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YY 0599-2024 (YY 0599-2015) PDF EnglishSearch result: YY 0599-2015 (YY 0599-2024 Newer Version)
YY0599-2015: PDF in EnglishYY 0599-2015 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.60 C 41 Replacing YY 0599-2007 Therapeutic laser equipment - Excimer laser cornea ametropia cure system ISSUED ON: MARCH 02, 2015 IMPLEMENTED ON: JANUARY 01, 2017 Issued by: China Food and Drug Administration. Table of Contents Foreword ... 3 1 Scope ... 5 2 Normative references ... 5 3 Terms and definitions ... 6 4 Product composition and basic parameters ... 7 5 Requirements ... 8 6 Test methods ... 12 7 Inspection rules ... 18 8 Marks, labels, user’s manual ... 19 9 Packaging, transportation, storage ... 20 Therapeutic laser equipment - Excimer laser cornea ametropia cure system 1 Scope This document specifies the terms and definitions, structure and basic parameters, requirements, test methods, inspection rules, marking, packaging, transportation, storage for excimer laser cornea ametropia cure system. This Standard applies to excimer laser cornea ametropia cure system (hereinafter referred to as the cure machine). The cure machine uses a 193nm excimer laser to remove corneal tissue to change the shape of the cornea to improve vision. It is mainly used for refractive keratectomy (PRK), in situ keratomileusis (LASIK) and other corneal refractive correction and therapeutic keratectomy (PTK). 2 Normative references The following referenced documents are indispensable for the application 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/T 191, Packaging and storage marks 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 9706.20, Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment GB 11239.1-2005, Operation microscopes - Part 1: Requirements and test methods GB/T 14710, Environmental requirement and test methods for medical electrical equipment GB/T 17736, Testing method of main parameters for laser protective eyewear YY 91057-1999, General specifications for medical foot switch ISO 10936-2, Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery ISO 15004-2, Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection ANSI Z80.11-2007, Ophthalmics - Laser System for Corneal Reshsping 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 small spots scan Use computer program to control the laser spot usually not larger than 2mm. Scan and cut out the required diopter on the cornea. It is a mode of excimer laser ablation of the cornea. 3.2 slit light spots scan Use computer program to control the laser slit spot with a maximum size of 5mm×10mm. Scan and cut out the required diopter on the cornea. It is a mode of excimer laser ablation of the cornea. 3.3 complicated spots scan Use computer program to control laser circular variable spot with diameter of 0.65mm~6.5mm usually, as well as laser cylinder slit variable spot with width of 0.65mm~6.5mm. Scan and cut out the required diopter on the cornea. It is a mode of excimer laser ablation of the cornea. 3.4 optical zone The area of the cornea that receives the full expected refractive treatment. NOTE: The treatment area is the sum of the optical zone plus the transition zone. It is the entire corneal area involved in laser treatment. The transition zone is outside the optical zone, but within the treatment area. 3.5 alignment Position the treatment laser beam to the desired 3D position for treatment. 3.6 fluence The ratio of the energy of a single pulse of an excimer laser beam acting on the cornea and its area of action. 3.7 UV hazard effective exposure; Heff The cure machine shall be able to work normally under the following conditions at least: - Ambient temperature: +18℃~+24℃; - Relative humidity is not more than 50%; - Atmospheric pressure: 860hPa~1060hPa; - Power supply: AC 220V, 50Hz; - No strong electromagnetic field interference around; - No obvious vibration and disturbance of airflow around. 5.2 Treatment laser 5.2.1 Laser wavelength 193nm. The tolerance is ±5nm. 5.2.2 Laser mode Basic mode or multimode. 5.2.3 Laser terminal output energy The manufacturer shall specify the nominal value of the terminal output energy. If the output energy can be set, the setting range shall be given. The tolerance of nominal value or setting range shall not exceed ±20%. 5.2.4 Fluence of laser treatment face The manufacturer shall specify the nominal value of the fluence of the treatment surface. If the fluence can be set, the setting range shall be given. The tolerance of nominal value or setting range shall not exceed ±20%. 5.2.5 Laser pulse width The manufacturer shall specify the nominal value of the terminal laser pulse width. If the pulse width can be set, the setting range shall be given. The tolerance of nominal value or setting range shall not exceed ±20%. 