GB/T 16886.11-1997
Replaced
T/SZJCH 0007-2025
Active
Group standards
T/SZJCH 0007-2025 Ultrasonic Therapy Device User's Guide
T/SZJCH 0007-2025
Price:
$ 20.00
Basic Information
Standard Code:
T/SZJCH 0007-2025
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2025-05-13
Implement Date:
2025-05-20
Scope
Main technical content: 4.1 The equipment shall comply with the requirements of GB 4706.1, GB 9706.1, GB/T 16886.1, and GB/T 36419. 4.2 The equipment may adopt large focal field technology to achieve a wider single-treatment coverage area, significantly enhancing treatment efficiency and comfort during use. 4.3 The equipment may employ ultra-pulse technology to deliver energy more efficiently, effectively improving treatment efficiency and greatly reducing patient discomfort during use. 4.4 The equipment may utilize contact detection technology to ensure the safety and accuracy of the treatment process. 4.5 The equipment may adopt displacement detection technology to ensure the safety and controllability of the treatment process, effectively preventing adverse reactions caused by improper operation during use.
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