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现行 ISO 23402-3:2024
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Dentistry — Portable dental equipment for use in non‐permanent healthcare environment — Part 3: Portable suction equipment 牙科学.非永久性医疗环境中使用的便携式牙科设备.第3部分:便携式抽吸设备
发布日期: 2024-04-22
本文件规定了主要供牙科专业人员在非永久性医疗保健环境中使用的便携式抽吸设备的术语、分类、要求和测试方法。 本文件适用于便携式牙科设备中的便携式抽吸设备和独立式便携式抽吸设备。 本文档中的需求侧重于可移植性。 本文件规定了制造商提供的关于便携式抽吸设备的性能、操作和维护信息的要求,这些设备是为在非永久性医疗环境中使用而设计和建造的。本文件还规定了制造商提供的关于在非-永久医疗保健环境。 本文件不适用于固定式牙科设备、可穿戴设备(如头灯和放大镜)、移动式牙科设备或便携式牙科设备,这些设备不打算在非永久性医疗保健环境中使用,也不设计为可拆卸、折叠或包装以便在非永久性医疗保健环境之间进行人体运输。此外,本文件不考虑可安装在牙科移动医疗设施(例如车载或集装箱式移动牙科诊所)中的固定牙科设备的要求。 本文件规定了用于在套管连接器处提供减压和流量的便携式抽吸设备的要求。 本文件不适用于用于生命支持或清除卤化麻醉气体的便携式抽吸设备。

This document specifies terminology, classification, requirements and test methods for portable suction equipment primarily intended to be used by dental professionals in non-permanent healthcare environments.

This document applies to portable suction equipment incorporated in a portable dental unit and free-standing portable suction equipment.

The requirements in this document focus on portability.

This document specifies requirements for information to be supplied by the manufacturer on the performance, operation and maintenance of portable suction equipment designed and constructed to be transported for use in non-permanent healthcare environments. This document also specifies requirements for the instructions to be supplied by the manufacturer on assembling, disassembling and packing for human transport between non-permanent healthcare environments.

This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

This document specifies requirements for portable suction equipment used to provide reduced pressure and flow at the cannula connector.

This document does not apply to portable suction equipment used for life support or for scavenging halogenated anaesthetic gases.

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归口单位: ISO/TC 106/SC 6
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