This document specifies the requirements for excimer laser cornea ametropia equipment and describes the corresponding test methods.
This document is applicable to excimer laser cornea ametropia equipment (hereinafter referred to as the therapeutic equipment).
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 7247.1 Safety of laser products - Part 1: Equipment classification and requirements
GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.222 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
GB 11239.1-2005 Operation microscopes - Part 1: Requirements and test methods
YY/T 1057 General specifications for medical foot switch
YY 1296 Optics and photonics - Operation microscopes - Light hazard from operation microscopes used in ocular surgery
YY 9706.102 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 15004-2 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
optical zone
region of the cornea that receives all intended refractive therapy
Note: The therapy region consists of the optical zone and the transition zone, namely, the entire corneal region involved in laser therapy. The transition zone is outside the optical zone area, but within the therapy region.
3.2
alignment
positioning of the therapeutic laser beam to the desired location for therapy
4 Requirements
4.1 Therapeutic laser
4.1.1 Laser wavelength
The peak wavelength of the laser shall be 193nm, and the deviation of the measured value from the nominal value shall not exceed ±5nm.
4.1.2 Laser mode
The laser beam shall be of a fundamental mode or a higher-order mode.
4.1.3 Output power (energy) of laser terminal
The deviation of the measured value of the terminal output power (energy) from its nominal value shall not exceed ±20%.
If the terminal output power (energy) is adjustable, the adjustment range and stepping shall be specified, and the deviation of the measured value from the preset value shall not exceed ±20%.
4.1.4 Laser pulse width
The deviation of the measured value of the terminal laser pulse width from its nominal value shall not exceed ±20%; the range of pulse width may also be specified.
If the pulse width is adjustable, the adjustment range and stepping shall be specified, and the deviation of the measured value from the preset value shall not exceed ±20%.
4.1.5 Laser-repetition frequency
Foreword II 1 Scope 2 Normative references 3 Terms and definitions 4 Requirements 5 Test methods Annex A (Normative) Spectral weighting function for UV radiation hazard analysis
YY 0599-2024 Laser therapeutic equipment - Excimer laser cornea ametropia equipment
1 Scope
This document specifies the requirements for excimer laser cornea ametropia equipment and describes the corresponding test methods.
This document is applicable to excimer laser cornea ametropia equipment (hereinafter referred to as the therapeutic equipment).
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 7247.1 Safety of laser products - Part 1: Equipment classification and requirements
GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.222 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
GB 11239.1-2005 Operation microscopes - Part 1: Requirements and test methods
YY/T 1057 General specifications for medical foot switch
YY 1296 Optics and photonics - Operation microscopes - Light hazard from operation microscopes used in ocular surgery
YY 9706.102 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 15004-2 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
optical zone
region of the cornea that receives all intended refractive therapy
Note: The therapy region consists of the optical zone and the transition zone, namely, the entire corneal region involved in laser therapy. The transition zone is outside the optical zone area, but within the therapy region.
3.2
alignment
positioning of the therapeutic laser beam to the desired location for therapy
4 Requirements
4.1 Therapeutic laser
4.1.1 Laser wavelength
The peak wavelength of the laser shall be 193nm, and the deviation of the measured value from the nominal value shall not exceed ±5nm.
4.1.2 Laser mode
The laser beam shall be of a fundamental mode or a higher-order mode.
4.1.3 Output power (energy) of laser terminal
The deviation of the measured value of the terminal output power (energy) from its nominal value shall not exceed ±20%.
If the terminal output power (energy) is adjustable, the adjustment range and stepping shall be specified, and the deviation of the measured value from the preset value shall not exceed ±20%.
4.1.4 Laser pulse width
The deviation of the measured value of the terminal laser pulse width from its nominal value shall not exceed ±20%; the range of pulse width may also be specified.
If the pulse width is adjustable, the adjustment range and stepping shall be specified, and the deviation of the measured value from the preset value shall not exceed ±20%.
4.1.5 Laser-repetition frequency
Contents of YY 0599-2024
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
Annex A (Normative) Spectral weighting function for UV radiation hazard analysis
