ASTM_F_1218_-_89_2014.pdf

Designation:F121889(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 in 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in the practice of medicine.2.Referenced Documents2.1 ASTM Standards:2F1054 Specification for Conical Fittings(Withdrawn 2005)33.Terminology3.1 Definitions:3.1.1 bronchoscopes(rigid)a medical instrument havingviewing means,with or without optics,introduced into thelarynx or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 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 bronchoscope,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 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 intent 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 certaininstruments,such as electrosurgical units,light sources,othersuch instruments,and ventilation systems external 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 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 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 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 internal 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 3.1.7.3.1.9 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 by the vertex 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 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 Summary 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 States1 degrees)of the cone whose vertex is at the distal windowsurface of the instrument.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 all