nykek5i 发表于 2024-8-4 06:17:34

口罩CE认证价格大涨（附出口指南）


    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">▍<span style="color: black;">源自</span>：国家海关总署 / 华夏时报等</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">▍整理：赛柏蓝器械-巧克力</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">熔喷布、额温枪，<span style="color: black;">此刻</span>轮到CE认证</strong></p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/c45ebc88600041a8b3133690e7fa380c~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=32MQN6SH82PyDPRNeBUayIYWvbU%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">从8000涨到28000</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">近期</span>据华夏时报<span style="color: black;">报告</span>，一家承接代理认证业务的商家<span style="color: black;">暗示</span>，口罩、防护服、护目镜、耳温枪等CE认证<span style="color: black;">花费</span>飙升，之前只要8000元，3月19号涨到25000元，3月20号涨到28000元。</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">以上</span>商家<span style="color: black;">叫作</span>，今年3月<span style="color: black;">她们</span><span style="color: black;">已然</span>接了100多单，<span style="color: black;">此刻</span>CE认证价格一天一涨，今天的报价<span style="color: black;">不可</span>算明天的价格。<span style="color: black;">另外</span><span style="color: black;">日前</span>CE认证<span style="color: black;">必须</span>两周<span style="color: black;">上下</span>，之前最多7个工作日。</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">据介绍，<span style="color: black;">以上</span>商家给出的FDA认证办理的报价为年费约3.7万元，代理费5000元。还有商家报出FDA认证办理代理费9000元人民币的价格。</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国内口罩供<span style="color: black;">不该</span>求时，熔喷布从每吨1.8万涨到52万，<span style="color: black;">此刻</span>国外疫情日益严重，口罩等防护用品<span style="color: black;">海量</span>出口，CE认证又<span style="color: black;">起始</span>涨价。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">关于CE认证的价格，国内某第三方检测服务<span style="color: black;">公司</span>官网<span style="color: black;">表示</span>，CE认证的<span style="color: black;">花费</span><span style="color: black;">重点</span>和<span style="color: black;">制品</span>和<span style="color: black;">选取</span>的<span style="color: black;">公司</span><span style="color: black;">相关</span>，<span style="color: black;">另一</span><span style="color: black;">是不是</span>加急等<span style="color: black;">亦</span>会影响报价。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">公司</span>越权威有名报价越贵，SGS、TUV、ITS等知名<span style="color: black;">公司</span>可能比普通<span style="color: black;">公司</span>报价多一倍以上。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">同期</span>CE认证<span style="color: black;">花费</span><span style="color: black;">亦</span>和<span style="color: black;">制品</span>本身<span style="color: black;">关联</span>，<span style="color: black;">通常</span><span style="color: black;">来讲</span>：</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">普通低压<span style="color: black;">制品</span>，收费较低，2000元起；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">普通高压<span style="color: black;">制品</span>，收费<span style="color: black;">通常</span>，大概几千元不等；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">无线<span style="color: black;">制品</span>，收费较高，<span style="color: black;">通常</span>几千到几万不等。</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/c45ebc88600041a8b3133690e7fa380c~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=32MQN6SH82PyDPRNeBUayIYWvbU%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">械企<span style="color: black;">制品</span>出口，基本都要CE认证</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国内械企的<span style="color: black;">制品</span>要出口到欧盟，大多都<span style="color: black;">必须</span>进行CE认证。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">据国内第三方检测服务<span style="color: black;">公司</span>介绍，CE认证是欧盟<span style="color: black;">相关</span>安全管控的认证，<span style="color: black;">保证</span><span style="color: black;">制品</span>最基本的安全<span style="color: black;">保证</span>，这是欧盟法律对<span style="color: black;">制品</span>提出的强制性<span style="color: black;">需求</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">在欧盟市场“CE”标志属强制性认证标志，不论是欧盟内部企业生产的<span style="color: black;">制品</span>，还是其他国家生产的<span style="color: black;">制品</span>，<span style="color: black;">想要</span>在欧盟市场上自由流通，就<span style="color: black;">必要</span>加贴“CE”标志，以<span style="color: black;">显示</span><span style="color: black;">制品</span>符合欧盟<span style="color: black;">关联</span>指令的<span style="color: black;">需求</span>。</strong></p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/ef57a8845af84b6581e3d032d6521994~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=RDMrYVrqZ4aBjsiRCryW8SZrYjY%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"> CE证书样本</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">CE认证的<span style="color: black;">制品</span>范围<span style="color: black;">包含</span>医疗器械、个人防护设备、体外诊断医疗设备、<span style="color: black;">测绘</span>仪器等<span style="color: black;">制品</span>。