Some standard content:
National Metrology Verification Regulation of the People's Republic of China JJG581-—1999
Laser for Medical
1999-10-18
Implementation on 2000-03-15
Issued by the State Administration of Quality and Technical Supervision
Verification Regulation of
Laser for Medicine
JJG 581—1999
JJG581—1999
Generation #JJG:581-
JJG 651-
This regulation was approved by the State Administration of Quality and Technical Supervision on October 18, 1999 and came into effect on March 15, 2000.
Responsible unit: National Optical Metrology Technical Committee Drafting unit: Chengdu Metrology Supervision and Verification Testing Institute This regulation entrusts the National Optical Metrology Technical Committee to be responsible for the interpretation of this regulation Main drafters:
Participating drafters:
Li Yiping
Yu Zigang
JJG58I—1999
(Banbu Metrology Supervision and Verification Testing Institute) [Zhanluan City Xingjia Verification and Testing Institute]
(Maodu Second People's Hospital)
(Chengdu Second People's Hospital)
(Southwest Institute of Physical Technology, Chinese Academy of Sciences)
[Chengdu Metrology Supervision and Verification Testing Institute]
2 Technical requirements
2.1 Appearance quality and safety Reliability
2.2 Technical indicators of the light guide system,
2.3 Stability
2.4 Complexity.
2.5 Relative deviation of water-jet indication value:
2.6 Maximum T-operation efficiency...
3 Verification conditions and verification equipment
3.1 Environmental conditions:
3.2 Verification equipment:
4 Verification items and verification methods
Specific items·
Verification equipment..
Visual judgment
Leakage current measurement,
Measurement of indicator light output power
Measurement of the coaxiality of the laser beam and the indicator light
Judgment of the aiming cover equipped·bzxz.net
Shangguang Determination of single spot power output range
JJG:581-1999
Measurement of the rate of change of dynamic factor caused by rotation of light guide system
Measurement of average reflection ratio of hard unit
Measurement of transmittance L of single flexible unit
Measurement of transmittance of lens (group)
Measurement of longitudinal working range of light beam
4.15 Measurement of time stability
4.16 Measurement of output ratio reproducibility S.
4.17 Measurement of phase deviation of indication
5 Processing of calibration results and calibration period
5.1 Processing of calibration results
5.2 Calibration period -
·（3）
（6）
Appendix A Measurement principle diagram
Appendix R
Special equipment structure principle reference diagram
Classification of laser sources
Appendix) Warning mark
Appendix Normal laser wavelength table
Appendix Summary of laser treatment methods
JJ:581—1999
Appendix G
Verification certificate and verification result notification section back format
Various designations
JJG581—1999
Verification procedure for medical laser sources
This procedure applies to the verification of newly manufactured, used and repaired medical laser sources. The pulse frequency of the light source output energy is greater than 5h (excluding medical ophthalmic laser sources with precise aiming and positioning mechanisms), and the power (hereinafter referred to as power) ranges from 1.5mW to 150w. A medical laser source (called laser source by flux) is a luminous device used to treat human diseases. According to different medical needs, the laser source can have the following functions: in a continuous irradiation time, there are time or pulse settings, button switches, and controls equipped to start the laser at will! In terms of controlling the size and shape of the light beam, the laser source is equipped with a wide range of translucent mirrors and reflectors: in terms of controlling the direction of the light beam, the laser source is equipped with a direction rotating mechanism and can also be equipped with a convenient and flexible light guide system: in terms of power control, laser sources have various forms of blue and button switches: according to the mechanical and biological effects of the micro-light components when used on the human body, its use can be roughly divided into three major aspects (must be closed): different treatment methods have different requirements for laser performance and functions, among which Laser power is the most basic parameter of micro light source: the power of laser source can be adjusted by changing the current, pulse width, pulse peak, convex-to-space ratio, pulse rate and other methods: Note: (1) The light guide system can arbitrarily control the output of a certain number of carbon fibers; 2) The control switch can be used at the same time and can be used under the same laser source, and the output and commonality can be controlled.
2 Technical requirements
2.1 Appearance and safety and reliability
2.1.1 The laser source plate has the following markings: specification, model, manufacturing! Name, year and month of manufacture, factory number, classification mark, obvious grounding mark, warning signs and instruction marks (see Appendix (), 2.1.2 Make sure that the bottom of the parts are well tightened, and all adjustment knobs, buttons, switches, etc. can work normally without looseness. All connectors should be tightly matched and in good contact. 2.1.3 The laser source should be equipped with an allowable power display (the indicated value is referred to as the indicated value). 2, 1.4 When the source is halfway down, an auxiliary radiation warning signal should be issued. Laser sources above Class II A must be equipped with a switch controller. After the switch is strictly turned off, the laser source stops working: 2.1.5
2.1.6 Laser sources above Class III A must be equipped with an auxiliary radiation localization control mechanism so that the operator will not exceed the allowable radiation level of the Class II laser source when working. 2.1.7 All radiation doses of the observation system should be lower than the maximum allowable radiation of the first-class laser source. 2.1.8 The cooling system of the micro-light source should work reliably: if the cooling system emits radiation, there should be emergency safety protection measures.
