BS ISO 8600-1-2015 Endoscopes Medical endoscopes and endotherapy devices General requirements《内窥镜 医用内窥镜和内疗器件 通用要求》.pdf

1、BSI Standards Publication BS ISO 8600-1:2015 Endoscopes Medical endoscopes and endotherapy devices Part 1: General requirementsBS ISO 8600-1:2015 BRITISH STANDARD National foreword This British Standard is the UK implementation of ISO 8600-1:2015. It supersedes BS ISO 8600-1:2013 which is withdrawn.

2、 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 provisions of a contract. Use

3、rs are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 88294 4 ICS 11.040.55 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authori

4、ty of the Standards Policy and Strategy Committee on 31 October 2015. Amendments/corrigenda issued since publication Date T e x t a f f e c t e dBS ISO 8600-1:2015 ISO 2015 Endoscopes Medical endoscopes and endotherapy devices Part 1: General requirements Endoscopes Endoscopes mdicaux et dispositifs

5、 dendothrapie Partie 1: Exigences gnrales INTERNATIONAL STANDARD ISO 8600-1 Fourth edition 2015-10-15 Reference number ISO 8600-1:2015(E)BS ISO 8600-1:2015ISO 8600-1:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless oth

6、erwise 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 be requested from either ISO at the address

7、 below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgBS ISO 8600-1:2015ISO 8600-1:2015(E)Foreword iv 1 Scope . 1 2 Normative references 1

8、 3 T erms and definitions . 1 4 Requirements 5 4.1 General . 5 4.2 Surface and edges . 5 4.3 Maximum insertion portion width 5 4.4 Minimum instrument channel width . 5 4.5 Field of view 5 4.6 Direction of view . 5 4.7 Safety . 6 4.8 Biological compatibility. 6 4.9 Fittings/connectors for liquid or g

9、aseous media 6 4.10 Deflection control system for the controllable portion . 6 4.10.1 General 6 4.10.2 Deflection up and down . 6 4.10.3 Deflection right and left . 6 4.10.4 Arrangement of the hand wheels 6 4.10.5 Maximum angle of deflection 7 5 Testing . 7 5.1 General . 7 5.2 Surface and edges . 7

10、5.3 Maximum insertion portion width 7 5.4 Minimum instrument channel width . 8 5.5 Field of view 8 5.6 Direction of view . 8 6 Marking 8 6.1 Minimum marking . 8 6.2 Marking legibility 9 6.3 Marking exceptions . 9 7 Instruction manual 9 8 Packaging 10 Annex A (informative) Guidelines on the applicati

11、on of risk management to endoscopic system connector 11 Bibliography .13 ISO 2015 All rights reserved iii Contents PageBS ISO 8600-1:2015ISO 8600-1:2015(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). Th

12、e 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, governmental and non-gov

13、ernmental, 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 are described

14、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 is drawn to the

15、 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/or on the ISO l

16、ist 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 assessment, as w

17、ell 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 endoscopes. This fou

18、rth edition cancels and replaces the third edition (ISO 8600-1:2013), of which it constitutes a minor revision in order to update the definition and the corresponding Figure 1 for the term “field of view”. ISO 8600 consists of the following parts, under the general title Endoscopes Medical endoscope

19、s 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 insertion portion Part 5: Determination of optical resoluti

20、on 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 8600-1:2015INTERNATIONAL ST ANDARD ISO 8600-1:2015(E) Endoscopes Medical endoscopes and endotherapy devices Part 1: General requirement

21、s 1 Scope This part of ISO 8600 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its applicat

22、ion. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 86003, Optics and optical instruments Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and dire

23、ction of view of endoscopes with optics ISO 86004, Endoscopes Medical endoscopes and endotherapy devices Part 4: Determination of maximum width of insertion portion ISO 109931, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 14971, Medical

24、 devices Application of risk management to medical devices IEC 60601218, Medical electric equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment 3 T erms a nd definiti ons For the purposes of this document, the following terms and definiti

25、ons apply. 3.1 endoscope medical instrument having viewing means, with or without optics, introduced into a body cavity through a natural or surgically created body opening for examination, diagnosis, or therapy Note 1 to entry: Endoscopes may be of rigid or flexible type; all types may have differe

26、nt image pick-up systems (e.g. via lenses or ultrasonic sensors) and different image-transmitting systems (e.g. optical, via lenses, or fibre bundles, or electrical). Note 2 to entry: See also ISO 8600-6. ISO 2015 All rights reserved 1BS ISO 8600-1:2015ISO 8600-1:2015(E) 3.2 endotherapy device medic

27、al device intended to be inserted into a natural or surgically created body opening during endoscopic procedures, whether through the same or a different orifice from the endoscope (3.1) for examination, diagnosis, or therapy Note 1 to entry: Endotherapy devices include the instrument to create the

28、body opening and through which an endoscope (3.1) or endotherapy device is inserted, such as a guide tube, trocar pin, trocar sleeve, or sliding tube. Endotherapy devices include the devices to be inserted through the openings other than the opening for an endoscope (3.1), to ensure the safety of th

29、e devices for the intended use under the endoscopic view. Note 2 to entry: See also ISO 8600-6. 3.3 rigid endoscope (endotherapy device) endoscope (3.1) or endotherapy device (3.2) whose insertion portion is intended to be unyielding to natural or surgically created body cavities or instrument chann

30、els (3.8) Note 1 to entry: See also ISO 8600-6. 3.4 f le x ible endo s c op e ( endot her apy dev ic e ) endoscope (3.1) or endotherapy device (3.2) whose insertion portion is intended to conform to natural or surgically created body cavities or instrument channels (3.8) Note 1 to entry: See also IS

