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YY 0789-2024: Laser therapeutic equipment - Q-switched ophthalmic laser equipment
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YY 0789-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.70
CCS C 41
Replacing YY 0789-2010
Laser Therapeutic Equipment - Q-switched Ophthalmic
Laser Equipment
ISSUED ON. JULY 8, 2024
IMPLEMENTED ON. JULY 20, 2027
Issued by. National Medical Products Administration.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 5
4 Product Classification... 5
5 Requirements... 6
6 Test Methods... 9
Laser Therapeutic Equipment - Q-switched Ophthalmic
Laser Equipment
1 Scope
This document specifies the product classification and requirements for Q-switched ophthalmic
laser therapeutic equipment and describes the corresponding test methods.
This document applies to Q-switched ophthalmic laser therapeutic equipment (hereinafter
referred to as therapeutic equipment).
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through the normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB 7247.1-2012 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
YY/T 0065 Ophthalmic Instruments - Slit-lamp Microscopes
YY 9706.102 Medical Electrical Equipment - Part 1-2.General Requirements for Basic Safety
and Essential Performance - Collateral Standard. Electromagnetic Compatibility -
Requirements and Tests
3 Terms and Definitions
There are no terms or definitions that require definition in this document.
4 Product Classification
In accordance with the laser terminal pulse output mode, the therapeutic equipment can be
divided into single pulse output and pulse train output; in accordance with the number of sub-
pulses in a single output, the pulse train output mode can be divided into double pulse, triple
5.1.3.2 Single pulse output laser pulse width
If the therapeutic equipment has a single pulse output mode, under the single pulse output mode,
the deviation between the measured value of the laser pulse width and the nominal value shall
not exceed 20%; the nominal range of the laser pulse width can also be given, and the
measured value shall be within the nominal range. The nominal value and range of the pulse
width shall not be greater than 6 ns.
5.1.3.3 Laser pulse train width
If the therapeutic equipment has a pulse train output mode, under each pulse train output mode,
the deviation between the measured value of the laser pulse train width and the nominal value
shall not exceed 20%; the nominal range of the laser pulse train width can also be given, and
the measured value shall be within the nominal range.
5.1.3.4 Sub-pulse width and sub-pulse interval
If the therapeutic equipment has a pulse train output mode, the deviation between the measured
value of the sub-pulse width and the nominal value shall not exceed 20%; the nominal range
of the sub-pulse width can also be given, and the measured value shall be within the nominal
range. Both the nominal value and range of the sub-pulse width shall not be greater than 6 ns.
At the same time, under each pulse train output mode, the deviation between the measured
value of the sub-pulse interval and the nominal value shall not exceed 20%; the nominal range
of the sub-pulse interval can also be given, and the measured value shall be within the nominal
range.
5.1.3.5 Pulse (pulse train) repetition frequency or interval
If the pulse (pulse train) output of the therapeutic equipment is repeatable, the deviation
between the measured value of the pulse (pulse train) repetition frequency or interval and the
nominal value shall not exceed 20%.
5.1.4 Terminal output energy of laser pulse (pulse train)
If the terminal output energy of the laser pulse (pulse train) cannot be adjusted, under each laser
pulse output mode, the deviation between the measured value of the terminal output energy of
the laser pulse (pulse train) and the nominal value shall not exceed 20%.
If the terminal output energy of the laser pulse (pulse train) is adjustable, under each laser pulse
output mode, the deviation between the measured value in the adjustment range and the preset
value shall not exceed 20%.
5.1.5 Laser output energy reproducibility
The laser output energy reproducibility shall not exceed 20%.
5.1.6 Laser output beam convergence angle
The deviation between the measured value of the laser output beam convergence angle and the
nominal value shall not exceed 20%; the nominal range of the beam convergence angle can
also be given, and the measured value shall be within the nominal range.
5.1.7 Laser output focal spot diameter
The deviation between the measured value of the laser output focal spot diameter and the
nominal value shall not exceed 20%; a nominal range of the focal spot diameter can also be
given, and the measured value shall be within the nominal range.
5.2 Aiming System
5.2.1 Aiming light wavelength
The deviation between the measured value of the peak wavelength of the aiming light and the
nominal value shall not exceed 10 nm; a nominal range of the peak wavelength can also be
given, and the measured value shall be within the nominal range.
5.2.2 Aiming light power
The aiming light power shall not be greater than 1 mW.
5.2.3 Coincidence of aiming light
At the focal plane, the aiming light and the therapeutic laser shall coincide.
5.3 Laser Radiation at Slit Lamp Microscope and Eyepiece
5.3.1 Slit lamp microscope
Slit lamp microscope shall comply with the requirements of YY/T 0065.
5.3.2 Laser radiation at eyepiece
The laser radiation at the eyepiece of the slit lamp microscope shall not exceed the Class 1 AEL
value in GB 7247.1-2012.
5.4 Safety
The therapeutic equipment shall comply with the requirements of GB 9706.1, GB 9706.222
and GB 7247.1-2012.
5.5 Electromagnetic Compatibility
The therapeutic equipment shall comply with the requirements of YY 9706.102.
6 Test Methods
6.1 Therapeutic Laser
6.1.1 Laser wavelength
Use a wavelength meter or spectrometer for measurement and determine whether the results
meet the requirements of 5.1.1.
6.1.2 Laser mode
Use a laser beam analyzer for measurement and determine whether the results meet the
requirements of 5.1.2.
6.1.3 Laser pulse characteristics
6.1.3.1 Laser pulse output mode
Use a photoelectric probe and an oscilloscope for measurement, record the output waveform
and determine whether the results meet the requirements of 5.1.3.1.
