YY/T 0347-2002 General technical requirements for miniature medical diagnostic X-ray machines
Some standard content:
ICS1.140.50
Pharmaceutical Industry Standard of the People's Republic of China
YY/T 0347.-2002
General Specifications for Miniature Medical Diagnostic X-ray EquipmentGeneral specifications for miniature medical diagnostic X-ray equipment2002-09-21 Issued
State Food and Drug Administration
2003-04-01 Implementation
Specification
. Classification
H. "Naming Rules
3.2 Basic Composition
1 Requirements
4. 1 T conditions
Commercial rated research
X point cutting P when my pipe pressure
Wire system's beneficial line current
Loading center
The most effective visual scale
Limited point
Special pipe head rate sealing performance
Environmental test
Public installation and certification
4.14 Appearance -
5 Test method
.1 Test acceptance
5.2 Free high rated quantity
X-ray woven pipe,
Show vehicle effectiveness visual scale meter
Image state
To advance the standard
Text of the wire pipe actual performance
Complete test
Rack installation, disassembly!
Quick test see Sichuan
/1 J347—7007
YY/T034/2502
Inspection category
6. Inspection
6.3 Inspection method
? Instructions for use, cup mark, label, shipping and storage 3.1
7.2 Mark, cup label
7.3 Packaging
Respect the cold.
Attachment A (main period with record) Safety
YY 0327—2002
The national standard has been formulated in accordance with the requirements of the national standard. The standard will be formulated in the year of the medical micro-picture medical diagnostic equipment, and the unified requirements for the inspection and testing of the equipment will be effective for enterprises to ensure the use of diagnostic equipment × equipment. At present, the micro medical diagnostic equipment is a new national and industry standard. In the process of formulating this standard, the main participants read the technical instructions of the domestic micro medical equipment manufacturers, and made a statement on the technical requirements and test methods of medical diagnostic X-ray machines. The full requirements are quoted from GB 6-11995 Medical equipment Part 1: General safety requirements for diagnostic X-ray equipment, Part 2: General safety requirements for diagnostic X-ray equipment, Part 2: General safety requirements, and the standard for various radiation protection requirements for diagnostic radiation equipment. The annex to the standard also stipulates the requirements. This standard is issued by the National Medical Equipment and Appliance Standardization Technical Committee! .: This standard is for the inspection and maintenance of medical quality. The main persons in charge of this standard are: 1. Medical standard
General technical conditions for miniature medical diagnostic X-ray machines YY/T 0347:-2002
This standard stipulates the classification, test methods, structure, instructions for use, etc. of "micro-medical diagnostic X-ray machines". The standard contains only the X-ray machines that are suitable for use in clinics: 1. The product is referred to as X-ray machines. This product is especially suitable for outdoor mobile facilities, energy fields, sports fields, etc. 2. Normative referenced documents
The clauses in the two documents are the clauses of this standard through reference in this standard. It is a note-taking document, and all subsequent collection orders (including disconnection of medication, internal penetration, or excessive and unproven pressure) are required. This standard is for the treatment of blood, and the new version of this standard can be used for research and development of the product. The new version of the document is applicable to the standard of the month, -Self-made equipment Part 1: Safety requirements B7U5.2·20 Medical 1 Equipment Part 1: Special safety requirements for high-voltage generators for disconnecting × line generating devices Gh9706.11199
Wind power equipment Part 2: Special safety requirements for clinical X-ray source components and X-ray moment positions Yalai
(97E.121997 electrical equipment for use in electrical equipment, volume 1, requirements for the complete reverse use of equipment, parallel board standards, diagnostic X-ray equipment, radiation protection and general requirements
G4 medical equipment, part 1, safety and safety requirements for auxiliary equipment of X-ray equipment G0999.1-1922 product instructions for use, general provisions GB 11751-133 medical diagnostic X-ray practice, simulated parts, concave pressure test method, column 11755.21389 X-ray fighter pipe monthly flow test method GB/11375?049 X-ray time measurement method YY006-13 Classification and technical conditions of metal-made layers Y-1 X-ray equipment service requirements and temporary station methods YYT910551993. Treatment of fire and fire, and the following provisions YY1r99-1999 Civilian X-ray equipment marking, location award. Transportation and lighting 3 classification
3.? Naming rules
Mountain product standard regulations.
3.2H technical components
) with safety devices installed;
h: X-ray film speed collection:
machine channel.
