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Dentistry — Portable dental equipment for use in non‐permanent healthcare environments — Part 1: General requirements
牙科 用于非永久性医疗保健环境的便携式牙科设备 第1部分:一般要求
本文件规定了用于非永久性医疗保健环境的便携式牙科设备的一般要求和测试方法。
本文件适用于便携式牙科单元、便携式病人椅、便携式操作者凳、便携式手术灯、便携式吸力源设备、便携式空气压缩机和其他便携式牙科设备,在这些设备被设计和构造为运输以供在非永久性医疗保健环境中使用的情况下。
注意:在非永久性医疗保健环境中使用的特定类型的便携式牙科设备的特殊要求在本文件的后续部分中规定。
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)、移动式牙科设备或不打算用于非永久性医疗保健环境或设计为可拆卸、折叠或包装,以便人类在非永久性医疗保健环境之间运输。本文件未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)中的固定式牙科设备的要求。
This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.
This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.
NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document.
This document does not apply to stationary dental equipment, wearable equipment (e.g. 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. 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.