随着国内械企口罩、防护服等防护用品出口<span style="color: black;">增多</span>，对CE认证的需求<span style="color: black;">亦</span>在<span style="color: black;">持续</span>变大。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">如<span style="color: black;">近期</span>，蓝帆医疗在互动平台<span style="color: black;">暗示</span>，<span style="color: black;">机构</span><span style="color: black;">重点</span>出口医疗及防护手套，<span style="color: black;">日前</span>已收到美国、阿联酋、法国、英国等众多国家的订单。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">今年3月，迈瑞医疗<span style="color: black;">暗示</span>，意大利政府紧急向迈瑞医疗采购首批近万台抗疫设备，其中<span style="color: black;">重点</span>为监护仪、<span style="color: black;">呼气</span>机等<span style="color: black;">制品</span>，<span style="color: black;">机构</span>将<span style="color: black;">按照</span><span style="color: black;">状况</span>，分批有序交付。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3月11日，宝莱特在互动平台<span style="color: black;">暗示</span>，<span style="color: black;">机构</span><span style="color: black;">持续</span>接到来自疫情国家的订单，其中意大利一个订单就超过1000台高端监护仪。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">防护<span style="color: black;">制品</span>的出口在<span style="color: black;">增多</span>，<span style="color: black;">然则</span>国内CE认证<span style="color: black;">公司</span>有良莠不齐的<span style="color: black;">危害</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">据<span style="color: black;">认识</span>，权威国际知名<span style="color: black;">公司</span>如TUV、SGS、ITS等<span style="color: black;">颁布</span>的CE证书市场认可度较高，价格比较昂贵，测试标准流程相对严格，适合高<span style="color: black;">需求</span>的客户<span style="color: black;">选取</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">国内<span style="color: black;">关联</span><span style="color: black;">公司</span>数量众多，良莠不齐，械企在<span style="color: black;">必须</span>挑选有<span style="color: black;">必定</span>市场认可度的<span style="color: black;">公司</span>，避免实验室无资质的<span style="color: black;">公司</span>。</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">赛柏蓝器械<span style="color: black;">发掘</span>，淘宝中有不少商家<span style="color: black;">表示</span>，100元<span style="color: black;">就可</span>加急办理各国认证，<span style="color: black;">包含</span>口罩CE认证、护目镜FDA注册等。</strong></p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/c230ab05562044e5b589d47453f482c2~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=W5y3XR6gKrLTUOiFlwJApIsMabE%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/0f06bb57fa78417c95107d24ce42ec49~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=5tJOSNvHOmw6n3m7G1n4cCSAXIA%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/c45ebc88600041a8b3133690e7fa380c~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=32MQN6SH82PyDPRNeBUayIYWvbU%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">官方发布口罩出口指南</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">近期</span>国家海关总署官方<span style="color: black;">微X</span>公众号<span style="color: black;">暗示</span>，企业频繁咨询防护物资出口政策，结合国内外新冠肺炎疫情防控趋势等<span style="color: black;">原因</span>，发布口罩出口<span style="color: black;">关联</span>指南。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">防控物资出口通关<span style="color: black;">需求</span>及收集整理的口罩等国外<span style="color: black;">重点</span>技术性贸易<span style="color: black;">办法</span>提示如下：</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/f9160660dd0d4486aef587b86db18095~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=NMAAqY0B7JPgqU4GdS%2FlJbTY3jw%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">↓↓↓以下内容是<span style="color: black;">按照</span>国内外<span style="color: black;">关联</span>↓↓↓</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">政府<span style="color: black;">公司</span>、专业网站、<span style="color: black;">资讯</span><span style="color: black;">报告</span></strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">收集整理而成，仅供参考。<span style="color: black;">详细</span>内容以</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">关联</span>管理部门、国外官方<span style="color: black;">公司</span><span style="color: black;">需求</span>为准。</strong></p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/f9160660dd0d4486aef587b86db18095~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=NMAAqY0B7JPgqU4GdS%2FlJbTY3jw%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">出口前准备</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国外<span style="color: black;">根据</span>用途<span style="color: black;">通常</span>分为个人防护和医用两类口罩。</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/dc2d7e94d79143b0aa06631159a8721b~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=63GS4cXSmLouSMzkH0FAGV1Gd%2BQ%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1．