Some standard content:
ICS 11. 040. 55
Pharmaceutical Industry Standard of the People's Republic of China
YY0109—2003
Replaces YY/T0109—1993
Medical ultrasonic nebulizer
Medical ultrasonic nebulizer2003-06-20 Issued
State Food and Drug Administration
2004-01-01 Implementation
YY0109—2003
Articles 4 and 3 of this standard are recommended, and the rest are mandatory. The main differences between this standard and the original standard are:
--It fully implements GB9706.1-1995. Since the safety and main performance requirements are mandatory, this revision changes the recommended standard to a mandatory standard, and at the same time changes the standard name to "Medical Ultrasonic Nebulizer". 1. Delete the test requirements for the mean trouble-free working time in the original standard. Since the diameter of the mist particles mainly depends on the ultrasonic frequency and the atomized drug, and the test of the distribution of the mist particle diameter is relatively complicated, this revision cancels the test requirements for the distribution of mist particles in the original standard and changes it to the publication of basic parameters. Appendix A of this standard is a normative appendix.
This standard is proposed by the State Food and Drug Administration. This standard is drafted by the National Medical Ultrasonic Equipment Quality Supervision and Inspection Center. This standard is under the jurisdiction of the National Medical Ultrasonic Equipment Standardization Technical Committee. The main drafters of this standard are Mang Anshi and Wang Zhijian. The previous versions of the standards replaced by this standard are: -YY/T0109--1993.
Medical Ultrasonic Atomizer
YY0109—2003
This standard specifies the classification, requirements, test methods, inspection rules, signs and instructions for use of medical ultrasonic atomizers. This standard applies to ultrasonic nebulizers (hereinafter referred to as "nebulizers") that use ultrasound to atomize liquid drugs. This product is mainly used for inhalation therapy and can also be used for air humidification in medical environments. 2 Normative references
The clauses in the following documents become clauses of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated referenced documents, the latest versions shall apply to this standard. GB/T191-2000 Packaging, storage and transportation pictorial marking GB/T2828-1987 Batch inspection counting sampling procedures and sampling tables (applicable to continuous batch inspection) GB/T2829-2002 Periodic inspection counting sampling procedures and tables (applicable to the inspection of process stability) GB9706.1-1995 Medical electrical equipment Part 1: General safety requirements GB/T14710-1993 Environmental requirements and test methods for medical electrical equipment 3 Classification
3.1 According to the structure, it is divided into desktop and pocket type.
3.2 According to the power supply used, it is divided into AC power type, DC battery type and AC/DC dual-purpose type. 3.3 Distribution of the diameter of the mist particles generated by the nebulizer: The proportion of mist particles with a diameter of 1μm to 5um is greater than 60%. 3.4 The atomizer tank of the nebulizer should use non-toxic materials that are not corroded by general drugs. 4 Requirements
4.1 Safety performance
See Appendix A.
4.2 Main performance
4.2.1 Deviation between ultrasonic working frequency of nebulizer and nominal frequency: ≤ 10%. 4.2.2 The maximum atomization rate of nebulizer must not be less than the provisions in its enterprise standard, instruction manual (or nameplate). 4.2.3 Water temperature in nebulizer water tank: ≤ 60℃. 4.2.4 The whole machine noise of nebulizer during normal operation: ≤ 50dB (A weighted). 4.3 Control function
4.3.1 The atomization rate of nebulizer should be adjustable. 4.3.2 The nebulizer should be equipped with low water level alarm or shutdown device. 4.3.3 The nebulizer should be equipped with air volume adjustment device at appropriate position. 4.3.4 The nebulizer should have a timing control device, and the deviation of its control time from the nominal time should not exceed 10%. 4.4 Continuous working time
The desktop nebulizer using AC power supply shall not be less than 4h. 4.5 Appearance and structure
4.5.1 The appearance of the atomizer should be neat and tidy, with uniform color, without defects such as scars, scratches, cracks, etc. The text and logo on the face plate should be clearly visible. 111
YY0109—2003
4.5.2 The plastic parts of the atomizer should be free of bubbles, blistering, cracking, deformation, and overflow of the filling material. 4.5.3 The sink and pipes of the atomizer should be leak-free. 4.5.4 The control and adjustment mechanism of the atomizer should be installed firmly and reliably, and the fastening parts should not be loose. 4.6 Environmental test
According to the product characteristics, the groups of climatic environment and mechanical environment tests should be specified in GB/T14710 in the enterprise standard, and explained in the random documents. The test time, recovery time and test items shall be implemented in accordance with the supplementary provisions of Table 1. Table 1 Supplementary provisions for environmental tests
Environmental test items
Rated working low temperature
Low temperature storage
Rated working high temperature
High temperature storage
Rated working damp heat
Damp heat storage
Duration/h
Test requirements
Recovery time/h
Load status
Rated working
Rated working
Rated working
Note: The power-on inspection is to operate the atomizer for 5 minutes under the rated working voltage to observe whether it is atomized normally. 5 Test methods
5.1 Safety
See Appendix A for the test methods.