31、O 8600-6. 3.5 French Charrire Fr measure of the size of certain circular or non-circular cross-section endoscopes defined as 3 whereu is the perimeter of the cross-section, expressed in millimetres Note 1 to entry: See also ISO 8600-6. 3.6 distal any location of that portion of an endoscope (3.1) or

32、 endotherapy device (3.2) which is farther from the user than some referenced point Note 1 to entry: See also ISO 8600-6. 3.7 proximal any location of that portion of an endoscope (3.1) or endotherapy device (3.2) which is closer to the user than some referenced point Note 1 to entry: See also ISO 8

33、600-6. 3.8 instrument channel portion of an endoscope (3.1) or endotherapy device (3.2) through which an endoscope or an endotherapy device is intended to pass Note 1 to entry: See also ISO 8600-6.2 ISO 2015 All rights reservedBS ISO 8600-1:2015ISO 8600-1:2015(E) 3.9 insertion portion insertion tube

34、 portion of an endoscope (3.1) or endotherapy device (3.2) which is intended to be inserted into a natural or surgically created body opening or which is intended to be inserted into the instrument channel (3.8) of an endoscope (3.1) or endotherapy device Note 1 to entry: See also ISO 8600-6. 3.10 m

35、aximum insertion portion width maximum external width of an endoscope (3.1) or endotherapy device (3.2) throughout the length of the insertion portion (3.9) 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 ma

36、ximum insertion portion width, such as balloons, controllable parts, jaws and the like having variable insertion portion widths. Note 2 to entry: See also ISO 8600-6. 3.11 minimum instrument channel width minimum internal width of an instrument channel (3.8) Note 1 to entry: See also ISO 8600-6. 3.1

37、2 working length length of the insertion portion (3.9) stated in the instruction manual Note 1 to entry: See also ISO 8600-6. 3.13 f ie ld of v iew view of an endoscope (3.1) with optics as stated by the manufacturer or distributor Note 1 to entry: The field of view is not appropriate when the endos

38、cope is intended to be in contact with the object. Note 2 to entry: For non-circular images, the field of view may be the largest visible circle. Note 3 to entry: See Figure 1. Note 4 to entry: See also ISO 8600-6. ISO 2015 All rights reserved 3BS ISO 8600-1:2015ISO 8600-1:2015(E) Key 1 field of vie

39、w 2 visible area of a circular image 3 visible area of a non-circular image 4 non-visible area of a non-circular image Figure 1 Field of view 3.14 direction of view location of the centre of the object field relative to the normal axis of the endoscope (3.1), expressed as the angle (in degrees) betw

40、een the normal axis of the endoscope (0) and the central axis of the field of view (3.13) Note 1 to entry: See Figure 2. Note 2 to entry: See also ISO 8600-6. 12 3 Key 1 endoscope normal axis 2 direction of view 3 central axis of field of view Figure 2 Direction of view 3.15 controllable portion par

41、t of the insertion portion (3.9) of an endoscope (3.1) or endotherapy device (3.2) whose motion is intended to be remotely controlled by the user Note 1 to entry: See also ISO 8600-6. 3.16 f i t t i n g / c o n n e c t o r f o r l i q u i d o r g a s e o u s m e d i a port for input/injection or out

42、put/suction of liquid or gaseous media on endoscopes (3.1) or endotherapy devices (3.2)4 ISO 2015 All rights reservedBS ISO 8600-1:2015ISO 8600-1:2015(E) 3.17 a n g l e o f d e f l e c t i o n angle between the centre line of the straightened insertion portion (3.9) and the centre line of the deflec

43、ted distal (3.6) tip when deflection control system is operated Note 1 to entry: See Figure 3. Key angle of deflection F i g u r e 3 A n g l e o f d e f l e c t i o n 4 Requirements 4.1 General Design and construction of endoscopes and endotherapy devices shall comply with the following requirements

44、. 4.2 Surface and edges Endoscopes and endotherapy devices shall be designed in such a way that their intended use will not lead to any unintentional injuries. The surfaces of all endoscopes and endotherapy devices shall be free of pores, cracks, and remainders of tooling agents. 4.3 Maximum inserti

45、on portion width The maximum insertion portion width shall not be larger than that stated in the instruction manual see Clause 7 e) 3). 4.4 Minimum instrument channel width The minimum instrument channel width shall not be smaller than that stated in the instruction manual see Clause 7 e) 4). 4.5 Fi

46、eld of view If not otherwise specified by the manufacturer, the deviation of the field of view of an endoscope with optics from the value stated by the manufacturer or distributor shall not be greater than 15 %. 4.6 Direction of view If not otherwise specified by the manufacturer, the deviation of t

47、he direction of view of a rigid endoscope with optics from the value stated in the instruction manual shall not be greater than 10. ISO 2015 All rights reserved 5BS ISO 8600-1:2015ISO 8600-1:2015(E) 4.7 Safety Endoscopes and endotherapy devices shall conform to IEC 60601-2-18. 4.8 Biological compati

48、bility Materials used for the outer surface of the insertion portion shall be evaluated for biological compatibility in accordance with ISO 10993-1. 4.9 Fittings/c onnect or s for liquid or g aseous m edia Depending on their utilization, endoscopes and endotherapy devices shall be provided with fitt

49、ings for input or output of liquid or gaseous media. The manufacturer of endoscopes and endotherapy devices shall carry out a risk management procedure in accordance with ISO 14971 to consider the probability of misconnection of medical devices intended for connection to endoscopes or endotherapy devices to non-endoscopic patient connections (e.g. intravenous applications). The purpose of a risk management procedure is to assess both the physical possibility of a misconnec