2.1.9 If the laser source is equipped with a water cooling system, a window for viewing the water flow should be provided. After turning on the laser source power for 1 minute, there should be no gas pool of about 5rin in the system.-
;581199g
2.1, 10 The laser source that can be used for non-contact irradiation of the body surface should be equipped with a direction rotating mechanism and a corresponding locking device for the direction rotating mechanism. The locking rotating mechanism should be firm. When the laser device is working normally, the direction of the rotation is too small to be too small. 500A2.1.1||t t||2.1,12 The invisible laser source used for surgery shall be equipped with a small light, and the indicator light shall be clearly visible: 2.! .[3 The output power of the indicator light is 0.5m.2.1.14 The non-indicator light shall be kept coaxial with the laser. 2.1.5 The laser effect of the technology can be used, and the output port diameter is twice the size of the light source, and the laser beam can be fully equipped.
2.1.16 The light source of the laser beam is a point.
2.2 Technical indicators of the light guide system
2.2.1 The light guide system shall rotate flexibly, operate quickly, and have no dead spots in the space; the laser and the indicator light shall have no dead spots: 2.2.2 The laser source is equipped with a special light system composed of a domain operation unit, and the rate of change of the small light system rotation power and change shall be: less than 0%,
and , the effect of the system change rate of the system 2.2.3 The unit per unit meter of the system is not less than 10% (excluding the reverse mirror group) 2.2.4 The hard unit's flat reflection ratio is not less than 3% (excluding the lens group) 2.2.5 The lens (correction) transmittance is not less than 1%
2.2.G The laser source used in surgery, the longitudinal workpiece interval of the laser beam is not less than 10mm 2.3 Stability
Measure the continuous shooting, the laser source output stability range: should be better than three-laser. Or a variable laser source is required for the technical standard, measure the stability of the single continuous emission within T time: 2.4 Repeated adjustment of the indication value, and then repeat it. Power reproducibility: 110%: 2.2 Micro light source (same indication, automatic control switch: power reproducibility should be: excellent 110%: 2.5 Laser indication deviation
not more than 2%
2.fF Maximum operating power
not less than 0.5mW
3 Verification conditions and verification equipment
3.1 Environmental conditions
3.1.1 The external temperature is set according to the measurement system, and the temperature is not chaotic. 3.1.2 The whole measuring system should be placed in an environment with no light, no shock, no smoke and no electric field. Particularly avoid the shock and vibration that may cause non-comprehensive electricity. 3.2 Determined equipment 1. Power meter 2. Full power tester 3. Timer 4. Reading microscope 5. Heat paper, asbestos board, etc. 6. Vertical moving mechanism 7. Fixed stand
Fixed fixture
Straight (roll) ruler
Verification items and verification methods
Verification items
JJG581—1999
Table 1 Verification equipment list
Precision level
Uncertainty 5%, nonlinearity ±0.5%,
Relative zero drift +0.5%, response time
0.2 --5 s, 0.5 mW~150 W.
Graduation grid: 20.5m
Concave or with graduation grid.5mm case grid
Graduation grid; 0.5mm
Purpose Remarks
Measure power, calibration, reproducibility, variability, reflectivity and continuous reflection ratio, relative error of indication.
Measure the current
Measure the spot size
Record the light spot image
Measure the working range
Fix the beam direction, meter detector
Fix the rigid unit rotation
Measure the port diameter of the light guide system
Measure the length
According to the energy of the laser source, the range and the wavelength of the light wave are determined. The items to be tested in 2.1~2.6 are as follows: The length of the laser source can be found in the appendix. The classification of the laser source is not included in the appendix. 4.2 Verification equipment
Based on the verification items selection table "verification equipment in the standard verification. 4.3 Judgment
Carry out a quality inspection on the laser source according to the requirements of 2.1, 1.2.1.9. If it does not meet the requirements, no further processing will be carried out. -Step inspection. If the laser source does not meet the requirements of 2.1.10, and the optical signal system is not in compliance with 2.12, the next step of inspection will not be selected. 23.1 Start the excitation circuit 11, the equipment and environmental water system is * load platform 2.1.9, 4.3.2 Adjust the laser source power and lubrication to the minimum, start the laser workpiece power, and check whether the radiation signal is working properly; when the switch control ticket is removed, it is sufficient to meet 2.1.5: After the cooling source is cut off, it meets 2.1.$. 2.4 Leakage current measurement
Check whether the light source meets 2.1.11 during the work, and if it meets the requirements, the next step of inspection will be carried out
4.5 Indicator light withdrawal power measurement | |tt||Measurement principle See Appendix A Figure A. 1.
4.51 Use the corresponding power meter (power ratio is 2:1) to measure the actual light beam. If the power meter detector is aimed at the light beam to be tested, make sure that the light beam is directly projected into the deep measuring head of the power meter. 4.5.2 Use a baffle to block the light beam, zero the power meter, and then open the baffle to measure. 4.5.3 Take any indicator light beam transmission path for measurement and output all the results at the terminal of the measurement according to 2.1, 13 for judgment. The light source can only be used for technical preparation. If it does not meet the requirements, it is not necessary to go through the next step of calibration.
