CHN/1665
WTO/TBT
CN China
  • 11 - Health care technology
2022-06-04
2022-04-06

Photodynamic Therapy and Photodynamic Diagnosis Equipment

National Standard of the P.R.C., Medical Electrical Equipment-Part 2-75:Particular Requirements for the Basic Safety and Essential Performance of Photodynamic Therapy and Photodynamic Diagnosis Equipment; (23 page(s), in Chinese)

This document applies to photodynamic therapy and photodynamic diagnosis equipment used to eliminate or alleviate disease, injury or disability.

 This document does not apply to:

• light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia;

• low-level laser therapy equipment not intended for use with photosensitizer;

• illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with photosensitizer.