5.2 Performance test
5.2.1 Ultrasonic oscillation frequency
Test items
Initial test
Intermediate or final test
Power-on check
Power-on check
Power-on check
Power-on check
Power-on check
Open the shell of the atomizer, use an oscilloscope (time base error is less than 3%) to monitor at both ends of the ultrasonic transducer (chip) or other ultrasonic excitation output ends, inject an appropriate amount of distilled water or drinking water into the atomization tank, put the atomizer in normal working state, measure the time period of the excitation waveform, and then calculate the ultrasonic frequency, which should meet the requirements of 4.2.1. 5.2.2 Maximum atomization rate
Use a measuring tube to measure an appropriate amount of distilled water or drinking water and inject it into the atomizer tank. The water temperature is 20℃±5℃. The water volume is in accordance with the instructions for use or the product standard. If there are atomization rate and air volume control functions, adjust them to the maximum. Use a stopwatch to record the time while turning on the machine. After atomizing for 5 minutes, stop the machine and measure the remaining water in the atomizer tank with a measuring cylinder. Calculate the maximum atomization rate according to formula (1): A = (B-B)/5
Where:
A atomization rate, in milliliters per minute (mL/min); B. - the amount of water pre-filled in the atomizer tank, in milliliters (mL); B - the amount of water remaining in the atomizer tank after atomizing for 5 minutes, in milliliters (mL). (1)
Note: If the product needs to be preheated, the atomizer tank can be put in after preheating or water can be injected into the atomizer tank after preheating. The timing starts from the time the atomizer is installed or the water is injected. 5.2.3 Temperature in the atomizer water tank
Pour an appropriate amount of distilled water or drinking water (water temperature is 20℃±5℃) into the atomizer tank and atomizer tank, and use a thermometer with a minimum indication of no more than 0.1℃ to monitor the water tank, or measure immediately at the following times: 112
u) When the pocket atomizer is automatically shut down or there is no water in the atomizer tank; YY 0109--2003
b) When the desktop atomizer works continuously for 4 hours or the time specified in the product standard (it is allowed to add an appropriate amount of water during the work). The maximum value displayed by the thermometer shall comply with the provisions of 4.2.3. 5.2.4 Whole machine noise test
Put the sound level meter and atomizer on the workbench, and set the atomization rate and air volume adjustment to the maximum if there are any. During normal operation, test the noise level at the front, back, left and right four directions 1m away from the atomizer, and the maximum value shall comply with the provisions of 4.2.4. 5.3 Control function
5.3.1 Atomization volume adjustability
When the atomizer is working normally, turn the atomization volume adjustment mechanism and visually check whether the atomization volume can change continuously. 5.3.2 Low water level alarm device
After the atomizer is connected to the power supply and works for 2 minutes, use a syringe or other tools to draw out the water in the water tank until the warning water level is reached. The atomizer should be powered off or send out an alarm message. When the power supply is connected, turn on the power switch twice intermittently, and then add water to check whether the atomizer is working normally. 5.3.3 Air volume adjustment device
When the atomizer is working normally, adjust the air volume and check whether the mist particle flow rate has changed significantly. 5.3.4 Timing error
Set the timing of the atomizer to the maximum, press the stopwatch to record the time while starting the machine, and record the actual working time after stopping the machine. Calculate the deviation between the actual working time and the set time (for some atomizers with non-adjustable timing, it is the nominal timing time), which should comply with the provisions of 4.3.4.