4.6 The micro beam and the indicator light are measured at the same time. Use thermal paper (or right) at a distance of 1 (Ⅲ from the input port) to measure. 1. Use the laser to irradiate the laser beam instantaneously, then start the indicator light source, and check whether the indicator light spot and the image of the light beam overlap. Then, under the same beam transmission path, shorten the thermal paper (or convex cotton board) arbitrarily, and measure the output port and position. Change the optical channel transmission path and measure again. According to the measured overlap degree, judge whether it meets the requirements of 21 and 14. If it does not meet the requirements, then proceed to the next step of calibration. 4.7 Judgment of laser source equipped with aiming device
For surgery without aiming device, use thermal paper (or convex cotton board) perpendicular to the light beam and close to the output port, and irradiate for a sufficient time until the thermal paper (or asbestos board) cannot burn. Use the thermal paper (or asbestos board) to learn the coordinate grid, or use a reading microscope to measure the maximum geometric size in the light spot. Use a caliper to measure the output port diameter, and judge the measured result according to 2.1.15. The laser source can only be used for surgery: If it does not meet the requirements, the next step of verification will not be carried out. 4.8 Determination of single point of light beam
Use thermal paper (or cotton) to illuminate the working laser beam vertically, and judge whether it meets the requirements of 1.16 according to its irradiated image: If it meets the requirements, the next step of verification will not be carried out. 4.9 Accurate beam power range
See Appendix A Figure A.1 for the measurement principle diagram.
A quasi-original beam refers to a beam whose transmission direction of the laser beam is inconsistent with the excitation and cannot be measured: Before measurement, remove the light guide system and ensure that the measurement is for the quasi-original beam output. Carry out measurements according to 4.5.1 and 4.5.2 to find out the maximum and minimum values of the power of the laser light from the source and select the indication Ps within its output range: use a power meter to measure the output power so that the rate of change of power caused by the rotation of the light-guiding system is as small as possible. See Appendix A Figure A, 2 for the measurement principle.
Rotate the light guide system at will, and observe the pointer light (or laser spot) in three-dimensional space to see if there is an output dead point. If there is no output dead point, then under the condition of P value, first use the fixing clamp to lock the rotation of the judgment unit so that the laser beam transmission path is in one plane, and then remove one of the fixing clamps one by one so that the light guide system has only one rotation plane. Then, in the rotation plane, set the parallel double standard original light coordinates: at each 90 degree rotation, read a power value according to the steps of 4, 5.1 and 4.52, and measure the output of each rotation direction one by one. Then substitute all the measured power values PA into formula (1) for calculation. PA _PAI ×100%
Wherein: the total number of times a right-handed rotating surface reads the power value in the "effective" direction per revolution; (1)
MIG5S1-19
—the average power in the i-th measurement;
——mean value P, the average value below:
——the number below the half mean value.
1.11 Rigid unit reduction flat Ma-sub reflectance ratio measurement principle diagram See Figure A.1 of the recording: Under the working condition of Ps indication, remove the lens group of the light guide system, and use the fixing clamp to lock the mutual rotation between all rigid units, so that the micro beam transmission path is in a plane: According to the operating steps of 4.5.1 and 4.5.2, measure the power to make P5 and substitute it into formula (2) for calculation. 1/
Wherein: α is the rigid unit of the light guide Number, 4.12 Measurement of transmittance of flexible unit per meter X100%
Measurement principle See Appendix A Figure A1, under the minimum working condition, remove the lens (red) at the end of the flexible unit, without the operation steps of 4.5.1 and 4.5.2, measure the output power F of the flexible unit and then measure the length of the flexible unit (m): and substitute them into formula (3) respectively, Peti
4.13 Transmittance of lens (group)! Test product (3)
Measurement principle See Appendix 4 Figure 1. Under the condition of P. indicating the position of the workpiece, keep the light beam transmission path alternate with 4.11 or 4.12, according to the operation steps of 4.5.1 and 4.5.2, measure the output power P of the lens (group): and substitute them into formula (4).
