多参数监护仪国家培训中心.pptVIP

Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. LOGO 多参数监护设备(第二类) 技术审查指导原 上海市食品药品监督管理局 认证审评中心 2011年6月 Vaudon onl ith Aspose slides for NET 4o client P Evaluation only. Created with Aspose Slides for NET 4.0 Client Profile 171 Copyright 2004 -2017 Aspose Pty Ltd  Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. LOGO 适用范围 本指导原则适用于《医疗器械分类目录》中 第|去无创监护仪器(病人监护仪)类产品,类代号 6821 如果产品包含有创血压监护部分根据《目录》 6821规定,属Ⅲ凑医疗器械管理。 本指导原则不涉及有创血压监护的内容。 Valadon only. ith Aspose slides for NET 4o client P Evaluation only. Created with Aspose Slides for NET 4.0 Client Profile 171 Copyright 2004 -2017 Aspose Pty Ltd  Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. LOGO 技术审查要点 产品名称的要求 ●顶期用途 产品结构组成、分类 产品工作原理 产品适用的相关标准 产品风险 主要技术指标 检测要求 临床要求 说明书、标签、包装要求 注册单元划分原则和实例 同一注册单元典型产品的确定和实倒 Valadon only. ith Aspose slides for NET 4o client P Evaluation only. Created with Aspose Slides for NET 4.0 Client Profile 171 Copyright 2004 -2017 Aspose Pty Ltd  Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. LOGO 产品名称的要求 应采用《医疗器械分类目录》或国家标准 行北标准中的通用名称。 般可以按“生理参数十功能(或结构)+ 监护设备(或监护仪)”的方式命名。 例:多参数患者监护设备、 多参数床边监护仪 心电血氧监护仪、 插件式多参数患者监护设备等 Valadon only. ith Aspose slides for NET 4o client P Evaluation only. Created with Aspose Slides for NET 4.0 Client Profile 17