GB 9706.275-2022
Medical electrical equipment—Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (English Version)

Standard No.

GB 9706.275-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB 9706.275-2022

Scope

Replacement: This document applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment. If a chapter or clause applies only to me equipment or me systems, the title and content of the chapter or clause will clearly state this. Otherwise, this clause or clause applies to both ME EQUIPMENT and ME SYSTEMS. In addition to 7.2 of the general standard.

GB 9706.275-2022 Referenced Document

• GB 7247.1-2012 Safety of laser products.Part 1:Equipment classification and requirements
• GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• GB 9706.222-2022 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
• GB/T 20145 Photobiological safety of lamps and lamp systems
• YY 9706.257-2021 Medical electrical equipment Part 2-57: Specific requirements for basic safety and basic performance of non-laser light source equipment used for treatment, diagnosis, monitoring and plastic surgery/medical aesthetics
• YY/T 0664 Medical device software software life cycle process

GB 9706.275-2022 history

• 2022 GB 9706.275-2022 Medical electrical equipment—Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

GB 9706.275-2022 -All Parts