Some standard content:
5,11.040.50
Pharmaceutical Industry Standard of the People's Republic of China
YY/T 0010200?
Model Y551019s
Oral X-ray Machine
X-ray unit for oral cavity
2002-09-24 Released
Released by the State Food and Drug Administration
2003-04-C1 Implementation
Normative reference document
Terminology and meaning
1 Classification
1.1 Classification by electric shock protection
4.2 Classification by use
4.3 Classification by structure and safety method
4.4 Classification by structure and safety method
5. Working conditions of the machine
5.21 Maximum capacity of the empty machine
5.3 Selection of special specifications for reasons of war
5.4 Confirmation of the data
5.5 Power supply purchase section
5. 6 5. Viscosity indicator 5. Safety performance of mechanical products 5.10 Environmental test of glue machine... Appearance 6 Test method Test case 5. Visual test 3.3 Small size filter 3. 1 Maximum rated capacity inspection
3.5 Loading flash selection range according to clinical
Working compensation number push maintenance verification
Seven source adjustment clinical test
6.KX injection head rate sealing drive
5.9 Indicator accuracy inspection
Electrical performance
Safety test type·bZxz.net
Environmental after
6, 12
YY/T0010—2DC2
YY/T CC10—2002
7.2 Specifications
7.3 Factory inspection
7.4 Type comparison inspection
X Instructions for use, marking, labeling, packaging, hazardous materials, disposal 8.1 Instructions for use
Marking, labeling
8.4 Storage
Appendix A (Standard arrangement Appendix Safety
Table] Children's visit to the site of cardiac source heart block
Table agreed length
Table 3 Working data allowed to confirm
Table 1 Test requirements and inspection items Date
Required factory inspection
Table Type control method, etc.
￥0010200|| tt||This standard is not to report some of the management requirements of the drugs at the end of the month. The standard YY0U0--09 Oral X-ray System 3 is revised. Compared with the original standard, the changes are as follows:
This standard divides GBU7U6.11\G internal wear single pull. Edit as Appendix A (normative appendix), and lists the relevant electrical safety clauses in the original standard A:
Appendix A of this standard is the normative list,
This standard is under the jurisdiction of the National Product Supervision and Evaluation Management and the National Medical X-ray Equipment and Equipment Standardization Technical Committee, and this standard is initiated by Yuqing Medical Equipment Factory: The main developers of the standard are: Chen Shi, Ming Wenping, and Zhang Ming. This standard replaces the previous publications: ZBC430031Ug5, YY0010-193
1 Fan Guo
Oral X-ray Machine
Y+/T 010 2002
This standard specifies the classification, requirements, test methods, specifications, labels, time, table, operation and storage of X-ray machines.
The standard applies to 1 cavity × radiation machine (hereinafter referred to as glue machine): water-based high-frequency X-ray emitter, nuclear product X-ray photography, 2 Normative referenced documents
The terms in the following documents are certified for use within this standard and become the terms of this standard. All dated documents with all amendments (excluding design contents) are not applicable to this standard. However, the parties to the standard who have reached an agreement can use the latest version of this document: For the referenced documents not noted, the latest version applies This paragraph is in accordance with G13/T28291987 or periodic inspection and sampling table (applicable to: the production process is stable) GB/T465.2-1996 Electrical engineering drawing number GB5555-1 European diagnostic X-ray mechanical device wine equipment GB! /06-1-19S5 [pressure electric device part 2: family full monthly requirements 5.5-2 medical electrical equipment service part 2: diagnostic X-ray generator safety requirements 9706.119 application equipment part 1: use of the interruption group load group cattle safety requirements
GE 47(06, 15-1997
extreme judgment anti-pull requirements
electrical equipment part 1, safety umbrella general requirements, parallel standard diagnostic X-ray E 9706. 1439
Medical equipment specifications, X-ray equipment safety requirements Gk956s.1998
1 General rules for industrial product safety control
151014S12883 Book X-ray equipment number G31155.1—1489 New X-ray equipment for diagnosis and treatment C11755.2—1985 Medical diagnostic X-ray equipment for diagnosis and treatment GR11757-1XD|| tt||271 Technical conditions for the prohibition of the natural layer of metal parts
YY/T291-198 Technical requirements and test methods for the use of X-ray equipment YY/T9i0i5-1S Medical equipment reporting paint adding category, technical conditions YY31099-1599 Medical X-ray equipment marking, packaging, is the transport and storage of 3 terms and definitions
10149198 The following technical certificates and documents are established to accept the applicable vehicle standards 3.1
K-rayunitfororal Cavity X-ray machine and oral treatment of the country according to the level of the old name. #T GC13—2002
Dental X-ray machinedentalY-rayunit
Used to take dynamic X-rays of the teeth
Cavity full surface X-ray paarmi-romugraptrrayunittaroraiavliy used to take the frontal return rate of the oral cavity and the original X-ray or photo of the body. 3. 1
Gentle telepicarm
And X-ray products can be connected with the active mechanism,
4 Classification
4.1, electric shock protection classification: type of equipment service.
