GB 9706.218-2021

Active

Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment

医用电气设备 第2-18部分:内窥镜设备的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.70
CCS
C40
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 particular safety and performance requirements for endoscopic equipment used in medical diagnosis and surgery. It applies to all medical electrical equipment classified as endoscopes, including rigid, flexible, and video endoscopes, as well as their associated accessories and control systems. The standard is used by manufacturers and testing laboratories to ensure these devices meet essential safety criteria, such as protection against electrical hazards, thermal risks, and mechanical failures during clinical use.

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.