BS ISO 8600-6-2005 Optics and photonics - Medical endoscopes and endotherapy devices - Vocabulary《光学和光子学 医用内窥镜和内疗器件 词汇表》.pdf

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1、BRITISH STANDARD BS ISO 8600-6:2005 Optics and photonics Medical endoscopes and endotherapy devices Part 6: Vocabulary ICS 01.040.37; 11.040.55; 37.020 BS ISO 8600-6:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 24 August 2005 BSI 24 A

2、ugust 2005 ISBN 0 580 46291 9 National foreword This British Standard reproduces verbatim ISO 8600-6:2005 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee LBI/33, Microscopes, which has the responsibility to: A list of organi

3、zations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index

4、”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confe

5、r immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate th

6、em in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments pages ii and iii, a blank page,

7、 pages 1 to 7 and a back cover. Reference number ISO 8600-6:2005(E)INTERNATIONAL STANDARD ISO 8600-6 First edition 2005-03-15 Optics and photonics Medical endoscopes and endotherapy devices Part 6: Vocabulary Optique et photonique Endoscopes mdicaux et dispositifs dendothrapie Partie 6: Vocabulaire

8、BS ISO 8600-6:2005ii iiiForeword 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 interested in

9、 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 Commiss

10、ion (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 technical

11、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 shall

12、not be held responsible for identifying any or all such patent rights. ISO 8600-6 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 Optics and photonics Medical endosc

13、opes 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 resol

14、ution of rigid endoscopes with optics Part 6: Vocabulary BS ISO 8600-6:2005blank 1Optics and photonics Medical endoscopes and endotherapy devices Part 6: Vocabulary Scope This part of ISO 8600 defines terms for endoscopes and endotherapy devices commonly used in the endoscopic area. 1 Types of endos

15、copes 1.1 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 Endoscopes may be of rigid or flexible type; all types may have different image pick-up

16、 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 IEC 60601-2-18 deals with electrical safety aspects of endoscopic systems and therefore the endoscope is regarded as an applied part of medical

17、 electrical equipment introduced into a patient. In IEC 60601-2-18:1996, the endoscope is defined as the “applied part of medical electrical equipment introduced into a patient to provide an internal view or image for examination, diagnosis and/or therapy”. 1.2 fiberscope endoscope (1.1) in which th

18、e image is transmitted via a fibre bundle 1.3 rigid endoscope endotherapy device endoscope (1.1) endotherapy device (4.1) whose insertion portion is intended to be unyielding to natural or surgically-created body cavities or instrument channels 1.4 flexible endoscope endotherapy device endoscope (1.

19、1) endotherapy device (4.1) whose insertion portion is intended to conform to natural or surgically-created body cavities or instrument channels 1.5 video endoscope endoscope (1.1) in which the image is transmitted by a solid state imaging device 1.6 ultrasonic endoscope ultrasound endoscope endosco

20、pe (1.1) with an electro-acoustical image pick-up system BS ISO 8600-6:20052 1.7 telescope rigid optical device for endoscopic imaging 1.8 rigid bronchoscope open straight tube-type rigid endoscope (1.3) fitted with a means of illumination through the distal end and intended to be introduced into th

21、e tracheobronchial airway, having an internal lumen sufficiently large to permit free respiration of the patient ISO 8600-2:2002 1.9 rigid ventilation bronchoscope rigid bronchoscope (1.8) fitted with a removable end-cap at the proximal end of the open straight tube and having an internal lumen suff

22、iciently large to permit ventilation of the patient through an integral ventilation connector ISO 8600-2:2002 1.10 rigid jet-ventilation bronchoscope rigid bronchoscope (1.8) provided with a jet-injector ISO 8600-2:2002 2 Optical specifications 2.1 field of view size of the object field viewed throu

23、gh an optical endoscope (1.1), expressed as the vertex angle (in degrees) of the cone whose vertex is at the distal window surface of the endoscope See Figure 1. NOTE The field of view is not appropriate when the endoscope is intended to be in contact with the object. Key 1 central axis of field of

24、view 2 field of view 3 distal window surface of endoscope Figure 1 Field of view BS ISO 8600-6:2005 32.2 direction of view location of the centre of the object field relative to the normal axis of the endoscope (1.1), expressed as the angle (in degrees) between the normal axis of the endoscope (0) a

25、nd the central axis of the field of view (2.1) See Figure 2. Key 1 endoscope normal axis 2 direction of view 3 central axis of field of view Figure 2 Direction of view 2.3 forward-viewing type of endoscope (1.1) having a 0 direction of view (2.2) NOTE The term “end viewing” is used in IEC 60601-2-18

26、. 2.4 forward oblique viewing fore-oblique side-viewing with forward view type of endoscope (1.1) having a direction of view (2.2) larger than 0 and less than 90 2.5 side-viewing type of an endoscope (1.1) having a 90 direction of view (2.2) 2.6 retro-viewing backward side-viewing side-viewing with