5.4 Continuous working time
The atomizer should be able to work normally after 4 hours or the time specified in the product standard (allowing an appropriate amount of water to be added to the atomizer during the work).
Note: This test can be combined with 5.2.3. 5.5 Appearance and adjustment mechanism
Inspect visually and by operation, and it should comply with the requirements of 4.5. 5.6 Environmental test
Carry out according to the method specified in GB/T14710. 6 Inspection rules
6.1 Inspection classification
The inspection of atomizers is divided into factory inspection and type inspection. Safety performance inspection rules
See Appendix A.
6.3 Factory inspection
6.3.1 Sampling for factory inspection shall be carried out in accordance with the provisions of GB/T2828-1987. 6.3.2 The sampling plan type adopts one-time sampling, and the strictness of the sampling plan starts from the normal inspection sampling plan. The inspection level is ⅡI, and the number of unqualified items is used for judgment. The unqualified classification, inspection items and AQL shall be in accordance with the provisions of Table 2. Table 2 Factory inspection
Classification of non-conformity
Inspection items
6.4 Type inspection
4.2.2, 4.2.3, 4.2.4, 4.4
Type inspection should be carried out in one of the following situations: C
4.3, 4.5
YY 0109--2003
Before new products are put into production (including old products transferred to other factories for production); a)
In normal production, no less than once a year; Resuming production after long-term suspension;
When there are major changes in design process or materials that may cause changes in equipment performance; d)
When the national quality supervision and inspection department makes a request. Type inspection should be carried out by sampling from the batches that have passed the factory inspection. Sampling for type inspection shall be carried out in accordance with the provisions of GB/T2829-2002. 6.4.3
Type inspection adopts a single sampling plan, and the discrimination level (DL) is II. Its non-conforming classification, inspection items, non-conforming quality level (RQL) and discrimination array are in accordance with the provisions of Table 3. Table 3
Non-conforming classification
Inspection items
Judgment array
Type inspection
4.2,4.4,4.6
n=-2(A.-0,R.=1)
6.4.5 Samples that have passed type inspection shall not be shipped as qualified products without sorting. 7 Marking, Instructions for Use
7.1 Marking
7.1.1 Product Marking
Each atomizer shall be firmly and clearly attached with the following markings in a conspicuous position: a) Product name and model;
b) Manufacturer's name;
c) Power supply used;
d) Factory number or date.
7.1.2 Packaging Marking
The following markings shall be on the packaging box:
a) Manufacturer's name and address;
b) Product name and model;
4.3, 4.5
n=2(A.-1,R.= 2)
c) "Fragile", "Upward", "Rainproof" and other graphic marks, the pattern of which shall comply with the provisions of GB/T191; d) Gross weight and dimensions.
7.2 Instruction manual
Should be able to guide users to correctly install, use and maintain, and provide necessary technical indicators and information. 114
A.1 Product features
Appendix A
(Normative Appendix)
The following safety features of the product should be indicated in the enterprise standard or accompanying documents: a) Safety type of the atomizer;
Power source used by the atomizer;
Power consumption of the atomizer;
d) Liquid-proof degree of the atomizer.
A.2 Requirements and test methods
A.2.1 External markings
At least the following "permanently affixed" and "clearly recognizable" markings should be present: enterprise name and atomizer trademark (or name); a)
b) Atomizer model;
c) Connection to power supply;
d) Safety classification.
