醫(yī)療材料 滅菌器和洗滌機消毒器檢測

醫(yī)療材料 滅菌器和洗滌機消毒器檢測項目報價？??解決方案？??檢測周期？??樣品要求？

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GB 4793.1-2007測量、控制和實驗室用電氣設(shè)備的安全要求 第1部分：通用要求

1.1．1 本部分適用的設(shè)備GB 4793的本部分規(guī)定了預(yù)定作用、工業(yè)過程用以及教育用的電氣設(shè)備的通用安全要求，當(dāng)在1．4的環(huán)境條件下使用時，這些符合下列a)～d)定義的任何一種設(shè)備可以配備計算裝置： a) 電氣試驗和測量設(shè)備 是指用電氣方法試驗、測量、指示或記錄一個或多個電量或非電量的設(shè)備，也包括非測量設(shè)備，如信號發(fā)生器、測量標(biāo)準(zhǔn)器、電源、換能器和發(fā)射機等。 注：除了設(shè)計成僅嵌裝在其他設(shè)備上的面板儀表外．所有指示和記錄用的電氣測量儀器(1．1．2的那些設(shè)備除外)均在GB 4793的范圍內(nèi)。嵌裝式面板儀表被認(rèn)為是元件，僅需要滿足GB 4793的相關(guān)要求，或者作為嵌裝這些儀表的設(shè)備的一個部件滿足其他標(biāo)準(zhǔn)。 b) 電氣控制設(shè)備 是指將一個或多個輸出量控制在特定量值的設(shè)備，而且每一個量值由手動設(shè)置、本地或遠(yuǎn)地編程，或者由一個或多個輸入變量來確定的。 c) 電氣實驗室設(shè)備 是指測量、指示、監(jiān)視或分析物質(zhì)的設(shè)備，或者用于制備材料的設(shè)備，包括體外診斷(IVD)設(shè)備。 這種設(shè)備也可用于實驗室以外的地方，例如自我檢查用的IVD設(shè)備就可以在家庭中使用。 d) 預(yù)定要與上述設(shè)備一起使用的附件(例如樣品處理設(shè)備)。1．1．2不包括在本部分范圍內(nèi)的設(shè)備 不適用于包括在下列標(biāo)準(zhǔn)范圍內(nèi)的設(shè)備： a) GB 8898(音頻、視頻及類似電子設(shè)備安全要求)； b) GB 4706(家用和類似用途電器的’安全)； c) GB 4943(信息技術(shù)設(shè)備的安全，但1．1．3規(guī)定的設(shè)備除外)； d)GB 9706(醫(yī)用電氣設(shè)備)； e) GB/T 15283(0．5、1和2級交流有功電度表)； f) GB l9212(電力變壓器、電源裝置和類似產(chǎn)品的安全)； g)IEC 60204(電氣機械控制裝置)； h)IEC 60364(建筑物電氣裝置)； i)IEC 60439-1(低壓開關(guān)裝置和控制裝置)。1．1．3 計算設(shè)備本部分僅適用于組成本部分范圍內(nèi)的設(shè)備的一部分或設(shè)計成僅與設(shè)備一起使用的計算機、處理器等。 注：在GB 4943范圍內(nèi)的并符合其要求的汁算裝置和類似設(shè)備被認(rèn)為適合與本部分范圍內(nèi)的設(shè)備一起使用。但是，GB 4943對防潮和防液體的某些要求沒有本部分嚴(yán)格。如果潮濕和液體引起的危險可能會影響符合GB 4943的設(shè)備，而且該符合GB 4943的設(shè)備如果又與符合本部分的設(shè)備一起使用，則使用說明要規(guī)定出所需要的任何附加的預(yù)防措施。

GB/T 16886.5-2017醫(yī)療器械生物學(xué)評價 第5部分:體外細(xì)胞毒性試驗

GB/T 16886的本部分描述了評定醫(yī)療器械體外細(xì)胞毒性的試驗方法。本部分規(guī)定了與器械和/或器械浸提液直接接觸或通過擴散的方式與培養(yǎng)細(xì)胞接觸的孵育方法。本部分適用于適宜的生物學(xué)參數(shù)體外測定哺乳動物細(xì)胞的生物學(xué)反應(yīng)。

NF C42-020-2-040-2015測量、控制和實驗室用電氣設(shè)備的安全要求.第2-040部分:處理醫(yī)療材料用滅菌器和清洗消毒器的特殊要求

Cet article de la Partie 1 est applicable, à l'exception de ce qui suit:

JS 61010-2-040-2010測量,控制和實驗室用電氣設(shè)備的安全要求.第2-040部分:處理醫(yī)療材料用滅菌器和清洗消毒器的詳細(xì)要求

This Standard specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. .

DIN 58946-7-2014消毒.蒸汽消毒器.第7部分:衛(wèi)生設(shè)施中用蒸汽消毒器建造的先決條件、服務(wù)和操作要求

This standard specifies requirements and the appropriate tests for the installation of steam sterilizers and their supply of resources. It also includes requirements for the environmental conditions and for the operator in the sterilization of medical devices with moist heat. NOTE 1 Some places of this standard indicate to any requirements of specific product information on the installation and operation of steam sterilizers. NOTE 2 Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may apply to other products, devices and applications. Sections 5.2, 5.4 and 5.8 of this standard are not usually on small sterilizers in accordance with DIN EN 13060 apply. This standard supports the requirements of DIN EN ISO 17665-1. NOTE 3 DIN EN 285 and DIN EN 13060 requiremen technical requirements and requirements for carrying out the tests for steam sterilizers for use in health care facilities. This draft standard contains no requirements relating to occupational safety and safeguards of the sterilizer. It assumes, however, that are designed to operate such facilities available and operational. NOTE 4 Attention is drawn to the Medical Devices Operator Ordinance and the Ordinance on Industrial Safety. This draft standard contains no requirements for technical properties and the use of failure-detection systems. NOTE 5 At the present time no generally accepted performance criteria for failure-detection systems. failure-warning systems are in practice also been referred to as eg \"Batch monitoring systems.\"

DIN 58948-7-2017消毒.低溫消毒器.第7部分:環(huán)氧乙烷消毒器及其電源的安裝和操作要求

This standard specifies requirements for the installation and operation of ethylene oxide sterilizers and their supply sources in accordance with DIN EN 1422 with one or more fixed operating cycles for use in health care facilities and industry This standard applies to the operation of ethylene oxide sterilizers (EO sterilizers), preferably for the sterilization of thermolabile medical devices. NOTE 1 For the requirements of fully automated EO sterilizers, see Technical Rules for Hazardous Substances (TRGS 513). NOTE 2 Although the scope of this standard is limited to medical devices, it establishes requirements and provides guidance that could also apply to other products, devices and fields of application. This standard is not applicable for the sterilization of liquids, pastes and powders.

DIN 58948-17-2016消毒.低溫消毒器.第17部分:低溫蒸汽甲醛和甲醛消毒器及其電源的安裝和操作用要求

This standard specifies requirements for the installation and operation of low temperature steam and formaldehyde sterilizers and their supply sources for use in health care facilities, primarily for the sterilization of thermolabile medical decvices.