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YY/T 1685-2020 English PDF

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YY/T 1685-2020: Pneumatic impulse oscillation equipment for sputum excretion
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Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1685-2020	English	149	Add to Cart	3 days [Need to translate]	Pneumatic impulse oscillation equipment for sputum excretion	Valid	YY/T 1685-2020

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Basic data

Standard ID	YY/T 1685-2020 (YY/T1685-2020)
Description (Translated English)	Pneumatic impulse oscillation equipment for sputum excretion
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C42
Classification of International Standard	11.040.60
Word Count Estimation	8,882
Date of Issue	2020
Date of Implementation	2021-01-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the terms and definitions, classification and composition, requirements and test methods of pneumatic pulse oscillating expectoration equipment (hereinafter referred to as equipment). This standard applies to the pulse air flow generated by the air pulse air flow generator, which enters the inflatable air bag through the air guide hose and acts on the chest cavity to assist in the discharge of respiratory secretions. For a multifunctional device (if there is atomization function), the content specified in this standard is only applicable to the expectoration function of the pneumatic pulse oscillation principle in the device. For other functions, if there are corresponding national standards and (or) industry standards, It should also meet the requirements of other relevant standards. This standard does not apply to vibration percussion expectoration machine.

YY/T 1685-2020: Pneumatic impulse oscillation equipment for sputum excretion

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Pneumatic impulse oscillation equipment for sputum excretion ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standard Pneumatic pulse oscillation expectoration equipment 2020-02-21 released 2021-01-01 implementation Issued by the State Drug Administration

Preface Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Classification and composition 2 5 Requirements 2 6 Test method 3

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. 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). The main drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Wuxi Warner Medical Technology Co., Ltd., Suzhou Haobo Medical Devices Co., Ltd., Beijing Medical Device Technology Review Center. The main drafters of this standard. Qi Lijing, Zhou Huilin, Qian Xuebo, Yang Guojuan, Chen Ran, Fan Weihua, Zhang Jianwu. Pneumatic pulse oscillation expectoration equipment

1 Scope

This standard specifies the terms and definitions, classification and composition, requirements, and test methods of pneumatic impulse oscillation sputum discharge equipment (hereinafter referred to as equipment). This standard applies to the pulsed air flow generated by the air pulse airflow generator, which enters the inflatable airbag through the air guide tube and acts on the chest cavity to assist A device to drain secretions from the respiratory tract. For a multi-functional device (if it has an atomization function), the content specified in this standard only applies to the device The expectoration function based on the principle of pneumatic impulse oscillation in preparation, if other functions have corresponding national standards and/or industry standards, they should also comply with other relevant Standard requirements. This standard does not apply to vibration percussion expectoration machines.

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 in the Process of Risk Management 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 Pneumatic impulse oscilation equipment for sputum excretion The pulsed air flow generated by the air pulse airflow generator enters the inflatable airbag through the air guide tube and acts on the chest to assist in expelling the airway. Secretion equipment. 3.2 Inflatable airbag A component of the device, used to store pulsed airflow and act on the patient's chest, generally inflatable vest and (or) inflatable chest strap. 3.3 Airhose The hose used to connect the air outlet of the host and the air bag. 3.4 Manualmode The operating mode of pneumatic frequency, pneumatic pressure and treatment time is set and adjusted by the operator within the allowable setting range of the equipment. The device does not have a storage function. 3.5 Fixedmodel The manufacturer will fix the output pneumatic frequency and pneumatic pressure in the output mode of the equipment according to a certain time rule before leaving the factory. 3.6 Custommode The manufacturer allows the operator to set the pneumatic frequency, pneumatic pressure and/or treatment within the allowable setting range of the equipment according to the needs of use. Treatment time, and store this setting in the device in a self-named way.

4 Classification and composition

4.1 Classification Divided by the applicable crowd. children type, adult type, mixed type of children and adults. Divided by output mode. manual mode, fixed mode, custom mode. 4.2 Composition It is generally composed of a host, an inflatable air bag, an air guiding hose, and (or) a handheld controller.

