The scope of this standard is upper layer [i.e., the International Organization for Standardization's (ISO's) open systems interconnection (OSI) application, presentation layer, and session layer] services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications (MDC). This standard is the base standard of the ISO/IEEE 11073-20000 medical device application profiles (MDAP), as harmonized through the Committee for European Normalization (CEN) and the ISO.
This standard will define the base message syntax and data encoding for medical device application profiles. The definitions will augment and in some cases optimize related industry standards, chiefly ISO Systems Management standards, particularly with respect to cost-performance improvements for real-time medical data communication. It is limited to upper-layer (i.e., ISO OSI Application, Presentation, and Session) services and protocols used for medical device communication. As a base… read more standards, it neither defines application-specific content of messages nor specific application profiles. read less
The scope of this standard is a communication protocol specification for a distributed system of point-of-care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices by defining a profile for Web Service specifications and defining additional Web Service specifications as part of this standard.
This standard provides recommendations to protect personnel in military environments against established adverse health effects associated with exposure to electric, magnetic, and electromagnetic fields, induced and contact current, and contact and arcing voltages over the frequency range of 0 Hz to 300 GHz. The recommendations, expressed as dosimetric reference limits (DRLs) and exposure reference levels (ERLs), incorporate safety factors that address uncertainties such as uncertainties in the… read more experimental data, measurement uncertainties, and differences in threshold variability between individuals, so as to establish an appropriate margin of safety. The DRLs are expressed in terms of in situ electric field strength, specific absorption rate (SAR), and incident power density. The ERLs are expressed in terms of environmental exposure fields and power densities. In the case of contact current, however, only ERLs are provided. The DRLs and ERLs are intended to protect against established adverse human health effects associated with electrostimulation of tissue and partial and whole-body heating, but may not protect against electromagnetic interference (EMI) with implanted medical devices. This standard does not apply to exposure of informed volunteers in medical or scientific research studies subject to approval by institutional review boards for the use of human subjects, nor does it include exposure assessment techniques, risk management/safety program procedures, warning sign design, procedures for medical treatment of suspected overexposures, nor assessment of hazards associated with exposure of ordnance, fuel, or electro-explosive devices. read less
This standard extends the base nomenclature provided in ISO/IEEE 11073-10101:20206 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions… read more may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2]7) or with other standards, such as Health Level Seven International (HL7). read less
Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The process part of cybersecurity is risk analysis of use cases specific to a PHD/PoCD. For PHDs/PoCDs, this standard defines an iterative, systematic, scalable, and auditable approach to identification of… read more cybersecurity vulnerabilities and estimation of risk. This iterative vulnerability assessment uses the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the remaining vulnerabilities are reduced to an acceptable level of risk. read less
This standard defines a nomenclature for communications of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object oriented information model that is for medical device communications.
The scope of this project is to define a general object-oriented information model that may be used to structure information and identify services used in point-of-care (POC) medical device communications. The scope is primarily focused on acute care medical devices and the communication of patient vital signs information.
The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked point-of-care medical devices need to be controlled. The standard provides a Participant Model and Communication Model derived from the IEEE 11073™ Domain Information Model (IEEE 11073-10201™ DIM). Furthermore, it utilizes the IEEE 11073 Nomenclature (IEEE 11073-10101™) and supports other coding systems to convey the semantics of any information elements. The definition of network transport mechanisms is outside the scope of this standard.
This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.
The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked point-of-care medical devices need to be controlled. The standard provides a Participant Model and Communication Model derived from the IEEE 11073 Domain Information Model (IEEE 11073-10201(TM) DIM). Furthermore, it utilizes the IEEE 11073… read more Nomenclature (IEEE 11073-10101(TM)) and supports other coding systems to convey the semantics of any information elements. The definition of network transport mechanisms is outside the scope of this standard. read less