1.1本规程涵盖可重复使用、热稳定的内窥镜附属器械（EAI），其设计用于插入柔性内窥镜，并在用户说明中明确定义为用于患者之间重复使用的设备。本规程涵盖的EAI可能有或可能没有内腔或松散连接的表面，可能有或可能没有冲洗用的接入口，并且可能有或可能无法在重新处理之前完全拆卸。 1.2本实施规程不适用于单个- 一次性使用EAS由其制造商专门设计和标记。 1.3本规程不旨在解决热敏EAI的再加工问题，例如，那些不能承受热灭菌的EAI。必须根据EAI和低温灭菌设备制造商的具体说明，单独考虑对每个热敏EAI进行再加工。 1.4本规程旨在补充而非取代产品制造商提供的说明。 EAI制造商应提供适当验证的说明和标签，以便用户了解特定附件的基本设计、规格、术语和组件，并正确检查、准备、使用、再加工和存储这些仪器。 1.5本规程不包括内窥镜技术和内窥镜的医学方面。 1.6本规程详细说明了重新处理热稳定EAI并使其为患者做好准备所需的基本步骤。 1.7为患者准备的EAI是指使用经验证的清洁程序彻底清洁、用水冲洗以去除残留洗涤剂、润滑（如有必要）并排空以去除多余润滑剂、干燥、包装、热灭菌和储存以防止在使用前影响无菌的EAI。 1.8本规程仅描述手动再处理，不涉及通过自动再处理设备清洁EAI。 1.9为确保正确遵守本惯例，后处理人员应满足To中规定的某些要求。 1.10本实施规程不涉及柔性内窥镜再加工所需的步骤（见实施规程F 1518）。 本标准并非旨在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。

1.1 This practice covers reusable, heat-stable endoscopic accessory instruments (EAI) designed to be inserted into flexible endoscopes and clearly defined in the user instructions as devices intended for reuse among patients. The EAIs covered by this practice may or may not have lumens or loosely joined surfaces, may or may not have access ports for flushing, and may or may not be capable of being completely disassembled prior to reprocessing. 1.2 This practice is not intended to be applied to the reprocessing of single-use, disposable EAIs specifically designed and labeled as such by their manufacturers. 1.3 This practice is not intended to address reprocessing of heat-sensitive EAIs, for example, those not capable of withstanding heat sterilization. Reprocessing of each heat-sensitive EAI must be considered on an individual basis according to specific instructions from the manufacturers of the EAI and the low-temperature sterilization device. 1.4 This practice is intended to complement, not replace, the instructions provided by product manufacturers. EAI manufacturers should provide properly validated instruction and labeling necessary for users to understand the basic design, specifications, nomenclature, and components of specific accessories and to properly inspect, prepare, use, reprocess, and store these instruments. 1.5 Endoscopic technique and the medical aspects of endoscopy are not covered in this practice. 1.6 This practice details the basic steps necessary to reprocess a heat-stable EAI and render it patient-ready. 1.7 A patient-ready EAI is one that has been thoroughly cleaned using a validated cleaning procedure, rinsed with water to remove residual detergent, lubricated (if necessary) and drained to remove excess lubricant, dried, packaged, heat sterilized and stored to prevent from being compromised sterility before use. 1.8 This practice describes only manual reprocessing and does not address cleaning of an EAI by an automated reprocessing device. 1.9 To ensure the proper adherence to this practice, reprocessing personnel should meet certain requirements as specified in to. 1.10 This practice does not address the steps necessary for the reprocessing of flexible endoscopes (see Practice F 1518). 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 to determine the applicability of regulatory limitations prior to use.