4.2 Classification by purpose
Dense expansion is divided into core and type
2) Tooth material × injection machine: cylinder standard not material machine); control full amount typical surface layer into the opportunity simple test lead market protection 4.3 Classification by structure and installation method
a country;
Mobile support:
City installation:
n}Other types:
1. Oral related requirements
4.4.1 Oral hygiene The machine should at least have the following main parts: strand pipe head;
h times controller,
) frame (with telescopic bamboo!
4.4.7 For the forehead machine: it should also have a head positioning structure and a rotating mechanism, 5 2
5. The oral machine has multiple working parts
5.\.1 Environmental conditions
The environmental temperature is 4 (
b) The state is not too high for the company's city road:
Ao 5.1.2 Power supply (single-phase 220 V = 22 V) The voltage is sinusoidal: The power capacity and the power supply voltage should meet the requirements of the manufacturer. The maximum power supply capacity should not exceed 200 V. 5.3 Selection range for additional requirements 5.3.1 Selection range for power supply and power supply quality table? 3.3.1.1 Dental machine tube voltage adjustment range
limit telephone
nominal voltage
YY1:99-0—2902
effective time
with the color moon tube fixed voltage adjustable two forms for the medium voltage of the scientific tube car bed is not less than 60 ten positive adjustable machine, adjusted to more than forget the tube voltage, take section adjustment, the street block tube three quantity should not exceed,
5.3.1.2 Embedded machine tube voltage adjustment range with high voltage section take juice section adjustment, each voltage should be more than 3V5.3.2 Tube current selection range
The tube current selection range of the compressor is (5m4A: 1.) The intelligent current selection type can be closed, the tube current is fixed, and the current is adjusted. There are three types of current time limit. 5-3.2 Loading time and current time adjustment range 5.3.3.1 Loading time adjustment range
a The load time of the compressor should be not less than 100%;
: The number of grades should be selected according to the priority system R1: 5.3.3.2 The current time product adjustment range of the compressor a) should meet the requirements of 5.3.2 and 3.3.3.1 of this standard: For the fixed compressor, the current product should be the smallest; 15.5. 4. The working efficiency data is accurate. The tube back pressure, reporting current, load time and electric test time product of the machine are not wrong as shown in Table 3 or the specified table. The working data are allowed to deviate from the specified table. ttu:+ut:
Electric test time product
-(Ix:+u. 2.ua -.)
YY/T QC1J—2002
5.5 Power supply regulation
The electric voltage should be able to be released within the specified range and the current is still within 220. 5. GX The head should be in good condition, with no airtightness inside, and no sealant on the surface and seal. The 57 indicator instruments should not show level 15. 5.3 Machine performance 5.8.1 Mechanical properties of dental machine 5.3.1.1 Mechanical properties of the frame The head should be adjusted smoothly within the adjustment range, and the positioning line should not move too much. The box should be able to press on the plane and form a certain shape. Rotate, hand-mounted machine center line to read the plane, the rotation of the single groove should not be less than the fixed or moving machine, the rotation position should not be greater than. Liu ten people m of the wall stomach machine to learn - outward to the machine flat forget not less than three 14)r:1,
) for "you too 2 degree of environment dental machine limit East wood (outside the south door), the maximum height between the machine support should be less than 25mm.