Y/T 0347-2002
4 Requirements
4.1 Working conditions
4.1.1 Environmental conditions
Unless otherwise stated, the working environment of X-ray analyzer shall meet the following requirements: 1) Environmental temperature: 10~40℃
b) Temperature greater than 75%:
) Air temperature 7uPa~(c
4.1.2 Power supply conditions
Power supply voltage: AC22V internal power supply
Current consumption: 0H+1H:
Power supply voltage: specified in product standard
4. The maximum rated capacity shall be as specified in product standard.
4.3 X-ray tube voltage of X-ray machine
4.3.1 The voltage of the X-ray end of X-ray machine shall be fixed or modulated, and the voltage of the tube shall not be lower than 4-4.3.2 The deviation of the tube voltage shall not exceed 101:
1. The pre-radiation current of the X-ray machine
4.4.1 The X-ray current regulation of X-ray machine shall be determined by the product standard,
4.4.2 The error of the tube current
shall not exceed the following:
4.5. Loading time
X-ray machine with transparent function shall be set with a time-limited loading mode, and only the X-ray machine with uniform imaging function shall be set with a time-limited loading mode.
4.5.1 The loading time of X-ray machine
shall be specified by the product standard.
1.5.2 Screening difference during shielding
This system principle
2. Effective field size of the display
The effective visual angle of the X-ray screen should be less than aCm4.7.
4.7.1 The brightness
should not be less than 2 cd/n
4.7.7 The spatial resolution
should not be less than +HuLF/a.
1.7.3 The degree of contrast
should be greater than 6.
4. Beam blocking
The radiation should have beam control measures
4.9 The distance between the tube and the surface should be specified in the product manual. 4.10 X-ray tube head sealing performance
The X-ray tube head should be well sealed, with a square airtight interior and no paint or oil. 4.11 Safety
See Appendix A (Appendix to the specification).
4.12 Environmental test
YY/T 0347-2002
It should comply with the requirements of the climate group and machine environment group specified in the meeting and the provisions of Table 1. 4. 13. Installation and disassembly
The frame should be installed and repaired
4.14. Appearance
4.11. The appearance of the X-ray machine should be neat and tidy, the surface should be clean, the color should be uniform, and there should be no defects such as cracks. 4.14-2. The electrical components of the X-ray machine should comply with the requirements of Class 2 appearance in Y6-1. 4.14.3. The paint parts of the X-ray machine should comply with the requirements of Y910-139. The appearance of the whole coating room should not be less than 2000Nm. 5. Test method
5.1 Test source
: Unless otherwise specified, all energy tests are conducted under the conditions specified in the test period! The electrician only uses the meter to make up for the accuracy of the meter. 1. The accuracy of the meter should not be less than 1000Nm. 5.2 The high-efficiency meter should be set according to the product standard. 5.3 Transmitting line voltage
5.3.1 X-ray tube voltage adjustment range
Change for inspection.
5-3.2 X-ray tube voltage deviation
When the voltage deviation of the X-ray tube is in accordance with the provisions of GB/T11751, please measure the voltage deviation of the tube. Please adjust the current of the tube according to the provisions of GB/T11751. 5.1 X-ray tube current
5.4, X-ray current adjustment range
Detection and inspection,
5.4.2 X-ray tube voltage deviation
When the voltage deviation of the X-ray tube is in accordance with the provisions of GB/T11751, please measure the voltage deviation of the X-ray tube according to the provisions of GB/T11751. 5.5 Add time
5.5.1 Average load time, limit the actual operation of the installation and adjustment device
5.5.2 According to the provisions of GB/T11/57, 5. 6 Display screen effect specification is within the scope of general city quality products, 5.7 Image performance 5.7.1 Full degree test will be based on the head beauty paste enough display screen fire, the ray machine is in the normal state of 1 test its careful industry meets the requirements of 4.1. 3 YY/T0347.-2002 5.2 Resolution test will be divided into car test card and image strength device maintenance, day two risk out of the lead, the reading can be divided into small value of 72. 5.7.3 Gray scale test will be divided into gray scale test card and image strength test, the reading can be divided into small value of 72. 5.8 Limit measures force inspection.
5.9 Baking distance
There are accompanying documents
5. ~0K X-ray head sealing performance
Place the X-ray tube head in a constant temperature pen of -544 at room temperature R6, then place it in a room with a temperature of 1, take it out and cool it down. After one day, observe it. It should comply with this standard. 4.5.11 Safety
Go to Appendix A for further inspection.
