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<p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: ' ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">根据《医疗器械监督管理条例》：国家对医疗器械实行分类管理</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">第一类：按《产品质量法》，通过常规管理，足以保证其安全性、有效性的医疗器械（如血压计、打诊锤、氧气袋、消毒器等）。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">第二类：产品机制已取得国际、国内认可，技术成熟，其安全性、有效性必须加以控制的医疗器械（如电子体温表、脑或心电图、B超、胃镜、牙科设备等）</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">第三类：植入人体，或用于生命支持，或技术结构复杂、对人体可能具有潜在危险、安全性和有效性必须加以严格控制的医疗器械。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">1.任何材料制成的、植入人体的。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">2.放射性治疗设备。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">3.呼吸麻醉设备。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">4.体外循环设备。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">5.X线、CT、超声、正电子。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'ingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">6.接触在体血液、带介入治疗器具的超声显像设备，视同植入人体的产品。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'PingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">7.高压氧舱、婴儿培养箱、视同生命支持产品、</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'PingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">8.心血管内镜。</p><p style="margin-top: 1em; color: rgb(34, 34, 34); font-family: 'PingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei', 'WenQuanYi Micro Hei', 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 32px; white-space: normal; background-color: rgb(255, 255, 255);">9.仿真性辅助器具。</p><section class="pEditor " style="line-height: 25.6px; white-space: normal;"><section data-css="background-color: rgb(239, 239, 239);border-radius: 5px;border: 1px solid rgb(153, 153, 152);margin: 0px;padding: 5px" style="padding: 5px; border-radius: 5px; border: 1px solid rgb(131, 147, 209); text-align: center; background-color: rgb(239, 239, 239);"><section data-css="color: inherit;display: inline-block;margin: 1px" style="margin: 1px; color: inherit; display: inline-block;"><span style="padding: 2px 10px; border-color: rgb(204, 204, 204); border-radius: 2px; color: rgb(1, 1, 3); font-weight: bold; font-size: 18px; background-color: rgb(109, 205, 25);">推荐阅读</span></section><section data-css="color: inherit;margin: 0px;padding: 10px" style="padding: 10px; color: inherit;"><p style="line-height: 1.75em; text-align: left;"></p><ol class=" list-paddingleft-2" style="list-style-type: lower-alpha;"><li><p style="line-height: 1.75em; text-align: left;">没有了GPS,CMEF那些井喷的CT<br /></p></li><li><p style="line-height: 1.75em; text-align: left;">终于知道CT机为什么要按时保养了！<br /></p></li><li><p style="line-height: 1.75em; text-align: left;">哥卖的是技术，不是配件！请尊重我们的服务价值<br /></p></li><li><p style="line-height: 1.75em; text-align: left;">如果你有一个做医疗设备维修的朋友<br /></p></li><li><p style="line-height: 1.75em; text-align: left;">中国医疗器械维修企业推介（1）</p></li><li><p style="line-height: 1.75em; text-align: left;">做医疗器械维修 需具备哪些方面的素质和知识？<br /></p></li></ol></section></section></section><p></p><section class="pEditor " style="line-height: 25.6px; white-space: normal;"><section style="border: 0px; max-width: 100%; font-size: 16.3636px; text-align: center; word-wrap: break-word !important; box-sizing: border-box !important;"><section style="max-width: 100%; display: inline-block; word-wrap: break-word !important; box-sizing: border-box !important;"><section style="max-width: 100%; display: inline-block; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; word-wrap: normal; min-height: 1em; box-sizing: border-box !important;"><strong style="max-width: 100%; text-transform: uppercase; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></strong></p><p style="max-width: 100%; word-wrap: normal; min-height: 1em; box-sizing: border-box !important;"><strong style="max-width: 100%; text-transform: uppercase; box-sizing: border-box !important; word-wrap: break-word !important;">·END·</strong><br style="max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;" /></p><p style="max-width: 100%; word-wrap: normal; min-height: 1em; box-sizing: border-box !important;"><strong style="max-width: 100%; text-transform: uppercase; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></strong></p></section><section class="gulangutitle" style="margin: 0em 0.5em 0.1em; max-width: 100%; color: rgb(16, 146, 113); font-size: 1.8em; line-height: 1; font-weight: inherit; word-wrap: break-word !important; box-sizing: border-box !important;"><p><span style="font-size: 20px;"><strong class="pBrush" style="padding-right: 50px; padding-bottom: 3px; padding-left: 50px; border-bottom-style: solid; border-bottom-width: 1px; border-color: rgb(2, 2, 2); display: block; line-height: 28px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"></strong></span></p></section><section class="pbrush" style="margin: 0.5em 1em; max-width: 100%; font-size: 1em; line-height: 1; font-weight: inherit; text-align: inherit; text-decoration: inherit; color: rgb(120, 124, 129); word-wrap: break-word !important; box-sizing: border-box !important;"><p><span style="font-size: 14px;"><strong><span class="pBrush" style="max-width: 100%; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 28px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%;">ID: </span><span style="max-width: 100%;"></span></span></strong><strong><span class="pBrush" style="max-width: 100%; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 28px; box-sizing: border-box !important; word-wrap: break-word !important;"></span></strong></span></p><p><span style="font-size: 14px;"><strong><span class="pBrush" style="max-width: 100%; color: rgb(131, 104, 28); font-family: Avenir, sans-serif; line-height: 28px; box-sizing: border-box !important; word-wrap: break-word !important;">大家都在关注的医疗器械维修新媒体平台</span></strong></span></p><p><strong style="color: rgb(131, 104, 28); 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发表于 2020-10-21 12:41:32