T/ZSA 186-2023 Joint surgery navigation positioning system availability

Scope

Scope: This document specifies the human-centered design requirements, risk management requirements for misuse, and usability requirements for the user interface that manufacturers should follow during the development of joint surgery navigation and positioning systems. Human-centered design includes all interaction points between the product and the user, such as display, control, labeling, and user manuals. This document applies to full knee joint replacement surgery navigation and positioning systems and full hip joint replacement surgery navigation and positioning systems based on optical navigation technology. Main technical content: This document aims to ensure that the user interface design of joint surgery navigation and positioning systems can eliminate or reduce potential harm or reduced medical quality during device use. This document focuses on the quality of user interaction with joint surgery navigation and positioning systems, such as obtaining information on the display, selecting items in the software menu, connecting accessories to medical devices, and understanding the correct use of medical devices by reading the accompanying documents. This document includes three aspects: "Human-centered design principles for joint surgery navigation and positioning systems", "Risk management for misuse", and "Usability specifications for user interfaces". Chapter 4 introduces human-centered design principles to help design teams optimize user interface design. Chapter 5 provides methods for applying "risk management for misuse" to help manufacturers identify, evaluate, and control misuse and its risks to ensure the safe and effective use of medical devices. Chapter 6 stipulates the basic requirements for safe use of the user interface of joint surgery navigation and positioning systems.

Development Information

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