YY/T 1896-2023 in English
VALIDMethod for defining the wavelength range of spectral radiation therapy equipment
- Issued on:2023-06-20
- Implemented on:2024-07-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$156.00
本文件规定了光谱辐射治疗设备的波长范围界定方法。
本文件适用于临床上波长为180nm-3000nm,利用包括可见光、红外光、紫外光等非相干光进行治疗的设备。
Introduction
Standard Background and Scope of Application
This standard was proposed by the State Food and Drug Administration and is applicable to incoherent light therapy equipment with a wavelength of 180nm~3000nm, including visible light, infrared light and ultraviolet light therapy equipment. The standard systematically regulates the wavelength definition method of spectral radiation therapy equipment for the first time.
Core Terminology Analysis
| Terms | Definition Points | Application Scenarios |
|---|---|---|
| RMS Spectral Width | The weighted average width of the spectrum based on the Gaussian function, σrms2=∫(λ-λ0)2P(λ)dλ/∫P(λ)dλ | Accurately reflects the spectral energy distribution characteristics |
| -3dB Spectral Width | The wavelength interval when the peak intensity drops by 50% (full width at half maximum) | Main parameters of laser equipment |
| Specific dose ratio wavelength range | The minimum wavelength range that contains a specific ratio (e.g. 80%) of the total radiation dose | Key indicators for therapeutic dose control |
Comparison of wavelength definition methods
4.2.1 Spectral peak and spectrum width method
Applicable to single-peak spectrum equipment, by determining the peak wavelength A and the RMS/-3dB spectrum width A1-A2 to define the range
4.2.2 Specific intensity ratio method
Using a specific ratio (e.g. 10%) of the peak intensity P as the threshold, select the maximum interval wavelength points A1-A2
4.2.3 Specific dose ratio method
The minimum wavelength range is determined by the cumulative radiation dose ratio (such as 90%), which directly affects the evaluation of treatment effect
Standard implementation recommendations
5.1 Principle of multi-method combination
For composite spectral equipment, it is recommended to use the 4.2.1+4.2.2 combination method to describe different spectral components respectively
Test condition specifications
When measuring, ensure that:
1. The equipment is in standard working mode
2. Use a calibrated spectroradiometer
3. The ambient temperature is 23±5℃
Technical document requirements
Product registration should include:
- Description of the definition method used
- Spectral test raw data
- Wavelength range verification report
Technology Evolution Analysis
This standard introduces the concept of RMS spectrum width into the field of medical devices for the first time, which can better reflect the true characteristics of wide-spectrum devices compared to the traditional -3dB spectrum width method. Main updates of the 2023 version:
1. Added a method for defining specific dose ratio
2. Clarified the processing principles of multi-peak spectra
3. Standardized the test data recording format

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