ASTM F1218-1989(2007) Standard Specification for Bronchoscopes (Rigid)《医用刚性气管镜的标准规范》.pdf

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1、Designation: F 1218 89 (Reapproved 2007)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:2F 1054 Specification for Conical Fittings33. 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, through a natural ors

4、urgically 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 bronchoscope, or through

5、 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 accessory whose insertion por-

6、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 intent is to include forc

7、eps, 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 ventilation systems external to t

8、he 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 avoid the need for such

9、 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 portion of a bronchoscope

10、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 expressions for the sam

11、e 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 internal sizes as minima,

12、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 3.1.7.3.1.9 working lengththe max

13、imum 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 by the vertex angle (i

14、ndegrees) 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 and Laryngoscopes.Current

15、edition approved Nov. 1, 2007. Published November 2007. Originallyapproved in 1989. Last previous edition approved in 1999 as F 1218 89 (1999).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards vo

16、lume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.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 with the object. (See Fig.

17、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 viewthe location of the c

18、enter 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 the insertion por-tion of an

19、 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 to the user. In order to

20、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/3.1416 pi! for noncircula

21、r 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 measure of size enjoys world

22、-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 specification applies to rigid

23、 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:5.1.1 The maximum inserti

24、on 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 width and thelumen width;

25、 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 bronchoscope. (See Note 1.)5.1

26、.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 an adaptor to connect with

27、 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 of the instrument and mar

28、kings 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 length, and working length

29、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 instrument when it is used, cl

30、eaned, 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 inhibit design and process inno

31、va-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 to4Commonly used by many manufacturers of endoscopic accessories.FIG. 1 Field of ViewFIG. 2 Direction of ViewF 1218 89 (2007)2instrument size or configuration, the required markings

32、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 bronchoscopes or endo-scopic acce

33、ssories shall provide the user with at least thefollowing information:NOTE 5Asignificant 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 educational processwithout engaging

34、 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 pertinent parts and characteristi

35、cs 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 The dimensional characteristi

36、cs 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 instructions for their replacement, a

37、nd6.2.4.7 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,6.2.6 Precautions and other

38、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 theinstrument is in working ord

39、er,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 storage of theinstrument prior to

40、 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.NOTE 7The manufacturer shou

41、ld 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 rights asserted in connection

42、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 time by the responsible te

43、chnical 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 will receive careful consider

44、ation 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 ASTM International, 100 Barr

45、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 (2007)3