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牙科學 病人椅檢測項目報價???解決方案???檢測周期???樣品要求? |
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本文件規定了非移動的牙科治療機、牙科病人椅以及兩者組合的要求和測試方法,不論它們是否是電動的。本文件還規定了使用說明書、技術說明書、標記和包裝的要求。本文件不適用于醫師椅、可攜帶的牙科設備和口腔燈。
本標準規定了口腔醫療保健人員工作區域內牙科設備位置信息系統,在這些工作區域內可以進行直接和患者有關的診斷、治療和其他臨床操作。本信息系統提供了描述牙科設備所處位置一般信息的方法,以及描述該設備及其附件空間的靈活性和適應性特征的方法。此外,本標準提供了該區域所使用的牙科設備一般術語的定義。
本標準規定了預期需要消毒的牙科設備外表面材料耐受化學消毒劑特性的確定的三種試驗方法:浸泡試驗、噴霧試驗、接觸試驗。選擇使用何種試驗方法由試驗者自行決定。本標準未涉及消毒劑對細菌、病毒、真菌的有效性。本標準未規定試驗材料在耐受試劑試驗時,所受應力對測定可能產生的影響。
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 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 European Standard specifies general requirements for 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 apply to 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 EN 1639.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
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