5.12 Environmental test
According to the relevant provisions of YY/T21 and 4.12, Table 1 Environmental test requirements and inspection items
Method and procedure parameters
Virtual monitoring frequency FI
Regular working mode
Low range test
Regular working test
High frequency monitoring test
Regular working heat test
Wake-up hot storage test
Exploration mode (sub-vertical)
5.13 Frame installation and disassembly
Inspection requirements
Refresh time
Calibration time
The machine shall be installed and disassembled according to the requirements of the installation manual 5. 74 Appearance
Observe by force.
5 Steps and rules
G.1 Quick inspection
New products
All products are completed (except for safety enterprises)
X-ray machine product inspection and model inspection. 6.2 Factory inspection
China or products
Need to test the policy
Full parts
Need to reach the inspection parts
Training parts
: Positive hope to hit the work
Normal test parts
Positive test risk
Opening test spare parts
E.2.1X judgment line bottom south manufacturing technical inspection department through the platform rush collection, 4.4.4.5.4.7 can be shipped, 62.? Principle of non-light judgment: For the unqualified items in the inspection, repair is allowed, and the repair amount is like a new item. If there is not a single item that is not qualified, it is judged as unqualified:
6.3 Type test
6.3.1 When one of the following conditions occurs, a type trial should generally be carried out: New products are the first step in the production of products: After formal production, there are significant changes in the process of production, which may affect the product performance. When the product has been produced for more than one year, the production can be resumed; when the factory inspection results are different from the requirements of the national quality supervision agency for type or test, 6.3.2 Sampling method
YY/T 03472302
The products selected for type trial should be from! The qualified products shall be inspected according to all the requirements of the standard. 6-3.3 Principles for determining the quality of unit products: 1) The safety certification test plan will allow the product to be tested until it is qualified: b! During the product registration period, if there is one unqualified item in the performance test or two items in the appearance test are not qualified, and there are still ten items in the plan that are not qualified, the plan will be deemed unqualified. 7 Instructions for use Instructions, labels, packaging, transportation and storage 7.1 Instructions for use GR4-1XGB6.1-G3SL6.3-2UU, GES7C.11-!G1370.1--937.GR9706, 4-1997. 7.2 Marks, labels
yuan group contains! 1-10 discount record A village customs calendar 1 weighing point put good number Shangshe individual 3706.3- 2300 Li G. related regulations and should have product numbers.
7.3 Packaging
Specifications:
7.4 Transportation and storage
Product conforms to the provisions of Y9919 No. 1:2002. YY/TC347:2002
4.1 Product characteristics
(Normative Appendix)
Equipment for each category: "US internal bar road than product b no equipment service Type, type;
Equipment power type: Power product standard: c
! ) Equipment storage box power rate: daily strict product standard distance: e) Equipment only application;
Equipment has a number booth or signal output part: no line can use the environment type equipment street!
h) Equipment without AP type or A1\G type equipment:! Equipment discount line mode time account loading my dye operation, .2 requirements but try some methods
4.2.1 External marking
4.2.7.1 Requirements
The following "non-standard" and "standard" markings must be present: The production and supply points must comply with the requirements of H97me.2-195e and G.1196:
) The power supply should comply with the requirements of GB970:-!-14954t:2. .9 The power socket of the power supply can meet the requirements of 6.1 in .【-1; c
Class 9706.1-196.11 requirements
k) The physical effect must meet the requirements of 3i.1936.1g: 4.2.1.2 Test method
1B676.1--199 yuan 6.1 of the familiar method for testing to verify whether it meets the requirements, A.2.2 Internal marking|| tt||A.2.2.1 Requirements
The following "marks of verification" must be present:) High voltage components must comply with 96.1-1592cG7-94 requirements) Installation method (such as the method of use must comply with (976.1.2 installation requirements: can only be used to break the connection and comply with the requirements of 6) Ensure that the grounding terminal complies with the requirements of [-]!
