GB/T 16886.11-1997
Replaced
T/TMAC 112.F-2024
Active
Group standards
T/TMAC 112.F-2024 Medical device enterprise credit qualification evaluation
T/TMAC 112.F-2024 Medical device enterprise credit qualification evaluation
Price:
$ 20.00
Basic Information
Standard Code:
T/TMAC 112.F-2024
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:
2024-10-20
Implement Date:
2024-10-20
Scope
Scope: This document is applicable to the credit qualification evaluation of relevant enterprises in the medical device industry chain, including production and manufacturing, technological research and development, and sales; Main technical content: This document stipulates the terms and definitions, basic principles, evaluation content and evaluation indicators, evaluation process, credit rating, and credit evaluation reports for the credit qualification evaluation of medical device enterprises.
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