YY 0789-2024 in English
TO BE VALIDLaser therapeutic equipment-Q-switched ophthalmic laser equipment
- Issued on:2024-07-08
- Implemented on:2027-07-20
- File Format:PDF
- Delivery:Via email within 1~3 business days
Price(USD)：
$140.00
$136.00
$136.00
| Standard No: | YY 0789-2024 |
| Document status: | TO BE VALID |
| Title in English: | Laser therapeutic equipment-Q-switched ophthalmic laser equipment |
| Title in Chinese: | 激光治疗设备 调Q眼科激光治疗机 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2024-07-08 |
| Implemented on: | 2027-07-20 |
| ICS Classification: | 11.040.70-Ophthalmic equipment |
| Chinese Classification: | C41-Medical ultrasound, laser, high-frequency instrument and equipment |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | laser pulse characteristics
version laser therapeutic equipment-q-switched ophthalmic laser equipment introduction standard evolution q-switched ophthalmic laser therapy machine pulse characteristics |
Introduction
Standard Evolution and Scope of Application
The main technical changes of the YY0789-2024 standard replacing the 2010 version include:
| Technical Dimensions | Requirements of the 2010 version | Changes in the 2024 version |
|---|---|---|
| Laser parameters | Only single pulse characteristics are specified | New pulse train output modes (double/triple/quadruple pulses) and sub-pulse parameters |
| Safety requirements | GB 7247.1 Basic requirements | Integration of GB 9706.22 special standards + new electromagnetic compatibility tests |
| Test method | Traditional optical measurement | Specify the oscilloscope waveform analysis method (50% peak power point measurement) |
Detailed explanation of core performance requirements
5.1.3 Laser pulse characteristics
The new standard makes more detailed provisions on the pulse characteristics of Q-switched ophthalmic laser therapy machine:
- Single pulse width: ≤6ns and deviation±20%
- Pulse train structure: The sub-pulse interval must be controlled within ±20% of the nominal value
- Waveform measurement: It is required to use a photoelectric probe + oscilloscope to record the complete waveform
Clinical application example
In retinal photocoagulation, the three-pulse train mode (sub-pulse interval 50μs) can effectively reduce tissue carbonization, and the pulse energy reproducibility ≤±20% ensures treatment consistency.
Implementation recommendations
Key points for equipment verification
- Wavelength calibration: Use a spectrometer to verify the 1064nm/532nm dual-wavelength system separately
- Energy test: ≥5 test points need to be selected within the full adjustment range
- Electromagnetic compatibility: Perform radiated immunity test in accordance with YY9706.102
Document management requirements
The manufacturer should keep complete waveform test records, including:
- Original oscilloscope screenshot
- Sub-pulse width calculation process
- 5 original data of energy reproducibility test
Sample only — not a preview of YY 0789-2024
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