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Lung ventilators for medical use-Particular requirements for basic safety and essential performance. Part 4: Coperator-powered resuscitators
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YY 0600.4-2013
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YY 0600.4-2013
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YY 0600.4-2013: PDF in English
YY 0600.4-2013
Lung ventilators for medical use-Particular requirements for basic safety and essential performance. Part 4. Coperator-powered resuscitators
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 0600.4-2013/ISO 10651-4..2002
Medical ventilator
Specific requirements for basic safety and main performance
Part 4. artificial resuscitator
(ISO 10651-4..2002, IDT)
2013-10-21 release
2014-10-01 implementation
Published by the State Food and Drug Administration
Contents
Foreword III
1 range 1
2 Normative references 1
3 Terms and definitions 1
4 connector 3
4.1 Patient connection port connector 3
4.2 * Exhale connector 3 for breathing gas
4.3 Mask connector 3
4.4 * Airbag valve connector 3
4.5 Airbag inlet valve connector 3
4.6 Threaded Gas Filter Connector 3
4.7 Oxygen fittings and manometer fittings 3
5 Operating requirements 3
5.1 General 3
5.2 Disassembly and assembly 3
5.3 Patient valve function after vomit contamination 3
5.4 Mechanical shock 3
5.5 Immersion in water 3
5.6 Airbag inflation valve 3
5.7 Construction materials 3
6 Ventilation requirements 3
6.1 Supplemental oxygen and delivered oxygen concentration 3
6.2 Expiratory impedance 3
6.3 Inspiratory impedance 4
6.4 Patient valve failure 5
6.5 Patient valve leak-forward leak 5
6.6 Resuscitator Dead Space and Repeated Breathing 5
6.7 Ventilation performance 5
7 Storage and handling conditions 5
7.1 Storage 5
7.2 Operating conditions 6
8 Requirements for sterile-packed resuscitators or components 6
8.1 Aseptic Assurance 6
8.2 Aseptic packaging of resuscitators or components 6
9 Mark 6
9.1 General 6
9.2 Indication of operating conditions 6
YY 0600.4-2013/ISO 10651-4..2002
9.3 Indication of pressure limit system settings 7
10 Information to be provided by the manufacturer in the operation and maintenance instructions 7
10.1 General 7
10.2 Content 7
Appendix A (Normative) Test Method 8
Appendix B (Informative) Basic Principles 16
References 18
YY 0600.4-2013/ISO 10651-4..2002
Foreword
The general title of YY 0600 is `` Special Requirements for Basic Safety and Main Performance of Medical Ventilators '', which consists of the following parts.
--- Part 1. Household respiratory support equipment;
--- Part 2. Home ventilator for ventilator dependent patients;
--- Part 3. Ventilator for emergency and transport;
--- Part 4. artificial resuscitator;
--- Part 5. Pneumatic emergency resuscitator.
This section is Part 4 of YY 0600.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is equivalent to the international standard ISO 10651-4..2002 "Medical ventilator Part 4. Specific requirements for artificial resuscitators" (English
Version), and made the following editorial changes.
--- Modify the standard name to "Special Requirements for Basic Safety and Main Performance of Medical Ventilators-Part 4. Artificial Resuscitators";
--- The international standards quoted in ISO 10651-4..2002 are correspondingly adopted as national standards and industry standards.
Use these national standards and industry standards as the normative use; if there is no corresponding adoption as national standards and industry standards, the
The cited international standards are used as norms.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This part is proposed and managed by the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This section was drafted. Shanghai Medical Equipment Testing Institute.
The main drafters of this section. Wang Wei and Xu Chang.
YY 0600.4-2013/ISO 10651-4..2002
Medical ventilator
Specific requirements for basic safety and main performance
Part 4. artificial resuscitator
1 Scope
This part of YY 0600 specifies special requirements for portable artificial resuscitators applicable to all ages, for
Pulmonary ventilation is provided in separate personnel. For infants and children, artificial resuscitators are identified based on their weight range and their corresponding approximate age.
Electric resuscitators and pneumatic resuscitators are not included in the scope of this section.
Note. The basic principles of this section are listed in Appendix B. Article numbers with principle descriptions are marked with "*".
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 4999-2003 Anesthesia breathing equipment term (ISO 4135..2001, IDT)
YY/T 0615.1-2007 Requirements for marked "sterile" medical devices Part 1. Requirements for final sterilized medical devices
(EN556-1..2001, IDT)
YY 0801.1 Terminals for medical gas piping systems-Part 1. Terminals for compressed medical gases and vacuum (YY 0801.1-
2010, ISO 9170-1..2008, IDT)
YY 1040.1 Conical joints for anesthesia and breathing equipment-Part 1. Taper heads and sleeves
1..1996, IDT)
EN148-1 Threads for respiratory protective masks-Part 1. Standard threaded connections (Respiratoryprotective)
devices-Threadsforfacepieces-Part 1. Standardthreadconnection.)
