GB/T 16886.11-1997
Replaced
T/CMEAS 049-2025
Active
Group standards
T/CMEAS 049-2025 Medical equipment innovation and transformation norms
T/CMEAS 049-2025 Medical equipment innovation and transformation norms
Price:
$ 20.00
Basic Information
Standard Code:
T/CMEAS 049-2025
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2025-06-27
Implement Date:
2025-06-27
Scope
Scope: This document is applicable to scenarios where various organizations, including scientific research institutions, medical institutions, medical equipment development enterprises, and innovation teams, carry out activities related to the innovation and transformation of medical equipment. Main technical content: This document stipulates standardized operations in the process of medical equipment innovation and transformation, including project demonstration, product design and development, intellectual property management, product transformation and promotion, and evaluation and improvement.
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