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YY 0042-2018 English PDF (YY0042-2018)

YY 0042-2018 English PDF (YY0042-2018)

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YY 0042-2018: High-frequency jet ventilator
This Standard specifies the basic safety, performance, marking and information provided by the manufacturer for high-frequency jet ventilator. This Standard applies to high-frequency jet ventilator with both exhalation and inhalation open. The device is suitable for use by patients who need respiratory support, respiratory therapy and emergency resuscitation under the supervision of medical staff.
YY 0042-2018
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Replacing YY 0042-2007
High-Frequency Jet Ventilator
ISSUED ON: DECEMBER 20, 2018
IMPLEMENTED ON: JUNE 01, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Gas-Source Supply ... 6
5 Power Supply ... 7
6 Mechanical Strength ... 8
7 Waterproof ... 8
8 Fireproof ... 8
9 Cleaning, Disinfection or Sterilization ... 8
10 Material Compatibility ... 9
11 Accuracy of Work Data ... 9
12 Prevention of Dangerous Outputs ... 10
13 Connection ... 11
14 Marking ... 11
15 Information Provided by the Manufacturer ... 12
High-Frequency Jet Ventilator
1 Scope
This Standard specifies the basic safety, performance, marking and information provided by the manufacturer for high-frequency jet ventilator (hereinafter referred to as ventilator). This Standard applies to high-frequency jet ventilator with both exhalation and inhalation open. The device is suitable for use by patients who need respiratory support, respiratory therapy and emergency resuscitation under the supervision of medical staff.
2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.
GB/T 4999 Anesthetic Equipment and Breathing Machine - Vocabulary
GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Safety GB 18278.1 Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
GB 18279.1 Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
GB 18280.1 Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
GB 18281.1 (all parts) Sterilization of Health Care Products - Biological Indicators YY/T 0466.1-2016 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements YY 0600.3-2007 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 3: Emergency and Transport Ventilators YY 0601 Medical Electrical Equipment - Particular Requirements for Basic Safety and normally within the input pressure range of 280kPa~600kPa. It shall not cause any hazard when the pressure of the air inlet is up to 1000kPa. When the gas source pressure is 280kPa, the average gas flow measured at the high-pressure gas input port of the ventilator shall not exceed 60L/min (over 10s time-weighted average); and the instantaneous flow shall not exceed 200L/min (within 3s).
4.2 Alarm of abnormal gas-source supply
The ventilator shall have an alarm function of abnormal gas-source supply. When the gas- source supply pressure is too low to maintain the normal operation of the ventilator, the ventilator shall be able to generate a high-priority alarm or a continuous audible alarm in accordance with YY 0709; and the audible alarm signal shall at least last 120s. 4.3 One gas missing in the air-oxygen mixing system
In addition to the air-oxygen mixing system mixed with the atmosphere, if a gas is missing in the air-oxygen mixing system, the ventilator shall be able to automatically switch to make the remaining gas continue working; and at the same time, it shall generate an alarm signal of at least low priority in accordance with YY 0709.
5 Power Supply
5.1 Alarm on the abnormality of grid power supply
The ventilator that is powered only by the grid power supply shall have the function of alarming the abnormality of grid power supply. When the voltage of the grid power is too low to maintain the normal operation of the ventilator, a high-priority alarm or a continuous audible alarm in accordance with YY 0709 shall be activated; and the audible alarm signal shall last at least 120s. 5.2 DC power supply
In addition to the grid power supply, if the ventilator is additionally equipped with a DC power supply (internal power supply or external DC power supply), and can automatically switch to DC power supply when the grid power supply is abnormal to maintain its normal operation, then when the grid power supply is abnormal, the alarm on the abnormality of grid power supply shall not be activated. For the conversion of such power supply, it shall comply with the provisions of the information prompt signal or low-priority alarm signal specified in YY 0709. The ventilator that is powered by DC power supply should activate a medium-priority alarm in accordance with YY 0709 when the battery is low; and should activate a high-priority alarm in accordance with YY 0709 before all power is lost.
If the ventilator is equipped with a DC power supply, a method for the operator to determine the status of the DC power supply shall be provided.
5.3 Prevent mis-operation of the power switch
A method to prevent mis-operation of the power switch shall be provided. 5.4 Power cord
If the ventilator does not have a backup power supply, its equipped grid power cord shall be a non-detachable power cord; or measures shall be provided to prevent the grid power cord from accidentally falling off the ventilator.
