标准摘要
[中文适用范围]： 本文件规定了用于指示气道装置（例如喉上气道、气管导管或气管造口管）袖带内压力的袖带压力指示器的基本性能和安全要求。 本文件还适用于将袖带内压力指示与袖带充气方法相结合的设备（例如注射器或泵）。 该装置还可以提供一种自动将袖带充气维持在特定压力或压力范围内的方法。 本文件中规定的要求适用于独立的袖带压力指示器和集成到其他医疗设备（例如呼吸机、麻醉工作站等）中的袖带压力指示器。 [外文原描述]： This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices , such as supralaryngeal airways , tracheal tubes or tracheostomy tubes . This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range. The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.
英文名称Anaesthetic and respiratory equipment — Cuff pressure indication, control and regulation devices