Test method: According to the test method specified in 6.1 of GB9706.1-1995. A.2.2 Internal marking
The following "permanently affixed" and "clearly recognizable" markings shall be provided: a) If there is a battery, the model and installation method shall be marked; b) If there is a fuse that can only be reached by using tools, the specifications shall be marked near the fuse. Test method: According to the provisions of 6.2a) of GB9706.1--1995. A.2.3 Control device and instrument marking
Should comply with the requirements of 6.3 of GB9706.1--1995. Test method: Verify by operation inspection. A.2.4 Symbols
The symbols used for marking in A.2.1~A.2.3 must be consistent with the requirements of Appendix D of GB9706.1-1995. Test method: Verify by inspection. A.2.5 Wire insulation color
Class I equipment using mains power supply shall comply with the following requirements: YY 0109-2003
The insulation of the protective earthing wire shall be green/yellow throughout its length. The insulation on the wire connected to the protective earthing terminal inside the equipment must be at least a) green/yellow at the wire terminal;
b) The color of the wire insulation in the power cord shall comply with the requirements for the color of three-core cables in GB9706.1-1995, and the insulation of the wire connected to the neutral wire of the power supply shall be light blue. Test method: Verify by inspection. A.2.6 Gas identification
Not applicable.
YY 0109---2003
A.2.7 Gas connection point identification
Not applicable.
A.2.8 The color of the indicator light
shall meet the requirements of 6.7a) in GB9706.1-1995. Test method: verify by inspection. A.2.9 The color of the button
shall meet the requirements of 6.7b) in GB9706.1-1995. Test method: verify by inspection. A.2.10 The completeness of the random documents
shall meet the requirements of 6.8.1 in GB9706.1--1995. Test method: verify by inspection. A.2.11 The instruction manual
shall contain the contents specified in 6.8.2a), c) and d) in GB9706.1-1995. Test method: verify by checking the instruction manual. A.2.12 Technical specification
Should contain the following contents:
a) The contents specified in 6.8.3a), b) and d) of GB9706.1--1995; b) The commitment of the enterprise to provide the documents listed in 6.8.3c) of GB9706.1--1995 upon request. The technical specification can be combined with the instruction manual. Test method: Verify by checking. A.2.13 Input power
Desktop atomizers using AC power supply should comply with the provisions of 7.1 of GB9706.1-1995. Test method: According to the method specified in 7.1 of GB9706.1--1995. A.2.14 Environmental test
A.2.14.1 Transportation and storage: Should comply with the provisions of 10.1 of GB9706.1-1995. A.2.14.2 Operation: It shall comply with the provisions of 10.2 of GB9706.1-1995. A.2.14.3 Test method: It shall be verified through inspection and relevant tests. A.2.15 Safety type
It shall comply with the provisions of Chapter 14 of GB9706.1-1995. Test method: It shall be verified through inspection and relevant tests. A.2.16 Residual voltage
Desktop atomizers using AC power supply shall comply with the requirements of 15b) of GB9706.1-1995. Test method: According to the provisions of 15b) of GB9706.1-1995, use a residual voltage tester to test. A,2.17 Residual energy
Not applicable.
A.2.18 Enclosure of the casing
It shall comply with the provisions of 16a) of GB9706.1--1995. Test method: Use standard test finger, test needle and straight test finger to test. A.2.19 The safety of covers and doors that can be opened without tools shall comply with the requirements of 16a) 5) in GB9706.1-1995. Test method: Use standard test finger, test needle and straight test finger to test. A.2.20 Safety of lamps
Not applicable.
A.2.21 Safety of the top cover
Should meet the requirements of 16b) of GB9706.1-1995. Test method: Test with a standard test rod. A.2.22 Protective impedance of control devices
Not applicable.
A.2.23 Protection and marking of live parts
Should meet the requirements of 16d) of GB9706.1-1995. Test method: Verify by inspection. A.2.24 Safety of the whole machine casing
The casing that prevents contact with live parts must be removed only with tools. Test method: Operation and observation.
A.2.25 Safety of the adjustment hole
Not applicable.
