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病人椅檢測(cè)項(xiàng)目報(bào)價(jià)???解決方案???檢測(cè)周期???樣品要求? |
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除以下內(nèi)容外,通用標(biāo)準(zhǔn)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(shè)備、口腔燈(后文中統(tǒng)稱為牙科設(shè)備)的基本安全和基本性能要求。不包括銀汞調(diào)合器、消毒滅菌設(shè)備和牙科X線設(shè)備。如果條款或子條款明確僅適用于醫(yī)用電氣設(shè)備或僅適用于醫(yī)用電氣系統(tǒng),那么在其標(biāo)題和內(nèi)容中將會(huì)進(jìn)行說明。若未進(jìn)行說明,則該條款或子條款同時(shí)適用于相關(guān)的醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)。除了通用標(biāo)準(zhǔn)中7.2.13和8.4.1中規(guī)定的內(nèi)容以外,本部分范圍內(nèi)相關(guān)醫(yī)用電氣設(shè)備或醫(yī)用電氣系統(tǒng)特性功能固有的危險(xiǎn)未在本部分中的特定要求中進(jìn)行說明。替換:本專用標(biāo)準(zhǔn)的目的在于確定牙科設(shè)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(guī)定了非移動(dòng)的牙科治療機(jī)、牙科病人椅以及兩者組合的要求和測(cè)試方法,不論它們是否是電動(dòng)的。本文件還規(guī)定了使用說明書、技術(shù)說明書、標(biāo)記和包裝的要求。本文件不適用于醫(yī)師椅、可攜帶的牙科設(shè)備和口腔燈。
本標(biāo)準(zhǔn)規(guī)定了口腔醫(yī)療保健人員工作區(qū)域內(nèi)牙科設(shè)備位置信息系統(tǒng),在這些工作區(qū)域內(nèi)可以進(jìn)行直接和患者有關(guān)的診斷、治療和其他臨床操作。本信息系統(tǒng)提供了描述牙科設(shè)備所處位置一般信息的方法,以及描述該設(shè)備及其附件空間的靈活性和適應(yīng)性特征的方法。此外,本標(biāo)準(zhǔn)提供了該區(qū)域所使用的牙科設(shè)備一般術(shù)語(yǔ)的定義。
本標(biāo)準(zhǔn)規(guī)定了預(yù)期需要消毒的牙科設(shè)備外表面材料耐受化學(xué)消毒劑特性的確定的三種試驗(yàn)方法:浸泡試驗(yàn)、噴霧試驗(yàn)、接觸試驗(yàn)。選擇使用何種試驗(yàn)方法由試驗(yàn)者自行決定。本標(biāo)準(zhǔn)未涉及消毒劑對(duì)細(xì)菌、病毒、真菌的有效性。本標(biāo)準(zhǔn)未規(guī)定試驗(yàn)材料在耐受試劑試驗(yàn)時(shí),所受應(yīng)力對(duì)測(cè)定可能產(chǎn)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.