ASTM F1218-1989(1999) Standard Specification for Bronchoscopes (Rigid)《支气管镜(硬质的)》.pdf

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1、Designation: F 1218 89 (Reapproved 1999)Standard Specification forBronchoscopes (Rigid)1This standard is issued under the fixed designation F 1218; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number

2、 in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers definitions and requirementsfor rigid bronchoscopes and certain bronchoscopic accessoriesused in the practice of m

3、edicine.2. Referenced Documents2.1 ASTM Standards:F 1054 Specification for Conical Fittings of 15 mm and 22mm Sizes23. Terminology3.1 Definitions:3.1.1 bronchoscopes (rigid)a medical instrument havingviewing means, with or without optics, introduced into thelarynx or tracheobronchial airway, or both

4、, through a natural orsurgically created body opening for examination, diagnosis, ortherapy, and intended to be unyielding to natural or surgicallycreated body cavities.3.1.2 optical endoscopea medical instrument with optics,having viewing means, which may be introduced into a bodycavity through a b

5、ronchoscope, or through a naturally orsurgically created body opening for examination, diagnosis, ortherapy. An optical endoscope may be of rigid or flexibledesign.3.1.3 endoscopic accessorya medical instrument insertedthrough a bronchoscope for diagnosis or therapy.3.1.3.1 rigid accessoryan accesso

6、ry whose insertion por-tion is intended to be unyielding to natural or surgically createdbody cavities or instrument lumens.3.1.3.2 flexible accessoryan accessory whose insertionportion is intended to conform to natural or surgically createdbody cavities or instrument lumens.3.1.3.3 DiscussionThe in

7、tent is to include forceps, snares,electrodes, and other such instruments which can be passedthrough a bronchoscope or with a bronchoscope throughanother accessory. The intent is also to exclude certain instru-ments, such as electrosurgical units, light sources, other suchinstruments, and ventilatio

8、n systems external to the broncho-scope.3.1.4 distalthe location of that portion of a bronchoscopeor endoscopic accessory which is farther from the user thansome reference point.3.1.4.1 DiscussionThe terms given in 3.1.4 and 3.1.5,commonly used in endoscopy, are defined in their most generalform to

9、avoid the need for such definitions as “distal tip,”“distal end,”“ area proximal to .,” “X cm distal to the . .”3.1.5 proximalthe location of that portion of a broncho-scope or endoscopic accessory which is closer to the user thansome reference point.3.1.5.1 See 3.1.4.3.1.6 insertion portionthat por

10、tion of a bronchoscope orendoscopic accessory which is intended to be inserted into anatural or surgically created body opening; or which is in-tended to be inserted into the lumen of a bronchoscope orendoscopic accessory.3.1.6.1 DiscussionAlthough the term defined seems self-explanatory, different

11、expressions for the same portion of theinstrument are used by different manufacturers.3.1.7 maximum insertion portion widththe maximum ex-ternal width of a bronchoscope or endoscopic accessorythroughout the length of the insertion portion.3.1.7.1 DiscussionBy defining external sizes as maximaand int

12、ernal sizes as minima, sufficient instrument informationfor selection of an instrument will be provided to users.3.1.8 minimum lumen widththe minimum internal widthof a bronchoscope or endoscopic accessory through which abronchoscope or endoscopic accessory is intended to pass.3.1.8.1 See 3.1.7.3.1.

13、9 working lengththe maximum length of the insertionportion.3.1.10 overall lengththe distance between the proximaland distal ends of a rigid bronchoscope or bronchoscopicaccessory, expressed in metric units.3.1.11 field of viewthe size of the object field viewedthrough an optical endoscope and stated

14、 by the vertex angle (indegrees) of the cone whose vertex is at the distal windowsurface of the instrument.1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.12 on Airways, Bronchoscopes, an

15、d Laryngoscopes.Current edition approved March 31, 1989. Published July 1989.2Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.11.1 DiscussionThe endoscope is not intended to bein contact w

16、ith the object. (See Fig. 1.)3.1.11.2 DiscussionThe definitions given in 3.1.11 and3.1.12, as illustrated, describe characteristics of optical endo-scopes paramount for effective use, thereby allowing the userto select instruments of specific values for particular medicalpurposes.3.1.12 direction of

17、 viewthe location of the center of theobject field relative to the normal axis of the optical endoscope,and stated as the angle (in degrees) between the normal axis ofthe optical endoscope and the center of the field of view. (SeeFig. 2.)3.1.12.1 See 3.1.11.3.1.13 controllable portionthat part of th

18、e insertion por-tion of an optical endoscope whose motion is intended to beremotely controlled by the user.3.1.13.1 Many optical endoscopes incorporate provisionsfor remote control of the motion of the distal tip by the user.The mechanisms for these controls vary widely, and areobviously of interest

19、 to the user. In order to avoid constraint offuture designs, control characteristics are defined in the mostgeneral terms.3.1.14 French (Charriere) size (Fr)a measure of the sizeof certain endoscopic accessories of circular and noncircularcross-section. The measure has several definitions:Fr 5 3 3 u

20、/3.1416 pi! for noncircular cross2sectionwhere u is the perimeter of the cross-section, mm.Fr 5 3.1416pi! 3 d for circular cross2sectionwhere d is the diameter of the cross-section, mm.Fr 5 3.0 3 d for circular cross2section3where d is the diameter of the cross-section, mm.3.1.14.1 DiscussionThis me