5 requirements

5.1 Pneumatic frequency setting upper limit and output accuracy 5.1.1 Pneumatic frequency setting upper limit. adult type should not exceed 25Hz, and child type should not exceed 15Hz. 5.1.2 Pneumatic frequency output accuracy. the error between the output value and the set value should not exceed ±20% or ±2Hz, whichever is greater. 5.2 Pneumatic pressure safety and effective range and output accuracy The manufacturer shall specify the adjustment range of pneumatic pressure, and the error between the output value and the set value shall not exceed ±0.2kPa; if the equipment is If the pressure exceeds 6kPa, it should be marked in the corresponding position and the possible risks and preventive measures should be notified in the manual. 5.3 Working noise When the equipment is working normally, the noise should not exceed 65dB(A). 5.4 Treatment time The manufacturer should specify the treatment time setting range, the treatment time setting range should not exceed 60min, and the setting error should not exceed ±10%. 5.5 Requirements for inflatable airbags and air hoses 5.5.1 Inflatable airbag specifications The manufacturer shall specify the size and tolerance of different specifications of inflatable airbags. 5.5.2 Maximum air pressure bearing capacity of inflatable airbag The inflatable air bag should be able to withstand a pressure twice the maximum pneumatic pressure output of the equipment. 5.5.3 Connection reliability of air hose The air hose of the equipment should be connected reliably. 5.6 Fixed mode output If the device has a fixed mode output, the manufacturer shall specify the combination of device output parameters and the law of change, and the output accuracy of each parameter is incorrect The difference should meet the requirements of 5.1, 5.2, and 5.4. 5.7 Device function 5.7.1 The equipment should have a setting indicating device to indicate the working pressure and pneumatic frequency under the current program. 5.7.2 If the device is equipped with a handheld controller, the handheld controller should at least have the function of suspending vibration or stopping the output. 5.7.3 The equipment should have a pressure relief function. After the pressure relief is started, the time for the pressure of the inflatable bag to drop from the maximum pressure to 0.2kPa should not be greater than 10s. 5.7.4 If the device has the function of a custom mode, the parameters of the custom mode should not be changed when the power supply of the device is restored after a short interruption. 5.8 Power adaptability The power supply of the equipment is within ±10% of the rated voltage, and the output pneumatic frequency and the maximum pneumatic pressure change rate of the equipment should not exceed ±10%. 5.9 Biocompatibility Parts and accessories that are expected to come into contact with the human body should be evaluated and documented in accordance with the guidelines and principles given in GB/T 16886.1. 5.10 Appearance 5.10.1 The surface of the equipment should be clean and tidy, and the text, symbols and signs should be clear, free of corrosion, peeling of the coating, obvious scratches, damage and deformation, etc. damage. 5.10.2 The equipment fasteners should be connected firmly, and the function switches and output control mechanisms should be installed accurately and adjusted reliably. 5.11 Specification requirements 5.11.1 The instructions should suggest that the operator's pneumatic frequency setting should be gradually increased from low to high, which can be adjusted according to patient tolerance. 5.11.2 The instructions should specify the treatment sites of different inflatable airbags and the suitable population. 5.11.3 The cleaning and disinfection method and service life of the inflatable air bag shall be given in the instruction manual. 5.11.4 The instructions should provide warnings of contraindications for people with fractures, osteoporosis, pneumothorax, breast implants, etc. 5.12 Electrical safety The electrical safety of the equipment should meet the requirements of GB 9706.1. 5.13 Electromagnetic compatibility The equipment should meet the requirements of YY 0505. 5.14 Environmental test The environmental test of the equipment should be carried out in accordance with the requirements of climate environment group Ⅱ and mechanical environment group Ⅱ in GB/T 14710.

6 Test method

6.1 Test conditions 6.1.1 Pretreatment Before the test, the equipment should be parked at the test site without power for at least 24h. Before the actual series of tests, the Requires warm-up and operation of equipment. 6.1.2 Test environment It shall be specified by the manufacturer itself, if not specified, it shall be carried out in accordance with the requirements of GB 9706.1. 6.2 Pneumatic frequency setting upper limit and output accuracy In actual operation, check the adjustment range of the pneumatic frequency setting of the equipment, and it should meet the requirements of 5.1.1; use a vibrometer to test and select to cover At least 4 test points of the minimum, middle, maximum, and manufacturer-defined frequency range of the equipment set frequency range, perform the test, and output the actual measured value and The error of the set value should meet the requirements of 5.1.2. 6.3 Safe and effective range of pneumatic pressure and output accuracy Use a pressure tester to select the minimum, intermediate, and maximum values that cover the set pressure range of the device, turn on the pressure output, and test the device The error of static inflation pressure at the outlet should meet the requirements of 5.2. 6.4 Working noise The device is not connected to the airbag, and the front, rear, left, and right positions are 1m away from the device, and the noise generated under the maximum pressure and maximum frequency output is measured. The sound should meet the requirements of 5.3. 6.5 Treatment time Select the middle and maximum set point of the equipment treatment time, and use a universal stopwatch to measure the treatment time, which should meet the requirements of 5.4. 6.6 Inflatable air bag and air guide hose 6.6.1 Inflatable airbag specifications According to the manufacturer's description or schematic diagram, measuring the size of the inflatable airbag should meet the requirements of 5.5.1. 6.6.2 Maximum air pressure bearing capacity of inflatable airbag Connect the air guide hose, and inflate the air bag through the hose with gas twice the maximum pneumatic pressure of the equipment. After maintaining for 10 minutes, the air bag is inflated There should be no rupture or permanent deformation, and the air guide hose should not detach; if the inflatable airbag has an overpressure release device, and the release pressure is less than 2 times the equipment The maximum pneumatic pressure value, the test pressure can be reduced to the critical value of the airbag release pressure. 6.6.3 Reliability of air hose connection Assemble the inflatable airbag according to the connection method of the air guide hose in the manual, apply a force of 20N in the direction of the pipeline connection, keep it for 1min, and guide it. The air hose should not be separated from the equipment and the inflatable airbag, and should meet the requirements of 5.5.3. 6.7 Fixed output mode According to the fixed output mode parameters specified by the manufacturer, the output accuracy should meet the requirements of 5.6. 6.8 Device function Actual operation, to be verified, should meet the requirements of 5.7. 6.9 Power adaptability Under the test voltage of 10% of the upper limit of the rated voltage and -10% of the lower limit of the rated voltage claimed by the manufacturer, in accordance with the test of 6.2 and 6.3 Method, measuring the aerodynamic vibration frequency and pneumatic pressure, and the error of the vibration frequency and pressure under the rated working voltage should meet the requirements of 5.8. 6.10 Biocompatibility The biocompatibility test should be performed according to the methods and procedures specified in GB/T 16886.1, and should meet the requirements of 5.9. 6.11 Appearance Visual observation and hand feel inspection should meet the requirements of 5.10. 6.12 Manual Check the contents of the manual and should meet the requirements of 5.11. 6.13 Electrical safety According to the test method specified in GB 9706.1, it should meet the requirements of 5.12. 6.14 Electromagnetic compatibility According to the test method of YY 0505, it should meet the requirements of 5.13. 6.15 Environmental test According to the methods and procedures specified in GB/T 14710, it should meet the requirements of 5.14.

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