醫(yī)用口罩產(chǎn)品注冊技術(shù)審查指導(dǎo)原則范文(存儲版)
【正文】 mm must be not greater than 8% diameter of 200 mm or less shall not be greater than 6%. Wall thickness of the pipe wall thinning rate must not exceed the original 15%. Crease roughness: diameter 125 mm or less, shall not exceed 3 mm diameter less than or equal to 200 mm, not more than 4 mm. simmering bending production of square steel tube extension, to use the whole tube bending. Interface if necessary, the welding position should be located in the middle of the vertical arm. install expansion joints should be done. If design is not required, pipe pensator lengthen should conform to the requirements in the following table: square scale length δ x is equal to 1/2. Pre stretch tolerance: casing + 5 mm, +10 mm. pipe form, location, spacing shall meet the design and specifications. piping on back or return pipe at higher levels of the upper to automatic valve to install a drain valve below the horizontal parts. supports and hangers of checks and the number 1) hanger installed must be checked before installation of supports and hangers part models, specifications of springs setting values, whether the materials meet the requirements of drawings and documents。（二）產(chǎn)品技術(shù)報(bào)告要求 應(yīng)關(guān)注醫(yī)用口罩的質(zhì)量控制要求，主要包括過濾材料和生產(chǎn)工藝。（十二）注冊單元?jiǎng)澐值脑瓌t醫(yī)用口罩產(chǎn)品的注冊單元原則上以技術(shù)結(jié)構(gòu)、性能指標(biāo)和預(yù)期用途為劃分依據(jù)。型式檢驗(yàn)應(yīng)為產(chǎn)品標(biāo)準(zhǔn)的全性能檢驗(yàn)。針對產(chǎn)品的各項(xiàng)風(fēng)險(xiǎn)，企業(yè)應(yīng)采取應(yīng)對措施，確保風(fēng)險(xiǎn)降到可接受的程度。即所引用標(biāo)準(zhǔn)中的條款，是否在注冊產(chǎn)品標(biāo)準(zhǔn)中進(jìn)行了實(shí)質(zhì)性的條款引用。4. 靜電吸引沉積：粒子被過濾纖維的靜電作用產(chǎn)生的沉積。按照佩戴方式可以分為耳掛式、綁帶式或頭帶式。但是，審評人員需密切關(guān)注相關(guān)法規(guī)的變化，以確認(rèn)申報(bào)產(chǎn)品是否符合法規(guī)要求。本指導(dǎo)原則不作為法規(guī)強(qiáng)制執(zhí)行，不包括行政審批要求。2. 醫(yī)用口罩一般有以下幾種形式：按照面罩形狀可以分為平面形、鴨嘴形、拱形或折疊式等。大粒子、高密度、速度快時(shí)截留效果好。 其次對引用標(biāo)準(zhǔn)的采納情況進(jìn)行審查。企業(yè)在進(jìn)行風(fēng)險(xiǎn)分析時(shí)，至少應(yīng)考慮表2中的主要危害，企業(yè)還應(yīng)根據(jù)自身產(chǎn)品特點(diǎn)確定其他危害。出廠檢驗(yàn)項(xiàng)目至少應(yīng)有以下項(xiàng)目：外觀、結(jié)構(gòu)與尺寸、鼻夾、口罩帶、微生物指標(biāo)、環(huán)氧乙烷殘留量（若采用環(huán)氧乙烷滅菌）的要求。2. 醫(yī)用防護(hù)口罩除應(yīng)達(dá)到以上要求還應(yīng)包含：（1）應(yīng)注明使用前需進(jìn)行的檢查；（2）應(yīng)
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