Glossario normativa UE Medical Device Regulation (EU MDR)

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Glossario normativa UE Medical Device Regulation (EU MDR)

机译：词汇表欧盟医疗器械法规（EU MDR）

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UDI: codice numerico o alfanumerico univoco che deve essere apposto su ogni dispositivo medico, etichetta o packaging e deve essere in un formato leggibile sia dall'uomo (solo testo alfanumerico) che dalle macchine (codici a barre o da-tamatrix).

机译：UDI：唯一的数字或字母数字代码，必须粘贴到每个医疗设备，标签或包装上，并且必须采用既可以由人（仅字母数字文本）读取，又可以由机器（条形码或tamatrix）读取的格式。

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《Italia imballaggio》 |2018年第12期|12-12|共1页
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1. Glossary of EU regulations Medical Device Regulation (EU MDR) [J] . Italia imballaggio . 2018,第11a12期

机译：欧盟法规的词汇医疗器械法规（EU MDR）
2. Digital health – Software as a medical device in focus of the medical device regulation (MDR) [J] . KurtBecker, MyriamLipprandt, RainerR?hrig, Information Technology . 2019,第5a6期

机译：数字健康 - 软件作为医疗器械规则的重点（MDR）的医疗器械
3. EU Medical Device Regulation (MDR) labelling compliance [J] . Manufacturing Chemist: Pharmaceutical Development, Formulation, Processing and Outsourcing . 2018,第5期

机译：欧盟医疗器械监管（MDR）标签合规性
4. Investigating the Capability of Agile Processes to Support Medical Devices Regulations: The Case of XP, Scrum, and FDD with EU MDR Regulations [C] . Mohmood Alsaadi, Alexei Lisitsa, Mohammed Khalaf, International conference on intelligent computing methodologies . 2019

机译：调查敏捷过程支持医疗器械法规的能力：带有欧盟MDR法规的XP，Scrum和FDD案例
5. The Use of Predicates in FDA Regulation of Medical Devices: A Case Study of Robotic Surgical Devices [D] . Lefkovich, Charlotte. 2018

机译：医疗器械FDA调节谓词的使用 - 以机器人外科手术装置为例
6. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR) [O] . Petra Hoffmüller, Monika Brüggemann, Thomas Eggermann, 2021

机译：AWMF临时委员会在体外诊断医疗器械的咨询意见这些医疗器械均仅在工会中建立的卫生机构内根据条例（欧盟）2017/746（IVDR）
7. Devices and desires: industry fights toughening of medical device regulation in Europe [O] . 2013

机译：设备和欲望：工业争夺欧洲医疗设备监管的增韧
8. Medical Device Regulation Too Early to Assess European Union (EU) System's Valueas Model for FDA [R] . 1996

机译：医疗器械监管过早评估欧盟（EU）系统的FDa的Valueas模型

Glossario normativa UE Medical Device Regulation (EU MDR)

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