GB/T 16886.11-1997
Replaced
T/NSSQ 083-2025
Active
Group standards
T/NSSQ 083-2025 Design specification for artificial intelligence-based medical software evaluation platforms
T/NSSQ 083-2025 Design specification for artificial intelligence-based medical software evaluation platforms
Price:
$ 20.00
Basic Information
Standard Code:
T/NSSQ 083-2025
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 is applicable to medical institutions, testing and inspection institutions, higher education institutions, research and development institutions, and other units in the design and evaluation of a universal artificial intelligence medical software evaluation platform, supporting scenarios such as third-party evaluation, registration verification, and clinical auxiliary review. This document specifies the general requirements, functional requirements, performance requirements, safety requirements, quality and compliance requirements, risk assessment and response measures, and implementation methods for artificial intelligence medical software evaluation platforms.
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