ISO IEEE 11073-10418 pdf free download
ISO IEEE 11073-10418 pdf free download.Health informatics – Personal health device communication- Part 10418: Device specialization: International Normalized Ratio (INR) monitor.
4.2.5 Implementing the models
An 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. The agent should implement the recommended elements. and it may implement any combination of the optional elements. A manager implementing this standard shall utilize at least one of the mandatory, conditional. recommended, or optional elements. In this context, “utilize” means to use the element as part of the primary function of the manager device. 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.
4.3 Compliance with other standards
Devices 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. 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. Typically, medical devices will comply with the IEC 60601-1:2005 IBII base standard and its parts, such as IEC 60601-1-1:2000 [B2j, with respect to electrical and mechanical safety, and any device-specific standard as might be defined in IEC ()60l-l-2:2007 1B31. Software aspects may apply through standards such as IEC 62304:2006/ EN 62304:2006 [B51.
Devices that comply with this standard shall implement higher layers of network software and utilize lower layers as appropriate to the application. The requirements on performance of such applications and conformance are defined elsewhere and are outside the scope of this standard. Additionally, the network environment within which devices operate should be specified. 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. The requirements of such risk assessment and risk management and conformance are outside the scope of this standard.
5. INR monitor device concepts and modalities
5.1 General
This clause presents (he general concepts of INR monitor devices. In the context of personal health devices in this family of standards, an INR monitor is a device that determines the normalized ratio for the coagulation time when a thromboplastin reagent is added to a sample of venous or capillary blood. In general, the INR monitor will be taking a measurement that is representative of the coagulation time of the bkxxl, and it is used to follow the status of anticoagulation therapy in patients using an oral anti-vitamin K anticoagulant. such as warfarin.
Typically, such measurements are initially needed frequently and, depending on the patient, the adjustment of dose of medication requires some time. Travelling to the healthcare professional or laboratory means time off for active people, less independence, and a disruption of daily routine. Later, when the patient is properly adjusted and stabilized, INR monitoring is commonly done at intervals of 3 to 4 weeks.
Coagulation tests are performed on the plasma fraction of blood. In the laboratory. this is usually on plasma separated from citrated blood by centrifugation. but where testing can be performed immediately, in point- of-care test devices, often on the plasma fraction of a native (noncitrated) sample of whole blood. The liquid serum that is left following the formation of a blood clot is not useful for bhx1 coagulation testing.ISO IEEE 11073-10418 pdf download.
