1 Classification等级 Rule规则 A/NA Description Non-invasive devices非侵略性设备 1.1Rule 1 All non-invasive devices are in Class I,unless one of the rules set out hereinafter applies 所有非侵入性设备在I类,除非下文列出的适用规则之一 1.2Rule 2 All non-invasive devices intended for channeling or ...
CLASSIFICATIONMajor Depression Disorder (MDD), a complex mental health disorder, poses significant challenges in accurate diagnosis. In addressing the issue of gradient vanishing in the classification of MDD using current data-driven electroencephalogram (EEG) data, this study introdu...
MDD_Classification_Chart.doc,MDD Art. 9, ANNEX IX III. Classification Performer:执行者 Company: 公司 Date: 时间 Product产品 Name名字 Model/Article nr型号/物品编码 Version版本 Intended use预期用途 Duration 持续性 Temporary 暂时性 Short 简短 Prolonged 持久
4.1国际标准:介绍国际上常见的器械分类标准和指南,例如美国FDA的MedicalDeviceClassification,欧盟的MedicalDeviceDirective等。 4.2国家标准:介绍我国相关的器械分类标准和指南,如《医疗器械分类目录》等。 4.3临床应用指南:介绍器械分类对于医护人员在临床实践中的指导意义,帮助其更好地选择合适的医疗器械进行诊治工作。 五、...
MDCG也发布了MDR下医疗器械分类的指南文件:MDCG 2021-24 Guidance on classification ofmedical devices 对应分类规则如下: MDD中与分类相关是93/42/EEC中的 Annex IX 和相应的指南MEDDEV 2. 4/1 Rev. 9;新的MDR中Article51和Annex VIII 详细阐述了产品的分类信息。主要变化是由MDD的“18条”,改为MDR的“22...
Category: according to MDD classification provided for in annex IX to Directive, this device belongs to the IIa class. 翻译结果3复制译文编辑译文朗读译文返回顶部 Category: according to MDD classification provided for in annex IX to Directive, this device belongs to the IIa class. ...
16MEDDEV2.4/1–rev.8PART2:GUIDELINESFORTHECLASSIFICATIONOFMEDICALDEVICES(July2001)...4.2GENERALEXPLAN..
2.4 Classification of the product产品分类 2.5 List of standards used使用标准 2.6 Essential requirements (Annex-1) 基本要求(附录一) 2.7 Risk analysis风险分析 2.8 Product Lifetime产品寿命 3. Technical specifications of product产品技术规格型号 3.1 List of components, Specifications of used mater...
参考文献:Kim, S., Yoon, H., Shin, J., & Yang, C. M. (2023). Classification of fNIRS signals from adolescents with MDD in suicide high-and low-risk groups using machine learning.Journal of affective disorders,34...
Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES: Guidance document MEDDEV 2.4/1 Rev.8 July 2001 GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES The present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical ...