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YY 0833-2020: General technical requirements for compression physiotherapy equipment for limbs
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General technical requirements for compression physiotherapy equipment for limbs
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Basic data | Standard ID | YY 0833-2020 (YY0833-2020) | | Description (Translated English) | General technical requirements for compression physiotherapy equipment for limbs | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 9,951 | | Date of Issue | 2020-02-21 | | Date of Implementation | 2022-01-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, classification and composition, requirements and test methods of limb compression physiotherapy equipment (hereinafter referred to as equipment). This standard is applicable to electrical equipment that wraps a pressurized cavity on the periphery of the limb, applies positive pressure to the limb according to certain treatment procedures, and performs physical therapy on the patient through changing air pressure. This standard does not apply to the following equipment: hemostatic equipment; anti-decubitus air cushion; shock wave therapy equipment; cupping device; | YY 0833-2020: General technical requirements for compression physiotherapy equipment for limbs---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
General technical requirements for compression physiotherapy equipment for limbs
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0833-2011
General technical requirements for limb compression physiotherapy equipment
2020-02-21 released
2022-01-01 implementation
Issued by the State Drug Administration
Foreword
All technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0833-2011 "Extremity Compression Physical Therapy Equipment". Compared with YY 0833-2011, except for editorial changes, the main
The technical changes are as follows.
---The definitions of treatment pressure, pressure pulse width, and output pressure have been added (see Chapter 3);
---Added the requirements and test methods of treatment procedures (see 5.1, 6.1);
---Modified the requirements and test methods for the treatment pressure (see 5.2, 6.2, 5.3, 5.4, 5.5, 6.3, 6.4, 6.5 in the.2011 edition);
---Modified the requirements and test methods of overvoltage protection (see 5.3, 6.3, 5.6, 6.6 of the.2011 edition);
---Modified the requirements and test methods of functional switches (see 5.4, 6.4, 5.8, 6.8 in the.2011 edition);
---Modified the requirements and test methods for pressure relief measures (see 5.5, 6.5, 5.9, 6.9 in the.2011 edition);
---Added the requirements and test methods for failure prompts (see 5.6, 6.6);
---Modified the requirements and test methods of working noise (see 5.7, 6.7, 5.15, 6.15 of the.2011 edition);
---Modified the requirements and test methods for appearance and structure (see 5.8.1, 6.8.1, 5.2 and 6.2 of the.2011 edition);
---Modified the requirements and test methods of pressure resistance (see 5.8.2, 6.8.2, 5.11, 6.11 of the.2011 edition);
---Modified the requirements and test methods for fatigue performance (see 5.8.3, 6.8.3, 5.12, 6.12 of the.2011 edition);
---Modified the connection requirements (see 5.9, 5.14 in the.2011 edition);
---Added electromagnetic compatibility requirements and test methods (see 5.11, 6.11);
---Deleted the requirements and test methods of the timing device (see 5.7 and 6.7 in the.2011 edition);
--- Deleted the air tightness requirements and test methods (see 5.10, 6.10 in the.2011 edition).
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Chongqing Medical Device Quality Inspection Center, Sichuan Qianli Beiyi
Kang Medical Technology Co., Ltd., Kangtis (Shanghai) Medical Equipment Co., Ltd.
The main drafters of this standard. Gao Shan, Zhang Yun, Liu Bo, Zhou Ping, Jiang Yongyu, Wang Zhifang, Zhang Wen.
The previous versions of the standard replaced by this standard are as follows.
---YY 0833-2011.
General technical requirements for limb compression physiotherapy equipment
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements and test methods of limb compression physiotherapy equipment (hereinafter referred to as equipment).
This standard is applicable to sleeve the compression chamber around the limbs, apply positive pressure to the limbs according to certain treatment procedures, and treat the patients through changing air pressure.
Electrical equipment for physical therapy.
This standard does not apply to the following equipment.
---Hemostatic equipment;
---Anti-decubitus air cushion;
---Shockwave therapy equipment;
---Cupping device;
---Bag type external counterpulsation device;
---Ballistic extracorporeal pressure wave therapy equipment;
---Training equipment for ischemic preconditioning;
---First aid equipment.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Safety
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing
YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard. Electromagnetic Compatibility Requirements and Tests
3 Terms and definitions
The following terms and definitions defined in GB 9706.1 apply to this document.
3.1
Limb compression physiotherapy equipment
Put the compression chamber around the limbs, apply positive pressure to the limbs according to certain treatment procedures, and perform physical therapy on the patient through the changing air pressure
Electrical equipment for treatment.
