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病人椅检测项目报价? 解决方案? 检测周期? 样品要求? |
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除以下内容外,通用标准的第1章适用。替换:本部分适用于牙科单元、牙科病人椅、牙科手持设备、口腔灯(后文中统称为牙科设备)的基本安全和基本性能要求。不包括银汞调合器、消毒灭菌设备和牙科X线设备。如果条款或子条款明确仅适用于医用电气设备或仅适用于医用电气系统,那么在其标题和内容中将会进行说明。若未进行说明,则该条款或子条款同时适用于相关的医用电气设备和医用电气系统。除了通用标准中7.2.13和8.4.1中规定的内容以外,本部分范围内相关医用电气设备或医用电气系统特性功能固有的危险未在本部分中的特定要求中进行说明。替换:本专用标准的目的在于确定牙科设备的基本安全和基本性能方面的要求(如201.3.202定义)。
本文件规定了非移动的牙科治疗机、牙科病人椅以及两者组合的要求和测试方法,不论它们是否是电动的。本文件还规定了使用说明书、技术说明书、标记和包装的要求。本文件不适用于医师椅、可携带的牙科设备和口腔灯。
本标准规定了口腔医疗保健人员工作区域内牙科设备位置信息系统,在这些工作区域内可以进行直接和患者有关的诊断、治疗和其他临床操作。本信息系统提供了描述牙科设备所处位置一般信息的方法,以及描述该设备及其附件空间的灵活性和适应性特征的方法。此外,本标准提供了该区域所使用的牙科设备一般术语的定义。
本标准规定了预期需要消毒的牙科设备外表面材料耐受化学消毒剂特性的确定的三种试验方法:浸泡试验、喷雾试验、接触试验。选择使用何种试验方法由试验者自行决定。本标准未涉及消毒剂对细菌、病毒、真菌的有效性。本标准未规定试验材料在耐受试剂试验时,所受应力对测定可能产生的影响。
This International Standard is applicable to all patient chairs, regardless of their construction, and regardless of whether they are operated manually, electrically or by other means, or as a combination of these. This International Standard specifies requirements, test methods, manufacturer's information, marking and packaging.
Le présent document spécifie les exigences et les méthodes d'essai relatives aux unités dentaires fixes, aux fauteuils dentaires patient et aux combinaisons des deux, qu'ils soient ou non commandés électriquement.Le présent document spécifie également les exigences relatives à la notice d'utilisation, à la description technique, au marquage et à l'emballage.Les sièges d'opérateur, l'équipement dentaire portable et les scialytiques ne relèvent pas du domaine d'application du présent document.
This European Standard specifies general requirements for items of dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.This European Standard does not include requirements for dental X-ray equipment.This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by the level 2 and level 3 standards for dental instruments.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
This European Standard defines minimum requirements for the design and performance of mechanically assisted carrying chairs for use in road ambulances for handling and carrying a patient. It deems to ensure patient safety and minimize the physical effort required by staff operating the equipment
This International Standard specifies an information system for the location of items of dental equipment thatare used in the working area of the team of the oral health care provider where examination, treatment andother clinical procedures, with the patient directly involved, are carried out.The identification system provides the means of giving general information about the presence of items and ofdescribing relevant characteristics concerning dimensional flexibility and adaptability of the items and parts oftheir accessories.In addition, this International Standard provides definitions for general terms used in the area of dentalequipment.
This document specifies requirements and test methods for stationary dental units, dental patient chairs, and combinations of both regardless of whether they are electrically powered or not. It also specifies requirements for the manufacturer's instructions, marking and packaging. Operator's stools are not in the scope of this International Standard.
This International Standard is applicable to all patient chairs, regardless of their construction, and regardless of whether they are operated manually, electrically or by other means, or as a combination of these.This International Standard specifies requirements, test methods, manufacturer’s information, marking and packaging.