21、asure of size enjoys world-wide favor in many branches of medicine. In usage, themeasurement is imprecise, as shown in 3.1.14. The user shouldbe provided with the manufacturers definition if the term is tobe of any value. Metric measures appear to be more precise.4. Significance and Use4.1 This spec

22、ification applies to rigid bronchoscopes, thoseendoscopic accessories through which rigid bronchoscopes areused, those accessories which are passed through rigid bron-choscopes in use, and those associated accessories which areinserted into the body.5. Required Characteristics5.1 Critical Dimensions

23、:5.1.1 The maximum insertion portion width shall not ex-ceed that stated by the manufacturer. (See Note 1.)NOTE 1These sizes are given to help the user to select the instrumentsfor a given procedure. Compatibility of instruments in combinationrequires certain clearances between the insertion portion

24、 width and thelumen width; the clearance required depends upon the configuration anddimensions of the instruments. There is no guarantee that the instrumentsselected solely by these criteria will be compatible in combination.5.1.2 The minimum lumen width shall not be less than thatmarked on the bron

25、choscope. (See Note 1.)5.1.3 The overall length shall not exceed that marked on thebronchoscope.5.1.4 The working length shall not be less than that markedon the bronchoscope.5.2 Ventilation ConnectorsVentilation connectors shallmeet the requirements of Specification F 1054 or shall beprovided with

26、an adaptor to connect with the 15/22-mmconnector.6. Marking, Labeling, and Packaging6.1 Marking:6.1.1 Instrument Marking (see Note 2)Dimensions shallbe given in metric units. Each individual bronchoscope andendoscopic accessory shall have, as a minimum, the followingmarkings:NOTE 2The identification

27、 of the instrument and markings listed in6.1.1 are sufficient to permit the user to select the appropriate instrumentwhen necessary.6.1.1.1 A catalog number and other mark sufficient toidentify the instrument and its manufacturer,6.1.1.2 Maximum insertion portion width, minimum lumenwidth, overall l

28、ength, and working length for rigid broncho-scope, and6.1.1.3 Maximum insertion portion width, working length,field of view, and direction of view of the optical endoscope.6.1.2 Marking Legibility (see Note 3)The marking re-quired in 6.1.1 shall remain legible throughout the expected lifeof the inst

29、rument when it is used, cleaned, disinfected, steril-ized, and stored in accordance with the manufacturers instruc-tions.NOTE 3The primary requirement of instrument marking is that it belegible. Any more detailed requirements on marking methods, materials,sizes, and other characteristics could inhib

30、it design and process innova-tion.6.1.3 Marking Exceptions (see Note 4)When the markingrequired in 6.1.1 and 6.1.2 is impossible to achieve due to3Commonly used by many manufacturers of endoscopic accessories.FIG. 1 Field of ViewFIG. 2 Direction of ViewF 1218 89 (1999)2instrument size or configurati

31、on, the required markings shallaccompany the instrument.NOTE 4Design innovation in the trend towards smaller endoscopesand endoscopic accessories would be seriously inhibited without thismarking exception.6.2 Information to Be Supplied by the Manufacturer (seeNote 5)The manufacturer of rigid broncho

32、scopes or endo-scopic accessories shall provide the user with at least thefollowing information:NOTE 5A significant number of hazards and performance problems ofendoscopes and endoscopic accessories are best addressed by education ofthe user. The objective of 6.2 is to provide a part of the educatio

33、nal processwithout engaging in the practice of medicine.6.2.1 A statement of intended uses of the instrument anddirections for proper assembly for each use,6.2.2 Instructions for proper maintenance of the instrument,6.2.3 An annotated illustration of the instrument, if neces-sary, to identify pertin

34、ent parts and characteristics of theinstrument which are referenced in the information supplied,and6.2.4 The specifications of the instrument, including thefollowing:6.2.4.1 The name and address of the manufacturer, orsupplier, or both,6.2.4.2 The catalog number and name of the instrument,6.2.4.3 Th

35、e dimensional characteristics specified in 6.1.1,6.2.4.4 If applicable, the field of view and the direction ofview,6.2.4.5 If applicable, the remote controls and associatedcontrollable portion positions available to the user,6.2.4.6 An identification of any parts replacable by the userand instructio

36、ns for their replacement, and6.2.4.7 A listing of the names and addresses of authorizedservice agents.6.2.5 Instructions for assembling the instrument for itsintended uses and for the dismantling and reassembly of theinstrument after cleaning, disinfection or sterilization, or com-bination thereof,6

37、.2.6 Precautions and other instructions applicable to theintended uses of the instrument, including those related toelectrical, electronic, electro-optical, electrosurgical, or venti-latory apparatus intended to be used with the instrument,6.2.7 Inspection instructions to provide assurance that thei

38、nstrument is in working order,6.2.8 Instructions for the cleaning of reusable instruments,including recommended cleaning agents and equipment,6.2.9 Details of disinfection and sterilization environmentswhich the instrument can withstand without damage, and6.2.10 Recommended procedures for the storag

39、e of theinstrument prior to use, and, for reusable instruments, betweenuses.6.3 Packaging.NOTE 6Problems due to improper packaging have been reported.Rather than impose innovation-limiting design requirements on themanufacturer, we believe that the disclosure approach cited above is moreappropriate.

40、NOTE 7The manufacturer should package the instrument in a mannerto protect the instrument from the adverse effects of shipping environ-ments.7. Keywords7.1 bronchoscope; bronchoscopy; endoscope; endoscopy;optical endoscopeASTM International takes no position respecting the validity of any patent rig

41、hts asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any

42、 time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments wi

43、ll receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by AS

44、TM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 1218 89 (1999)3