营业执照（经营范围有<span style="color: black;">关联</span>经营内容）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2．企业生产许可证（生产企业）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3．<span style="color: black;">制品</span>检验报告（生产企业）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4．医疗器械注册证（非医用不<span style="color: black;">必须</span>）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5．<span style="color: black;">制品</span>说明书（跟着<span style="color: black;">制品</span><span style="color: black;">供给</span>）、标签（随附<span style="color: black;">制品</span><span style="color: black;">供给</span>）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6．<span style="color: black;">制品</span>批次/号（外包装）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7．<span style="color: black;">制品</span>质量安全书或合格证（跟着<span style="color: black;">制品</span><span style="color: black;">供给</span>）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">8．<span style="color: black;">制品</span>样品<span style="color: black;">照片</span>及外包装<span style="color: black;">照片</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">9．贸易<span style="color: black;">机构</span>须取得海关收发货人注册备案。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">生产个人防护<span style="color: black;">或</span>工业用非医疗器械管理的普通口罩，有进出口权的企业，可<span style="color: black;">自动</span>直接出口。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">生产属于医疗器械管理的口罩用于出口，中国海关不<span style="color: black;">必须</span>企业<span style="color: black;">供给</span><span style="color: black;">关联</span>资质证明文件，但<span style="color: black;">通常</span>进口国会<span style="color: black;">需求</span>生产企业提供<span style="color: black;">制品</span>三证，以证明该进口的商品在中国已合法上市，<span style="color: black;">详细</span>如下：</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1.营业执照（经营范围<span style="color: black;">包括</span>有医疗器械<span style="color: black;">关联</span>，非医疗级别的物品不<span style="color: black;">必须</span>）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2.医疗器械<span style="color: black;">制品</span>备案证<span style="color: black;">或</span>注册证。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. 厂家检测报告。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">生产企业有进出口权，<span style="color: black;">能够</span><span style="color: black;">自动</span>出口，如<span style="color: black;">无</span>进出口权，<span style="color: black;">能够</span><span style="color: black;">经过</span>外贸代理进行出口<span style="color: black;">营销</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1. 向市场监管<span style="color: black;">分部</span>取得营业执照，<span style="color: black;">增多</span>经营范围“货物进出口、技术进出口、代理进出口”。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2. 向商务<span style="color: black;">分部</span>取得进出口权，可直接在商务部业务系统统一平台（</p>http://iecms.mofcom.gov.cn/）申请，网上提交材料。

    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. 向外汇管理局申请取得开设外汇账户许可。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4. 办理进出口货物收发货人海关注册登记。</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/f9160660dd0d4486aef587b86db18095~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=NMAAqY0B7JPgqU4GdS%2FlJbTY3jw%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">各国口罩准入<span style="color: black;">要求</span></strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">制品</span>准入<span style="color: black;">要求</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">美国</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">必要</span>取得美国 NIOSH检测认证，即National Institute for Occupational Safety and Health美国国家职业安全卫生<span style="color: black;">科研</span>所认证。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">须取得美国FDA注册许可。</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p26-sign.toutiaoimg.com/pgc-image/4d30fa3a080643fa9222817870eef915~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=kVGo0WgPLrO%2FhA2zAMy5HqmwswI%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">欧盟</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">个人防护口罩的欧盟标准是EN149，<span style="color: black;">根据</span>标准将口罩分为FFP1/FFP2和FFP3三个类别。所有出口欧盟的口罩<span style="color: black;">必要</span><span style="color: black;">得到</span>CE认证证书。CE认证是欧盟实行的强制性<span style="color: black;">制品</span>安全认证制度，目的是为了<span style="color: black;">保证</span>欧盟国家人民的生命财产安全。</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p26-sign.toutiaoimg.com/pgc-image/1f0b491749684de39a42799f8c6f336d~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=Jzhok1yZ9APQwcfVMSjLCabBlC8%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">医用口罩对应的欧盟标准是EN14683。