5.2.6 Laser repetition frequency The manufacturer shall specify the nominal value of the terminal laser repetition frequency. If the repetition frequency can be set, the setting range shall be given. The tolerance of nominal value or setting range shall not exceed ±20%. 5.2.7 Terminal divergence angle The manufacturer shall specify the laser termination divergence angle (X and Y) and its tolerance or range. The tolerance shall not exceed ±20%. 5.2.8 Spot size of laser treatment surface The manufacturer shall specify the spot size of the laser terminal output (the treatment surface) and its tolerance. The tolerance shall not exceed ±20%. 5.2.9 Laser terminal output energy instability (St) It shall not exceed ±5%. 5.2.10 Laser terminal output energy reproducibility (Rp) It shall not exceed ±10%. 5.2.11 Laser beam drift It shall not be greater than 0.1mm. 5.3 Alignment system 5.3.1 The cure machine shall have an alignment system for the user to observe and align the desired position of the cornea. The alignment system may include microscopes, fixation lamps, aiming or focusing beams, or other suitable measures. The manufacturer shall give the composition of the alignment system. 5.3.2 The deviation of the alignment system shall not exceed ±0.1mm. 5.4 Range of optical zone The manufacturer shall give the range of the optical zone and its tolerance. The tolerance shall not exceed ±20%. 5.5 Refractive correction range and tolerance 5.5.1 The manufacturer shall specify the range and tolerance of refractive correction. The tolerance shall not exceed those specified in Table 1. Laser safety goggles shall be equipped and meet the following requirements: a) Indicate the wavelength range and optical density value of the protection; b) The optical density value of the protective wavelength is ≥4; c) The visible light transmittance: ≥50%. 5.13 Appearance 5.13.1 Fasteners shall be firmly connected. The function switch and control mechanism shall be installed correctly. Adjustment is reliable. 5.13.2 Appearance shall be neat. Text, symbols and signs are clear. There are no mechanical damage such as corrosion, coating peeling, obvious scratches, breakage and deformation. 5.14 Safety 5.14.1 The cure machine shall meet the requirements of GB 9706.1, GB 9706.20 and GB 7247.1. The illumination light source of the operating microscope shall meet the limits specified in ISO 10936-2. Other lighting sources shall comply with the limits specified in ISO 15004-2. 5.14.2 Photobiological hazard. The manufacturer shall evaluate the photobiological hazard of the cure machine. In the non-therapeutic wavelength range of 200nm to 330nm, the effective exposure dose of UV hazard effective exposure Heff accumulated in a single operation caused by the laser system including the secondary emission shall be lower than 10mJ/cm2. 5.15 Environmental adaptability The environmental adaptability of the cure machine shall meet the requirements of GB/T 14710. The manufacturer shall give specific test conditions and inspection items. The inspection items shall at least include the output energy of the laser terminal in 5.2.3. 6 Test methods NOTE: The test methods listed in this chapter are recommended. If the same effect can be obtained, other test methods are allowed. 6.1 Requirements for therapeutic laser test equipment A measuring instrument with suitable wavelength, measuring range and measuring uncertainty shall be selected. 6.2 Treatment laser 6.2.1 Laser wavelength measurement Use a laser wavelength meter or spectrometer to measure. The results shall meet the requirements of 5.2.1. 6.2.2 Laser mode check Use a laser beam analyzer (multimode may not be checked) to check. The results shall meet the requirements of 5.2.2. 6.2.3 Measurement of laser terminal energy Use a laser energy meter that can test 193nm to measure. If the terminal energy can be set, select measurement points at equal intervals within the energy setting range (at least at the upper, lower and median points of the setting range). Measure the laser terminal energy. Measure each measurement point 10 times. Take the average value. The results shall meet the requirements of 5.2.3. 6.2.4 Measurement of fluence of laser treatment face Follow the instructions in the user’s manual. If the fluence can be set, select measurement points at equal intervals within the setting range (at least at the upper, lower and median points of the setting range). Measure the output energy of the laser terminal according to the method in 6.2.3. Measure each measurement point 10 times. Take the average value. Measure the spot size according.......Source: https://www.ChineseStandard.net/PDF.aspx/YY0599-2015 |