YY 0307-2022 English PDF (YY0307-2022)

This document specifies the requirements and test methods for Nd: YAG laser therapeutic equipment. This document is applicable to Nd: YAG laser therapeutic equipment with a wavelength of 1064 nm and 532 nm.

YY 0307-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
CCS C 41
Replacing YY 0307-2011, YY 1300-2016, YY 1475-2016
Laster Therapeutic Equipment - Nd: YAG Laser Equipment
激光治疗设备
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 1, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 6
2 Normative References ... 6
3 Terms and Definitions ... 7
4 Product Classification ... 7
5 Requirements ... 7
6 Test Methods ... 13
Laser Therapeutic Equipment - Nd: YAG Laser Equipment
1 Scope
This document specifies the requirements and test methods for Nd: YAG laser therapeutic equipment (hereinafter referred to as therapeutic equipment).
This document is applicable to Nd: YAG laser therapeutic equipment with a wavelength of 1,064 nm and 532 nm.
This document does not apply to Nd: YAG laser therapeutic equipment for ophthalmology. 2 Normative References
The contents of this document 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 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 9706.19 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment
GB 9706.20 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment
GB/T 14710 Environmental Requirement and Test Methods for Medical Electrical Equipment GB/T 26599.1 Lasers and Laser-related Equipment - Test Methods for Laser Beam Widths, Divergence Angles and Beam Propagation Ratios - Part 1: Stigmatic and Simple Astigmatic Beam
YY/T 0758 General Requirements for Medical Laser Fiber
YY 1057 General Specifications for Medical Foot Switch
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 11146-2 Lasers and Laser-related Equipment - Test Methods for Laser Beam Widths, 5.1.5 Terminal laser output power (or energy)
5.1.5.1 Continuous output
The manufacturer shall specify the terminal laser output power and the tolerance; the tolerance shall not exceed  20%.
If the power is adjustable, the manufacturer shall specify the setting range, tolerance and step; the tolerance shall not exceed  20%.
5.1.5.2 Free-oscillating pulse output
5.1.5.2.1 Terminal laser pulse energy
The manufacturer shall specify the terminal laser pulse energy and the tolerance; the tolerance shall not exceed  20%.
If the energy is adjustable, the manufacturer shall specify the setting range, tolerance and step; the tolerance shall not exceed  20%.
NOTE 1: if the therapeutic equipment expresses the laser output value with the energy density, then, the “terminal laser pulse energy” in this clause is modified into “terminal laser energy density”.
NOTE 2: if the therapeutic equipment expresses the laser output value with the average power, then, the “terminal laser pulse energy” in this clause is modified into “terminal laser average power”.
NOTE 3: if the therapeutic equipment expresses the laser output value by the pulse power (that is, the laser output value is adjusted by setting the pulse power), then, the “terminal laser pulse energy” in this clause is modified into “terminal laser pulse power”. 5.1.5.2.2 Maximum pulse power
The manufacturer shall specify the nominal value and tolerance of the maximum pulse power of the terminal (corresponding to 10% pulse duration and 50% pulse duration); the tolerance shall not exceed  20%.
NOTE: if the therapeutic equipment expresses the laser output value by the pulse power (that is, the laser output value is adjusted by setting the pulse power), then, the “maximum pulse power” in this clause is modified into “maximum pulse energy”.
5.1.5.3 Q-switched pulse output (including picosecond pulse)
5.1.5.3.1 Terminal laser pulse energy
The manufacturer shall specify the terminal laser pulse energy and the tolerance; the tolerance shall not exceed  20%.
If the energy is adjustable, the manufacturer shall specify the setting range, tolerance and step; the tolerance shall not exceed  20%.
NOTE: if the therapeutic equipment expresses the laser output value by the energy density, then, the “terminal laser pulse energy” in this clause is modified into “terminal laser energy density”.
5.1.5.3.2 Maximum peak power
The manufacturer shall specify the nominal value and tolerance of the maximum peak power of the terminal; the tolerance shall not exceed  20%.
