DZ/T 0101.12-1994
Active
YY/T 1993-2025
Pending
Industry standards-Medicine
YY/T 1993-2025 Reliability testing methods for robotically assisted surgical equipments
YY/T 1993-2025 Reliability testing methods for robotically assisted surgical equipments
Price:
$ 54.00
Basic Information
Standard Code:
YY/T 1993-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical electronic instruments and equipment
ICS Name:
-
Publish Date:
2025-10-30
Implement Date:
2026-11-01
Pages:
32 pages
Scope
This document describes the path and methods for conducting reliability verification on RASE.
This document is applicable to assistive surgical devices (RASE) that employ robotics technology.
This document is not applicable to software reliability verification for software systems, but it can be used to verify the overall reliability of RASE that includes control software.
Development Information
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 34986-2017 Methods for product accelerated testing
GB/T 34987-2017 Weibull analysis
YY/T 1712-2021 Assisted surgical medical equipment and assisted surgical medical system employing robotictechnology
YY/T 1813-2022 Methods for operational reliability information collection and evaluation of medical electrical equipment
YY/T 1837-2022 Medical electrical equipment—General requirements for reliability
YY/T 1901-2023 Requirements and test methods for orthopaedic surgical navigation equipment employing robotic technology
YY/T 1941-2024 Robotically-assisted laparoscopic surgical system
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