[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"tag-landing-medical-zh":3,"tag-related-11-zh":57},{"id":4,"slug":5,"name":6,"description":7,"seo_title":8,"cover_image":9,"is_hot":10,"is_native_locale":11,"count_news":10,"count_brand":10,"count_product_series":10,"count_product":10,"count_wiki":10,"news":12,"brands":13,"product_series":42,"products":43,"wiki":44,"intro_md":45,"faqs":46,"parents":56},11,"medical","医疗","医疗器械行业对精密机加工、洁净生产、ISO 13485 体系合规要求严苛，Siemens Healthineers、Dräger、B. Braun 是德国领先品牌。","医疗器械 工业品 Siemens Healthineers ISO 13485 - 0so",null,0,true,[],[14,18,22,26,30,34,38],{"brand_id":15,"brand_name":16,"url_path":17},149,"SIEMENS","\u002Fsiemens",{"brand_id":19,"brand_name":20,"url_path":21},172,"SARTORIUS","\u002Fsartorius",{"brand_id":23,"brand_name":24,"url_path":25},329,"Honeywell","\u002Fhoneywell",{"brand_id":27,"brand_name":28,"url_path":29},494,"Endress+Hauser","\u002Fendress-hauser",{"brand_id":31,"brand_name":32,"url_path":33},2926,"GEA","\u002Fgea",{"brand_id":35,"brand_name":36,"url_path":37},3043,"Heraeus","\u002Fheraeus",{"brand_id":39,"brand_name":40,"url_path":41},28158,"Sensirion","\u002Fsensirion",[],[],[],"医疗器械行业对精密机加工、洁净生产、ISO 13485 合规要求严苛。Siemens Healthineers（影像）、Dräger（呼吸\u002F麻醉）、B. Braun（输液\u002F外科）是德国领先品牌；MDR 2017\u002F745 是欧盟入市新法规。",[47,50,53],{"q":48,"a":49},"MDR 与原 MDD 区别？","MDR 加严：临床证据扩展、UDI 唯一标识、PRRC 法规负责人、PSUR 上市后监督，过渡期 2024 全面强制执行。",{"q":51,"a":52},"洁净级别要求？","植入器械 ISO Class 7（Class 10000）；普通医疗器械 ISO Class 8（100000）；体外诊断 IVD 试剂 ISO Class 5。",{"q":54,"a":55},"中国出口医疗器械合规？","NMPA 国内注册 + CE MDR 欧盟注册 + 510(k) 美国，三套体系并行；多数产品需公告机构（Notified Body）审核。",[],{"list":58},[59,63,67,71,75,79,83,87],{"id":60,"slug":61,"name":62},94,"instrumentation","仪器仪表",{"id":64,"slug":65,"name":66},4,"food-beverage","食品饮料",{"id":68,"slug":69,"name":70},5,"chemical","化工",{"id":72,"slug":73,"name":74},12,"pharma","制药",{"id":76,"slug":77,"name":78},19,"process-automation","过程自动化",{"id":80,"slug":81,"name":82},49,"pressure-transmitter","压力变送器",{"id":84,"slug":85,"name":86},62,"petrochemical","石化",{"id":88,"slug":89,"name":90},96,"flow-meter","流量计"]