This standard applies to medical diagnostic X-ray mechanical devices. This standard does not apply to computer tomography (CT) mechanical devices. GB 5665-1985 General technical requirements for medical diagnostic X-ray mechanical devices GB5665-1985 Standard download decompression password: www.bzxz.net

National Standard of the People's Republic of China
Medical diagnostic X-ray mechanical devices
General technical conditions
General specification for mechanical units ofmedical diagnostic X-ray equipmentUDC 616073.75
: 615.471
GB 5665 --- 85
This standard applies to medical diagnostic X-ray mechanical devices (hereinafter referred to as devices): This standard does not apply to computed tomography (CT) mechanical devices.
Nouns and terms
1.1 Static working load
The static load that a machine can withstand under safe working conditions. 1.2 Ultimate static shear load
The maximum static load that a machine can withstand without permanent deformation. 1.3 Ultimate dynamic load
The maximum dynamic load that a machine can withstand without permanent deformation. 1.4 Static safety factor
The ratio of the ultimate static load to the static working load. 1.5 Total safety factor
Ratio of the ultimate dynamic load to the static working load. 2 Technical requirements
2.1 Working conditions
According to the requirements of the device for working conditions, it should be selected from Chapter 3 of GB4505-85 "General Technical Requirements for Medical Diagnostic X-ray Generators".
Length deviation
The actual indicated value of the length should be within the range of 98% to 102% of the basic size. 2.3 Angle deviation
The actual indicated value of the angle shall be within the range of ±2” of the basic angle. 2. 4 Weight deviation
The actual value of the weight shall be 80%-120% of the nominal value. 2.5 Movement deviation
The manual and electric movement deviations shall comply with the provisions of Table 1 and Table 2 respectively. 1
Maximum movement
Published by National Bureau of Standards 1985-1180
Deviation of stop position
+ 20 -
+ 40 10
Implementation on 1986-07-01
Moving speed
2.6 Moving speed deviation
GB 5665--85
The actual value of the moving speed should be 80%~120% of the design given value. 2.7 Performance load-bearing
Deviation of stop position
+20～-10
+ 40 ～-10
The device for supporting the human body should be able to work normally after bearing a human body weighing 100kg. 2.8 NoiseWww.bzxZ.net
Under no-load condition, the noise emitted from the device should not be greater than 70dB (excluding non-continuous and non-periodic noise within 3s). 2.9 Safety
2.9.1 Safety load-bearing and human body supporting devices should not produce permanent deformation after bearing a human body weighing 135kg. 2.9.2
The bed and table device for fluoroscopic photography must be equipped with Accessories that do not move the patient during the diagnosis process. The tools used to fix the patient must be simple and reliable to fasten and easy to release. 2.9.3
2.9.4 In order to prevent the driving part from causing harm to the human body, appropriate protective measures such as installing an outer cover must be taken. 2.9.5 The powered moving part that may cause harm to the human body must have the function of automatically stopping when it comes into contact with the human body. 2.9.6
The shape of the surface, corners, and edges of the device must ensure that it does not cause harm to the human body. The device is in operation (moving ) During the process of power failure and power restoration, no harm should be caused to the human body. 2.9.8 When the patient must be compressed for diagnosis, there should be means to easily release the compression in the event of a power failure. For diagnostic beds that can rotate to negative 90 degrees, there should be a manual reset device that allows the bed to return to the horizontal position from the negative position. 2.9.9 The anti-fall mechanism should ensure that the distance from the start to the end of the hanging object falling should not exceed 30mm. 2.9.10 The suspension system made of metal without an anti-fall mechanism should comply with the following Provisions: a.
