ASTM F 1518 : 2000

CONTAINED IN VOL. 13.01, 2008 Defines requirements for flexible fiber-optic and video endoscopes that are fully immersible in liquid and are used in the examination of the hollow viscera (ie. colonoscopes, gastroscopes, duodenoscopes, sigmoidoscopes, and enteroscopes). These endoscopes will be referred to as flexible gastrointestinal (GI) endoscopes.

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, and sigmoidoscopes). These endoscopes will be referred to as flexible gastrointestinal (GI) endoscopes.

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 A patient-ready endoscope is one that has been rendered visibly clean after being subjected to a validated cleaning procedure, subjected minimally to a high-level disinfection process, and rinsed so that it does not contain residual reprocessing chemicals in amounts which can be harmful to humans.

1.5.1 It is recognized that in some circumstances, portions of endoscopes that neither contact patients directly nor contact fluids that may contact patients probably do not have to be subjected to high-level disinfection.

1.6 This practice details manual reprocessing as well as automated reprocessing of flexible GI fiberoptic and video endoscopes.

1.7 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.

1.7.1 To ensure the proper adherence to this practice, those personnel should themselves meet certain requirements as specified in 4.8.

1.8 This practice does not detail the steps necessary for the reprocessing of endoscopic accessories.

1.9 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 Notes 1 and 2.