EN868-1 Packaging materials and systems for sterilization of medical articles. Part 1. General requirements and test methods
materialsandsystemsformedicaldeviceswhicharetobesterilized-Part 1. Generalrequirementsand
testmethods.)
EN1041 Information provided by medical device manufacturers (Informationsupplied by themanufacturerwithmedical
devices.)
prEN13544-2..2000 Respiratory therapy equipment-Part 2. Specific requirements for tubing and fittings (Respiratorytherapyequip-
ment-Part 2. Specificationsfortubingandconnectors.)
3 terms and definitions
The terms and definitions defined in GB/T 4999-2003 and the following apply to this document.
Note. Part of the definition comes from GB/T 4999, but for the sake of convenience, this section also includes them; GB/T 4999 gives the general equipment
He defined that this section has been slightly modified because it is specific to resuscitators.
3.1
Reverseleakage
No outflow from the exhalation port, but back to the exhaled breath volume of the resuscitator.
YY 0600.4-2013/ISO 10651-4..2002
3.2
Airbag inlet valve
A valve that opens when the pressure in the compression unit of the resuscitator is lower than atmospheric pressure and inflates the compression unit with gas at ambient air pressure.
3.3
Airbag inflation valve
A valve that opens when the pressure in the compression unit of the resuscitator is lower than atmospheric pressure and inflates the compression unit through the compressed air source. The valve is unmanned
Trigger.
3.4
Compressible unit
A component on an artificial resuscitator, such as an air bag or bellows, can send out a certain volume of gas when it is squeezed by the operator.
3.5
Delivered oxygen concentration
The average oxygen concentration of the gas delivered by the resuscitator.
3.6
Delivered volume, Vdel
In the inspiratory phase, the volume of gas output from the resuscitator through the patient connection port is expressed in milliliters.
3.7
Forwardleakage
The volume of gas that is delivered from the resuscitator in the inspiratory phase and is not delivered to the patient via the patient end, but leaks to the atmosphere.
3.8
Minutevolume
Volume of gas inhaled or exhaled by the patient's lungs per minute.
3.9
Artificial resuscitator operator-poweredresuscitator
Resuscitation equipment for lung ventilation is achieved by the operator pressing the compression unit on the device.
Note. hereinafter referred to as "resuscitator".
3.10
Patient connection port
The patient-side interface on the resuscitator, through which the patient inhales and exhales gas.
3.11
Patient connection port connector
A connector at the patient connection port that is directly connected to a mask or a suitable mating airway device.
3.12
Patient valve
A valve in the respiratory system that allows gas to enter the lungs in the inspiratory phase and the atmosphere in the expiratory phase.
3.13
Pressure limiting system
Device for limiting maximum delivery pressure
3.14
Resuscitator dead space
The volume of the exhaled gas from the previous exhalation in the next inspiratory phase.
(VD, app)
YY 0600.4-2013/ISO 10651-4..2002
3.15
Tidal volume
The volume of gas that enters during the inspiratory phase, or leaves the patient during the expiratory phase, or simulates the lungs, is expressed in milliliters.
VT
3.16
Ventilation cycle
The ventilation cycle contains the inspiratory and expiratory phases of breathing.
4 Connector
4.1 Patient connection port connector
The patient connector of the resuscitator shall be a 15 mm inner cone and 22 mm outer cone joint in accordance with ISO 5356-1.
4.2 * Exhale connector for breathing gas
If equipped with an exhalation port connector, it should be one of the following.
a) 30mm outer conical joint according to YY 1040.1; or
b) Permanent or special connectors that are not compatible with YY 1040.1 and YY 0801.1;
It cannot be connected to the lumen of any breathing accessory.
4.3 Mask connector
If the resuscitator is equipped with a mask, the mask should have a 22mm inner conical joint, or a 15mm outer conical joint, which should conform to YY 1040.1
The specified connectors match.
4.4 * Airbag Inflation Valve Connector
If the airbag inflation valve is equipped with a conical joint, it should be a special 32mm inner conical design and have a good fit with the gauge shown in Figure A.1.
Cooperation, the error is within the allowable range.
4.5 Airbag inlet valve connector
The airbag inlet valve connector should not match the connector in accordance with YY 1040.1. Airbag intake valves should be designed to minimize
Possibility of misconnection of the plug valve's breathing attachment.
4.6 Threaded Gas Filter Fitting
If the resuscitator can be fitted with a threaded gas filter fitting, it should comply with EN148-1.
4.7 Oxygen fittings and pressure gauge fittings
If equipped with an oxygen pipe joint, it shall comply with prEN13544-2..2000. Manometer fittings (if equipped) should not
The tubing of the connector is matched.
5 Operating requirements
5.1 General
When the resuscitator is operated by a single person, all performance requirements in this section should be met.
