Intended use, operating method, and whether implantation is involved.
Patient or user contact characteristics, including materials and components involved.
Energy or substances delivered to or extracted from the patient, including biological material handling.
Sterility status, required sterilization methods, and cleaning/disinfection needs.
Measurement, analytical functions, and interaction with other devices, drugs, or medical technologies.
Sensitivity to environmental factors and potential environmental impact.
Consumables, accessories, maintenance, calibration needs, and software inclusion.
Service life determinants, single-use designation, long-term effects, and end-of-use disposal requirements.
Installation, operation skills, user training requirements, and mechanisms for providing safety information.
Human-factors dependencies, user-interface risks, distraction-related use errors, and presence of connectors, interfaces, and information displays.