1.1本规程涵盖完全浸入液体中并用于检查中空脏器（即结肠镜、胃镜、十二指肠镜和乙状结肠镜）的柔性纤维内窥镜和视频内窥镜。这些内窥镜将被称为柔性胃肠内窥镜。 1.2本规程旨在补充而非取代产品制造商提供的说明和标签。内窥镜制造商必须提供必要的说明和标签，让用户了解特定柔性胃肠内窥镜的基本设计、规格、术语和组件，并正确检查、准备、使用、清洁、消毒、冲洗、干燥和储存这些仪器。 1.3本规程不包括内窥镜技术和胃肠内窥镜的医学方面。 1.4本规程详细说明了正确重新处理柔性胃肠内窥镜并使其为患者做好准备所需的步骤。 1.5准备好患者的内窥镜是指在经过验证的清洁程序后变得明显清洁，经过最低程度的高水平消毒过程，并进行冲洗，使其不包含对人体有害的残留再加工化学品。 1.5.1人们认识到，在某些情况下，既不直接接触患者也不接触可能接触患者的液体的内窥镜部分可能不必进行高水平消毒。 1.6本规程详细说明了柔性胃肠纤维和视频内窥镜的手动再处理以及自动再处理。 1.7与内窥镜后处理相关的所有实践的应用最终将属于内窥镜领域中分配给该任务的个人的权限。 1.7.1为确保正确遵守本惯例，这些人员自身应满足4.8中规定的某些要求。 1.8本规程未详细说明内窥镜附件再加工所需的步骤。 1.9本标准无意解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 附注1和2中给出了具体的预防说明。

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.