YY/T 1992-2025 Pending Industry standards-Medicine

YY/T 1992-2025 Robotically assisted surgery equipment—Summative usability test methods

Publish Date: 2025-10-30 Implement Date: 2026-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 1992-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical radiation equipment

ICS Name: -

Publish Date: 2025-10-30

Implement Date: 2026-11-01

Pages: 36 pages

Scope

This document specifies the summary usability testing methods for assistive surgical devices that utilize robotics technology.
This document is applicable to assistive surgical devices that employ robotics technology.
Note: This document is a methodological standard and does not set requirements for product functionality or product usage risks. Device manufacturers may adopt some or all of the testing methods listed in this document based on the specific circumstances of their products.

Development Information

Word Count: 54 Thousand words Pages: 36 pages

Referenced Standards

GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 42062-2022 Medical devices—Application of risk management to medical devices YY/T 1474-2016 Medical devices—Application of usability engineering to medical devices YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability

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