5.81.? The X-ray head should be on the horizontal plane! And the hand self-surface should be no less than 27" between the rotation, and there should be a scale value of not six 10 refers to the size of the corresponding rotating cloth:
5.8.2 Mechanical properties of the face plate
a) Rotational signal The load-carrying rotary mechanism reaches the standard of the diesel factory and the final rise is not more than 25mm, which can allow the desired positioning: b, the diesel production cost shall comply with the provisions of 3.8 in G36651585, 5.3 The actual performance of the mouth plate
See Appendix A of this standard)
5. The environmental damage test of the door plate
Conforms to Y/door (-[gas supply environment competition, cover environment 1 and See Table 1 for the requirements. Table test requirements and control test items
Reduction and requirements
Test items
Standardized work
Low-temperature test
Rated work
High humidity test
Contract work damp heat test
Point transfer acceptance
Special note time
Strict test items
Recognition and calibration
Blue performance
Same or point method
5. hb t5
. 3.5. 5
details have been added
normal test requirements
apply to electricity
normal test system
this electricity depends
normal test conditions
training method release
operation test
test cooling water
special sea judgment
table ()
fast mode time
Note 1. Except for the whole mode drive, the test is only time control reputation, the text contains the meaning of the common operation: etc. "heat release,
plan: record the head without entering,
5. 11 Appearance 5-11.1 The appearance of the engine shall be complete, without any defects such as scratches, bluish spots, etc. 5.11.2 The surface of the engine shall not have any defects such as scratches, bluish spots, etc. 5.11.3 The base of the engine shall not be silvery or shiny. 5.11.4 The engine oil-added coating shall comply with the regulations of the association.
6 Test method
6. 1. Test conditions
6-1.1 Environmental conditions
should meet the requirements of this specification.1.2 Power supply conditions
: single state. AC -220 V+11 V.50 H+0.5 Hz: b! The accuracy of the instrument shall be 105% of the specified value. 6.1.3 Instrument accuracy
) Type inspection: the instrument shall not be lower than Grade 1; general inspection: the instrument shall not be lower than Grade 2.
6.2 Appearance inspection: by oral observation.
5.3 4 feet, angle test
6.4 High capacity test
Under 5.2 dynamic conditions, the eye should be cold, the model should be especially different from the management, 6.5 Loading factor selection test
YY/I 001020C2
The maximum wave! The actual length
Sheli change the size of the device on each technical selection. The element is in accordance with the requirements of 3.3.1, 52.2, 5.3.3 of this standard. 5-6T. For data accuracy test
The load internal responsibility year seat meets the current requirements of G70200 01. 6.6.1 Tube voltage test
The provisions of GR 1155.1 18 are as follows.
Positive test type
Normal test service
YY/T 001C2002
6.6.2 Tube electro-hydraulic test
Perform according to the provisions of GB 113,2198.
6.6.3 Loading and auxiliary inspection
Perform according to the provisions.
5.6. 2. Current, time and specifications
According to 5B06.-203 small 111., carry out control test, 5-7. Check the power supply and control the voltage beyond the limit of 5.1.2 of this standard, and check whether the power supply can be adjusted to 220V. 5.8. X-ray tube sealing performance
Set the X-ray tube head to 205 (. Place it in a temperature box at 15 degrees, and then put it in a constant current range of 65 (4n , take it out and then cool it down for 1h to observe, it meets the requirements of this standard: 5.9 Indicator Accuracy Test
Science and Technology
6.0 Machine Performance
6.10.1 Dental Machine Performance
Multi-turn Pass;
1: Start for City Power! Test mode, Rongxing Huimin Zhi activity is carried out in the system, and the scraping star is the same as the total stroke. %. 6.10.2 Facial Machine Mechanical Performance
: Transfer Printing The structure of the selected carrier can be replaced by a US agency for type inspection: joint test according to 566-98: reverse: 5-11 safety test
according to this standard radiation record A specification thermal thank record. 6.12 environmental test
release YYT21597 see the appropriate
7 inspection regulations
7.1 acceptance
the machine should be manufactured! Quality control detailed door avoidance inspection after passing the close radiation and certificate of compliance! 1.2 Hazardous categories 7.3 Factory inspection 1.3.1. Inspection data and specifications. 7.3.2 Factory inspection form Special inspection form Table 5 Factory inspection form + current and light distance Same as above 7.3.3 Unit product non-conforming judgment E. 3.1. 3.3. 2.. , 5. 5,
F.*. 1. 启,1.:.s. *
,! Table 5! If one item in the group is not in place, the unit product will not be qualified; 3
..7.5, .1.1.5..1.2.3.1.1.
