2800-1-1 should provide requirements that guide the construction of the “Intended use and identification of characteristics related to the safety of the medical device” as necessary to establish compliance with 14971 Clause 4.2. 2800-1-1 should provide qualitative Severity and Likelihood declarations that are used across all ICE (or are at least consistent within cohorts). The following examples are from 14971 Appendix D. [Outline of portion of ICE Risk Management Process based on STPA to be included in 2800-1-1. Annotated Computational View of an ICE-based ICS 2800-1-1 needs to define a template structure for an ICE-based ICS based on the 10746 Computation View. This needs to be a refinement of a generic vocabulary in 2800-0 (or 2800-1). In each ICE-based ICS, list the component provider roles to be used in the Risk Management process for the system. In each ICE-based ICS, working from the 10746 Computation View template for an ICE-based ICS, Identify the ICE functional role of each component and the ICE medium realization of each communication link in the ICS. We anticipate the ICE component roles would include the usual component roles from the ICE architecture (app, service component (further specialized to physiological monitoring device/data stream, actuating device, information system, display, etc.). Communication medium indicates the nature of communication of physical substance, commands, or data between interoperable components for the purpose of establishing common faults for those components. Risk Responsibility Allocation For each component and communication link, declare the ICE provider roles that participate in the risk management associated with the component or link.] Risk Analysis Intended Use and Identification of Characteristics Related to the Safety of the Medical Device The intended use of this system is defined in Section 2.1 [Traceability/Compliance: Compliance with 2800-1-1 Clause XXX, Compliance with 14971 Clause 4.2]
2800-1-1 should provide requirements that guide the construction of the “Intended use and identification of characteristics related to the safety of the medical device” as necessary to establish compliance with 14971 Clause 4.2. 2800-1-1 should provide qualitative Severity and Likelihood declarations that are used across all ICE (or are at least consistent within cohorts). The following examples are from 14971 Appendix D. [Outline of portion of ICE Risk Management Process based on STPA to be included in 2800-1-1. Annotated Computational View of an ICE-based ICS 2800-1-1 needs to define a template structure for an ICE-based ICS based on the 10746 Computation View. This needs to be a refinement of a generic vocabulary in 2800-0 (or 2800-1). In each ICE-based ICS, list the component provider roles to be used in the Risk Management process for the system. In each ICE-based ICS, working from the 10746 Computation View template for an ICE-based ICS, Identify the ICE functional role of each component and the ICE medium realization of each communication link in the ICS. We anticipate the ICE component roles would include the usual component roles from the ICE architecture (app, service component (further specialized to physiological monitoring device/data stream, actuating device, information system, display, etc.). Communication medium indicates the nature of communication of physical substance, commands, or data between interoperable components for the purpose of establishing common faults for those components. Risk Responsibility Allocation For each component and communication link, declare the ICE provider roles that participate in the risk management associated with the component or link.] Risk Analysis Intended Use and Identification of Characteristics Related to the Safety of the Medical Device The intended use of this system is defined in Section 2.1 [Traceability/Compliance: Compliance with 2800-1-1 Clause XXX, Compliance with 14971 Clause 4.2]
ICE-PCA-MSIS-Mock-Vendor-Submission-v0.11.docx