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">制品</span>在欧盟<span style="color: black;">营销</span><span style="color: black;">必须</span>出具欧盟自由<span style="color: black;">营销</span>证书 Free Sale Certificate，有了CE标志并进行了<span style="color: black;">关联</span>指令中<span style="color: black;">需求</span>的欧盟注册后，中国的制造商出口欧盟不<span style="color: black;">必须</span>自由<span style="color: black;">营销</span>证书。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">日本</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票，日本国外的制造商<span style="color: black;">必要</span>向PMDA注册制造商信息。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">包装上印有ウィルスカット（中文翻译：病毒拦截）99%的字样</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">PFE：0.1um微粒子颗粒过滤效率</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">BFE：细菌过滤率</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">VFE：病毒过滤率</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/38c1afceacb64e468b7ddbbaa8d10a96~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=98ym9wXUogILEgf4ZhdEfZH%2B63M%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1. 医用防护口罩：符合中国GB 19083-2010 强制性标准，过滤效率≥95%（<span style="color: black;">运用</span>非油性颗粒物测试）。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2. N95口罩：美国NIOSH认证，非油性颗粒物过滤效率≥95%。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. KN95口罩：符合中国GB 2626 强制性标准，非油性颗粒物过滤效率≥95%。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">韩国</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票，韩国进口商营业执照。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">KF (Korean filter) 系列分为KF80、KF94、KF99</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/0b01d376d31c4e50a065037a2063ff7e~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=ROTLXMfbohr0DZ50%2FFVjaYH8pcA%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/80135843153448a5a069a9768412dc72~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=rlEH3BaaqYvBFOCnkSC%2BF1AQ4hQ%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">MFDS Notice No. 2015-69</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">韩国医疗器械准入的法规门槛</strong>，基本<span style="color: black;">归类</span>为I、II、III、IV类，持证为韩国<span style="color: black;">机构</span>（License holder），韩国收货人<span style="color: black;">必须</span>到韩国药监局Korea Pharmaceutical Traders Association. 提前备案进口资质（<span style="color: black;">无</span>不行）网址：www.kpta.or.kr。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">澳大利亚</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">须<span style="color: black;">经过</span>澳洲的<strong style="color: blue;">TGA注册</strong>，符合标准规范：AS/NZS 1716：2012，此规范是澳大利亚和新西兰的<span style="color: black;">呼气</span><span style="color: black;">守护</span><span style="color: black;">安装</span>标准。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">TGA </strong>是Therapeutic Goods Administration的简写，全<span style="color: black;">叫作</span>是治疗商品管理局，它是澳大利亚的治疗商品（<span style="color: black;">包含</span><span style="color: black;">药品</span>、医疗器械、基因科技和血液制品）的监督<span style="color: black;">公司</span>。澳大利亚对医疗器械分为I类，Is and Im， IIa, IIb, III类，<span style="color: black;">制品</span>的<span style="color: black;">归类</span>几乎和欧盟<span style="color: black;">归类</span>一致，<span style="color: black;">倘若</span><span style="color: black;">制品</span><span style="color: black;">已然</span><span style="color: black;">得到</span>CE标志，则<span style="color: black;">制品</span>类别<span style="color: black;">能够</span><span style="color: black;">根据</span>CE<span style="color: black;">归类</span>。</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/805bae99ee1e463f8dc5869b30e8eb01~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=dWhOZBx9EUQtA5JklOBcN9xUogo%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">各国注册、认证简要办理流程</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">美国NIOSH认证</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">需<span style="color: black;">根据</span>NIOSH的指南实施，企业需寄送样品至NIOSH实验室实施测试，<span style="color: black;">同期</span>提交技术性资料（<span style="color: black;">包含</span>质量体系部分资料）至NIOSH文审，<span style="color: black;">仅有</span>文审和测试都<span style="color: black;">经过</span>，NIOSH才核发批文。NIOSH将其认证的防颗粒物口罩分为9类，<span style="color: black;">详细</span>的测试则由NIOSH下属的NPPTL (National Personal Protective Technology Laboratory)实验室操作。<span style="color: black;">重点</span>测试指标<span style="color: black;">包含</span>呼气阻力测试、呼气阀泄漏测试、吸气阻力测试、过滤效率测试。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">美国FDA注册</strong></p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/1c394e67d9f1459198d835b8ba1647d6~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=qNfWWqA1sihQimpppjyXNcG5ZLQ%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">欧盟CE注册</strong></p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/6351e622f07e425eb5bc72ef00d3e681~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=d5qyywNX30Tdx8JMGBwzLkmADOc%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">日本PMDA注册</strong></p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/b25e7ea1c2a24b5c99276fe405957dd0~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=9PWwVLhH4Utxk4ezPOQQr7spu7Q%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1. 