GB/T 16886.11-1997
Replaced
T/NSSQ 084-2025
Active
Group standards
T/NSSQ 084-2025 Specification for clinical reliability management of intelligent surgical robots
T/NSSQ 084-2025 Specification for clinical reliability management of intelligent surgical robots
Price:
$ 20.00
Basic Information
Standard Code:
T/NSSQ 084-2025
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Urban transportation facilities
ICS Name:
Integrated medical equipment
Publish Date:
2025-10-25
Implement Date:
2025-10-30
Scope
This document applies to the reliability management work of medical institutions in conducting intelligent surgical robot-assisted diagnosis and treatment activities. This document does not apply to the structural performance testing, registration inspection, and technical evaluation of the intelligent surgical robot itself. This document specifies the reliability management requirements for intelligent surgical robots during clinical use, including basic requirements, preoperative preparation and evaluation, intraoperative operation control, postoperative evaluation and traceability, abnormal event reporting and handling, and continuous improvement and quality enhancement.
Development Information
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced