T/CGCPU 030-2024 Active Group standards

T/CGCPU 030-2024 The clinical trial protocol design specification for radiofrequency skin treatment devices

Publish Date: 2024-11-28 Implement Date: 2024-11-28 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CGCPU 030-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical ultrasound, laser, and high-frequency instruments and equipment

ICS Name: Treatment equipment

Publish Date: 2024-11-28

Implement Date: 2024-11-28

Scope

Scope: This document specifies the design guidelines for clinical trials of radiofrequency skin therapy devices used to reduce skin wrinkles, including design basis, design principles, design content, and design verification. This document is applicable to research and development enterprises conducting clinical trial design for registration purposes; Main technical content: Introduction; Preface; 1 Scope; 2 Normative referenced documents; 3 Terms and definitions; 4 Design basis; 5 Design principles; 6 Design content; 6.1 Study objectives; 6.2 Key elements of trial design; 6.3 Study participants; 6.4 Evaluation methods; 6.5 Follow-up cycle; 6.6 Risk prevention and control measures; 6.7 Sample size estimation; 6.8 Implementation points to be considered in the design of the protocol; 6.9 Bias control; 6.10 Special considerations; 7 Design verification; References