This standard specifies the definition, classification, requirements, test methods, sampling and inspection rules, marking, labeling and instruction manual, packaging, transportation and storage requirements of light curing machines. This standard applies to light curing machines equipped with halogen lamps that emit blue light wavelengths. This light curing machine can cure resin materials for dental restoration. YY 0055-2002 Dental Equipment Light Curing Machine YY0055-2002 Standard download decompression password: www.bzxz.net

Supervisory No.: 9934—2002
Pharmaceutical Industry Standard of the People's Republic of China
YY 0055—2002
Dental equipment
Light curing machine
Dental eguipment Powered polymerization 2002-02-28 Issued
State Food and Drug Administration
2002-07-01 Implementation
YY0055—2002
This standard is for YYCC55—1UU1<8 power curing machine. From the date of implementation of the standard, it will replace YY0055 on 991 "Light Curing Machine".
The main differences between this standard and the original standard are: 1. It fully conforms to B9735.1-15S5 for electrical equipment, part 1, general requirements; 2. The light range in the professional standard light characteristics is deleted, and the cut-off wavelength test is changed to The test method is clarified: 3. The color of the fruit in the temperature rise test of the source standard is changed to a lighter yellow color that is closer to the tooth color: the source standard obtains the center chain and the continuous requirements as the requirements for appearance. , and more thoroughly (31471C-13 Medical electrical equipment service circulation fee requirements and test methods 3. This standard is proposed by the National Drug Replacement Administration. This standard is supervised by the National Oral Materials and Equipment Standardization Technical Committee. This standard was issued by the Donghua Energy Sugar Quality Inspection and Adjustment Center. The main drafters of this standard are: Ben Huasong, Tu Peiku. Huang Qixin. The standard was first issued in 101.
1 Scope
Dental equipment light curing machine
YY 0055 --2002
This standard specifies the definition, classification, requirements, test methods, sample and inspection rules, marking, labeling and instruction manual, packaging, transportation and service requirements for curing materials.
This standard is applicable to light curing machines equipped with halogen lamps that emit blue light. The light curing machines can cure resin materials and are used for dental repair.
2 Cited standards
The clauses in the following documents shall become the references of this standard. For dated referenced documents, all subsequent amendments (excluding outdated content) or revisions shall not be applicable to this standard. However, the latest versions of these documents may be used as soon as possible after the completion of the work of this standard. For undated references, the The new version is applicable to this standard, GB191 Packaging and transportation rate six marks
G/T2823 Batch inspection counting sample sequence and sample table (applicable to inspection of ten consecutive batches) B/T2829 Periodic inspection counting sample procedure and sample table (applicable to inspection of stability of calcium production) G90%.1 Medical electrical equipment Part 1: Safety requirements G939.1 Medical product instruction manual General test
G/T117101993 Environmental requirements test method for medical electrical equipment 3 Classification
Light curing machines can be divided into two types: mobile type and integrated type. 3.1 Mobile type
The power supply and control part are separated from the light source part, and the light source part is installed inside the machine. The light is installed on the machine in the form of a fiber optic guide.
32 complete machine type
Compared to the good source, the control part and the light source part are installed in a body, and the light is guided by the light guide element. 4 Requirements
Normal working conditions
Environmental humidity++
b? The relative humidity is not more than sC%RH:
Pressure kP~P
) Use 22022VHz1H.
4.1 Appearance requirements
4.1.1 All the process components on the light curing panel are properly installed and semi-solid, and their functions should be in accordance with the energy indicated on the panel: 1.1. The shell of the light assimilation machine should be flat, without obvious dents, cracks, stop correction, and the filter should be clean. The outer surface should be clean, and the electroplated and painted parts should not have rust or other phenomena. YY0055—2002
4.2 Spectral characteristics
The wavelength of the outer wavelength should not exceed.
4.3 Solidification depth
The curing depth of the light curing machine for light-cured resin should not be less than 2mm. 4.4 Temperature rise
Under the conditions of 4.3, the temperature at any point in the curing machine's optical zone should not be less than 1=℃. 4.5 Transient sound level
The cooling fan of the light curing machine should run smoothly, without abnormal noise, and the noise should not be loud. 4.6 Timing error
The timing error of the light curing machine should not be greater than 10%. 4.7 Safety requirements
Requirements to be met,
4.8 Environmental test requirements
4.8-1 The environmental test of the light curing board shall comply with the requirements of the climate environment test group 1 and the micro-environment test group T in GB/T147101993.
4.8-2 The transportation test of the light curing machine shall comply with the requirements of Chapter 3 in GB/1471U-1993. 4.83 The power adaptability test of the light curing machine shall comply with the requirements of Chapter 1 in GB/T117101993. 5 Test method
5-1 Appearance
Physical observation and hand feeling inspection shall comply with the provisions of Article 1 and 1. 5.2 Spectral characteristic test
Use ultraviolet and visible spectrometer to measure the spectral characteristics of the optical assimilation filter. The measurement range is 335mm--700mm. The highest peak value A of the transmittance at the outer wavelength end is A×15%, which corresponds to the value of the measured value. It shall comply with the provisions of 4-2. 5.3 Chemical release test
Put the chemical into the recommended material block and fill it with a through hole with a depth of 6mm and a diameter of 4mm. Exclude the dangerous gas range and fish it out. In the model county, fish two kitchen effects and a production groove with a length of m and m. Withdraw the photocuring machine from the ethylene film and align it with the test specimen at a distance of 3m. Use the rated working time of 2 sections. If the party does not specify the rated working time, the irradiation time shall be 4 seconds. After 180 seconds, take out the specimen from the mold and gently remove the cured material with a plastic stick. Use a dial indicator to measure the minimum height of the cured part of the specimen. The result shall comply with the requirements of Article 4.3. 5.4 Heat rise test
In the case of Article 4.3, place the dot meter in the light spot 3mm away from the high light output of the yellow bag H, and let the automatic photocuring machine work for twice the rated working time. If the party does not specify the rated working time, the irradiation time shall be 4 seconds. The value shall include the requirements of Article 4.1.
