ASTM F1218-1989(2014) Standard Specification for Bronchoscopes &40 Rigid&41 《支气管镜40 刚性41的标准规范》.pdf

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1、Designation: F1218 89 (Reapproved 2014)Standard Specification forBronchoscopes (Rigid)1This standard is issued under the fixed designation F1218; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number i

2、n parentheses indicates the year of last reapproval. Asuperscript epsilon () 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 medi

3、cine.2. Referenced Documents2.1 ASTM Standards:2F1054 Specification for Conical Fittings (Withdrawn 2005)33. 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

4、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 bronchoscop

5、e, 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 accessory whose i

6、nsertion 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 intent is to

7、 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 certaininstruments, such as electrosurgical units, light sources, othersuch instruments, and ventilation systems ex

8、ternal to thebronchoscope.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

9、 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 portion of a bron

10、choscope 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 fo

11、r 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 internal sizes as

12、 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 3.1.7.3.1.9 working leng

13、ththe 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 by the vertex

14、 angle (in1This 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 edition approved Jan. 1, 2014. Published March 2014. Originallyapproved in

15、 1989. Last previous edition approved in 2007 as F1218 89 (2007).DOI: 10.1520/F1218-89R14.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Sum

16、mary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1degrees) of the cone whose vertex is at the distal windowsurface of the i

17、nstrument.3.1.11.1 DiscussionThe endoscope is not intended to be incontact with 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 instr

18、uments of specific values for particular medicalpurposes.3.1.12 direction of 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

19、. (SeeFig. 2.)3.1.12.1 See 3.1.11.3.1.13 controllable portionthat part of the 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

20、.The mechanisms for these controls vary widely, and areobviously of interest 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

21、and noncircularcross-section. The measure has several definitions:Fr 5 3 3 u/3.1416 pi! for noncircular cross 2 sectionwhere u is the perimeter of the cross-section, mm.Fr 5 3.1416pi! 3 d for circular cross 2 sectionwhere d is the diameter of the cross-section, mm.Fr 5 3.0 3 d for circular cross 2 s

22、ectionwhere d is the diameter of the cross-section, mm.NOTE 1Fr = 3.0 d for circular cross-section, commonly used bymany manufacturers of endoscopic accessories.3.1.14.1 DiscussionThis measure of size enjoys world-wide favor in many branches of medicine. In usage, themeasurement is imprecise, as sho

23、wn 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 bronchoscopes, thoseendoscopic accessories through which rigid bronchoscopes areused,

24、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 insertion portion width shall not ex-ceed that stated by the manufacturer. (See Note 2.)NOTE 2

25、These 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; the clearance required depends upon the configuration anddimensions of the instruments

26、. 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 2.)5.1.3 The overall length shall not exceed that marked on thebronchoscope.5.1.4 The working

27、 length shall not be less than that markedon the bronchoscope.5.2 Ventilation ConnectorsVentilation connectors shallmeet the requirements of Specification F1054 or shall beprovided with an adaptor to connect with the 15/22-mmconnector.6. Marking, Labeling, and Packaging6.1 Marking:6.1.1 Instrument M

28、arking (see Note 3)Dimensions shallbe given in metric units. Each individual bronchoscope andendoscopic accessory shall have, as a minimum, the followingmarkings:NOTE 3The identification of the instrument and markings listed in6.1.1 are sufficient to permit the user to select the appropriate instrum

29、entwhen 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 for rigidbronchoscope, and6.1.1.3 Maximum insertion portion width, working length,field

30、of view, and direction of view of the optical endoscope.6.1.2 Marking Legibility (see Note 4)The marking re-quired in 6.1.1 shall remain legible throughout the expected lifeof the instrument when it is used, cleaned, disinfected,sterilized, and stored in accordance with the manufacturersinstructions

31、.NOTE 4The primary requirement of instrument marking is that it belegible. Any more detailed requirements on marking methods, materials,FIG. 1 Field of ViewFIG. 2 Direction of ViewF1218 89 (2014)2sizes, and other characteristics could inhibit design and process innova-tion.6.1.3 Marking Exceptions (

32、see Note 5)When the markingrequired in 6.1.1 and 6.1.2 is impossible to achieve due toinstrument size or configuration, the required markings shallaccompany the instrument.NOTE 5Design innovation in the trend towards smaller endoscopesand endoscopic accessories would be seriously inhibited without t

33、hismarking exception.6.2 Information to Be Supplied by the Manufacturer(seeNote 6)The manufacturer of rigid bronchoscopes or endo-scopic accessories shall provide the user with at least thefollowing information:NOTE 6Asignificant number of hazards and performance problems ofendoscopes and endoscopic

34、 accessories are best addressed by education ofthe user. The objective of 6.2 is to provide a part of the educational 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

35、maintenance of the instrument,6.2.3 An annotated illustration of the instrument, ifnecessary, to identify pertinent 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 a

36、ddress of the manufacturer, orsupplier, or both,6.2.4.2 The catalog number and name of the instrument,6.2.4.3 The 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 por

37、tion positions available to the user,6.2.4.6 An identification of any parts replacable by the userand instructions 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 dism

38、antling and reassembly of theinstrument after cleaning, disinfection or sterilization, or com-bination thereof,6.2.6 Precautions and other instructions applicable to theintended uses of the instrument, including those related toelectrical, electronic, electro-optical, electrosurgical, or venti-lator

39、y apparatus intended to be used with the instrument,6.2.7 Inspection instructions to provide assurance that theinstrument 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 sterilizatio

40、n environmentswhich the instrument can withstand without damage, and6.2.10 Recommended procedures for the storage of theinstrument prior to use, and, for reusable instruments, betweenuses.6.3 Packaging.NOTE 7Problems due to improper packaging have been reported.Rather than impose innovation-limiting

41、 design requirements on themanufacturer, we believe that the disclosure approach cited above is moreappropriate.NOTE 8The manufacturer should package the instrument in a mannerto protect the instrument from the adverse effects of shipping environ-ments.7. Keywords7.1 bronchoscope; bronchoscopy; endo

42、scope; endoscopy;optical endoscopeASTM International takes no position respecting the validity of any patent rights 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 risko

43、f infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any 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

44、standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will 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 yo

45、ur views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F1218 89 (2014)3