T/ZMDS 10015-2022 Active
T/ZMDS 10015-2022 Joint surgery navigation system - Part 2: Usability
Abstract
Scope: This standard applies to joint surgery navigation positioning systems based on optical navigation technology, including total knee joint replacement surgery navigation positioning systems and total hip joint replacement surgery navigation positioning systems; Main technical content: Chapter 4 Overview. The human-centered design principles introduced in this chapter aim to help design teams optimize the user interface design. Chapter 5 Risk management of use errors. The methods introduced in this chapter aim to help manufacturers identify, evaluate, and control use errors and their risks, ensuring the safe and effective use of medical devices. Chapter 6 Usability specifications for user interfaces. This chapter stipulates the basic requirements for the safe use of user interfaces in joint surgery navigation positioning systems.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/ZMDS 10015-2022 |
| CCS | Medical radiation equipment |
| ICS | Integrated medical equipment |
| Implement Date | 2022-12-30 |