5. 1.8. 2.3-3
1:】Table 5【There are three items in the group that are not in place, and the unit product is judged to be unqualified. If there are four items in the group that are not in place, the unit product is qualified. 1 Type inspection
7.4.1 In the following circumstances, the unit product shall be taken for type control inspection: a) The product is produced by the old factory for trial production and identification: b) The product is clean and uniform, and the material is slightly changed, which may affect the product performance; Y:T00102032
Main inspection: During production, the product is regularly or cumulatively inspected for the same period; ) After long-term control of the product, the factory inspection results are compared with the previous type inspection results; () The user quality inspection type is required to be carried out according to the provisions of GB/T2829. 7.4.3 Before the type is inspected, ten samples are selected from the qualified batch of the factory for type control inspection. 744 Type inspection is carried out once, and the group accepts the case. The above non-conforming classification, inspection group, inspection items, daily classification of different combinations (more than the table.
Table 5 Type inspection plan
No reduction method
Not including quality!. Rate::
7.4.5 Unit product inclusion judgment
,b Book voltage error +,-65. ,b. X.1,. -2FA. - LH-. IT
Requirements】One item in the group does not meet the requirements of the unit product. 8 Instructions for use, signs, labels, packaging, transportation, purchase and storage 8.1 Instructions for use
Conform to GB569.11393.6725.32000.G795.1199797 (6.121597 has provisions
8-2 Marking, marking
Should be 1:99--199 and attached with X. For marking, it should be in accordance with G7.1-9 analysis GB/T5165.21986, and have product registration status. 6.3 Packaging
Should comply with Chapter 4, Section 5, Section 1091299 of YY1091299 6. Review requirements. B.4 Transportation and storage
The whole requirements of YY910S91999 3 and a half YY: TQU702C02
A.1 Product features
Appendix A
(Regulatory core appendix)
) Type: Type not required:
b The whole machine is fixed or dynamic support equipment; e: "I The whole machine has application parts:
) The machine has not only signal output parts: ") The machine has protection according to the ground:
EII machine is not AP type AP type equipment
and) the machine operation force is: material loading and continuous operation or. A.2. Requirements and methods of delivery
A.2.1 External marking
1.2.1.1 Requirements
The following "water-tight and firmly attached" and "clean and easy to use" markings must be included: (s?6.1G.1e) [)g) .5) 19 requirements should be met including 70h. 32300.1 requirements;) the degree of density requirements
d) should comply with the requirements of 6.202 and 29.2C.5 of B970121297 A.2-7. 2 Test method
The equipment must be inspected according to the provisions of 6.1 in 6976e.1905 to verify that the product meets the requirements. The remaining markings are complete in the random documents. A.2.2 Internal marking
A.2. 2. 1 Requirements
Should comply with 6.1—) requirements
A.7.7.2 Test method
Inspection should be carried out according to the methods specified in 33706.[_ to verify whether it meets the requirements A.2.3 Control device and receiving meter marking
A.2. 3. Requirements
Should comply with the requirements in B-:! , requirements.
A.7. 3.2 Test method
Applicable to the environment: Check whether the source is suitable for the fee record. A.2.4 Symbols
42.4.1 Requirements
The symbols used as symbols in A.2.1~.2.3 must be G910.:—129 Appendix Requirements Scan 1.2.4.2 Test method
Check whether the source meets the requirements. 3
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