5.1.5.4 Pulse train output
5.1.5.4.1 Terminal laser pulse train energy
The manufacturer shall specify the terminal laser pulse train energy and the tolerance; the tolerance shall not exceed  20%.
If the energy is adjustable, the manufacturer shall specify the setting range, tolerance and step; the tolerance shall not exceed  20%.
5.1.5.4.2 Sub-pulse power
The manufacturer shall specify the sub-pulse power and the tolerance; the tolerance shall not exceed  20%.
If the sub-pulse power is adjustable, the manufacturer shall specify the setting range, tolerance and step; the tolerance shall not exceed  20%.
NOTE: if the sub-pulse power in the pulse train can be respectively set, specify the power of each sub-pulse in detail.
5.1.6 Instability of laser output power (or energy)
It shall not exceed  10%.
5.1.7 Reproducibility of laser output power (or energy)
It shall not exceed  10%.
5.1.8 Time characteristics of laser pulse output
5.1.8.1 Free-oscillating pulse output
5.1.8.1.1 Pulse duration
The manufacturer shall specify 10% pulse duration and 50% pulse duration and the tolerance; the tolerance shall not exceed  20%.
When there is repetitive output of the pulse train, the manufacturer shall specify the repetition frequency of the pulse train (or pulse train interval time); the tolerance shall not exceed  20%. If the repetition frequency (or interval time) is adjustable, the manufacturer shall specify the setting range, tolerance and step; the tolerance shall not exceed  20%. 5.1.8.3.3 Sub-pulse width
The manufacturer shall specify the sub-pulse width and the tolerance; the tolerance shall not exceed  20%. Alternatively, the range of pulse width can be specified, and the measured value shall be within the range.
If the width is adjustable, the manufacturer shall specify the setting range, tolerance and step; the tolerance shall not exceed  20%.
NOTE: if the sub-pulse width in the pulse train can be respectively set, specify the width of each sub-pulse in detail.
5.1.8.3.4 Number of sub-pulses (or sub-pulse interval time)
The manufacturer shall specify the number of sub-pulses (or sub-pulse interval time) and the tolerance; the tolerance shall not exceed  20%.
If the number or the interval time is adjustable, the manufacturer shall specify the setting range, tolerance and step; the tolerance shall not exceed  20%.
5.1.8.3.5 Sub-pulse width stability
It shall not exceed 20%.
5.1.9 Spot size of therapeutic surface
The manufacturer shall specify the spot size of the therapeutic surface and the tolerance; the tolerance shall not exceed  20%.
5.1.10 Requirements for 1,064 nm laser in frequency-doubled 532 nm laser If there is a frequency-doubled 532 nm laser, then, the proportion of the 1,064 nm laser in the total output energy of the frequency-doubled laser shall not exceed 3%. 5.1.11 Beam uniformity
When the spot size of the therapeutic surface is not less than 1 mm, the uniformity of the beam shall be specified.
5.1.12 Dot matrix graphics
If the laser is output in dot matrix graphics, the requirements for the dox matrix graphics shall be provided.
5.2 Aiming Beam
5.2.1 Peak wavelength of aiming beam
The manufacturer shall specify the peak wavelength of the aiming beam laser, and the deviation between the measured value and the nominal value shall not exceed  10 nm. Alternatively, the peak wavelength range can be specified, and the measured value shall be within the wavelength range.
5.2.2 Output power Pc
It shall be not greater than 5 mW.
5.3 Beam Propagation System
5.3.1 When the laser beam is propagated in the beam propagation system, the spot shall not be blocked.
5.3.2 For the therapeutic equipment using guiding beam arm, the guiding beam arm shall be flexible, and there shall be no phenomena like joint jamming or inability to rotate. 5.3.3 For the therapeutic equipment using optical fibers, the optical fibers shall comply with the requirements of YY/T 0758.
5.4 Cooling System
5.4.1 When the cooling system fails, the laser device shall stop working. 5.4.2 If the mode of water cooling is adopted, the system shall have no leakage. 5.5 Protective Goggles
5.5.1 Identification of protective goggles
On the laser protective goggles, the protective wavelength range and optical density value shall be marked.
5.5.2 Optical density value
The optical density value of the laser wavelength in 5.1.1 shall be not less than 4. 5.5.3 Visible light transmittance
It shall be not less than 30%.
5.6 Foot Switch
The foot switch shall comply with the requirements of YY 1057.
5.7 Safety
shall be selected at equal intervals, and shall include at least the minimum value, the median value and the maximum value. At each measurement point, use a laser power meter to conduct the measurement for a total of 5 times, and take the average value (each value shall satisfy the requirements); the result shall comply with the requirements of 5.1.5.1. 6.1.5.2 Free-oscillating pulse output
6.1.5.2.1 Terminal laser pulse energy
In accordance with the time specified by the manufacturer, conduct the pre-heating; at each wavelength, measure the laser pulse energy. If the pulse energy is adjustable, the measurement points shall be selected at equal intervals, and shall include at least the minimum value, the median value and the maximum value. At each measurement point, use a laser energy meter to conduct the measurement for a total of 5 times, and take the average value (each value shall satisfy the requirements); the result shall comply with the requirements of 5.1.5.2.1. If the therapeutic equipment expresses the laser output value with the energy density, then, in accordance with the above-mentioned method, measure the laser pulse energy of each measurement point; in accordance with the method of 6.1.9, measure the spot size; divide the energy by the spot size to obtain the energy density, and the result shall comply with the requirements of 5.1.5.2.1.
If the therapeutic equipment expresses the laser output value with the average power, then, modify the “pulse energy” in the first paragraph to “average power”; modify the “laser energy meter” into “laser power meter”, and the result shall comply with the requirements of 5.1.5.2.1. If the therapeutic equipment expresses the laser output value with the pulse power, then, modify the “pulse energy” in the first paragraph into “pulse power”; modify the “laser energy meter” into “laser power meter”, and the result shall comply with the requirements of 5.1.5.2.1. 6.1.5.2.2 Maximum pulse power
In accordance with the stipulations of the manufacturer, conduct the setting. Use the laser energy meter to measure the pulse energy Q of each wavelength, meanwhile, use a photoelectric probe and an oscilloscope to measure the corresponding 10% pulse duration 10 and 50% pulse duration 50. In accordance with Formula (1) and Formula (2), calculate the maximum pulse power P10 and P50, and the results shall comply with the requirements of 5.1.5.2.2. Where,
Q---the pulse energy;
10---10% pulse duration;
50---50% pulse duration.
If the therapeutic equipment expresses the laser output value with the pulse power, then, in accordance with the time specified by the manufacturer, conduct the pre-heating. Use a laser energy meter (or an equivalent method) to measure the maximum laser pulse energy of each wavelength, and the result shall comply with the requirements of 5.1.5.2.2. 6.1.5.3 Q-switched pulse output (including picosecond pulse)
6.1.5.3.1 Terminal laser pulse energy
The test method is the same as 6.1.5.2.1, and the result shall comply with the requirements of 5.1.5.3.1.
6.1.5.3.2 Maximum peak power
In accordance with the stipulations of the manufacturer, conduct the setting. Use a laser energy meter to measure the pulse energy Q of each wavelength, meanwhile, use a photoelectric probe and an oscilloscope to measure the corresponding pulse width . In accordance with Formula (3), calculate the maximum peak power P, and the result shall comply with the requirements of 5.1.5.3.2.
Where,
Q---the pulse energy;
---the pulse width.