准备<span style="color: black;">周期</span>。确定<span style="color: black;">制品</span><span style="color: black;">归类</span>（I,II特殊<span style="color: black;">掌控</span>，II类<span style="color: black;">掌控</span>,III,IV）和<span style="color: black;">制品</span>JMDN编码，<span style="color: black;">选取</span>MAH（日本持证方）；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2. 制造商向PMDA注册工厂；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. II类特殊<span style="color: black;">掌控</span><span style="color: black;">制品</span>向授权认证<span style="color: black;">公司</span>PCB申请QMS工厂审核，其他II类<span style="color: black;">制品</span>和III类IV类<span style="color: black;">制品</span>向PMDA申请QMS工厂审核，并<span style="color: black;">得到</span>QMS证书；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4. 申请Pre-Market Apporval证书，II类特殊<span style="color: black;">掌控</span>由PCB发证，其他II类<span style="color: black;">制品</span>和III类IV类<span style="color: black;">制品</span><span style="color: black;">掌控</span>由MHLW（厚生劳动省）发证；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5. 支付申请<span style="color: black;">花费</span>；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6. 注册文件整改，注册<span style="color: black;">准许</span>；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7. 所有类别<span style="color: black;">制品</span>均<span style="color: black;">必须</span>MAH向RBHW（厚生省地区<span style="color: black;">公司</span>）进行进口通报注册后<span style="color: black;">才可</span>进口<span style="color: black;">营销</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">韩国KFDA注册</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">韩国卫生福利部（</p>MinistryofHealthandWelfare，MHW），简<span style="color: black;">叫作</span>卫生部，<span style="color: black;">重点</span>负责管食品、<span style="color: black;">药物</span>、<span style="color: black;">打扮</span>品和医疗器械的管理，是最<span style="color: black;">重点</span>的卫生保健<span style="color: black;">分部</span>。<span style="color: black;">按照</span>《医疗器械法》，韩国卫生福利部下属的食品<span style="color: black;">药物</span>安<span style="color: black;">所有</span>负责对医疗器械的监管工作。KFDA注册流程为：
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1. 确定<span style="color: black;">制品</span><span style="color: black;">归类</span>（I,II,III,IV），<span style="color: black;">选取</span>KLH(韩国持证方)；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2. II类<span style="color: black;">制品</span>需申请KGMP证书和接受现场审核，II类<span style="color: black;">制品</span>一般是授权的第三方审核员，并<span style="color: black;">得到</span>KGMP证书；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. II类<span style="color: black;">制品</span><span style="color: black;">必须</span>送样品到韩国MFDS授权的实验室进行韩国标准的测试；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4. 由KLH向MFDS（韩国食品<span style="color: black;">药物</span>安<span style="color: black;">所有</span>）提交技术文件（检测报告，KGMP证书等），进行注册审批；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5. 支付申请<span style="color: black;">花费</span>；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6. 注册文件整改，注册<span style="color: black;">准许</span>；</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7. 指定韩国代理商和经销商，产品<span style="color: black;">营销</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">澳大利亚TGA注册</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">依据Australian Therapeutic Goods (Medical Devices) Regulations 2002，澳大利亚对医疗器械分为I类，Is and Im， IIa, IIb, III类，<span style="color: black;">制品</span>的<span style="color: black;">归类</span>几乎和欧盟<span style="color: black;">归类</span>一致，<span style="color: black;">倘若</span><span style="color: black;">制品</span><span style="color: black;">已然</span><span style="color: black;">得到</span>CE标志，则<span style="color: black;">制品</span>类别<span style="color: black;">能够</span><span style="color: black;">根据</span>CE<span style="color: black;">归类</span>。<span style="color: black;">倘若</span><span style="color: black;">已然</span><span style="color: black;">得到</span>欧盟公告<span style="color: black;">公司</span>（Notified Body）签发的CE证书，是<span style="color: black;">能够</span>被TGA认可的，并<span style="color: black;">能够</span><span style="color: black;">做为</span>满足澳大利亚安全法规的重要注册资料。