2017年5月5日在欧盟官方期刊上正式公布IVDR体外诊断器械法规2017/746/EU用于取代旧的体外诊断医疗器械指令98/79/EEC, 并于2022年5月26号强制执行(生效日期2017年5月26号,过渡期五年)。 IVDR实施时间轴: IVDR被定义为:是指制造商预期用于体外检查从人体提取的样本,包括捐献的血液及组织,单独使用或组合使用的试剂、...
We have built a reputation for delivering robust, reliable and practicalin vitrodiagnostic mass spec solutions that are extremely easy to adopt and powerful enough to handle the everyday demands of the clinical lab. Our best-in-class technology is paired with our very own service and support org...
intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body”. The definition then outlines the principle or sole purpose of these devices: under the IVDR, an IVD medical device must have a medical applicat...
Placing your In Vitro Diagnostic Medical Device on the market As an IVD manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market. It is critical to work with a trusted EU Notified Body or UK Approved Body that understands the ...
In vitro diagnostic medical devices 选择语言:从中文简体中文翻译英语日语韩语俄语德语法语阿拉伯文西班牙语葡萄牙语意大利语荷兰语瑞典语希腊语捷克语丹麦语匈牙利语希伯来语波斯语挪威语乌尔都语罗马尼亚语土耳其语波兰语到中文简体中文翻译英语日语韩语俄语德语法语阿拉伯文西班牙语葡萄牙语意大利语荷兰语瑞典语希腊语捷克语...
Heavy metal in vitro diagnostics Immune deficiency in vitro diagnostics Immunoglobulin light chain amyloidosis in vitro diagnostics Immunohistochemistry (IHC) in vitro diagnostics In vitro diagnostic instrumentation In vitro diagnostics supported by over the counter (OTC), point of care (POC), or CLIA wa...
In Vitro Diagnostic Market Whether you’re designing a bench-top system for a physician’s office or a large-scale system for a clinical laboratory, Saint-Gobain Medical can help simplify the development of your In vitro diagnostic (IVD) device. Leveraging our deep materials expertise and applica...
5) device diagnostics 设备诊断学6) IVD 体外诊断(IVD)补充资料:电控设备故障自诊断 电控设备故障自诊断 self-diagnosis of electrical control equipment d旧nkong shebe一guzhongz一zhenduon电控设备故障自诊断(self一diagnosi,of elec-trical eontrol equipment)电气控制设备判别自身有无故障并确定故障部位的...
4) In-vitro Diagnostic Medical Device 体外诊断医疗器材(IVDD)5) IVD 体外诊断(IVD)6) infrared light diagnosis instrument 红外光诊断仪补充资料:坦克夜间观察瞄准仪器(见坦克观察瞄准仪器) 坦克夜间观察瞄准仪器(见坦克观察瞄准仪器) tank night observing and sighting instruments tanke yelion guancha mia0...