A.2.26 Degree of isolation
Should meet the requirements of 17a)3) and 4) of GB9706.1-1995. Test method: Consult relevant technical documents
A.2.27 Isolation of applied parts
Should comply with the requirements of 17c) in GB9706.1-1995. Test method: Through inspection, and carried out simultaneously with the test of continuous leakage current under normal operating temperature. A.2.28 Isolation of flexible shaft
Not applicable.
A.2.29 Isolation of accessible parts
Should comply with the requirements of 17g)1) and 17g)4) in GB9706.1-1995. Test method: Consult relevant technical documents. A.2.30 Potential equalization conductor connection device
Not applicable.
A.2.31 Protective earth impedance
Class 1 equipment using mains power supply shall meet the following requirements: YY 0109--2003
a) For equipment with power input socket or power input terminal, the impedance between its protective earth point or external protective earth terminal and all accessible metal parts that have been protectively grounded shall not exceed 0.1Ω; b) For equipment with non-detachable power cord, the impedance between the protective earth pin in the power input plug and all accessible metal parts that have been protectively grounded shall not exceed 0.2Ω. Test method: It shall comply with the provisions of 18f) in GB9706.1--1995 and be carried out using the protective earth impedance test device for medical electrical equipment.
A.2.32 Functional earth terminal
Not applicable.
A.2.33 Functional earth wire marking
Not applicable.
A.2.34 The continuous leakage current at normal working temperature shall not exceed the allowable value listed in Table 4 of GB9706.1-1995 according to the safety type specified in the enterprise standard. Test method: It shall comply with the provisions of 19.4 of GB9706.1--1995 and use the leakage current test device for medical electrical equipment for testing.
YY0109--2003
A.2.35 The patient auxiliary current at normal working temperature is not applicable.
A.2.36 Dielectric strength at normal working temperature The nebulizer using AC power supply shall comply with the requirements of 20.1 and 20.2 of GB9706.1--1995. The safety type and test position determined by the enterprise standard shall be able to withstand the test voltage specified in 20.3 of GB9706.1--1995. Test method: According to the provisions of 20.4 of GB9706.1-1995, use the dielectric strength test device for medical electrical equipment to perform A.2.37 Continuous leakage current after wet pretreatment. A.2.34.
Test method: Wet pretreatment is carried out according to 4.10 of GB9706.1-1995. The continuous leakage current test after wet pretreatment is carried out according to the provisions of 19.4 of GB9706.11995, using the leakage current test device for medical electrical equipment. A.2.38 Patient auxiliary current after wet pretreatment is not applicable.
A,2.39 Dielectric strength after wet pretreatment is the same as A.2.36
Test method: Wet pretreatment is carried out according to 4.10 of GB9706.1-1995. The dielectric strength test of wet pretreatment is carried out according to the provisions of 20.4 of GB9706.11995, using the dielectric strength test device for medical electrical equipment. A.2.40 The rigidity of the housing and its components
shall comply with the requirements of 21a) of GB9706.1-1995. Test method: According to the provisions of 21a) of GB9706.1-1995, use a force gauge device for testing. A.2.41 The strength of the housing and its components
shall comply with the requirements of 21b) of GB9706.1-1995. Test method: According to the provisions of 21b) of GB9706.1-1995, use a spring impact test device for testing. A.2.42 The carrying capacity of the lifting device
The atomizer with a lifting device shall comply with the requirements of 21c) of GB9706.1-1995. Test method: According to the provisions of 21c) of GB9706.1-1995. A.2.43 The carrying capacity of the support
is not applicable.
A.2.44 Falling
Not applicable.
A.2.45 Handling stress
Not applicable.
A.2.46 Safety of moving parts
Not applicable.
A.2.47 Safety of transmission parts
Not applicable.
A.2.48 Controllability of moving parts
Not applicable.
A.2.49 Traceability of wearing parts
Not applicable.
A.2.50 Safety of movement of electrically controlled machinery
Not applicable.