Function I must comply with 76.1199 port 6.2g Product requirements: The marking on or near the plate shall comply with the requirements of BE.1-15.2:) The marking on or near the plate shall comply with the requirements of G13705.1-995.1.2i1:) The connection method shall comply with the requirements of 6-25 in 676.1-19. A.2.7.2 Test method
The test shall be carried out according to the method of 5.2 in 576.1-15 to verify the requirements. A.2.3 Control device and receiving mark
A.2.3.1 Requirements
a) The identification of the power switch shall comply with the requirements of G1970.11S95.3:) 1) The positions of the control device and the switch shall comply with the requirements of GB (:-195.3); e) The surface of the control surface shall comply with CB6.1-1!! 56. Requirements; YY/T 0347-2002
The controller and indicator with safety function shall comply with the requirements of 6.3 in 9705.11SS5. A.2-3-2 Test method
Verify whether it meets the requirements by inspection. 1.2.4 Symbols
A.2.4.1 Requirements
A2.142.3 The symbols used for marking shall be consistent with the requirements of GB! 706.1-1! ! 31 and GB3465.2. h.2.4.2 Test method
Verify whether it meets the requirements by inspection. A.2.5 Wire insulation green color
4.2.5.1 Requirements
! The entire length of the protected wire must be insulated with green: noble color as the mark:) The insulation color of the protective grounding part of the equipment that is not accessible to the internal label or other protective grounding part with deep protection function must be marked with a missing / English mark on the conductor terminal; the ball / yellow is used as a mark to distinguish the insulation color of the neutral wire of the power supply should comply with the requirements of 6.5c of GB3706.[_993: d) The insulation color of the neutral wire of the power supply should be blue) The color of the neutral wire insulation of the power supply should comply with the requirements of 97e.-1996.5e: [] The insulation color of the main wire used as a protective wire between equipment is also continuous / yellow. A.2.5.2 Test method
Through inspection, the product price is verified
A.2.G Gas identification
Not applicable
A.2.7 Gas cylinder connection point identification
Not applicable.
A.2.6 Indicator light colors
A.2.8.1 Requirementswww.bzxz.net
a) Red should indicate danger and (or) require emergency action; h) Yellow should indicate loading status on the console; each color should be used to indicate the loading status; other colors should be used to indicate the loading status; A.2.8.2 Test operation
Through inspection, the requirements of the inspection card can be strictly checked. A.2.9 Without light color
A.2.S. 1 Requirements
Only purple can be used to interrupt the kinetic energy when the flow is new. A-2.5.2 Test method
Through inspection, it is verified that the product meets the requirements.7
YY/T 0347—2002
A.2.0 Completeness of random documents
A.7.0.1 Requirements
The equipment shall be accompanied by at least the instruction manual, technical manual and other documents that can be customized by the user. The equipment documentation shall be regarded as an integral part of the equipment, or the technical manual may be combined with the equipment documentation. 4.2.\0.2 Test method
The inspection shall be carried out through the inspection of the internal structure of the equipment. A.2.11 Instructions for use
A.2-1.1 The contents of the instructions for use shall meet the following requirements: a) The instructions for use shall comply with GB9706:1395.8.21.GB9 70c.320mm 6.8.2a city supplement, supplement requirements.
97(6.4—1997 e.8.2a> requirements
times the number signal person does not need
and the old connection parts please wash the set of fire south platform 6.19 requirements: the power network monthly supply industry for the power supply equipment to meet the 5$6.11=user 6.8.2> fee;) the removal of disposable batteries is not applicable
) the battery production meets the requirements of 11.:
has special redundant power supply battery charger equipment: the internal fuse i meets the requirements of GB6.1 6.: the power supply network disconnection includes 57i.1-199: .1: requirements. A.2.11.2 Test ride method
Through inspection, the written instructions can be used to verify that the requirements are met. A.2.12 Technical specification
4.2-12.1 Requirements
General part of the internal diameter K, 15, 8, the requirements of the replacement of other parts must be in accordance with the requirements of 1. The circuit diagram and components must comply with the requirements of 975-159. The storage environment and environmental restrictions must comply with the requirements of GB 1.5.R.>. This document describes a series of damaged content:
The technical content does not include the protection of the machine and its electrical connection. A.2.12.2 Test method
Through the technical test, the cumulative inspection is to meet the small requirements of Safety 4-2.13 Input power
A.2.13.1 Requirements
Virtually comply with 97351-15S5 No. 7 A-2.13-2 Test method
Under the maximum negative stripe, the effective value of the product is tested using the original X-ray torque table and the evil table.
A.2.14 Environmental testing
A.2.14.1 Transportation and storage
Unless otherwise specified by the manufacturer, the packaging state must not exceed the following conditions for transportation or storage: 1. Environmental conditions:
Temperature range: 10%;
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