</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/3702d1bc61c946bb8dec683153b4112d~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=PoMCItBq7ujZD52LzwmHrXcf0pg%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/f9160660dd0d4486aef587b86db18095~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=NMAAqY0B7JPgqU4GdS%2FlJbTY3jw%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">各国口罩技术标准对比</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（供生产企业参考）</p>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/c52b2ba6c82242e2bcedbb02a5b2fd9a~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=K%2Fl9wVFpDB%2FfdO%2BG%2BOcqmok17Wo%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/d890312043364140906ee01d453fe313~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=HDfq7bFkEqnwlnSp%2FAc3JXeR9zY%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p6-sign.toutiaoimg.com/pgc-image/805b8ab49a0c4e5c87ba5cdc59bc26d0~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=yvdNLS%2FRc%2FzuqgsZwvSTzvHhnmg%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/f9160660dd0d4486aef587b86db18095~noop.image?_iz=58558&amp;from=article.pc_detail&amp;lk3s=953192f4&amp;x-expires=1723310132&amp;x-signature=NMAAqY0B7JPgqU4GdS%2FlJbTY3jw%3D" style="width: 50%; margin-bottom: 20px;"></div>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">各国口罩技术标准</strong></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（供生产企业参考）</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">序号</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">标准号</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">标准名<span style="color: black;">叫作</span></p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">状态</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">发布时间</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国际</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">ISO 22609：2004</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">传染试剂防护服.医疗面罩.防人造血渗透的<span style="color: black;">实验</span><span style="color: black;">办法</span>(固定容积,水平注射)</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2004/12/3</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">欧盟</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">EN 136-1998</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span><span style="color: black;">守护</span><span style="color: black;">安装</span>.全面罩.<span style="color: black;">需求</span>,<span style="color: black;">实验</span>,标记。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1998/1/1</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">EN 140-1998+AC-1999</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span><span style="color: black;">守护</span><span style="color: black;">安装</span>.半面罩和四分之一面罩.<span style="color: black;">需求</span>,<span style="color: black;">实验</span>和标记。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1998/9/1</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">EN 143-2000</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span>防护<span style="color: black;">安装</span>.微粒过滤器.<span style="color: black;">需求</span>,<span style="color: black;">实验</span>,标记。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2000/2/1</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">EN 149-2001</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span>防护<span style="color: black;">安装</span>.颗粒防护用过滤半面罩.<span style="color: black;">需求</span>,检验和标记。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2001/4/1</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">EN 529-2005</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span><span style="color: black;">守护</span><span style="color: black;">安装</span>.<span style="color: black;">选取</span>,<span style="color: black;">运用</span>,保养和维修的<span style="color: black;">意见</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2005</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">EN 12942-1998</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span><span style="color: black;">守护</span>器.带全面罩,半面罩和四分之一面罩的鼓风过滤<span style="color: black;">安装</span>.<span style="color: black;">需求</span>,检验,标识。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1998</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">EN 14387-2004+A1-2008</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span><span style="color: black;">守护</span><span style="color: black;">安装</span>.气体过滤器和组合过滤器.<span style="color: black;">需求</span>、测试、标记。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2004/1/1</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">EN 14683-2019</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">医用口罩 <span style="color: black;">需求</span>和<span style="color: black;">实验</span><span style="color: black;">办法</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2019/3/1</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">美国</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">ASTM F1862/F1862M-2017</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">医用口罩抗人工合成血渗透的标准<span style="color: black;">实验</span><span style="color: black;">办法</span>(已知速度下固定体积的水平投影)。