Iso 14971 2007 free pdf11/10/2023 ![]() ![]() ![]() This clause presents (he general concepts of INR monitor devices. INR monitor device concepts and modalities The requirements of such risk assessment and risk management and conformance are outside the scope of this standard.ĥ. Use of any medical equipment within a network environment shall he subject to risk assessment and risk management appropriate to the application and use and should adhere to standards such as ISO 14971:2007 (B71 and IEC 80001-1:2010 [B6j. Additionally, the network environment within which devices operate should be specified. The requirements on performance of such applications and conformance are defined elsewhere and are outside the scope of this standard. Software aspects may apply through standards such as IEC 62304:2006/ EN 62304:2006 [B51.ĭevices that comply with this standard shall implement higher layers of network software and utilize lower layers as appropriate to the application. Typically, medical devices will comply with the IEC 60601-1:2005 IBII base standard and its parts, such as IEC 6:2000 [B2j, with respect to electrical and mechanical safety, and any device-specific standard as might be defined in IEC ()60l-l-2:2007 1B31. A user of this standard is expected to be familiar with all other such standards that apply and to comply with any higher specifications thus imposed. For example, a manager whose primary function is to display data would need to display a piece of data in the element in order to utilize it.ĭevices that comply with this standard may also be required to comply with other domain- and device- specific standards that supersede the requirements of this standard with respect to issues including safety, reliability, and risk management. In this context, “utilize” means to use the element as part of the primary function of the manager device. A manager implementing this standard shall utilize at least one of the mandatory, conditional. and it may implement any combination of the optional elements. The agent should implement the recommended elements. ISO IEEE 11073-10418 pdf free download.Health informatics – Personal health device communication- Part 10418: Device specialization: International Normalized Ratio (INR) monitor.Īn agent implementing this standard shall implement all mandatory elements of the information, service, and communication models as well as all conditional elements where the condition is met. ![]()
0 Comments
Leave a Reply.AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |