YY 0789-2024 English PDF (YY0789-2024)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY 0789-2024 (Self-service in 1-minute)
Historical versions (Master-website): YY 0789-2024
Preview True-PDF (Reload/Scroll-down if blank)

YY 0789-2024: Laser therapeutic equipment - Q-switched ophthalmic laser equipment
YY 0789-2024.Laser therapy equipment Q-switched ophthalmic laser therapy machine
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0789-2010
Laser therapy equipment Q-switched ophthalmic laser therapy machine
Released on 2024-07-08
2027-07-20 Implementation
The State Drug Administration issued
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY 0789-2010 "Q-Switch Nd.YAG Laser Ophthalmology Treatment Machine". Compared with YY 0789-2010, except for the structure
In addition to adjustments and editorial changes, the main technical changes are as follows.
--- Changed "Scope" (see Chapter 1, Chapter 1 of the.2010 edition);
--- Deleted "Product composition and basic parameters" (see Chapter 3 of the.2010 edition);
--- Added a chapter on "Product Classification" (see Chapter 4);
--- Deleted the requirements for "normal working conditions" (see 4.1 of the.2010 edition);
--- Changed the requirements for "laser wavelength" (see 5.1.1, 4.2.1 of the.2010 edition);
--- Changed the requirements for "laser mode" (see 5.1.2, 4.2.2 of the.2010 edition);
--- Changed the requirements for "laser pulse output mode" (see 5.1.3.1, 4.2.3.1 of the.2010 edition);
--- Changed the requirements and methods for "single pulse output laser pulse width" (see 5.1.3.2, 6.1.3.2, 4.2.3.2 of the.2010 edition,
5.2.3);
--- Changed the requirements and methods of "laser pulse train width" (see 5.1.3.3, 6.1.3.3, 4.2.3.3, 5.2.3 of the.2010 edition);
--- Added the requirements and methods for "sub-pulse width and sub-pulse interval" (see 5.1.3.4, 6.1.3.4);
--- Changed the requirements and methods for "pulse (pulse train) repetition frequency or interval" (see 5.1.3.5, 6.1.3.5,.2010 edition
4.2.3.4, 5.2.3);
--- Changed the requirements and methods for "terminal output energy of laser pulse (pulse train)" (see 5.1.4, 6.1.4, 4.2.4,.2010 edition
5.2.4);
--- Changed the requirements and methods of "laser output energy reproducibility" (see 5.1.5, 6.1.5, 4.2.5, 5.2.5 of the.2010 edition);
--- Changed the requirements for "laser output beam convergence angle" (see 5.1.6, 4.2.6 of the.2010 edition);
--- Changed the requirements and methods for "laser output focal spot diameter" (see 5.1.7, 6.1.7, 4.2.7, 5.2.7 of the.2010 edition);
--- Changed the requirements and methods of "aiming light wavelength" (see 5.2.1, 6.2.1, 4.3.1, 5.3.1 of the.2010 edition);
--- Changed the requirements and methods for "laser radiation at slit lamp microscope and eyepiece" (see 5.3, 6.3, see 4.4,.2010 edition
5.4);
--- Deleted the requirements and methods of "appearance" (see 4.5 and 5.5 of the.2010 edition);
--- Changed the requirements and methods of "safety" (see 5.4, 6.4, see 4.6, 5.6 of the.2010 edition);
--- Added the requirements and methods of "electromagnetic compatibility" (see 5.5, 6.5);
--- Deleted the requirements and methods of "environmental adaptability" (see 4.7 and 5.7 of the.2010 edition);
--- Deleted the chapter "Inspection Rules" (see Chapter 6 of the.2010 edition);
--- Deleted the chapter "Marking, Labeling, Instructions for Use" (see Chapter 7 of the.2010 edition);
--- Deleted the chapter “Packaging, Transport and Storage” (see Chapter 8 of the.2010 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and coordinated by the State Food and Drug Administration.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2010 as YY 0789-2010;
---This is the first revision.
Laser therapy equipment Q-switched ophthalmic laser therapy machine
1 Scope
This document specifies the product categories and requirements for Q-switched ophthalmic laser therapy devices and describes the corresponding test methods.
This document applies to Q-switched ophthalmic laser therapy machine (hereinafter referred to as therapy machine).
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies 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.Basic safety and basic requirements of laser equipment for surgery, plastic surgery, treatment and diagnosis
Special requirements for this performance
YY/T 0065 Ophthalmic instruments - slit lamp microscope
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 Categories
According to the laser terminal pulse output mode, the treatment machine can be divided into single pulse output and pulse train output; according to the sub-pulse output of a single
The pulse train output mode can be divided into double pulse, triple pulse, quad pulse, etc. Laser pulse output mode (based on the triple pulse mode in pulse train output)
The waveform diagram is shown in Figure 1.
5 Requirements
5.1 Therapeutic laser
5.1.1 Laser wavelength
The laser peak wavelength should be 1064nm or 532nm, and the deviation between the measured value and the nominal value should be less than ±5nm.
5.1.2 Laser Mode
The laser beam mode should be the fundamental mode or higher order mode.
5.1.3 Laser pulse characteristics
5.1.3.1 Laser pulse output mode
The manufacturer should provide the laser pulse output method.
5.1.3.2 Single pulse output laser pulse width
If the treatment machine has a single pulse output mode, the deviation between the measured value of the laser pulse width and the nominal value in the single pulse output mode should not exceed
The nominal value and range of the pulse width are not
Should be greater than 6ns.
5.1.3.3 Laser pulse train width
If the treatment machine has a pulse train output mode, the deviation between the measured value of the laser pulse train width and the nominal value under each pulse train output mode is not less than
It should exceed ±20%; the nominal range of the laser pulse train width can also be given, and the measured value should be within the nominal range.
5.1.3.4 Sub-pulse width and sub-pulse interval
If the therapeutic machine has a pulse train output mode, the deviation between the measured value of the sub-pulse width and the nominal value should not exceed ±20%;
The nominal range of pulse width and the measured value should be within the nominal range. The nominal value and range of sub-pulse width should not be greater than 6ns.
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 should not exceed ±20%;
The nominal range of the impulse interval, the measured value should 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 machine is repeatable, the deviation between the measured value of the pulse (pulse train) repetition frequency or interval and the nominal value is not
Should 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, the terminal output energy of the laser pulse (pulse train) in each laser pulse output mode
The deviation between the measured output energy value and the nominal value should not exceed ±20%.
If the terminal output energy of the laser pulse (pulse train) can be adjusted, the measured value and the preset value of the adjustment range under each laser pulse output mode
The deviation should not exceed ±20%.
5.1.5 Laser output energy reproducibility
The laser output energy reproducibility should not exceed ±20%.
5.1.6 Laser output beam convergence angle
The deviation between the measured value and the nominal value of the laser output beam convergence angle should not exceed ±20%; the nominal range of the beam convergence angle can also be given.
The actual measured value should be within the nominal range.
5.1.7 Laser output focal spot diameter
The deviation between the measured value and the nominal value of the laser output focal spot diameter should not exceed ±20%; the nominal range of the focal spot diameter can also be given, and the measured value should be within ±20%.
The value should be within the nominal range.
5.2 Aiming system
5.2.1 Aiming light wavelength
The deviation between the measured value and the nominal value of the peak wavelength of the aiming light should not exceed ±10nm; the nominal range of the peak wavelength can also be given, and the measured value should be within ±10nm.
The value should be within the nominal range.
5.2.2 Aiming light power
The aiming light power should not be greater than 1mW.
5.2.3 Coincidence of aiming light
The aiming light and the treatment laser should coincide at the focal plane.
5.3 Laser radiation from slit lamp microscope and eyepiece
5.3.1 Slit lamp microscope
Slit lamp microscope should comply with the requirements of YY/T 0065.
5.3.2 Laser radiation at the eyepiece
The laser radiation at the eyepiece of the slit lamp microscope should not exceed the Class 1 AEL value in GB 7247.1-2012.
5.4 Security
The treatment machine should comply with the requirements of GB 9706.1, GB 9706.222 and GB 7247.1-2012.
5.5 Electromagnetic compatibility
The treatment machine should 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 to measure and determine whether the results meet the requirements of 5.1.1.
6.1.2 Laser Mode
Use a laser beam analyzer to measure 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 to measure and record the output waveform to determine whether the result meets the requirements of 5.1.3.1.
6.1.3.2 Single pulse output laser pulse width
Use a photoelectric probe and an oscilloscope to measure, and take the time difference between 50% peak power points as the pulse width to determine whether the result is consistent with
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 to measure 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 to measure, and use the time difference between 50% peak power points as the sub-pulse width to determine whether the result is
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 to measure and determine whether the results meet the requirements of 5.1.3.5.
6.1.4 Terminal output energy of laser pulse (pulse train)
Use a laser energy meter to measure the energy of the terminal pulse (pulse train) in various output modes and determine whether the results meet the requirements of 5.1.4.
Requirements. If the laser pulse (pulse train) energy is adjustable, select measurement points within the entire range to verify the output energy.
6.1.5 Laser output energy reproducibility
Set the rated output energy in each pulse output mode and use a laser energy meter to measure the energy of the terminal pulse (pulse train);
Turn on the laser emission control switch, wait for 1 minute, then turn on the laser emission control switch, and use the laser energy meter to measure the terminal pulse (pulse train).
Energy measurement. Repeat this process 5 times to obtain 5 measurement values Ei (i=1, 2, 3, 4, 5). Calculate the laser output energy reproducibility according to formula (1).
Rp, judge whether the result meets the requirements of 5.1.5.
6.1.6 Laser output beam convergence angle
Focus accurately through the microscope and determine the focal plane D of the beam. The distance between the laser output end surface A and the focal plane D is the focal plane L2.
Take plane C at the focal plane, and take plane B at the distance (L1 L2) from the focal plane (as shown in Figure 2).
On the laser optical axis at plane B and plane C, use a beam profiler or other suitable methods such as the variable aperture method to measure the 1/e2
The defined beam diameters are φB and φC, and the laser output beam convergence angle θ is calculated according to formula (2). Determine whether the result meets the requirements of 5.1.6.
6.1.7 Laser output focal spot diameter
Select the appropriate energy level, measure according to 6.1.6, obtain θ, L1, L2, ϕB and ϕC, and calculate the laser output focal spot diameter according to formula (3).
Diameter φ.
6.2 Aiming system
6.2.1 Aiming Light Wavelength
Use a spectrometer to measure and determine whether the results meet the requirements of 5.2.1.
6.2.2 Aiming light power
Use a laser power meter to measure 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 to determine whether the results meet the requirements of 5.2.3.
6.3 Laser radiation from slit lamp microscope and eyepiece
6.3.1 Slit lamp microscope
Carry out measurement according to the method specified in YY/T 0065 and d...