<p class="MsoNormalCxSpFirst" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">美国食品药品监督管理局（<span lang="EN-US">FDA</span>，<span lang="EN-US">Food and Drug Administration</span>）是由美国国会授权，专门从事食品与药品管理的最高执法机关，其职责是确保美国本国生产或进口的食品、化妆品、药物、
生物制剂、医疗设备和放射产品的安全。<span lang="EN-US">FDA</span>是最早以保护消费者为主要职能的联邦机构之一，在美国乃至全球都有极其巨大的影响，有<span lang="EN-US">“</span>美国人健康守护神<span lang="EN-US">”</span>之称，它的信誉和专业水准深得诸多专家和广大民众的信赖，许多国家都通过寻求和接收<span lang="EN-US">FDA</span>的帮助来促进并监控其本国产品的安全。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">1968</span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">年，美国联邦政府发布了《<span lang="EN-US">Radiation Control for Health and Safety Act</span>，控制辐射、确保健康安全法》，奠定了对具有辐射的电子产品进行控制、检验、监督、管理的法律基础。该法律的目的在于保护公众不受不必要的电子产品辐射的伤害。为此，<span lang="EN-US">FDA</span>制定了有关电子产品辐射的有关性能标准，强制要求进入美国市场的辐射性电子产品都必须符合有关的性能标准。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">FDA</span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">对辐射性照明设备的要求主要收录在美国联邦法规<span lang="EN-US">21 CFR part 1040</span>中，要求照明设备中具有辐射性的太阳灯、杀菌灯、<span lang="EN-US">X</span>射线指示灯、手术灯、荧光灯、水银蒸汽灯、卤素灯和激光灯都必须满足<span lang="EN-US">FDA</span>的要求。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">1. </span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">产品进口的检验监管及违规处罚<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">FDA</span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">要求辐射性产品的外国生产厂在其产品销往美国之前，应向<span lang="EN-US">FDA </span>提交有关规定的材料，然后由<span lang="EN-US">FDA</span>赋予一个<span lang="EN-US">7 </span>位数字的注册号码。进口商在辐射性产品进口通关时除向海关申报以外，还必须以<span lang="EN-US">FDA
2877</span>表格<span lang="EN-US">(</span>电子产品申报表<span lang="EN-US">) </span>向<span lang="EN-US">FDA </span>申报。申报表除了需列明生产厂、进口商、产品等的有关信息外，还需要上述的<span lang="EN-US">FDA</span>的注册号。申报资料不全或不符合要求，都直接被<span lang="EN-US">FDA </span>拒之门外，即使海关批准放行也不能进入美国市场销售。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">除了对申报资料进行审核之外，<span lang="EN-US">FDA </span>还有权在其进入市场之前或之后进行取样、检验，以检查此进口产品是否确实符合有关法规的强制性要求，对违规产品<span lang="EN-US">FDA </span>将严格处理。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">FDA </span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">的处罚有两种：对违规产品的处罚有扣留、退回外国和就地销毁，与医疗器械类似，对违规电子产品也有<span lang="EN-US">“</span>自动扣留<span lang="EN-US">”</span>的制度；而对有意违规或假报资料，情节严重的，根据有关法律法规，可以罚款或判刑或两者兼有。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">2. </span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">辐射性照明设备的标签要求<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">(1) </span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">通用要求<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">产品生产商需在产品上刻写或设置固定标签，标签上需标示如下内容：<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">产品符合所执行的性能标准的声明；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">产品制造商的公司全名和地址（也可以同时标出公司名称的缩写）；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">生产地点和生产日期：生产地点可以用代码表示（当这个代码以前曾提供给<span lang="EN-US">FDA </span>医疗器械和辐射卫生中心时）<span lang="EN-US">, </span>生产日期不能使用代码或缩写，<span lang="EN-US">“</span>年<span lang="EN-US">”</span>用四位数字表示。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
auto;mso-add-space:auto;line-height:22.0pt;mso-line-height-rule:exactly;
layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">(2) </span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">特殊要求<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">a. </span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">太阳灯和太阳灯产品（<span lang="EN-US">21 CFR part 1040.20</span>）<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">太阳灯产品是一种把一个或多个紫外线灯合并起来，利用在空气中波长为<span lang="EN-US">200 ~400nm</span>的紫外线照射在人体上来晒黑皮肤的电子产品；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span style="font-size:12.0pt;
font-family:宋体;mso-bidi-font-family:宋体">所有标签需贴在使用者使用产品前最容易看到的外表面；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span style="font-size:12.0pt;
font-family:宋体;mso-bidi-font-family:宋体">每个太阳灯产品都需贴有标签：<span lang="EN-US">“</span>警告<span lang="EN-US">—</span>紫外线辐射危险，避免过度照射<span lang="EN-US">”</span>；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span style="font-size:12.0pt;
font-family:宋体;mso-bidi-font-family:宋体">此外，标签还必须包含：推荐暴露的身体姿势；做推荐暴露姿势的说明；推荐的暴露时间表；达到预期晒黑效果的总体时间安排；太阳灯中所使用的紫外线灯类型指示；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span style="font-size:12.0pt;
font-family:宋体;mso-bidi-font-family:宋体">在产品使用手册首页的显著位置必须同时再现标签中的信息。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">b. </span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">紫外线灯<span lang="EN-US">(21 CFR part 1040.20</span>）<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span style="font-size:12.0pt;
font-family:宋体;mso-bidi-font-family:宋体">紫外线灯是能产生在空气中波长为<span lang="EN-US">200</span>～<span lang="EN-US">400nm</span>紫外线辐射的灯；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
auto;mso-add-space:auto;line-height:22.0pt;mso-line-height-rule:exactly;
layout-grid-mode:both;mso-layout-grid-align:auto"><span style="font-size:12.0pt;
font-family:宋体;mso-bidi-font-family:宋体">所有标签需贴在使用者使用产品前最容易看到的外表面，且字体应使人容易识别；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span style="font-size:12.0pt;
font-family:宋体;mso-bidi-font-family:宋体">紫外线灯的标签上需标示：<span lang="EN-US">“</span>只能在有定时器的固定设备上使用<span lang="EN-US">”</span>；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">当紫外灯用于太阳灯产品上时，需标示：<span lang="EN-US">“</span>太阳灯<span lang="EN-US">—</span>危险<span lang="EN-US">—</span>有紫外线辐射，请遵守使用说明<span lang="EN-US">”</span>的字样。<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
auto;mso-add-space:auto;line-height:22.0pt;mso-line-height-rule:exactly;
layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">3. </span><span style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体">照明设备的辐射控制标准<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span style="font-size:12.0pt;
font-family:宋体;mso-bidi-font-family:宋体">太阳灯：用来将皮肤晒黑的产品。要求说明灯的互换性，基于紫外线辐射水平的最大暴露时间，精度为<span lang="EN-US">±10</span>％的定时器，保护眼罩，使用标签和说明等；<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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font-family:宋体;mso-bidi-font-family:宋体">高强度水银蒸汽放电灯：要求在泄漏或外壳破损后自动熄灭，并详细规定水银灯外包装和广告信息<span lang="EN-US"><o:p></o:p></span></span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:
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layout-grid-mode:both;mso-layout-grid-align:auto"><span lang="EN-US" style="font-size:12.0pt;font-family:宋体;mso-bidi-font-family:宋体"> </span></p><p style="text-align:justify;text-justify:inter-ideograph;line-height:22.0pt;
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