For the parts of the device that are not susceptible to wear, corrosion, material fatigue or aging, the total safety factor shall not be less than 2, and the static safety factor shall not be less than 4.
b. For the parts of the device that are susceptible to wear, corrosion, material fatigue or aging, the total safety factor shall not be less than 4, and the static safety factor shall not be less than 8.
c. In the supporting parts, when the elongation of the material used is less than 5%, the static safety factor specified in 2.9.10a shall be increased to 1.5 times.
d. The wire rope mechanism and chain mechanism in the device must be designed in accordance with relevant requirements. During the service life, the static safety factor shall not be less than 4.
2.9.11 Leakage current, grounding resistance, and insulation withstand voltage shall comply with the provisions of ZBC43004--85 "Technical Requirements and Test Methods for Leakage Current, Grounding Resistance, and Insulation Withstand Voltage for Medical Diagnostic X-ray Machines". 2.9.12 X-ray protection performance shall comply with the requirements of the "Regulations on Medical Diagnostic X-ray Hygiene Protection". 3 Test methods
3.1 Length, angle, weight, manual movement test Use general or special measuring tools to test.
3.2 Electric movement and movement speed test
Under no-load state, repeat the test five times and calculate with the maximum error value. 3.3 Performance load-bearing test
GB 5665-85
Place a load of 100kg (in a uniform load state) in the normal working position of the device to observe whether it can work normally. Note: The normal working position of the device refers to the non-extended state of the bed surface of the diagnosis and treatment bed. 3.4 Safety load-bearing test
Place a load of 135kg in the normal working position of the device, with a bearing area of ​​30×30cm2 and keep it for 1min. After removing the load, observe whether the device has permanent deformation.
3.5 Noise test
The microphone is 1m from the surface of the device and 1.5m from the ground. Use the "A" class weighting network of the sound level meter to measure and calculate according to the maximum noise value.
3.6 Human contact automatic stop function test
Apply a force not greater than 49N (5kgf) on the device to observe whether the safety device can work normally. 3.7 Anti-fall mechanism test
Remove the vulnerable hanging object, replace it with an object of equal weight, and place it in a proper position, so that it suddenly loses balance, and measure the distance of the anti-fall mechanism from the beginning to the end of the fall. , Marking
4.1 The graphic markings on the operation and control panel shall indicate the function, status and range of each operating element in accordance with the provisions of WS2-258-79 "Graphic markings for medical diagnostic X-ray equipment". 4.2 For devices that may work in darkroom conditions, the instruments used must have luminous or illuminated displays. 4.3 Each device shall be fixed with a nameplate in an appropriate and obvious position. The nameplate shall have at least the following marks: a. Manufacturer name, b. Device name and model, c. Factory number and date. 5 Factory technical documents The manufacturer shall provide the user with technical documents that meet the requirements of this standard in a complete set or in a component form according to the factory conditions of the device. 5.1 The technical documents to be provided include: a. Certificate of conformity issued by the manufacturer's technical inspection department; b. Technical, installation, use and maintenance instructions suitable for the device or component provided; c. Catalog of vulnerable and consumable parts or spare parts. For the content supplied by a third party, its model, name and specifications shall be given in accordance with the relevant standards; d. Packing self-recording and necessary unsealing and counting methods; e. Inspection certificates of safety and protection regulations that must be met as stipulated in other standards or certificates within the verification period; Quality assurance conditions of the manufacturer for the device or component provided. f.
5.2 Completeness of factory technical documents
5.2.1 The values ​​and units of measurement in the documents shall comply with the provisions of relevant standards. 5.2.2 The terms and codes in the documents shall comply with the provisions of relevant standards. 5.2.3 The following contents shall be clearly stated in the documents: a.
Requirements for power supply and technical measures when changing the power supply; b. Relevant technical data of key parts,
weight and dimensions of devices or components, d.
Description of necessary safety measures.
GB5665-85
Additional notes:
This standard was proposed by the National Technical Committee for Standardization of Medical Electrical Appliances and is under the jurisdiction of Shanghai Institute of Medical Devices. This standard was drafted by Beijing Medical X-ray Machine. The main drafter of this standard is Wang Qingyin.
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.