5-5 Noise Test
Place the light curing machine at a height of 1 meter away from the surface of the pool. Place the sound level meter at a height of 1 meter away from the surface of the light curing machine (transformer). Measure the sound level in the front, back, left and right directions with the positive and negative A-level meter. The maximum value should meet the requirements of 4.5. 5.6 Timing Error Test
Automatic light curing machine is screened out with light. Use the test meter to measure the working time of each time (interruption mode) or the time of each buzzer. Measure three times in total. Take the arithmetic mean value. The difference should meet the requirements of 4.6. 57 Safety Requirements Test
The test shall be carried out in accordance with the provisions of GH9706.1 and in accordance with the provisions of 4.Y. 5. Day Environment Test
Report the relevant provisions of 6R/T14710 and the requirements of Table 1 of this standard. 2
Other test items
Test requirements
and inspection items:
Condensation test
Low resistance test
Temperature tolerance test
Pre-certification. 1
High tear test
High risk test
Setting work:
Hot test
Wet heat test
Exhaustion test
Table 1 Environmental test
All performance
(Except safety performance)||tt| |Inspection direction positive belt. Working position quantity
Stop writing packaging inspection
: Machine connection ring test can be carried out under the ring halogen Liu bubble. "" Agricultural demonstration time is determined by the enterprise,
6 Sampling and inspection rules
6.1 Inspection classification
Inspection classification continuous world inspection (export" stability inspection) inspection (type inspection) 6-2 Batch by batch inspection
Contains sexual porridge
"Except safety seat)
6.2.1 The photosensitive machine blood mountain manufacturer's technical inspection department shall conduct inspection, and it can be submitted for acceptance only after passing the inspection. 6.2.2 Batch by batch inspection shall be carried out in accordance with the provisions of GR/T2829. YY0055—2D02
Re-voltage
6-2.3 Adopt one-time + method, the strict non-normal sample F tour of the sample plan, its clothing qualification classification inspection items, inspection level and A qualified quality level) clothing 2 regulations
Table of batch inspection
Unqualified classification
Inspection classification group
Check items
Inspection level
4- 2 ~ 4.6
YY 055—-2002
6.2.1 Transfer rules
6.2.4.1 When the light curing machine is in normal inspection, if there are two minor defects in the next five batches (not including those submitted for inspection again), the next batch of inspection shall be transferred to the strict inspection. If the main defects affect other test groups, the quality inspection department and the receiving party shall decide.
6.2.4.2 From strict inspection to normal inspection, from positive belt to functional inspection, from effective inspection to positive belt inspection, and from strict inspection to strict inspection, the supervision inspection shall be in accordance with the provisions of GB/2828.
6.3 Periodic inspection
6.3.1 Periodic inspection shall be carried out under the following conditions: a) Before batch production of new products: b) When the light curing machine is changed at least once a year: c) When it needs to be put into production again after one year: d) When there are major changes in design, process or materials: d) When the national quality registration and supervision agency makes a request. E3-2 Periodic inspection is in accordance with the current provisions of GB/299. 6.3.3 Before periodic inspection, each vehicle shall be inspected separately, including the vehicles sold in batches, and a one-time sampling plan shall be used for peri-periodic control. The level of discrimination is I, and the inspection items, discrimination groups and RQ. properties (unqualified quality level) are as specified in Table 3. Table 3. Comprehensive inspection
Classification
By product category
Inspection time
4. 2-- 4. 6
2 (A, - G, R, -13
-2(4,=1-R,-2
5.3.4 The qualified period inspection must be all the inspection items within the same period. Otherwise, the period inspection will be regarded as unqualified. 6.4 The daily inspection rules for safety items are stipulated in the enterprise product standards. 7 Signs, labels and instructions for use
7.1 The light-curing machine should be equipped with a nameplate in an appropriate visible position. The following signs should be marked on the nameplate:) Production station name and model!
) Source frequency and power,
) Output number:
Manufacturing year and month or production batch number:
e) Marking number, product process number.
7.2 The packaging of the light curing machine shall be marked with the following: manufacturer name and factory;
1) product name and model:
c) net weight:
height and width;
d) year and month of manufacture or batch number;
e) words and symbols such as "sun", "rain", etc., and the relevant symbols in G1191 shall be included. The words and symbols on the box shall ensure that they are not blurred after a long time. 7.3 When the light curing machine leaves the factory, the packaging box shall include the following random documents:
1) packing list: bzxZ.net
2) product certificate;
3) random spare parts list;
4) product instruction manual;
5) other documents specified in the product label; 7.3. 1 The certificate of conformity shall have the following marks: 1) Manufacturer’s name:
2) Product number:
3) Product factory number:
4) Inspection date,
5) Name of the inspector:
YY0055—2002
6) Operation manual shall guide the user to operate and maintain the machine correctly, and shall comply with the relevant provisions of GB9963.1. 7.3-2 The instruction manual shall guide the user to operate and maintain the machine correctly, and shall comply with the relevant provisions of GB9963.1. 8) Packaging, transportation and storage
81 The packaging of the curing machine shall meet the requirements of the manufacturer and shall not be damaged under foreseeable transportation conditions. 8.2 The packaging of the curing machine shall meet the requirements of the transportation contract, but the machine shall not be exposed to rain. 8.3 The installed light curing machine shall also be tested in a room with good light-conducting gas circulation: the temperature and humidity shall be in accordance with the manufacturer’s requirements for 5
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