GB/T 16886.11-1997
Replaced
T/CASME 962-2023
Active
Group standards
T/CASME 962-2023 Medical device product development and design management specifications
T/CASME 962-2023 Medical device product development and design management specifications
Price:
$ 20.00
Basic Information
Standard Code:
T/CASME 962-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medicine, health, and labor protection
ICS Name:
Integrated medical equipment
Publish Date:
2023-11-23
Implement Date:
2023-11-30
Scope
Scope: This document is applicable to the management and control of the R&D and design process of medical device products; Main technical content: This document stipulates the terms and definitions, basic requirements, R&D responsibilities, R&D support, R&D requirements, R&D document management, and R&D process management content of the R&D and design of medical device products.
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