官方发布最新口罩标准，儿童口罩国标首发！

admin · 发表于 2020-10-14 12:23:19

                  <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><p><span><strong><span>儿童口罩国标发布</span></strong></span></p><p><br  /></p><p><span>5月7日，根据市场监管总局消息，5月6日，市场监管总局（标准委）正式发布GB/T38880-2020《儿童口罩技术规范》推荐性国家标准，该标准自发布之日起实施。</span></p><p><br  /></p><p><p><img src="image/20201014/ef5f96a3874fc884f66096838f4837e9_2.png" /></p></p><p><br  /></p><p><span>《技术规范》推荐性国家标准规定了适用于6岁至14岁儿童用口罩的基本要求、外观质量和测试方法，同时提出了19项主要性能指标。</span></p><p><span> </span></p><p><span>防护性能方面，</span><span>儿童防护口罩要求颗粒物过滤效率不低于95%，防护效果不低于90%；儿童卫生口罩要求颗粒物过滤效率不低于90%，细菌过滤效率不低于95%</span><span>。</span></p><p><span> </span></p><p><span>舒适性能方面，考虑儿童生理发育阶段的呼吸特征，</span><span>儿童防护口罩要求呼气阻力和吸气阻力均不高于45Pa；儿童卫生口罩要求通气阻力不高于30Pa</span><span>。在口罩佩戴的舒适性方面，标准推荐采用可调节式口罩带。</span></p><p><br  /></p><section powered-by="gulangu"><section><p><img src="image/20201014/83938b8efaa3f5234bb5c83ddc1a5c97_3.png" /></p></section></section><section powered-by="gulangu"><section><p><span>图片来源：GBT 38880-2020 (儿童口罩技术规范)</span></p><p><br  /></p></section></section><p><strong><span>常用的N95 口罩的通气阻力通常都在 300 Pa 左右，高于适合儿童的通气阻力 10 倍之多。在儿童大量运动的时候佩戴，很容易让儿童产生呼吸困难，严重还可能发生窒息。</span></strong><span></span></p><p><br  /></p><p><span>安全性能方面，口罩应能安全牢固地罩住口、鼻、下颌，不应存在可触及的锐利尖端和锐利边缘，不应明显影响视野；口罩原材料不得使用再生料和可导致不良反应的材料，不应经过有氯漂白。</span></p><p><span> </span></p><p><span>要求口罩应配有呼吸阀的口罩，其呼吸阀应牢固不变形，内部件不应脱落；不应使用系带式口罩带；鼻夹应承受20次对折不断裂；口罩内层材料不应印花或染色。</span></p><p><span> </span></p><p><span>标准严格规定了有害物质残留，甲醛含量不高于20mg/kg；口罩外层的印花图案不应掉色，禁用可分解致癌芳香氨染料；环氧乙烷灭菌残留量不得高于2μg/g；不得检出可迁移性荧光增白物质。标准还规定了微生物指标应达到一次性卫生用品要求。</span></p><section><section><section><section><section><section><br  /></section><section powered-by="gulangu"><section><p><img src="image/20201014/b8651a081414f99ce10b22a2758f4954_4.png" /></p></section></section><section powered-by="gulangu"><section><p><span>图片来源：GBT 38880-2020 (儿童口罩技术规范)</span></p><p><br  /></p></section></section><section powered-by="gulangu"><p>色牢度是按照 1～5 个大级划分的，5 级为最高级，而标准对儿童口罩的耐干摩擦色牢度要求是大于等于 4 级，也就是说，如果使用过程中，仔细看发现口罩有一点点不明显的掉色，也是符合规范的，并不属于不合格产品。</p></section><section><br  /></section></section></section></section></section></section><p><span><strong><span>非医用口罩，质量标准提升</span></strong></span></p><p><br  /></p><p><span>除了要求儿童医用口罩技术规范，非医用口罩的出口质量标准也越来越严格。</span></p><p><span> </span></p><p><span>5月7日，市场监管总局官微也发布消息显示，所有口罩产品，出口前除了要符合出口地区（国家）的相关标准，也要符合我国的质量标准，否则不允许出口。</span></p><p><span> </span></p><p><span>对此，深圳市市场监管局组织相关技术机构编制《深圳市非医用口罩质量标准提升工作指引》，帮助相关企业合规生产，工作指引包括以下内容：</span></p><p><span> </span></p><p><span>在企业生产前须知：</span></p><p><span> </span></p><p><strong><span>一、取得经营资质</span></strong><span></span></p><p><span> </span></p><p><span>企业生产经营非医用口罩必须取得合法经营资质，主要有：取得营业执照；符合相应的经营范围，如生产、销售口罩等。</span></p><p><span> </span></p><p><strong><span>二、明确执行标准</span></strong><span></span></p><p><span> </span></p><p><span>1、明确拟生产非医用口罩的执行标准</span></p><p><span> </span></p><p><span>目前，我国现行有效的非医用口罩执行标准有：</span></p><p><br  /></p><p><p><img src="image/20201014/d2a726fb7ade9c1b0596c8d0033baa75_5.png" /></p></p><p><br  /></p><section 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