GB/T 41265-2022 in English

Analysis of the core content of the standard

Technical specifications for hazard categories

Safety Assessment Methodology

The standard requires assessment from three dimensions:

• Intended use assessment: Based on the normal use conditions declared by the manufacturer
• Unintended use assessment: Considering the potential risks at any contact distance and angle
• Single fault condition assessment: Simulating abnormal conditions such as optical film shedding

The spectral weighting function given in Appendix AC should be used during the assessment to calculate the equivalent irradiance/radiance value of each hazard type by integration.

Implementation recommendations and industry impact

Key requirements for manufacturers:

1. The product manual must clearly indicate the hazard category and protective measures
2. RG2/RG3 products must be permanently affixed with warning labels (see Figure 1 for example)
3. Therapeutic devices must be equipped with a professional operation training system

For the first time, the standard adjusts the evaluation parameters of IEC62471 based on the use characteristics of wearable devices that are close to the human body, especially:

• The evaluation benchmark time for skin contact devices is shortened from 200mm to direct contact
• Add considerations for Chinese skin type (Fitzpatrick type 3)
• Specify special requirements for the combined use of photosensitizers