GB 9706.202-2021

Active

Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

医用电气设备 第2-2部分:高频手术设备及高频附件的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.30
CCS
C41
Status
Active
Issue Date
2021-12-01
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the basic safety and essential performance requirements for high-frequency surgical equipment and its accessories, such as electrosurgical generators and active electrodes. It is applied in medical settings to ensure the safe operation of devices used for cutting and coagulating tissue during surgical procedures. The standard is critical for manufacturers, testing laboratories, and healthcare facilities to prevent electrical hazards and thermal injuries to patients and operators.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.