3.2
Treatment procedure
Composed of parameters such as compression chamber type, compression sequence, treatment pressure, pressure holding time, intermittent time (if applicable), total treatment time and other parameters,
A complete output program that can run automatically.
3.3
Treatment pressure
In a specific treatment procedure, the target pressure expected to be delivered to the surface of the limb usually refers to the pressure that can be maintained for more than 1s during a pressure maintenance period
Maximum pressure value. When the pressure pulse width is less than 4s, the treatment pressure can be specified by the manufacturer.
3.4
Pressure pulse width
During a pressure maintaining stage, the output pressure is maintained above 3kPa for a long time.
3.5
Output pressure
The actual pressure value delivered to the surface of the limb.
4 Classification and composition
4.1 Classification
According to the number of pressurized cavities, it can be divided into single cavity and multiple cavity.
According to the part of action, it can be divided into. upper limbs, lower limbs, hands, feet, etc.
4.2 Composition
Equipment usually includes. host (including air source, controller), pressurized chamber, connecting pipeline.
5 requirements
5.1 Treatment procedures
The manufacturer should specify the details of each treatment procedure in the random file, including at least the type of compression chamber, compression sequence, treatment pressure, pressure
Information on force retention time, intermittent time (if applicable), total treatment time, and adjustable parameters should indicate the adjustment range. The treatment procedure should
Manufacturer’s regulations.
If pressure monitoring is provided, the monitoring location and monitoring accuracy should be stated.
5.2 Treatment pressure
The treatment pressure should be no more than 40kPa (300mmHg), and the treatment pressure output error should be no more than ±20% of the set value, or ±3kPa
(±22.5mmHg), whichever is larger. When the pressure pulse width is less than 4s, the treatment pressure output error limit can be relaxed to the set value
±50%, but should not exceed ±7kPa (±52.5mmHg).
The output pressure should be maintained above 3kPa (22.5mmHg) for no more than 10 minutes.
If pressure monitoring is provided, the monitoring accuracy should meet the requirements of the accompanying documents.
The pressure setting and monitoring value should be expressed in Pascals (Pa) (including its decimal multiples) or millimeters of mercury (mmHg).
For a multi-chamber device where the treatment pressure of each cavity can automatically set the gradient value, if the setting value of each cavity is not displayed on the device, it should be
There is an obvious indication of the gradient pressure, and the pressure range or maximum pressure value is displayed. At the same time, the automatic setting rules are explained in the instruction manual.
For equipment that can automatically change the treatment pressure during the treatment process, the treatment pressure setting should be expressed in the range or upper limit of the treatment pressure.
Set the value, and explain the rules of automatic change in the instruction manual.
For equipment with non-adjustable treatment pressure, meters or labels should be used to indicate the treatment pressure.
5.3 Overvoltage protection
The equipment should have measures to ensure that the pressure transmitted to the limb exceeds 120% of the maximum therapeutic pressure under normal and single fault conditions.
The time is not more than 1s.
5.4 Function switch
The equipment should provide an output stop switch to stop the treatment program at any time. Except for devices with only one output state, the output stop switch should
Independent of the power switch. After the treatment procedure is terminated, the device should automatically release the pressure in the cavity.
5.5 Pressure relief measures
The equipment should provide measures to release the pressure in the cavity in an emergency. The internal cavity pressure should be restored to
Below 3kPa (22.5mmHg).
The pressure can be released by disconnecting the pipe connection, but the effective disconnection position and operation mode should be clearly indicated in the instruction manual.
And make a mark near the effective disconnection position, unless the pipeline is disconnected at any position to meet the above requirements.
After the power supply is interrupted, the device should automatically release the pressure in the cavity.
5.6 Fault prompt
If the device provides an overpressure prompt, the device should stop output and release the pressure after the overpressure prompt appears.
If the equipment does not provide an overvoltage warning, a clear warning should be given in the operating instructions for possible risks and measures to be taken.
5.7 Working noise
The manufacturer shall specify the operating noise of the equipment in the accompanying documents, expressed by the A-weighted sound pressure level, and if necessary, it shall be stated at the same time as the noise
For related installation requirements, the noise during normal operation of the equipment should not exceed the limit specified by the manufacturer.
Working noise may not include instantaneous noise, such as solenoid valve action or normal working exhaust. But this situation should be noisy in the random file
A note is given when the sound is announced, indicating that the instantaneous noise may exceed the published operating noise, and that the highest frequency of instantaneous noise may occur.
