GB 9706.275-2022

Active

Medical electrical equipment—Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

医用电气设备 第2-75部分:光动力治疗和光动力诊断设备的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.01
CCS
C40
Status
Active
Issue Date
2022-12-29
Implementation
2026-01-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、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 photodynamic therapy (PDT) and photodynamic diagnosis (PDD) equipment used in medical settings. It applies to devices that combine a light source and photosensitizing agents to treat conditions like certain cancers or skin diseases, or to diagnose lesions through fluorescence. The standard is used by manufacturers, testing laboratories, and healthcare facilities to ensure these medical electrical devices operate reliably and safely during clinical procedures.

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.