BS PD CEN/TR 17223:2018提供了EN ISO 13485:2016与医疗标准之间关系的指南 设备.质量管理体系.监管要求和要求 在关于医疗器械的欧盟法规2017/745和关于体外诊断的欧盟法规2017/746中 医疗设备。交叉引用:ISO 13485:2016BS EN ISO 13485:2016购买本文件时可获得的所有现行修订均包含在购买本文件中。

BS PD CEN/TR 17223:2018 provides guidance on the relationship between EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices.Cross References:ISO 13485:2016BS EN ISO 13485:2016All current amendments available at time of purchase are included with the purchase of this document.