IEC 80001-1:2010认识到将医疗设备纳入IT网络以实现预期效益（例如互操作性），定义了将医疗设备纳入IT网络以解决安全性、有效性、数据和系统安全性（关键属性）的风险管理所需的角色、责任和活动。IEC 80001-1:2010未规定可接受的风险水平。IEC 80001-1:2010适用于责任组织收购医疗器械并将其纳入IT网络的情况。它适用于It的整个生命周期- 包含医疗设备的网络。IEC 80001-1:2010适用于没有单一医疗设备制造商负责解决包含医疗设备的IT网络关键属性的情况。IEC 80001-1:2010适用于责任组织、医疗器械制造商和其他信息技术供应商，以对责任组织指定的包含医疗器械的IT网络进行风险管理。它不适用于患者、操作员和责任机构是同一个人的个人使用应用程序。

IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.