1、BSI Standards Publication BS ISO 8600-2:2015 Endoscopes - Medical endoscopes and endotherapy devices Part 2: Particular requirements for rigid bronchoscopesBS ISO 8600-2:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of ISO 8600-2:2015. It supersedes BS ISO 86
2、00-2:2002 which is withdrawn.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 necessary
3、provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 85854 3 ICS 11.040.55 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard wa
4、s published under the authority of the Standards Policy and Strategy Committee on 30 April 2015. Amendments issued since publication Date Text affectedBS ISO 8600-2:2015 ISO 2015 Endoscopes - Medical endoscopes and endotherapy devices Part 2: Particular requirements for rigid bronchoscopes Endoscope
5、s - Endoscopes mdicaux et dispositifs dendothrapie Partie 2: Exigences particulires pour bronchoscopes rigides INTERNATIONAL STANDARD ISO 8600-2 Second edition 2015-04-01 Reference number ISO 8600-2:2015(E)BS ISO 8600-2:2015ISO 8600-2:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUME
6、NT ISO 2015 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. Permission can
7、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 8600-2:2015ISO 8600-2:2015
8、(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Requirements 2 4.1 General . 2 4.2 Dimensions . 2 4.2.1 Working length 2 4.2.2 Total length . 2 4.2.3 Maximum insertion portion width . 2 4.3 Rigid ventilation bronchoscopes . 3 4.4 Rigid jet-ventilatio
9、n bronchoscopes 3 4.5 Side apertures 3 5 Testing . 7 5.1 General . 7 5.2 Test method for pressure drop . 7 5.2.1 Purpose 7 5.2.2 Apparatus . 7 5.2.3 Procedure . 8 5.2.4 Expression of results 8 5.3 Test method for security of attachment of a jet-injector to the rigid bronchoscope 9 5.3.1 Purpose 9 5.
10、3.2 Apparatus . 9 5.3.3 Procedure . 9 5.3.4 Expression of results .10 5.4 Test method for container pressure with an open-ended jet-injector bronchoscope .10 5.4.1 Purpose .10 5.4.2 Apparatus 10 5.4.3 Procedure 10 5.4.4 Expression of results .10 5.5 Test method for minimum instrument channel width 1
11、1 5.5.1 Purpose .11 5.5.2 Apparatus 11 5.5.3 Procedure 11 5.5.4 Expression of results .12 6 Marking .12 7 Instruction manual .12 8 Packaging 12 Annex A (informative) Rationale .13 Bibliography .15 ISO 2015 All rights reserved iii Contents PageBS ISO 8600-2:2015ISO 8600-2:2015(E) Foreword ISO (the In
12、ternational 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 for which a technical committee h
13、as 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 all matters of electrotechnical
14、 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. This document was drafted in a
15、ccordance 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 any or all such patent rights. De
16、tails 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 (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
17、 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 Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information. The committee
18、 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 8600-2:2002), of which it constitutes a minor revision. ISO 8600 consists of the following parts, under the general title
19、 Endoscopes Medical endoscopes and endoscopic accessories: 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: D
20、etermination of optical resolution of rigid endoscopes with optics Part 6: Vocabulary Part 7: Basic requirements for medical endoscopes of water-resistant typeiv ISO 2015 All rights reservedBS ISO 8600-2:2015ISO 8600-2:2015(E) Introduction Rigid bronchoscopes need to serve three simultaneous functio
21、ns during endoscopic procedures as an endoscope with distal illumination to allow visualization of the larynx, trachea and bronchi, and views into the bronchial trees, as a sheath for a flexible or rigid endoscope, aspirator (suction channel), biopsy forceps, scissors, etc., and as a gas passage (ai
22、rway) for the terminal part of an anaesthesia ventilation system or the upper respiratory tract. Rigid bronchoscopes, therefore, are to have sufficiently large channels with low gas-flow resistance and an adequate gas supply from the breathing system of an anaesthetic and/or breathing machine, or fr
23、om compressed air/oxygen gas sources. Particular attention therefore is paid to the life-sustaining ventilatory aspects of this part of ISO 8600. Ideally, all rigid bronchoscopes are to be usable to ventilate the patient whenever clinically necessary either under general anaesthesia or not, by means
24、 of a ventilation connector and an end-cap for assisted/controlled ventilation or by means of a jet-injector for intermittent jet ventilation. In addition to the general features of rigid bronchoscopes, the ventilatory aspects of both rigid ventilation bronchoscopes and rigid jet-ventilation broncho
25、scopes are especially included in this part of ISO 8600. Test methods other than those specified in this part of ISO 8600, but of equal or greater accuracy, may be used to verify compliance with the given requirements. However, in the event of a dispute, the methods specified in this part of ISO 860
26、0 are to be used as the reference methods. A rationale for the most important requirements is given in Annex A. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this part of ISO 8600, but will expedite any subsequent revision. ISO
27、 2015 All rights reserved vBS ISO 8600-2:2015BS ISO 8600-2:2015Endoscopes - Medical endoscopes and endotherapy devices Part 2: Particular requirements for rigid bronchoscopes 1 Scope This part of ISO 8600 specifies requirements for rigid bronchoscopes and their endoscopic accessories used in the pra
28、ctice of anaesthesia and medical endoscopy. 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 cited applies. For undated references, the latest edition of
29、the referenced document (including any amendments) applies. ISO 5356-1:1996, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ISO 8600-1:2013, Endoscopes Medical endoscopes and endotherapy devices Part 1: General requirements 3 T erms a nd definiti ons For the purpo