27、retro-view type of endoscope (1.1) having a direction of view (2.2) larger than 90 BS ISO 8600-6:20054 3 Portions of endoscopes 3.1 French F rCharrire measure of the size of certain circular or non-circular cross-section endoscopes (1.1) defined as: F r= 3u/ where u is the perimeter of the cross-sec

28、tion, expressed in millimetres 3.2 distal, adj any location of that portion of an endoscope (1.1) or endotherapy device (4.1) which is farther from the user than some referenced point 3.3 proximal, adj any location of that portion of an endoscope (1.1) or endotherapy device (4.1) which is closer to

29、user than some referenced point 3.4 instrument channel portion of an endoscope (1.1) or endotherapy device (4.1) through which an endoscope or an endotherapy device is intended to pass 3.5 insertion portion insertion tube that portion of an endoscope (1.1) or endotherapy device (4.1) which is intend

30、ed to be inserted into a natural or surgically-created body opening or which is intended to be inserted into the instrument channel (3.4) of an endoscope or endotherapy device NOTE ISO 8600-1: only defines “insertion portion”. 3.6 maximum insertion portion width maximum external width of an endoscop

31、e (1.1) or endotherapy device (4.1) throughout the length of the insertion portion (3.5) 3.7 minimum instrument channel width minimum internal width of an instrument channel (3.4) 3.8 working length maximum length of the insertion portion (3.5) 3.9 controllable portion that part of the insertion por

32、tion (3.5) of an endoscope (1.1) or endotherapy device (4.1) whose motion is intended to be remotely controlled by the user 3.10 air/water nozzle air/water feed nozzle nozzle that part of the distal (3.2) end for feeding air or water BS ISO 8600-6:2005 53.11 angulation range bending capability tip d

33、eflection bending range angle (in degrees) between the normal axis of the endoscope (1.1) (0) and the central axis of the deflected distal (3.2) end 3.12 flexible portion flexible section that part of the insertion portion (3.5) of a flexible endoscope (1.4) excluding the distal (3.2) end and bendin

34、g section 3.13 light guide cord light guide (or umbilical) cable light guide flexible section that part of an endoscope (1.1) which connects to a light source for transmitting illumination 3.14 eyepiece that part of an endoscope (1.1) located at its proximal (3.3) end through which an image can be o

35、bserved or to which a photographic or video camera can be attached 3.15 end-cap removable fitting at the proximal (3.3) end of a rigid ventilation bronchoscope (1.9) to seal its lumen ISO 8600-2:2002 3.16 working element handle element which secures an endotherapy device (4.1) and connects it to a s

36、heath (4.2) which, when operated, moves the device backwards and forwards 3.17 bridge element which connects a telescope (1.7) to a sheath (4.2) 3.18 ventilation connector breathing system connector integral part of a rigid ventilation bronchoscope (1.9) that permits connection to a breathing system

37、 of an anaesthetic or breathing machine ISO 8600-2:2002 3.19 jet-injector narrow-lumen tubular device utilizing compressed gases (often using the Venturi principle) to provide intermittent positive gas pressure to the lungs of a patient ISO 8600-2:2002 3.20 jet ventilation providing inflation of the

38、 lungs by intermittent release of compressed gases by means of a jet-injector within or towards the trachea and/or bronchi of a patient BS ISO 8600-6:20056 ISO 8600-2:2002 4 Endotherapy devices 4.1 endotherapy device medical device intended to be inserted into a natural or surgically-created body op

39、ening during endoscopic procedures, whether through the same or a different orifice from the endoscope (1.1) for examination, diagnosis or therapy NOTE 1 Endotherapy devices include the instrument through which an endoscope or endotherapy device is inserted, such as a guide tube, trocar tube or slid

40、ing tube, etc. Endotherapy devices include the devices to be inserted through the openings other than the opening for an endoscope, to ensure the safety of the devices for the intended use under the endoscopic view. NOTE 2 The term “endoscopically-used accessory” is used in 2.1.102 of IEC 60601-2-18

41、:1996. 4.2 sheath outer insertion tube for guiding a telescope (1.7) or an endotherapy device (4.1) 4.3 obturator mandrin element inserted into a sheath (4.2) having a distal (3.2) profile such that it minimizes any risk of trauma during insertion into a body cavity BS ISO 8600-6:2005 7Bibliography

42、1 ISO 8600-1: 1) , Optics and photonics Medical endoscopes and endotherapy devices Part 1: General requirements 2 ISO 8600-2:2002, Optics and optical instruments Medical endoscopes and endoscopic accessories Part 2: Particular requirements for rigid bronchoscopes 3 IEC 60601-2-18:1996, Medical elect

43、rical equipment Part 2: Particular requirements for the safety of endoscopic equipment 1) To be published. (Revision of ISO 8600-1:1997) BS ISO 8600-6:2005BS ISO 8600-6:2005 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible fo

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