6 Mechanical Strength
The ventilator that can be used for out-of-hospital transport shall be able to withstand the stress caused by rough operation during working; and the ventilator shall continue to work during and after the vibration impact test according to 21.6a), 21.6b) and 21.6aa) of YY 0600.3-2007. 7 Waterproof
The waterproof rating of ventilators that can be used for out-of-hospital transport shall be IPX4. 8 Fireproof
In normal or single fault conditions, combustible materials shall not be in both of the following conditions at the same time:
--- the material temperature reaches the minimum ignition temperature;
--- the presence of oxidizing agents.
9 Cleaning, Disinfection or Sterilization
Accessories and components in the ventilator breathing system that may be contaminated with rebreathing gases shall be removable for cleaning, disinfection, or sterilization. If the label indicates that the product is sterile, the product should be sterilized by appropriate and effective methods in accordance with the relevant descriptions in GB 18278.1, GB 18279.1, GB 18280.1 and GB 18281.
Packaging systems without passing through the sterilized equipment shall maintain product cleanliness prior to sterilization, use; and minimize the risk of bacterial contamination. (0.1kPa + 10% of the setting value).
11.6 Sigh
If the ventilator has a sigh function, the tidal volume during sighing shall be no less than 1.5 times the tidal volume during non-sighing.
11.7 Measurement of airway pressure
A device to measure the airway pressure at the patient's connection port shall be provided; and the accuracy of the pressure measuring device shall be ± (2% full scale + 8% actual reading). NOTE: The actual measurement can be carried out at any part of the ventilator breathing system; but the displayed pressure value shall be the pressure corresponding to the patient connection port. 11.8 Oxygen concentration monitoring
The ventilator should be equipped with an oxygen concentration monitor that complies with the provisions of YY 0601 for measuring the oxygen concentration at the inspiratory branch or the patient connection port.
12 Prevention of Dangerous Outputs
12.1 Protection against maladjustment
Protection shall be provided to prevent maladjustment that could produce dangerous outputs. 12.2 Maximum ultimate pressure
Under normal use and single fault conditions, the pressure at the patient connection port shall not exceed 12.5kPa.
12.3 Alarm on high airway pressure
The ventilator shall have a function of alarming the high airway pressure. When the airway pressure reaches a preset limit value, the ventilator shall be able to generate a high-priority alarm signal in accordance with YY 0709.
12.4 Alarm on respiratory system integrity
The ventilator shall have a function of alarming the respiratory system integrity; and the alarm signal shall be a high-priority alarm in accordance with YY 0709.
NOTE: Alarms with low airway pressure, low expiratory volume, and pipeline detachment can be considered to meet the requirements of this clause.
symbols of reference number 5.4.2 in YY/T 0466.1-2016), if applicable;
--- the word "sterile" or an equivalent symbol (such as the graphic symbols of reference numbers 5.2.1 ~ 5.2.5 in YY/T 0466.1-2016), if applicable;
--- recommended cleaning, disinfection or sterilization methods, if applicable; --- The packaging containing rubber shall be clearly marked with the words "natural rubber latex" or an equivalent symbol (such as the graphic symbol of reference number 5.4.5 in YY/T 0466.1-2016).
14.4 All components that are sensitive to the direction of airflow, if the operator can disassemble and install them without tools; measures shall be taken to prevent misconnection. If not, the components shall be marked with clear, easy-to-recognize and permanently attached arrow to indicate the airflow direction.
14.5 If the needle advancing method is used to adjust the oxygen concentration, the advancing direction of the needle when the oxygen concentration increases shall be marked. 15 Information Provided by the Manufacturer
The manufacturer shall provide the following information:
a) the manufacturer's address or the name and address of an authorized representative; b) cleaning, disinfection or sterilization for reuse, and details of any other means of restriction, if applicable;
c) if the ventilator has internal and/or external backup power supply, the manufacturer shall indicate the corresponding parameters in the relevant documents, including at least: ● voltage;
● current;
● amp-hour rating or operating time from a fully charged power supply;
● a method for determining the status of the backup power supply.
d) if the ventilator is supplied by high-pressure gas, the supply pressure and flow range shall be stated;
e) a warning that the ventilator shall not be covered or placed in a location that affects the operation and performance of the ventilator (e.g., the ventilator shall not be placed next to a barrier, which shall prevent the flow of cool air and overheat the equipment), if applicable;
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