6.1.3.2 Single pulse output laser pulse width
Use a photoelectric probe and an oscilloscope for measurement, take the time difference
between 50% peak power points as the pulse width, and determine whether the results meet the
requirements of 5.1.3.2.If the pulse energy is adjustable, select measurement points within the
entire energy adjustment range to verify the pulse width.
6.1.3.3 Laser pulse train width
Use a photoelectric probe and an oscilloscope for measurement and determine whether the
results meet the requirements of 5.1.3.3.
6.1.3.4 Sub-pulse width and sub-pulse interval
Use a photoelectric probe and an oscilloscope for measurement, take the time difference
between 50% peak power points as the sub-pulse width, and determine whether the results meet
the requirements of 5.1.3.4.If the pulse energy is adjustable, select measurement points within
the entire energy adjustment range to verify the pulse width.
6.1.3.5 Pulse (pulse train) repetition frequency or interval
Use a photoelectric probe and an oscilloscope for measurement and determine whether the
results meet the requirements of 5.1.3.5.
6.1.4 Terminal output energy of laser pulse (pulse train)
In various output modes, use a laser energy meter to measure the energy of the terminal pulse
Or directly use a beam analyzer or other suitable instruments for measurement and determine
whether the results meet the requirements of 5.1.7.
6.2 Aiming System
6.2.1 Aiming Light wavelength
Use a spectrometer for measurement and determine whether the results meet the requirements
of 5.2.1.
6.2.2 Aiming light power
Use a laser power meter for measurement and determine whether the results meet the
requirements of 5.2.2.
6.2.3 Coincidence of aiming light
Check at the focal plane using a slit lamp microscope and determine whether the results meet
the requirements of 5.2.3.
6.3 Laser Radiation at Slit Lamp Microscope and Eyepiece
6.3.1 Slit lamp microscope
In accordance with the method specified in YY/T 0065, conduct the measurement and
determine whether the results meet the requirements of 5.3.1.
6.3.2 Laser radiation at eyepiece
In accordance with the method specified in GB 7247.1-2012, measure the laser radiation
emission level at the eyepiece of the slit microscope, and determine whether the results meet
the requirements of 5.3.2.
6.4 Safety
In accordance with the methods specified in GB 9706.1, GB 9706.222 and GB 7247.1-2012,
conduct the measurement, and determine whether the results meet the requirements of 5.4.
6.5 Electromagnetic Compatibility
In accordance with the method specified in YY 9706.102, conduct the measurement, and
determine whether the results meet the requirements of 5.5.
YY 0789-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.70
CCS C 41
Replacing YY 0789-2010
Laser Therapeutic Equipment - Q-switched Ophthalmic
Laser Equipment
ISSUED ON. JULY 8, 2024
IMPLEMENTED ON. JULY 20, 2027
Issued by. National Medical Products Administration.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 5
4 Product Classification... 5
5 Requirements... 6
6 Test Methods... 9
Laser Therapeutic Equipment - Q-switched Ophthalmic
Laser Equipment
1 Scope
This document specifies the product classification and requirements for Q-switched ophthalmic
laser therapeutic equipment and describes the corresponding test methods.
This document applies to Q-switched ophthalmic laser therapeutic equipment (hereinafter
referred to as therapeutic equipment).
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through the normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB 7247.1-2012 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
YY/T 0065 Ophthalmic Instruments - Slit-lamp Microscopes
YY 9706.102 Medical Electrical Equipment - Part 1-2.General Requirements for Basic Safety
and Essential Performance - Collateral Standard. Electromagnetic Compatibility -
Requirements and Tests
3 Terms and Definitions
There are no terms or definitions that require definition in this document.
4 Product Classification
In accordance with the laser terminal pulse output mode, the therapeutic equipment can be
divided into single pulse output and pulse train output; in accordance with the number of sub-
pulses in a single output, the pulse train output mode can be divided into double pulse, triple
5.1.3.2 Single pulse output laser pulse width
If the therapeutic equipment has a single pulse output mode, under the single pulse output mode,
the deviation between the measured value of the laser pulse width and the nominal value shall
not exceed 20%; the nominal range of the laser pulse width can also be given, and the
measured value shall be within the nominal range. The nominal value and range of the pulse
width shall not be greater than 6 ns.
5.1.3.3 Laser pulse train width
If the therapeutic equipment has a pulse train output mode, under each pulse train output mode,
the deviation between the measured value of the laser pulse train width and the nominal value
shall not exceed 20%; the nominal range of the laser pulse train width can also be given, and
the measured value shall be within the nominal range.
5.1.3.4 Sub-pulse width and sub-pulse interval
If the therapeutic equipment has a pulse train output mode, the deviation between the measured
value of the sub-pulse width and the nominal value shall not exceed 20%; the nominal range
of the sub-pulse width can also be given, and the measured value shall be within the nominal
range. Both the nominal value and range of the sub-pulse width shall not be greater than 6 ns.
At the same time, under each pulse train output mode, the deviation between the measured
value of the sub-pulse interval and the nominal value shall not exceed 20%; the nominal range
of the sub-pulse interval can also be given, and the measured value shall be within the nominal
range.
5.1.3.5 Pulse (pulse train) repetition frequency or interval
If the pulse (pulse train) output of the therapeutic equipment is repeatable, the deviation
between the measured value of the pulse (pulse train) repetition frequency or interval and the
nominal value shall not exceed 20%.
5.1.4 Terminal output energy of laser pulse (pulse train)
If the terminal output energy of the laser pulse (pulse train) cannot be adjusted, under each laser
pulse out...