A.2.51 Reliability of emergency devices
Not applicable.
A.2.52 Safety of faces, corners and edges
Should meet the requirements of Chapter 23 of GB9706.1-1995. Test method: Verify by inspection. A,2.53 Equipment stability
Desktop atomizers should meet the requirements of 24.1 and 24.3 of GB9706.1-1995. Test method: According to the provisions of 24.3 of GB9706.1-1995, observe the actual operation. A.2.54 Transportability
Not applicable.
A.2.55 Anti-splashing ability
Not applicable. wwW.bzxz.Net
A.2.56 Anti-implosion and impact ability of picture tubesNot applicable.
A.2.57 Suspension system with safety device
Not applicable.
A.2.58 Metal suspension system without safety wingNot applicable.
A.2.59 Ionizing radiation
Not applicable.
A.2.60 Location requirements for AP and APG type equipment
Not applicable.
A.2.61 Marking for AP and APG type equipment
Not applicable.
A.2.62 Documents accompanying AP and APG type equipment
Not applicable.
A.2.63 Electrical connections
Not applicable.
A.2.64 Housing structure
Not applicable.
A.2.65 Prevention of static electricity
Not applicable.
A.2.66 Corona
Not applicable.
A.2.67 Performance requirements for AP type equipment
Not applicable.
A.2.68Performance requirements for APG type equipment
Not applicable.
A.2.69Prevention of over-temperature operation
Atomizers using AC power transformers shall meet the following requirements: YY 0109--2003
a) Component temperature under normal conditions: The maximum temperature of the transformer winding and the iron core in contact with the winding shall not exceed the provisions of Table 10a of GB9706.1-1995;
b) Component temperature under specific conditions: Not applicable; c) Surface temperature of non-thermal therapy equipment: Not applicable; d) Heat source protection parts: Not applicable.
YY0109-2003
Test method: According to the provisions of 4) in 42.3 of GB9706.1-1995, measure with a thermometer in the temperature test angle. A.2.70 Overflow
Not applicable.
A.2.71 Liquid spillage
Not applicable.
A.2.72 Leakage
shall comply with the requirements of 44.4 of GB9706.1-1995. Test method: in accordance with the provisions of 44.4 of GB9706.1-1995. A.2.73 Moisture
shall comply with the requirements of 44.5 of GB9706.1--1995. Test method: carried out simultaneously with the tests A.2.37 and A.2.39. A.2.74 Liquid ingress
shall comply with the requirements of 44.6 of GB9706.1--1995. Test method: in accordance with the provisions of 44.6 of GB9706.1-1995. A.2.75 Cleaning, disinfection and sterilization
For reusable inhalation masks and tubes, the requirements of 44.7 of GB9706.1-1995 shall be met. Test method: According to the provisions of 44.7 of GB9706.1-1995, the disinfection and sterilization methods specified in the instruction manual shall be adopted. A.2.76 Water pressure test of pressure vessels
Not applicable.
A.2.77 Maximum pressure that pressure-bearing parts should withstandNot applicable.
A.2.78 Pressure relief device
Not applicable.
A.2.79 Selection of automatic reset device
Not applicable.
A.2.80 Reset after power failure
Should comply with the provisions of 49.2 of GB9706.1-1995. Test method: Verify by inspection. A.2.81 Relieve mechanical pressure after power failureNot applicable.
A.2.82 Prevention of dangerous output
Not applicable.
A.2.83 Hazards that must be considered for safetyNot applicable.
A.2.84 Requirements for single fault conditions
Shall comply with the requirements of 52.5.1, 52.5.4 and 52.5.5 of GB9706.1-1995. Test method: Verify by inspection. A.2.85 Marking of components
Shall comply with the requirements of 56.1b) of GB9706.1-1995. Test method: Check the rated values of components, consult relevant information to clarify these rated values and the conditions of use of components in the equipment, and compare whether they are inconsistent.
A.2.86 Fixing of components
Shall comply with the requirements of 56.1d) of GB9706.1-1995. 120
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