T/ZSA 187-2023

Scope: This document specifies the general requirements and test methods for accelerated testing and reliability index verification of joint surgery navigation positioning systems using robotics technology. This document is applicable to joint surgery navigation positioning systems based on optical navigation technology, including total knee replacement surgery navigation positioning systems and total hip replacement surgery navigation positioning systems. Main technical content: This document details several accelerated aging test methods based on single-aperture models, multi-aperture models, event compression acceleration models, and time compression models, which can significantly shorten testing time and development cycles and are one of the effective means to quickly verify high reliability and long-life indicators. In the main body of the document, referring to the common methods of accelerated testing for electrical components and mechanical components, combined with the characteristics of joint surgery navigation positioning systems, the test methods are introduced from the perspective of system architecture, electronic control parts, pedal parts, caster parts, positioning accessories, reliability index verification, and accelerated life testing, providing a feasible document guidance for comprehensively improving the quality and reliability level of orthopedic surgical robots in China. The main methods of this document have been applied in a number of orthopedic surgical robot products and are highly practical.