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2017</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">ASTM F2100-2019</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">医用口罩材料性能标准规范。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2019</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">ASTM F2101-2019</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">用金黄色葡萄球菌生物气溶胶<span style="color: black;">评估</span>医用口罩材料的细菌过滤效率(BFE)的标准<span style="color: black;">实验</span><span style="color: black;">办法</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2019</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">ASTM F2299/F2299M-2003(2017)</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">用胶乳球测定医用面具材料粒子渗透性初始效率的标准<span style="color: black;">实验</span><span style="color: black;">办法</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2003</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">澳大利亚</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">AS/NZS 1715:2009</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span><span style="color: black;">守护</span>设备的<span style="color: black;">选取</span>，<span style="color: black;">运用</span>和<span style="color: black;">守护</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2009/2/6</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">AS/NZS 1716:2012</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span><span style="color: black;">守护</span><span style="color: black;">安装</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2012/2/13</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">日本</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">JIS T 8062:2010</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">预防传染性病原体的防护服.面罩.防止人造<span style="color: black;">血液</span>渗透的<span style="color: black;">实验</span><span style="color: black;">办法</span>(确定容量,平行注射)。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2010/5/25</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">JIS T 8159:2006</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span>防护设备的<span style="color: black;">选取</span>、<span style="color: black;">运用</span>和<span style="color: black;">守护</span>指南。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2006/4/25</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">JIS T 8159:2006</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">呼气</span><span style="color: black;">守护</span><span style="color: black;">安装</span>泄漏率<span style="color: black;">实验</span><span style="color: black;">办法</span>。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2006/2/20</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">韩国</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">KS M 6673-2008</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">防尘口罩</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2008/2/22</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">KS K ISO 22609-2018</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">传染试剂防护服.医疗面罩.防人造血渗透的<span style="color: black;">实验</span><span style="color: black;">办法</span>(固定容积、水平喷射)。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">现行</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2018/11/14</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">*以上技术标准如有动态<span style="color: black;">调节</span>，以<span style="color: black;">关联</span>标准管理<span style="color: black;">公司</span>官方发布为准。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">— END —</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">严正声明</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1.本文版权归赛柏蓝器械（ID：medchina）所有。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2.<span style="color: black;">媒介</span>与其他公众号欲转载稿件，请务必<span style="color: black;">经过</span>文末留言提出申请，经回复许可后方可转载。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3.转载须在“标题下+正文前”位置标注<span style="color: black;">源自</span>、作者。</p>
    <p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4.未经授权删减转、截图转、用于<span style="color: black;">商场</span>用途、不<span style="color: black;">根据</span><span style="color: black;">需求</span>标明<span style="color: black;">源自</span>和作者，一律追责与投诉到底。</p>




nykek5i 发表于 2024-11-13 17:54:26

期待楼主的下一次分享！”

nykek5i 发表于 4 天前

你的留言真是温暖如春，让我感受到了无尽的支持与鼓励。

j8typz 发表于 前天 04:32

期待你更多的精彩评论，一起交流学习。
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