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ASTM F 1518 Document Information:
Title
Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera
ASTM International
Publication Date:
Apr 10, 2000
Scope:
1. Scope
1.1 This practice covers the flexible fiberoptic and video endoscopes that are fully immersible in liquid and are used in the examination of the hollow viscera (that is, colonoscopes, gastroscopes, duodenoscopes, sigmoidoscopes, and enteroscopes). These endoscopes will be referred to as flexible gastrointestinal (GI) endoscopes.
1.1.1 It is strongly recommended that only immersible endoscopes be used in order to assure that all parts of the endoscope will be high-level disinfected; however, it is recognized that, in some instances, portions of endoscopes that neither contact patients nor patient fluids may not be immersible. In these instances, care must be taken to disinfect the nonimmersible portions to the highest degree with which they are compatible, according to the manufacturer's directions.
1.2 This practice is intended to complement, not replace the instructions and labeling provided by product manufacturers. Endoscope manufacturers must provide instructions and labeling necessary for users to know the basic design, specifications, nomenclature, and components of specific flexible GI endoscopes and to properly inspect, prepare, use, clean, disinfect, rinse, dry, and store these instruments.
1.3 Endoscopic technique and the medical aspects of gastrointestinal endoscopy are not covered in this practice.
1.4 This practice details the steps necessary to properly reprocess flexible GI endoscopes and render them patient-ready.
1.5 This practice details manual reprocessing as well as automated reprocessing of flexible GI fiberoptic and video endoscopes.
1.6 The application of all practices relating to endoscopic reprocessing will ultimately fall into the purview of the individual assigned to that task in an endoscopic area.
1.6.1 To ensure the proper adherence to this practice, those personnel should themselves meet certain requirements as specified in 4.8.
1.7 This practice does not detail the steps necessary for the reprocessing of endoscopic accessories.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in Note 1 and Note 2.
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