ASTM_F_1992_-_99_2007.pdf

Designation:F199299(Reapproved 2007)Standard Practice forReprocessing of Reusable,Heat-Stable EndoscopicAccessory Instruments(EAI)Used with FlexibleEndoscopes1This standard is issued under the fixed designation F1992;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 practice covers reusable,heat-stable endoscopicaccessory instruments(EAI)designed to be inserted intoflexible endoscopes and clearly defined in the user instructionsas devices intended for reuse among patients.The EAIscovered by this practice may or may not have lumens orloosely joined surfaces,may or may not have access ports forflushing,and may or may not be capable of being completelydisassembled prior to reprocessing.1.2 This practice is not intended to be applied to thereprocessing of single-use,disposable EAIs specifically de-signed and labeled as such by their manufacturers.1.3 This practice is not intended to address reprocessing ofheat-sensitive EAIs,for example,those not capable of with-standing heat sterilization.Reprocessing of each heat-sensitiveEAI must be considered on an individual basis according tospecific instructions from the manufacturers of the EAI and thelow-temperature sterilization device.1.4 This practice is intended to complement,not replace,theinstructions provided by product manufacturers.EAI manufac-turers should provide properly validated instruction and label-ing necessary for users to understand the basic design,specifications,nomenclature,and components of specific ac-cessories and to properly inspect,prepare,use,reprocess,andstore these instruments.1.5 Endoscopic technique and the medical aspects of endos-copy are not covered in this practice.1.6 This practice details the basic steps necessary to repro-cess a heat-stable EAI and render it patient-ready.1.7 A patient-ready EAI is one that has been thoroughlycleaned using a validated cleaning procedure,rinsed with waterto remove residual detergent,lubricated(if necessary)anddrained to remove excess lubricant,dried,packaged,heatsterilized and stored to prevent from being compromisedsterility before use.1.8 This practice describes only manual reprocessing anddoes not address cleaning of an EAI by an automated repro-cessing device.1.9 To ensure the proper adherence to this practice,repro-cessing personnel should meet certain requirements as speci-fied in 5.5 to 5.7.1.10 This practice does not address the steps necessary forthe reprocessing of flexible endoscopes(see Practice F1518).1.11 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and to determine theapplicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F1518 Practice for Cleaning and Disinfection of FlexibleFiberoptic and Video Endoscopes Used in the Examina-tion of the Hollow Viscera(Withdrawn 2009)33.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 clean,adjvisibly free from external debris after athorough,manufacturer-validated regimen.3.1.2 critical medical device,nan instrument that may beintroduced directly into the bloodstream or into other normallysterile areas of the body,that is,an invasive device.3.1.3 endoscopic accessory instrument,EAI,nmedicalinstrument designed to be inserted into a flexible endoscope.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.35 on GI Applications.Current edition approved Dec.1,2007.Published January 2008.Originallyapproved in 1999.Last previous edition approved in 1999 as F1992 99.DOI:10.1520/F1992-99R07.2For 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 3.1.3.1 DiscussionEAIs may be critical-or semi-criticaldevices.EAIs may or may not have lumens,porous or looselyjoined surfaces,or access ports for flushing and may or maynot be capable of being completely disassembled duringreprocessing.3.1.4 flexible endoscope,na flexible tubular instrumentthat utilizes fiberoptic or video imaging technology to examinethe interior of a canal or hollow viscus.3.1.5 heat-stable medical device,nan instrument capableof withstanding sterilization using a heat-based process.3.1.6 lubrication,nthe application of a substance used toreduce friction or