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天然膠乳醫(yī)用手套檢測(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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本標(biāo)準(zhǔn)定義了橡膠工業(yè)所使用的術(shù)語(yǔ)。本標(biāo)準(zhǔn)不對(duì)預(yù)定用于特殊橡膠制品的術(shù)語(yǔ)進(jìn)行定義,對(duì)于這些術(shù)語(yǔ),請(qǐng)參見(jiàn)參考文獻(xiàn)所列標(biāo)準(zhǔn)。本標(biāo)準(zhǔn)不適用于特殊橡膠制品的術(shù)語(yǔ)和定義。有些術(shù)語(yǔ)在其定義前加有帶括號(hào)的說(shuō)明,以表明該術(shù)語(yǔ)專(zhuān)門(mén)限用于某一具體領(lǐng)域,例如“<膠乳>”。當(dāng)某一術(shù)語(yǔ)有一個(gè)或多個(gè)同義詞時(shí),這些術(shù)語(yǔ)的同義詞列于優(yōu)選術(shù)語(yǔ)之后。除非另有說(shuō)明,所有術(shù)語(yǔ)均為名詞。
本標(biāo)準(zhǔn)規(guī)定了膠乳制品主要技術(shù)用語(yǔ)及其定義。本標(biāo)準(zhǔn)適用于膠乳制品制修訂標(biāo)準(zhǔn)及編寫(xiě)技術(shù)文件、書(shū)刊時(shí)使用。
警告——本標(biāo)準(zhǔn)使用者應(yīng)熟悉一般實(shí)驗(yàn)室操作。本標(biāo)準(zhǔn)不涉及任何安全性問(wèn)題,即使是與它有關(guān)的也不例外,使用者應(yīng)建立相應(yīng)的安全和健康規(guī)范,并使之符合的規(guī)定。1 范圍 本標(biāo)準(zhǔn)規(guī)定了天然膠乳醫(yī)用手套水抽提蛋白質(zhì)含量的測(cè)定,也適用于其他天然膠乳制品中水抽提蛋白質(zhì)含量的測(cè)定,但抽提過(guò)程和次數(shù)沒(méi)有得到證實(shí),會(huì)隨試驗(yàn)樣品類(lèi)型不同而變化。附錄C介紹了醫(yī)用手套中幾種特種蛋白質(zhì)的其他測(cè)定方法,但不具有通用性。 本標(biāo)準(zhǔn)僅涉及分析方法,與取樣無(wú)關(guān),也不涉及測(cè)定結(jié)果的安全性或標(biāo)志要求。
本標(biāo)準(zhǔn)規(guī)定了醫(yī)用手套表面殘余粉末、水抽提蛋白質(zhì)的限量。本標(biāo)準(zhǔn)適用于一次性使用醫(yī)用橡膠手套、一次性使用滅菌橡膠外科手套、一次性使用醫(yī)用丁腈橡膠檢查手套、一次性使用聚氯乙烯醫(yī)用檢查手套和一次性使用非滅菌橡膠外科手套。
YY/T 0616的本部分規(guī)定了用以確定在其終包裝中、貯存在典型倉(cāng)貯條件下的醫(yī)用手套的貨架壽命的研究設(shè)計(jì)。本部分適用于所有由合成或天然乳膠制成的外科和檢查手套。
本標(biāo)準(zhǔn)是GB 7544的使用指南,規(guī)定了避孕套在開(kāi)發(fā)、生產(chǎn)、質(zhì)量認(rèn)證以及采購(gòu)時(shí)涉及的質(zhì)量問(wèn)題。本標(biāo)準(zhǔn)以避孕套在設(shè)計(jì)、生產(chǎn)以及流通環(huán)節(jié)的質(zhì)量管理體系為中心,強(qiáng)調(diào)避孕套的性能、安全和可靠性。
This International Standard specifies a method for the determination of the amount of water-extractable protein in natural rubber (NR) gloves for medical use. The method is potentially suitable for the determination of extractable protein in other articles made from NR latex; however the extraction procedures and times have not been validated and will vary with the type of article to be tested. Other methods for the determination of specific proteins in medical gloves exist (see Annex C) but they are not of general applicability.nThis International Standard is concerned solely with the method of assay. It is not concerned with sampling nor does it purport to address the safety implications of the values obtained or requirements for labelling.
This International Standard specifies a method for the determination of the amount of water-extractable protein in natural rubber (NR) gloves for medical use. The method is potentially suitable for the determination of extractable protein in other articles made from NR latex; however the extraction procedures and times have not been validated and will vary with the type of article to be tested. Other methods for the determination of specific proteins in medical gloves exist (see Annex C) but they are not of general applicability. This International Standard is concerned solely with the method of assay. It is not concerned with sampling nor does it purport to address the safety implications of the values obtained or requirements for labelling.
This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies therequirements for labelling and the disclosure of information relevant to the test methods used.This European Standard applies to existing, new and significantly changed designs. Existing designs that do notcurrently have ageing data available should generate that data within a reasonable period of time.This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associatedwith the distribution and control of very large lots. The recommended maximum individual lot size for production is500 000.
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