Powered by Google-Search & Google-Books Chinese Standards Shop Database: 169760 (Oct 24, 2020)
HOME   Quotation   Tax   Examples Standard-List   Contact-Us   View-Cart
  

YY/T 1685-2020

Chinese Standard: 'YY/T 1685-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1685-2020English159 Add to Cart Days<=3 Pneumatic impulse oscillation equipment for sputum excretion Valid YY/T 1685-2020
YY/T 1685-2020Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YYT1685-2020 (YYT1685-2020)
Description (Translated English) Pneumatic impulse oscillation equipment for sputum excretion
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 8,839
Date of Issue 2020-02-21
Date of Implementation 2021-01-01
Drafting Organization Tianjin Medical Device Quality Supervision and Inspection Center, Wuxi Warner Medical Technology Co., Ltd., Suzhou Haobo Medical Device Co., Ltd., Beijing Medical Device Technology Evaluation Center
Administrative Organization National Medical Appliance Standardization Technical Committee Physical Therapy Equipment Sub-Technical Committee (SAC / TC 10 / SC 4)
Regulation (derived from) Announcement No. 20 of 2020 by the State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 1685-2020
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
Table of contents
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
Preface
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.
Related standard:   YY/T 1624-2019  YY/T 1626-2019
Related PDF sample:   YY/T 1095-2015  YY 0950-2015
   
 
Privacy   ···   Product Quality   ···   About Us   ···   Refund Policy   ···   Fair Trading   ···   Quick Response
Field Test Asia Limited | Taxed in Singapore: 201302277C | Copyright 2012-2020