope or a

24、n endotherapy device 3.6 nominal diameter ND diameter mentioned on the label 3.7 minimum inner diameter ID ts inner dimension of a trocar sleeve Note 1 to entry: This minimum inner diameter is comparable to the definition for instrument channel width of an endoscope. 3.8 maximum insertion portion wi

25、dth OD maximum external width of an endoscope or endotherapy device throughout the length of the insertion portion to be inserted Note 1 to entry: The maximum width of any expandable or transformable portion of the insertion portion is not considered as a maximum insertion portion width, such as bal

26、loons, controllable parts, jaws and the like having variable insertion portion widths. Note 2 to entry: See also ISO 8600-6:2005. SOURCE: ISO 8600-1:2013, definition 3.10 4 Dimensions 4.1 General There is a wide range of trocar sleeves as well as endotherapy devices used with trocar sleeves with dif

27、ferent dimensions available. If the nominal diameter of an endotherapy device is smaller than the nominal diameter of the sleeve, the usage of both together is obviously possible without problems. In order to keep the incision small, trocar sleeves and endotherapy devices may have the same nominal d

28、iameter. In this case it is very important to ensure that the endotherapy device can be introduced through the sleeve. Thus, the maximum insertion portion width (OD) of the endotherapy device shall be smaller than the minimum inner diameter (ID ts,min ) of the trocar sleeve. 4.2 Trocar pin and troca

29、r sleeve There is no relation between working length and total length. See Figure 1 and Figure 2. 2 ISO 2015 All rights reserved PD ISO/TS 18340:2015 ISO/TS 18340:2015(E) Key L s,tp shaft length of the trocar pin OD maximum insertion portion width (outer diameter) of trocar pin NOTE Free choice of l

30、ength. Figure 1 Trocar pin Key L tot,ts total length of the trocar sleeve L w,ts working length of the trocar sleeve ID ts inner diameter of the trocar sleeve NOTE Free choice of intermediate sizes. Figure 2 Trocar sleeve without trocar pin (schematic) ISO 2015 All rights reserved 3 PD ISO/TS 18340:

31、2015ISO/TS 18340:2015(E) Key A visible area of the cylindrical part of trocar pin 0 L w,ts working length of the trocar sleeve L s,tp shaft length of the trocar pin NOTE Free choice of intermediate sizes. Figure 3 Trocar sleeve with trocar pin (schematic) If the nominal diameter is 5 mm, the inner d

32、iameter shall be 0,05 mm larger. If the nominal diameter is 5 mm the inner diameter shall be 0,1 mm larger. See Table 1 for details. Table 1 Dimensions Dimensions in millimetres Nominal diameter ND Minimum inner diameter ID ts,min 5 ND + 0,05 5 ND + 0,1 4.3 Endotherapy device for use through a troca

33、r sleeve See Figure 4. 4 ISO 2015 All rights reserved PD ISO/TS 18340:2015 ISO/TS 18340:2015(E) Key 1 distal part OD maximum insertion portion width 2 sheath L w working length 3 handle L S sheath length (length without distal part) 1 and 2 insertion part L tot total length x maximum size with opene

34、d branches L dpc length of closed distal part The sheath length L Sshall be longer than the total length of the trocar sleeve L tot,ts . NOTE Free choice of length. Figure 4 Endotherapy device for use through a trocar sleeve (schematic) Figure 5 Open distal part Due to design of endotherapy devices

35、moving parts may protrude. Sheath length shall not cover them. See Figure 5. The maximum insertion portion width OD of the device shall fit to the minimal inner diameter of the trocar sleeve ID ts, min To ensure the compatibility to a trocar sleeve the maximum insertion portion width shall not be la

36、rger than the nominal diameter. ISO 2015 All rights reserved 5 PD ISO/TS 18340:2015ISO/TS 18340:2015(E) 4.4 Endotherapy device with spring handle for use through a trocar sleeve There are also devices (forceps etc.) with “spring handle” available. These devices have branches without joint, see Figur

37、e 6. In this case the inner part has to be moved forward within the sheath to open the branches, or the sheath has to be moved backwards for opening. This means, the user has to take care of the relative movement of the distal part. Another disadvantage is the maximum opening of the branches, which

38、is smaller compared to the branches with joint. The length of closed branches L b,cis shorter than the length with open branches L b,o . a) Closed 6 ISO 2015 All rights reserved PD ISO/TS 18340:2015 ISO/TS 18340:2015(E) b) Opened Key OD maximum outer diameter of the insertion part L tot,o total leng

39、th of the device, opened L tot,c total length of the device, closed L w,o working length of the device, opened L S,o sheath length, opened L w,c working length of the device, closed L S,c sheath length, closed L b,o length of the branches, opened L b,c length of the branches, closed NOTE L S,o L S,c

40、 ; L tot,o = L tot,c , L = L b,o L b,c Figure 6 Variability of lengths on forceps in closed a) and opened b) state 5 Material Metallic, non-metallic or combination of both materials can be used. The material shall meet the requirements of medical devices. 6 Finish The endotherapy devices shall be fr

41、ee of burrs, pores, cracks, groves and production residues. These requirements shall be proved without visual aids. 7 Marking The marking shall be in accordance with ISO 8600-1:2013, Clause 6. ISO 2015 All rights reserved 7 PD ISO/TS 18340:2015ISO/TS 18340:2015(E) Bibliography 1 ISO 10993 (all parts

42、), Biological evaluation of medical devices 8 ISO 2015 All rights reserved PD ISO/TS 18340:2015This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services. BS

43、I is incorporated by Royal Charter. British Standards and other standardization products are published by BSI Standards Limited. British Standards Institution (BSI) BSI Group Headquarters 389 Chiswick High Road London W4 4AL UK About us We bring together business, industry, government, consumers, in

44、novators and others to shape their combined experience and expertise into standards -based solutions. The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process. Organizations of all sizes and across all sectors choos

45、e standards to help them achieve their goals. Information on standards We can provide you with the knowledge that your organization needs to succeed. Find out more about British Standards by visiting our website at or contacting our Customer Services team or Knowledge Centre. Buying standards You c

46、an buy and download PDF versions of BSI publications, including British and adopted European and international standards, through our website at where hard copies can also be purchased. If you need international and foreign standards from other Standards Development Organizations, hard copies can b

47、e ordered from our Customer Services team. Subscriptions Our range of subscription services are designed to make using standards easier for you. For further information on our subscription products go to With British Standards Online (BSOL) youll have instant access to over 55,000 British and adopt

48、ed European and international standards from your desktop. Its available 24/7 and is refreshed daily so youll always be up to date. You can keep in touch with standards developments and receive substantial discounts on the purchase price of standards, both in single copy and subscription format, by

49、becoming a BSI Subscribing Member. PLUS is an updating service exclusive to BSI Subscribing Members. You will automatically receive the latest hard copy of your standards when theyre revised or replaced. To find out more about becoming a BSI Subscribing Member and the benefits of membership, please visit With a Multi-User Network Licence (MUNL) you are able to host standards publications on your intra