6.1.5.4 Pulse train output
6.1.5.4.1 Terminal laser pulse train energy
The test method is the same as 6.1.5.2.1 (in which, the pulse energy is modified into pulse train energy), and the result shall comply with the requirements of 5.1.5.4.1. 6.1.5.4.2 Sub-pulse power
The test method is the same as 6.1.5.2.2 (in which, 10% pulse duration and 50% pulse duration are modified into sub-pulse width, and the maximum pulse power is modified into sub-pulse power), and the result shall comply with the requirements of 5.1.5.4.2. 6.1.6 Laser output power (or energy) instability
Adjust the terminal laser power (or energy) of each wavelength of the therapeutic equipment to s---the standard deviation;
 ---the average value of 10% pulse duration and 50% pulse duration of n times; i---the 10% pulse duration and 50% pulse duration for the ith time;
n---the number of measurements, n = 100.
6.1.8.2 Q-switched pulse output (including picosecond pulse)
6.1.8.2.1 Pulse width
Use a photodetector and an oscilloscope to measure the pulse width of each wavelength. If the pulse width is adjustment, then, within the set range, select the measurement points; the measurement points shall be selected at equal intervals, but shall at least include the minimum value, the median value and the maximum value; conduct the measurement at the maximum energy, median energy and minimum energy, and the result shall comply with the requirements of 5.1.8.2.1.
6.1.8.2.2 Pulse repetition frequency
The test method is the same as 6.1.8.1.2 [in which, the pulse repetition frequency (or pulse interval time) is modified into pulse repetition frequency], and the result shall comply with the requirements of 5.1.8.2.2.
6.1.8.2.3 Pulse width stability
The test method is the same as 6.1.8.1.3 (in which, the 10% pulse duration and 50% pulse duration are modified into pulse width), and the result shall comply with the requirements of 5.1.8.2.3.
6.1.8.3 Pulse train output
6.1.8.3.1 Pulse train width
The test method is the same as 6.1.8.2.1 (the pulse width is modified into pulse train width), and the result shall comply with the requirements of 5.1.8.3.1.
6.1.8.3.2 Pulse train repetition frequency (or pulse train interval time) The test method is the same as 6.1.8.1.2 [in which, the pulse repetition frequency (or pulse interval time) is modified into pulse train repetition frequency (or pulse train interval time)], and the result shall comply with the requirements of 5.1.8.3.2.
6.1.8.3.3 Sub-pulse width
The test method is the same as 6.1.8.2.1 (in which, the pulse width is modified into the sub- pulse width), and the result shall comply with the requirements of 5.1.8.3.3. 6.1.8.3.4 Number of sub-pulses (or sub-pulse interval time)
The test method is the same as 6.1.8.1.2 [in which, the pulse repetition frequency (or pulse interval time) is modified into the number of sub-pulses (or sub-pulse interval time)], and the result shall comply with the requirements of 5.1.8.3.4.
6.1.8.3.5 Sub-pulse width stability
The test method is the same as 6.1.8.1.3 (in which, the 10% pulse duration and 50% pulse duration are modified into sub-pulse width), and the result shall comply with the requirements of 5.1.8.3.5.
6.1.9 Spot size of therapeutic surface
In accordance with the method specified in GB/T 26599.1, ISO 11146-2 or ISO 11146-3, or an equivalent method, measure the spot size on the therapeutic surface, and the result shall comply with the requirements of 5.1.9.
6.1.10 Requirements for 1,064 nm laser in frequency-doubled 532 nm laser If there is a frequency-doubled 532 nm laser, use a laser energy meter to measure the laser output energy Q1; use a dichroic mirror to separate the 532 nm laser and the 1,064 nm laser; use an energy meter to measure the 532 nm laser energy Q2. Use Formula (15) to calculate the proportion  of the 1,064 nm laser in the laser output, which shall comply with the requirements of 5.1.10.
Or, use an equivalent method to conduct the measurement, and the result shall comply with the requirements of 5.1.10.
6.1.11 Beam uniformity
On the therapeutic surface, use a beam analyzer to measure the power density (or energy density) and the effective radiation area; use Formula (16), Formula (17), Formula (18) and Formula (19) to calculate the beam uniformity U, and the result shall comply with the requirements of 5.1.11.
For continuous output:
For pulse output: