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YY/T 1751-2020 English PDF

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YY/T 1751-2020: Therapeutic laser equipment - Laser diode irradiation therapeutic equipment for nasal cavity
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Standard similar to YY/T 1751-2020

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Basic data

Standard ID YY/T 1751-2020 (YY/T1751-2020)
Description (Translated English) Therapeutic laser equipment - Laser diode irradiation therapeutic equipment for nasal cavity
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C41
Classification of International Standard 11.040.60
Word Count Estimation 8,824
Date of Issue 2020-09-27
Date of Implementation 2021-09-01
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies) State Drug Administration

YY/T 1751-2020: Therapeutic laser equipment - Laser diode irradiation therapeutic equipment for nasal cavity


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Therapeutic laser equipment - Laser diode irradiation therapeutic equipment for nasal cavity People's Republic of China Pharmaceutical Industry Standards Released on 2020-09-27 Implementation of 2021-09-01 Issued by the National Medical Products Administration 1 Scope 1 2 Normative references 1 3 Product composition and basic parameters 1 4 Technical requirements 1 5 Test method 3

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Subcommittee of Medical Optics and Instruments (SAC/TC103/SC1). Drafting organization of this standard. Zhejiang Medical Device Inspection and Research Institute. The main drafters of this standard. Du , Ye Yueshun, Fang Chunzi, Li Min, Huang Dan. Laser treatment equipment Semiconductor laser nasal cavity irradiation treatment instrument

1 Scope

This standard specifies the product composition and basic parameters, technical requirements and test methods of the semiconductor laser intranasal radiation therapy instrument. This standard applies to the use of semiconductor lasers with a peak wavelength of 630 nm to 670 nm for the treatment of irradiating the mucosa of the human nasal cavity instrument. The therapeutic apparatus uses the photobiological mechanism of weak laser and human tissue to achieve the purpose of auxiliary treatment.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) 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 basic performance GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods GB/T 14710 Environmental requirements and test methods for medical electrical appliances GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management GB/T 26599.1 Lasers and laser-related equipment. Test methods for laser beam width, divergence angle and beam transmission ratio Part 1 Points. no astigmatism and simple astigmatism beam The Pharmacopoeia of the People's Republic of China (2015 edition four parts)

3 Product composition and basic parameters

3.1 The components of the therapeutic apparatus. a) Semiconductor laser; b) Power supply and control system; c) Light guide parts. 3.2 The basic parameters are as follows. a) The peak wavelength of the output laser; b) Laser output power; c) The divergence angle of the laser terminal beam; d) Pulse modulation frequency and pulse width (if there is a modulated pulse working mode). 3.3 Laser radiation safety category According to the relevant requirements of GB 7247.1, the laser radiation category is specified.

4 Technical requirements

4.1 Normal working conditions The normal working conditions are as follows. ---Ambient temperature. 10℃～40℃; ---Relative humidity (RH). not more than 80%; ---Atmospheric pressure. 86.0kPa～106.0kPa; ---Power supply. grid power supply (~220V, 50Hz) and/or internal power supply. 4.2 The laser output performance of the treatment device 4.2.1 Laser peak wavelength The manufacturer shall give the nominal value of the peak wavelength of the laser with a tolerance of ±5nm. 4.2.2 Maximum laser output power The manufacturer shall give the nominal value with a tolerance of ±20%. 4.2.3 Laser terminal beam divergence angle The manufacturer shall give the nominal value with a tolerance of ±20%. Better than ±10%. Better than ±10%. 4.2.6 Control of laser output exposure 4.2.6.1 Output power setting. adjustable in stages or continuously, and the allowable difference between the measured value and the set value is ±20%. 4.2.6.2 Irradiation time setting. The laser irradiation time should be settable, and the allowable difference between the measured value and the set value is ±5%. 4.2.7 Modulation pulse If the laser output provided by the treatment device is a modulated pulse working mode, the manufacturer should specify the pulse frequency and pulse width, with a tolerance of ±20%. 4.3 Light guide parts 4.3.1 Dimensions of light guide parts The light guide component will not fall off by itself when inserted into the nasal cavity, and the outer diameter of the maximum insertion part shall not exceed 15mm. Other requirements can be specified by the manufacturer. 4.3.2 Repeatability and interchangeability of the treatment device If the light guide part and the laser assembly need to be connected to each other, they should not fall off by themselves after being connected. The connection is caused by repeated plugging and swapping. The relative standard deviation value of the output laser power change should be less than 5%. The light guide parts that are used for one-time use may not be subjected to repeated plug-in tests. 4.3.3 Biological evaluation The materials in contact with tissues should meet biocompatibility, and carry out biological evaluation in accordance with the provisions of GB/T 168886.1. 4.3.4 Microbiological testing If the manufacturer claims that the light guide component is a sterile product for single use, the product should be sterile. 4.3.5 Residual amount of ethylene oxide For light guide parts sterilized with ethylene oxide, the residual amount of ethylene oxide should be less than 10μg/g. 4.4 Overvoltage prompt function When the treatment device is working, when the voltage supplied by the internal power supply is lower than the lowest normal working voltage, there should be a low voltage prompt signal output, and The therapy device stops laser output. 4.5 Security 4.5.1 Laser radiation safety should meet the requirements of GB 72447.1.The laser radiation category of the treatment device should not exceed 3R. 4.5.2 General requirements for electrical safety shall comply with the provisions of GB 9706.1. 4.6 Appearance 4.6.1 The appearance of the treatment device should be uniform in color, without obvious defects such as spots, scratches, burrs, bubbles, dents, cracks, etc. 4.6.2 The text and marks on the treatment device should be clear, correct and firm. 4.7 Environmental test The environmental adaptability of the treatment device should meet the requirements of GB/T 14710, and the manufacturer should provide specific test conditions and inspection items. test The project shall at least include the requirements for the maximum output power of the laser in 4.2.2.

5 Test method

5.1 Laser peak wavelength Use a wavelength meter or spectrometer to measure the peak wavelength of the output laser, and the result should meet the requirements of 4.2.1. 5.2 Maximum laser output power After turning on, select the maximum output power, after warming up and stabilizing, use the laser power meter to measure the output power of the illuminator, and observe continuously within 10 min. Observe the power fluctuation, pay attention to record the peak value of each fluctuation, take the maximum value, and the result should meet the requirements of 4.2.2. 5.3 Laser terminal beam divergence angle Measure according to the method specified in GB/T 26599.1 or an equivalent method, and the result should meet the requirements of 4.2.3. 5.4 Instability of laser output power Turn on the therapy device, select the rated output power, and specify that the measurement time is not less than 15 minutes. Use a laser power meter at an interval of 1min The instability of the optical output power should meet the requirements of 4.2.4. 5.5 Reproducibility of laser output power When the treatment device is at the minimum, middle, and maximum values of the set value, the interruption time is 1min and the laser output is turned on, and the laser power is used. Equation (2) Calculate the reproducibility Rp of the optical output power, and the results should meet the requirements of 4.2.5. ×100% (2) Where. 5.6 Control of laser output exposure 5.6.1 Turn on the treatment device, make the laser at the minimum, intermediate, and maximum set values, and use the power meter to measure the laser output power. For measurement, the relative deviation between the measured value and the set value should meet the requirements of 4.2.6.1. 5.6.2 Set time control test. After turning on, the treatment time is set to the minimum and maximum values, and the laser output time is measured with a stopwatch. The results should meet the requirements of 4.2.6.2. 5.7 Modulated pulse If 4.2.7 is applicable, use a photodetector and an oscilloscope (or other equivalent equipment) to measure the laser pulse width and repetition frequency. The results should meet the requirements of 4.2.7. 5.8 Dimensions of light guide parts Use vernier calipers or general measuring tools for testing, and the results should meet the requirements of 4.3.1. 5.9 Repeatability and interchangeability of therapeutic equipment Turn on the treatment device, make the laser at the maximum output power, take any light guide part, connect the light guide part with the laser assembly, and use the laser The optical power meter measures the output laser power. Separate the light guide part, change the connection position, and reconnect with the laser assembly, a total of 5 times, record 5 For the laser power value, calculate its relative standard deviation value, and the result should meet the requirements of 4.3.2. Take any 5 light guide parts, connect the light guide parts with the laser assembly in turn, measure the output laser power with a laser power meter, and record 5 laser power values, calculate the relative standard deviation value, the result should meet the requirements of 4.3.2.The calculation formula is as formula (3) ~ formula (5). 5.10 Biological evaluation According to the method specified in GB/T 168886.1, evaluate the biocompatibility of the relevant materials, and the results should meet the requirements of 4.3.3. 5.11 Microbiological testing The test is carried out in accordance with the four general rules 1101 of the "Pharmacopoeia of the People's Republic of China".2015 edition, and the results should meet the requirements of 4.3.4. 5.12 Residual amount of ethylene oxide Carry out the test according to the method in Chapter 9 of GB/T 14233.1-2008, and the results should meet the requirements of 4.3.5. 5.13 Overvoltage prompt function Adjust the input voltage and check the voltage prompt function of the therapy device. The result should meet the requirements of 4.4. 5.14 Security Carry out the test in accordance with the methods specified in GB 9706.1 and GB 7247.1, and the results should meet the requirements of 4.5. 5.15 Appearance Using the intuitive method to detect, the results should meet the requirements of 4.6. 5.16 Environmental test The inspection is carried out in accordance with the method specified in GB/T 14710 and the manufacturer’s specific test conditions and inspection items. The results should meet the requirements of 4.7 Claim.

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