5.8 Pressure chamber and connecting pipeline
5.8.1 Appearance and structure
The surface of the pressure chamber, connecting pipes and joints should be smooth and free of burrs.
The contact surface between the compression chamber and the patient should be free of abnormal protrusions that may cause local compression of the limbs, such as seams,
Pipeline joints, etc.
The fixing method of the pressurized cavity should be reliable. When pressurized and subjected to external force, the relative position of each cavity of the multi-cavity equipment should not occur
change.
5.8.2 Pressure resistance
The pressurized chamber and connecting pipeline should be able to withstand a pressure 1.5 times the nominal maximum therapeutic pressure of the equipment for 1 min, and should not break or be permanent
(Plastic) Deformation, the connection should not be loose or visible to the naked eye, and the cavity and the connecting pipeline should not cause local protrusion due to instantaneous external force.
Burst.
5.8.3 Fatigue performance
After applying the device's nominal maximum treatment pressure of 30,000 times to the reinforced cavity and connecting pipeline (assembled together), the cavity and connecting pipeline should
There should be no obvious deformation, the connection between the cavity and the pipeline should not be loose, the joint of the cavity should not be cracked or damaged, and the relative position of each cavity of the multi-cavity equipment should be
No change.
The cavities and connecting pipes marked as reusable by a single patient are reduced to 5000 times.
The pressurized chamber and connecting pipeline cannot be used after the nominal use times, and the test is performed according to the nominal use times.
5.8.4 Biocompatibility
The parts of the equipment and accessories that are expected to come into contact with the patient’s skin should be evaluated according to the guidelines and principles given in GB/T 16886.1.
Estimate and document.
5.9 Connection
The host can be connected to pressurized chambers of different parts or different functions, and the manufacturer shall provide measures to prevent the output parameters from being applied to the wrong
On the cavity.
For equipment that can connect two or more cavities at the same time, the connection of the cavity, connecting pipeline and host should be a knot to prevent incorrect connection.
Structure. If the wrong connection cannot be avoided structurally, it can be identified with a striking mark near the connection, and at the same time near the output start button or
An obvious warning is given on the display, requiring confirmation of the correctness of the connection before the output is activated.
The above-mentioned measures may not be taken to exchange pipes and cavities between multiple channels with exactly the same output parameters.
5.10 Electrical safety
The equipment should meet the requirements of GB 9706.1.
5.11 Electromagnetic compatibility
The equipment should meet the requirements of YY 0505.
5.12 Environmental test
The environmental test of the equipment shall be carried out in accordance with the provisions of GB/T 14710.
6 Test method
6.1 Treatment procedures
Check the random files and actually operate the equipment.
6.2 Treatment pressure
The treatment pressure of the device is tested as follows.
a) Fix the pressure chamber on the hard humanoid model (see A.2 of Appendix A) according to the method specified in the instruction manual, and the equipment is
Commonly used, a pressure measuring device (see A.1, the same below) to measure the treatment pressure is placed in the cavity, and when the pressure reaches the peak (except
(Unless otherwise specified in the random document) The read pressure value is the therapeutic pressure output value. When the pressure holding time is not less than 5s, you can
The end of the connecting pipe close to the cavity is measured with a three-way gas pressure gauge. The total volume of the additional gas pipes, joints, and meters should not be
More than 10% of the total volume of the tested cavity and pipeline;
b) For equipment with adjustable therapeutic pressure, measure at 100% and 50% (or near) of the maximum setting value;
c) For devices that automatically change the treatment pressure, determine the test plan according to the information given in the random file;
d) Each output channel of the host should be tested at least once for the maximum therapeutic pressure;
e) If it is stated in the instruction manual that the pressure will take a period of time to reach a stable state, the therapeutic pressure output error test can be
Start after that time;
f) When the power supply voltage is 90% and 110% of the rated value, test the maximum therapeutic pressure output error.
Repeat the tests in a)~f);
g) When it will not affect the test results, a rigid cylinder can also be used to simulate the treatment part of the human body;
h) When the gas pressure cannot truly reflect the pressure applied by the cavity, or other conditions that are not suitable for measurement with a gas pressure gauge, it can be used
Use the device of A.3 to measure.
