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#22 Introduction for all DevSpecs
Introduction
This standard facilitates the interoperability of ENDOSCOPIC CAMERA SYSTEMs with other Point-of-Care medical devices and components by specifying their communication behaviour. As a Device Specialisation, it constitutes a particular interoperability standard that profiles the general ISO/IEEE 11073 Service-oriented Device Connectivity (SDC) standards to be used consistently for ENDOSCOPIC CAMERA SYSTEMs. Therefore, the requirements herein specify the representation of ENDOSCOPIC CAMERA SYSTEMs that participate in an SDC SYSTEM. This allows for uniformly modelling their functional capabilities and for safely and effectively providing SYSTEM FUNCTION CONTRIBUTIONs to a SYSTEM FUNCTION that is distributed over two or more SDC PARTICIPANTS. Furthermore, the standardised network representation enables other SDC PARTICIPANTS to interact with functionally similar devices from different manufacturers in a consistent way.
This Device Specialisation builds upon the general ISO/IEEE 11073 SDC standards in order to achieve interoperability by normatively referencing their applicable clauses. The model for ENDOSCOPIC CAMERA SYSTEMs that is specified herein conforms to the ISO/IEEE 11073-10207 Domain Information and Service Model and restricts optionality wherever necessary. To precisely define the semantics of each data model element, terms from the ISO/IEEE 11073-1010X series of Nomenclature standards are specified for use. In addition, this standard requires ENDOSCOPIC CAMERA SYSTEMs to demonstrate conformance to various clauses of the ISO/IEEE 11073-20701 Service-oriented Medical Device Exchange Architecture and Protocol Binding that specifies behaviour of participants in an SDC SYSTEM.
To support the safe and effective provision of an ENDOSCOPIC CAMERA SYSTEM’s SYSTEM FUNCTION CONTRIBUTIONs, this standard also refers to the IEEE 11073-1070X SDC Participant Key Purpose (PKP) standards. These provide the means for allocating responsibilities to SDC PARTICIPANTs based on the roles they play in an SDC SYSTEM by defining requirements related to the technical design as well as to the development process, risk management, and usability/human factors engineering. The SDC PKP standards consider the roles of provider and consumer of metric data, alert data, and external control commands.
In addition, this Device Specialisation references other standards where they apply. This includes, most notably, the IEC 60601 family of standards, specifically IEC 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment. IEC 60601-2-18 relates to the safety and effectiveness of endoscopic equipment whereas the following IEEE 11073 SDC standards relate to these devices’ participation in a service-oriented networked system of medical devices and IT systems.
• IEEE 11073-10722 - Device Specialization - Endoscopic camera
• IEEE 11073-10723 - Device Specialization - Endoscopic light source
• IEEE 11073-10724 - Device Specialization - Endoscopic insufflator
• IEEE 11073-10725 - Device Specialization - Endoscopic pump
