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除以下內容外,通用標準的第1章適用。替換:本部分適用于牙科單元、牙科病人椅、牙科手持設備、口腔燈(后文中統稱為牙科設備)的基本安全和基本性能要求。不包括銀汞調合器、消毒滅菌設備和牙科X線設備。如果條款或子條款明確僅適用于醫用電氣設備或僅適用于醫用電氣系統,那么在其標題和內容中將會進行說明。若未進行說明,則該條款或子條款同時適用于相關的醫用電氣設備和醫用電氣系統。除了通用標準中7.2.13和8.4.1中規定的內容以外,本部分范圍內相關醫用電氣設備或醫用電氣系統特性功能固有的危險未在本部分中的特定要求中進行說明。替換:本專用標準的目的在于確定牙科設備的基本安全和基本性能方面的要求(如201.3.202定義)。
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。
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.