ASTM F1992-1999 Standard Practice for Reprocessing of Reusable Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes《与软性内窥镜一起使用的可重复使用的耐热内窥镜辅助仪器(EAI)再加工的标.pdf
《ASTM F1992-1999 Standard Practice for Reprocessing of Reusable Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes《与软性内窥镜一起使用的可重复使用的耐热内窥镜辅助仪器(EAI)再加工的标.pdf》由会员分享,可在线阅读,更多相关《ASTM F1992-1999 Standard Practice for Reprocessing of Reusable Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes《与软性内窥镜一起使用的可重复使用的耐热内窥镜辅助仪器(EAI)再加工的标.pdf(6页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F 1992 99Standard Practice forReprocessing of Reusable, Heat-Stable EndoscopicAccessory Instruments (EAI) Used with FlexibleEndoscopes1This standard is issued under the fixed designation F 1992; the number immediately following the designation indicates the year oforiginal adoption or,
2、in the case of revision, the year of last revision. A number 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 practice covers reusable, heat-stable endoscopicaccessory instruments (EAI)
3、 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 capabl
4、e 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,
5、 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 compl
6、ement, 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, speci-fications, nomenclature, and components of specificaccessories and to properly inspect, prep
7、are, use, reprocess,and store these instruments.1.5 Endoscopic technique and the medical aspects of endo-scopy 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
8、 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 m
9、anual 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 repr
10、ocessing of flexible endoscopes (see Practice F 1518).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 theapplicabilit
11、y of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:F 1518 Practice for Cleaning and Disinfection of FlexibleFiberoptic and Video Endoscopes Used in the Examinationof the Hollow Viscera23. Terminology3.1 Definitions of Terms Specific to this Standard:3.1.1 clean, adjvi
12、sibly 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, n
13、medicalinstrument designed to be inserted into a flexible endoscope.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 duringrep
14、rocessing.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
15、, nthe application of a substance used toreduce friction or wear.1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of Subcommittee F04.35 on GI Endoscopes.Current edition approved October 10, 1999. Published J
16、anuary 2000.2Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.7 manual cleaning, nremoval of debris from an in-strument by hand using detergent solution, cleaning devicessuch as brushes, cl
17、oths, and irrigating devices, and water forrinsing.3.1.8 patient-ready, adjterm used to describe endoscopicaccessory instrument that, following prior patient use, hasundergone an appropriate reprocessing protocol, including heatsterilization, to render it safe, as established by contemporaryprofessi
18、onal standards, for use on a subsequent patient; anoperational check to ensure proper functionality is an essentialcomponent of preparing the EAI for reuse.3.1.9 reprocessing, nthe precise sequence of cleaning,lubricating (if necessary), and sterilizing steps that, whenperformed properly and complet
19、ely, will assure an endoscopicaccessory instrument is patient-ready.3.1.10 reusable, adjinstrument designed and validated bythe manufacturer to be used more than once, provided that aftereach use, an appropriate reprocessing protocol and functional-ity check is performed.3.1.11 semi-critical medical
20、 device, nan instrument in-tended to contact only mucous membranes or non-intact skinduring use.3.1.12 sterilization, nthe complete elimination or destruc-tion of all forms of microbial life, including high numbers ofbacterial spores.3.1.12.1 DiscussionIn this standard, the only methods ofsterilizat
21、ion considered are heat-based, for example, saturatedsteam under pressure (a steam autoclave) or a forced-air dryheat oven certified for medical use.3.1.13 ultrasonic cleaning, na process in which ultra-highfrequency sound waves are converted into mechanical vibra-tions capable of cleaning via a pro
22、cess called cavitation.3.1.13.1 DiscussionDuring cavitation, microscopicbubbles in the cleaning solution implode (burst inward),resulting in a vacuum action that pulls soil and debris awayfrom the surface of items being cleaned.4. Summary of Practice4.1 Each brand, type, and model of EAI has unique
23、speci-fications, nomenclature, interior design, function, and compo-nents.4.2 Most EAIs are critical medical devices because theycome into direct contact with the bloodstream, enter normallysterile areas of the body, or break normally intact mucosalsurfaces.4.3 To prevent patient-to-patient transmis
24、sion of infection,heat-stable EAIs should be thoroughly cleaned, rinsed, lubri-cated if necessary, dried, packaged, and sterilized using aheat-based process, for example, a steam autoclave or aforced-air dry heat oven.4.4 After sterilization, a packaged EAI should be stored in alimited-access, well-
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