6.3 Overvoltage protection
The overvoltage protection of the equipment is tested as follows.
a) The test arrangement is as described in 6.2a), the treatment pressure is set to the maximum value, the output is started, and the output is stopped when the treatment pressure is reached, within 1s
(Or the shortest possible time) start again and record the treatment pressure during the process; if it exceeds 120% of the treatment pressure setting value, measure
The duration of the pressure exceeding;
b) For multi-cavity equipment, pressurize the second cavity (if possible) under the pressure-holding state of the first cavity, and verify according to the process described in a);
c) If in doubt, follow the process described in a) under other conditions for verification;
d) Short-circuit and disconnect the pressure sensor (if any), verify according to the process described in a);
e) The equipment that controls the output through the solenoid valve is short-circuited and disconnected in turn, and verified according to the process described in a);
f) The output equipment is controlled by the mechanical device, jam it (if possible), and verify according to the process described in a).
6.4 Function switch
Actually operate the equipment.
6.5 Pressure relief measures
The test arrangement is as described in 6.2a) and 6.2b), connect the compression chamber with the largest volume, set the treatment pressure to the maximum, and start the output, respectively
The pressure relief measures were operated during the pressurization process and the air pressure maintaining stage, and the pressure in the cavity was recorded after 10s.
Cut off the power supply during the air pressure maintaining phase, and record the pressure in the cavity after 10s.
For multi-chamber equipment, the above test is carried out when the maximum possible chamber maintains air pressure.
6.6 Failure Prompt
Make the device operate at the maximum therapeutic pressure, apply external force to the pressurized cavity in the pressure holding stage, and increase the pressure in the cavity to
A reminder signal.
For equipment that does not provide overvoltage warning, consult the accompanying documents.
6.7 Working noise
Install the equipment in accordance with the most unfavorable installation conditions specified in the accompanying documents, and connect the pressurizing chamber and the connecting pipeline according to the provisions of the accompanying documents to make
The equipment is working in the normal use state where the maximum noise may be generated, and the A weighting is measured at 1m in front, back, left, right, and above the main unit of the equipment
Sound level.
6.8 Pressure chamber and connecting pipeline
6.8.1 Appearance and structure
Observe visually, if in doubt, arrange the pressurization chamber according to 6.2, and pressurize the pressurization chamber in a different pressurization sequence until the maximum
Large treatment pressure, during the pressurization process, a force of no more than 100N can be applied to the pressurized cavity, and the force can be applied in any direction to no less than 25cm2
On the area.
6.8.2 Pressure resistance
Connect the pressurizing chamber and the connecting pipeline to the external air source, all other air outlets are all closed, pressurized to the test pressure for 1 min.
During the test, a 10mm diameter disc is used to apply a force of 20N to any position of the pressure chamber and the connecting pipeline, and each time does not exceed
After 2s. No force is applied during the negative pressure test.
6.8.3 Fatigue performance
Use the test air source to repeatedly inflate and deflate the pressurized cavity, and the test pressure is the maximum therapeutic pressure of the equipment.
6.8.4 Biocompatibility
Verify by checking the information provided by the manufacturer or according to the method specified in GB/T 16886.1.
6.9 Connection
Visual observation and actual operation.
6.10 Electrical safety
The electrical safety of the equipment is tested according to the method specified in GB 9706.1.
6.11 Electromagnetic compatibility
The electromagnetic compatibility of the equipment shall be tested according to the method specified in YY 0505.
6.12 Environmental test
The environmental test of the equipment is carried out according to the method specified in GB/T 14710.
Appendix A
(Informative appendix)
Pressure measuring device and phantom
A.1 Pressure measuring device
The pressure measuring device can be a gas pressure gauge/negative pressure gauge, a varistor or other pressure sensors.
A.2 Hard humanoid phantom
Hard humanoid phantoms include upper limbs (including hands) phantoms, lower limbs (including feet) phantoms, and separate hand and foot phantoms.
The body of the phantom is made of rigid material.
The upper and lower limb phantoms should be straight.
The posture of the hand phantom should be straight with four fingers together and thumbs apart.
Some special compression cavities may require upper limb phantom with chest, or lower limb phantom with hip.
The phantom should have at least two specifications to reflect the adaptability of the equipment to different body types.
A.3 Phantom with pressure measuring device
The pressure sensor is attached to the surface of the hard humanoid phantom. For easy fixation, the outside of the pressure sensor can be covered with a protective layer.
The thickness should not affect the pressure measurement more than ±3%.
The arrangement of the pressure sensor. each airbag should have a pressure sensor at the contact position of the phantom, and the joint protrusion should have a sensor.
The palm, the back of the hand and both sides, the sole of the foot, the instep and both sides should have sensors, and the fingers and toes may not be placed with sensors.
The sensor range should not be less than 120% of the measured pressure, the accuracy should not be less than 0.1kPa, and the sampling frequency should not be less than 1Hz. Some fast
High-speed pressurization equipment may require a higher sampling frequency.
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