30、ses of this document, the terms and definitions given in ISO 8600-1 and the following apply. 3.1 rigid bronchoscope open straight tube-type rigid endoscope fitted with a means of illumination through the distal end and intended to be introduced into the tracheobronchial airway, having an internal lu
31、men sufficiently large to permit free respiration of the patient 3.2 rigid ventilation bronchoscope rigid bronchoscope, fitted with a removable end-cap at the proximal end of the open straight tube and having an internal lumen sufficiently large to permit ventilation of the patient through an integr
32、al ventilation connector 3.3 rigid jet ventilation bronchoscope rigid bronchoscope provided with a jet-injector Note 1 to entry: Rigid bronchoscopes provided with only a gas nipple should not be included within the category of jet-ventilation bronchoscopes, because the Venturi principle does not nec
33、essarily function sufficiently to ventilate the patient. 3.4 ventilation connector breathing system connector integral part of a rigid-ventilation bronchoscope that permits connection to a breathing system of an anaesthetic or breathing machine INTERNATIONAL ST ANDARD ISO 8600-2:2015(E) ISO 2015 All
34、 rights reserved 1BS ISO 8600-2:2015ISO 8600-2:2015(E) 3.5 end-cap removable fitting at the proximal end of a rigid-ventilation bronchoscope to seal its lumen 3.6 jet-injector narrow-lumen tubular device utilizing compressed gases (often using the Venturi principle) to provide intermittent positive
35、gas pressure to the lungs of a patient Note 1 to entry: Gases selected may include air, oxygen and/or other gases. 3.7 jet ventilation artificial inflation of the lungs by intermittent release of compressed gases by means of a jet-injector within or towards the trachea and bronchi of a patient 3.8 m
36、aximum insertion portion width 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 po
37、rtion width, such as balloons, controllable parts, jaws and the like having variable insertion portion widths. Note 2 to entry: See also ISO 8600-6. SOURCE: ISO 8600-1:2013, definition 3.10 3.9 total length distance between the proximal and distal ends of a rigid bronchoscope 4 Requirements 4.1 Gene
38、ral Rigid bronchoscopes shall comply with the requirements specified in ISO 8600-1. In addition, rigid bronchoscopes shall also comply with the requirements specified in 4.2 and 4.5; rigid-ventilation bronchoscopes shall also comply with the requirements specified in 4.3 and rigid jet-ventilation br
39、onchoscopes shall also comply with the requirements specified in 4.4. 4.2 Dimensions 4.2.1 Working length The actual working length of a rigid bronchoscope shall be at least as long as, and not more than, 10 mm longer than the working length stated in the instructions for use provided by the manufac
40、turer. 4.2.2 Total length The total length shall be in the range 10 mm to the length stated in instructions for use. 4.2.3 Maximum insertion portion width The maximum insertion portion width shall be in the range 1 mm stated in the instructions for use provided by the manufacturer.2 ISO 2015 All rig
41、hts reservedBS ISO 8600-2:2015ISO 8600-2:2015(E) 4.3 Rigid ventilation bronchoscopes 4.3.1 A rigid ventilation bronchoscope shall be provided with an integral ventilation connector and an end-cap at its proximal end. Provision shall be made for insertion of endoscopes and endoscopic accessories thro
42、ugh the end-cap. The end-cap shall not accidentally detach at an airway pressure of less than 4,0 kPa (40 cmH 2 O). An end-cap may incorporate a transparent window and/or may permit the insertion of an endoscope or endoscopic accessory through the opening or an airtight gasket. Removal or opening of
43、 the end-cap for accessory insertion may be achieved by the detachment, rotation or sliding of the end-cap. 4.3.2 A rigid ventilation bronchoscope shall be provided, in a side-arm, either with an integral ventilation connector or shall be provided with a detachable adapter which shall meet the requi
44、rements for 15 mm male conical connectors specified in ISO 5356-1 (see Figure 1). This shall not be a connector in which the internal lumen has been reduced. The ventilation connector, when fitted to the rigid ventilation bronchoscope, shall permit to-and-fro ventilation of the patient. Adding a sma
45、ller connector to a 15 mm adapter creates a low dead-space connector. Users should be aware of the danger of using two connected low dead-space connectors, which may cause excessive flow resistance. A ventilation connector may be located at either side of the rigid bronchoscope (see Figure 1) and ma
46、y swivel around the shaft of the rigid bronchoscope. 4.4 Rigid jet-ventilation bronchoscopes 4.4.1 Rigid jet-ventilation bronchoscopes shall be provided with a jet-injector intended for jet ventilation. Jet ventilation through a rigid bronchoscope is usually possible without a separate jet-injector
47、port. Figure 2 gives examples of different bronchoscopes where jet injection is possible. 4.4.2 When tested in accordance with 5.3, a jet-injector supplied with a bronchoscope shall withstand a minimum force of 20 N without becoming detached. 4.4.3 When tested in accordance with 5.4, the container p
48、ressure generated by a rigid jet-ventilation bronchoscope with any jet-injector provided by the manufacturer shall not exceed 6,0 kPa (60 cmH 2 O). If the bronchoscopist uses jet-injectors other than those provided by the manufacturer, he/she is responsible for its function and performance. The vent
49、ilation pressure developed by any jet-injector depends on the characteristics of the bronchoscope with which it is used or tested. Users should be aware that ventilation pressure can be greatly increased by insertion of any obstruction, e.g. an aspirator or forceps, into the lumen of the rigid bronchoscope. 4.5 Side apertures 4.5.1 Side apertures, if provided, shall be located on the rigid bronchoscope no closer than 5 % of the working length from the distal tip. 4.5.2 The minimum total area of the side apertures s
