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<section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><section><section><section><section><section><section><p>从KN30到KN100,六个等级<br /></p></section></section></section></section></section></section><p><br /></p><section><section><section><section><em>0<em>1</em></em></section><section><section>口罩熔喷布标准,最新发布</section></section></section></section></section><p> <span></span></p><p><span>4月24日,根据江苏省市场监督管理局消息,江苏省纺织工业协会正式发布团体标准《口罩用聚丙烯熔喷非织造布》(T/JSFZXH001-2020),<span>将于4月26日正式实施。</span></span></p><p><span> </span></p><p><p><img src="image/20201014/4e3a8c3f4d111ac1c854a5a64496c89c_2.png" /></p></p><p><span> </span></p><p><span>该标准是全国首次发布口罩用熔喷布团体标准,主要适用于卫生防护用口罩熔喷布,由团体成员按照约定采用,并供社会自愿采用。</span></p><p><span> </span></p><p><span>江苏省市监局消息显示,此次发布的团体标准围绕口罩用聚丙烯熔喷非织造布,规定了原料要求、产品分级、基本技术要求、专项技术要求、检验判定方法,并对产品标识提出了明确要求。</span></p><p><span> </span></p><p><span>团体标准的主要技术指标包括颗粒物过滤效率、细菌过滤效率、断裂强力、单位面积质量偏差率以及外观质量要求。</span></p><p><span> </span></p><p><span>该标准规定了如下内容:</span></p><p><span> </span></p><p><span>第一,根据产品过滤效率水平对产品给出了分级,分为KN30、KN60、KN80、KN90、KN95、KN100共 6个等级。</span></p><p><span> </span></p><p><span>第二,对使用的原料作出规定,应符合《塑料聚丙烯(PP)熔喷专用料》(GB/T 30923-2014)要求,限制了有毒有害物质的使用。</span></p><p><span> </span></p><p><span>第三,针对不同过滤效率水平所对应的颗粒物过滤效率和细菌过滤效率提出具体要求,以满足不同类别口罩对熔喷布的要求。</span></p><p><br /></p><section><section><section><section><em>02</em></section><section><section>熔喷布质量参差不齐,85级别以上很少见</section></section></section></section></section><p><span> </span> </p><p><span>据了解,熔喷布具有孔径小、孔隙率高、过滤效率高等特点,作为口罩生产的核心材料,当前需求远远大于供给。</span></p><p><span><br /></span></p><p><span>本次团体标准发布之前,我国有2项熔喷布相关行业标准,分别是《纺粘/熔喷/纺粘(SMS)法非织造布》(FZ/T 64034-2014)和《熔喷法非织造布》(FZ/T 64078-2019)。</span></p><p><span><br /></span></p><p><span>前者适用于以丙纶为主要原料,以热轧粘合方式加固的SMS产品;后者适用于以熔喷法生产的非织造布,<span>最终用途不限于口罩,标准仅对幅宽、单位面积质量等提出要求,过滤效率、透气率等关键指标的标准值规定由供需合同约定。</span></span></p><p><span><br /></span></p><p><span>目前市场中,企业组织熔喷布生产主要依据企业标准,但相关指标规定参差不齐。</span></p><p><span><br /></span></p><p><span>扬中市某熔喷布生产商曾表示,扬中市200多家生产熔喷布的企业,没有一家有检测报告。</span></p><p><span><br /></span></p><p><span>若客户有需求,只能根据厚度、均匀度等现场判断熔喷布质量,如果在生产口罩过程中发现熔喷布质量问题,他们概不负责,因为已当面验过货。</span></p><p><span><br /></span></p><p><span>4月23日,扬中市另一家熔喷布经营商负责人表示,现在市场中的熔喷布质量参差不齐,劣质品居多,基本都没有检测报告,想知道质量怎么样只能现场看,具体质量等级需要自己用设备检测。</span></p><p><span><br /></span></p><p><span>赛柏蓝器械获悉,近日不少医疗器械资源交流群中经常见到类似“95-175-25熔喷布”的描述,95指熔喷布防护效果级别,175指熔喷布宽度175mm,25指每平方米重量25g。</span></p><p><span><br /></span></p><p><span>但是上述负责人表示,<span>市场中85级别以上的熔喷布基本没有了,全被收了。“从普通厂家买的熔喷布,级别能有60都算好的,有厂家试过,用65级别的机器,加上比较好的熔喷料,可以生产出来接近80级别的熔喷布,但是这个级别也要自己去检测。”</span></span></p><p><span><span><br /></span></span></p><p><span> </span></p><section><section><section><section><em>03</em></section><section><section>扬中市熔喷布企业,即将复产</section></section></section></section></section><p> <span></span></p><p><span>除了上述《口罩用聚丙烯熔喷非织造布》团体标准的发布,近日据新华报业集团下属交汇点新闻报道,扬中市市场监管局相关负责人表示,扬中已谋划制定了《熔喷布生产经营企业生产经营规范》。</span></p><p><span><br /></span></p><p><span>同时,扬中市一批熔喷布生产企业或即将复产。</span></p><p><span><br /></span></p><p><span>上述扬中市市监局负责人表示,<span> 扬中市部分生产环境好、设备规格高的企业主动提档升级,准备投资数百万甚至数千万,购置标准化、规范化、自动化的专业设备,规范提升熔喷布生产水平。</span></span></p><p><span><br /></span></p><p><span><span>“现在有10多家企业提出申请,购买先进生产线,提档升级熔喷布生产。”</span>扬中市市监局相关负责人说。</span></p><p><span><br /></span></p><p><span>据了解,受熔喷布市场刚性需求带动,3月下旬开始,扬中熔喷布生产经营企业数量快速上升。</span></p><p><span><br /></span></p><p><span>4月1日开始,扬中市正式开展熔喷布行业规范化整治,对无证无照的,一律取缔;对生产条件或安全、环保等存在隐患的,停产整顿;虽然有证照,但生产不合格产品的,一律关停。</span></p><p><span><br /></span></p><p><span>到4月15日晚,扬中市对熔喷布行业实施休克疗法,全市所有熔喷布生产经营企业全面停产整顿。</span></p><p><span><br /></span></p><p><span>对于合规企业也被关停的问题,交汇点新闻报道显示,扬中市针对部分依法合规、定位较高的生产企业,按照“规范提升一批”的思路,通过与上级市场监管、应急管理等部门沟通对接,已制定适用本地区的企业生产经营规范,同时开展点对点的精准企业服务。</span></p><p><br /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br /></section></section><section 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