× 100%
×100%
414 Measurement of the longitudinal area of the low light
The working area of the laser beam refers to the front and rear position of the light waist (or the minimum point of the light beam), the geometric size of the spot is twice the total length of the light waist, and the measurement is based on the measurement of the half working interval. H measurement method:
Start the laser, use thermal paper (or asbestos board) to align the light spot from the minimum point of the diameter, and move it more than 5Hm in the direction of the light beam output. Keep the thermal paper (or asbestos board) perpendicular to the light beam. At this time, if the image on the thermal paper (or asbestos board) is clear everywhere, and there is no change in color depth and brightness, the geometric size of the laser beam half working area is more than 5m
Accurate measurement (measurement basis diagram Appendix Figure A, 3): In the day measurement method, it cannot be established. After finding the smallest spot diameter with thermal paper [or asbestos board], use thermal paper (or asbestos electrode) to irradiate perpendicularly to the light beam for a certain time: then advance 5mm in the direction of light transmission and irradiate perpendicularly for the same time. The irradiation time should be selected to ensure that the thermal paper [or asbestos board] burns and spreads. Use thermal paper 5
JIG:581—1999
【or right cotton pole】The scale of the two irradiated images is measured by the scale of the scale and reading microscope. The two scales should read the length value in the parallel direction of the two images (vertical or horizontal! direction). If the measurement result is that the ratio of the image scale at the front to the image scale at the near is more than 2, it is considered that the half-working interval is 5m:4.15 and is called stable. The original figure is shown in Appendix A Figure A1: When the laser source T is working, the power change characteristics within (or) are called time stability, expressed by S, and the calculation formula is: S, =+ Pg Pa 1n0%
Where: \: Within 10min (or T), the number of times the power meter value is read at equal intervals (#≥5):, Puxw The maximum value in the first measurement:
Pria\n The minimum value in the second measurement:
When the user is off for the first time, the value of the power meter is (5)
The laser source is out of the power range, and the appropriate point is selected to indicate the value: full product 4.51 measurement bar rises. The value remains unchanged, and the laser beam transmission path is to be changed and the power detection position is required to be determined by the mother. 4.16.1 Adjust the lifting and lowering buttons to the same value for a total of (5) times, and follow 4.5.1 Measurement System During measurement: Keep the laser beam transmission path fixed with the power meter, and repeat 4.5.2 for each measurement: and replace the power obtained in each measurement with the value S. (6PmPmx100%
Where: Pm—maximum value in one measurement; Pm—minimum value in one measurement.
4.6.2 Under the same indication, meet the measurement conditions of 4.51, in the measurement, ensure that the laser transmission path is light and the power meter and detector are fixed. Use the control switch to turn it on and off. Each time the control switch is turned off, the power meter should be calibrated. After the combustion, the measurement should be carried out, and the results should be substituted into formula 6 for calculation. 4.1 Measurement of the deviation of the indication value
See the attached diagram for the measurement principle. Fig.1 Select measuring points; the measured beam should be practical. If the laser source has no continuous power adjustment button, then press the buttons one by one to measure the indicated value: if the laser source has a multifunctional laser source, press the function selection key or the display dial to select the guide system and lens group of the light source to process the beam, and then measure: each energy must be measured.Ju.uat.S Penin
Pcam<1. 5 P.
Measurement requirements: 4.5.1 Test conditions: During the test, keep the laser beam transmission path and the power meter position constant, and repeat the steps of 4.5.2 when measuring the value. Record the measured results in (I, (2, (3) Appendix H8: Tables GI, (2, (4) and (5) respectively. The indicated value and actual output power indicated in Tables GI, (2, (5) are the user's power values. Calculation:
Pr×10%
Where: P represents the average indicated value;
micro-light source indicated value,
5. Processing of verification results 5.1 Verification is the necessary process for the results. The measured data and calculated results obtained during the verification shall be recorded in a table format. (7) 5.1.1 The calculation and processing of the data for each verification process have been described in Section 4. The results shall be given in three significant figures. 5.1.2 Laser sources that do not meet the requirements of 2.1.3 shall not be allowed to be used. 5.1.3 Laser sources that do not meet the requirements of 2.1.10 shall not be allowed to be used. 5.1.4 Laser sources that meet the requirements of 2.1.12 and 2.1.13 shall not be allowed to be used. 5.1.5 Based on the scope of use of laser power, the qualification of laser source shall be judged in accordance with 2.1~2.6: For laser sources that are not within the scope of 5.1.3 and 5.1.4, the final judgment of the product shall also be made according to the relevant clauses of 2.1--2.6. 5.1.6 Laser micro repairs must be re-calibrated frequently: 5.1. If qualified, a certificate of inspection shall be issued; if unqualified, a notification of the inspection result shall be issued. 5.2 Inspection cycle: The inspection cycle of the light source shall not exceed 1 year: bring the previous qualification certificate card every year,
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