ISO 23402-1:2020 牙科 非永久性医疗保健环境中使用的便携式牙科设备 第1部分：一般要求

标准编号：ISO 23402-1:2020

中文名称：牙科 非永久性医疗保健环境中使用的便携式牙科设备 第1部分：一般要求

英文名称：Dentistry — Portable dental equipment for use in non‐permanent healthcare environment — Part 1: General requirements

发布日期：2020-09

标准范围

本文件规定了非永久性医疗环境中使用的便携式牙科设备的一般要求和试验方法。本文件范围内的便携式牙科设备包括便携式牙科设备、便携式患者椅、便携式操作员凳子、便携式操作灯、便携式吸液源设备、便携式空气压缩机和其他便携式牙科设备，如果这些设备的设计和构造是为了在非医疗场所使用而运输的-永久性医疗环境。注:本文件后续部分规定了用于非永久性医疗环境的特定类型便携式牙科设备的特殊要求。本文件不适用于固定式牙科设备、可穿戴设备（如前照灯和百叶窗）、移动式牙科设备或便携式牙科设备，这些设备不打算用于非永久性医疗环境，也不设计为可拆卸、折叠或包装，以便在非永久性医疗环境之间进行人类运输-永久性医疗环境。此外，本文件不考虑可安装在牙科移动医疗设施（如车载或集装箱移动牙科诊所）中的固定牙科设备的要求。

This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.

Portable dental equipment within the scope of this document includes 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 (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.

标准预览图