ISO 14971-2007 医疗装置.医疗装置风险管理的应用

标准号：ISO 14971-2007
中文标准名称：医疗装置.医疗装置风险管理的应用
英文标准名称：Medical devices - Application of risk management to medical devices
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：11.040.01
适用范围：This International Standard specifies a process for a manufacturer to identify the hazards associated withmedical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associatedrisks, to control these risks, and to monitor the effectiveness of the controls.The requirements of this International Standard are applicable to all stages of the life-cycle of a medicaldevice.This International Standard does not apply to clinical decision making.This International Standard does not specify acceptable risk levels.This International Standard does not require that the manufacturer have a quality management system inplace. However, risk management can be an integral part of a quality management system.