YY 0600.4-2013/ISO 10651-4..2002
5.2 * Disassembly and assembly
Resuscitators intended to be disassembled by the user, if disassembled for cleaning purposes, should be designed so that there is a risk of incorrect assembly between the various components
lowest.
The manufacturer shall recommend a method of performance inspection performed after reassembly [see 10.2d)].
5.3 * Patient valve function after vomit contamination
After testing in accordance with A.4.3, the resuscitator shall meet the requirements of 6.2, 6.4, 6.7.1 and 6.7.2.
Note. The structure of the valve chamber is preferably designed so that its mechanical operation can be observed by the operator, such as using a transparent housing. Observe the mechanism of the patient valve to help operate
Avoid incorrect operation.
5.4 Mechanical shock
5.4.1 * Drop test
At room temperature, after the drop test according to A.4.4, the resuscitator should meet the requirements of 6.2, 6.4, 6.7.1.
5.5 Immersion
After immersion in water according to the method of A.4.5, the resuscitator shall meet the requirements of 6.2, 6.4, 6.7.1 and 6.7.2.
5.6 * Airbag inflation valve
There should be no manually operated device on the airbag inflation valve used with the resuscitator.
5.7 Construction materials
All air-conducting parts shall be made of materials that have been declared by the manufacturer to be used in artificial resuscitators, taking into account their physical and chemical characteristics
Manufacturing.
6 Ventilation requirements
6.1 * Supplemental oxygen and oxygen delivered
According to the requirements of its corresponding classification (see 6.7.1), when tested by the method of A.4.6, the resuscitator is connected to the flow rate no higher than
15L/min oxygen source should provide at least 35% oxygen by volume; and the ability to provide 85% oxygen by volume
(See note). The manufacturer should declare that it is conveyed at some representative flow rate (such as 2L/min, 4L/min, 6L/min, 8L/min, etc.)
Range of oxygen concentration.
Note. The requirement of 85% volume fraction can be met by using accessories.
6.2 * expiratory impedance
Without using positive end-expiratory pressure, test according to the method described in A.4.7, and the pressure generated at the connection port of the patient should not exceed
0.5kPa (≈5cmH2O). [See also 10.2c) 8)].
6.3 * Inspiratory impedance
According to the method described in A.4.8, the pressure generated at the connection port of the patient should not exceed 0.5kPa (≈5cmH2O) at atmospheric pressure.
[See also 10.2c) 8)].
YY 0600.4-2013/ISO 10651-4..2002
6.4 * Patient valve failure
Tested according to the method described in A.4.9, when the maximum flow rate of 30L/min is added according to the manufacturer's instructions, it should not cause more than
Unexpected positive end expiratory pressure of 0.6 kPa (≈6 cmH2O).
6.5 * Patient Valve Leak-Forward Leak
When the resuscitator has a design feature of forward leakage, it should be explained in the instruction manual.
6.6 * Resuscitator Dead Space and Repeated Breathing
Test according to the method described in A.4.10. According to the requirements of its corresponding classification, the dead space of the resuscitator should not exceed a minimum of 5mL (110%).
Conveying capacity (see 6.7.1).
During spontaneous breathing, excessive repeated breathing should not occur.
6.7 * Ventilation performance
6.7.1 * Minimum delivery capacity (Vdel)
According to the compliance, impedance, frequency, and breathing ratio given in Table 1, and test according to the method described in A.4.11, the minimum delivery capacity should conform to Table 1.
Requirements.
6.7.2 * Pressure Limit
6.7.2.1 According to the method described in A.4.12, resuscitators designed for patients weighing less than 10 kg should be equipped with airway pressure limiting
The pressure limit system does not exceed 4.5kPa (≈45cmH2O). But it should be able to generate airway pressure of at least 3kPa (≈30cmH2O).
Note. Super control device is available.
6.7.2.2 If a resuscitator designed for a patient weighing more than 10 kg is equipped with a pressure limitation system,
Working pressure [see 10.2c) 9)]. Any pressure-limiting device that limits the pressure to less than 6kPa (≈60cmH2O) should be equipped with a super-control device.
Home. If the override device is provided with a locking device, the override device should be designed so that the operator can
Clearly identify the mode of operation (eg on or off).
Compliance is checked by inspection.
Table 1 Test conditions for ventilation performance
Patient weight Ba compliant impedance inhalation. exhalation time is greater than breathing frequency f minimum delivery capacity Vdel
kg L/kPa kPa/(L/s) ± 20% ± 10% mL
B≤5 0.01 40 1. 1 60 20
5 \u003cB≤10 0.1 2 1∶2 25 150
10 \u003cB≤40 0.2 2 1∶2 20 15×Ba
B > 40 0.2 2 1. 2 20 600
aB = Bodymass (weight), expressed in kg, indicated by the manufacturer in the manual.
7 Storage and handling conditions
7.1 Storage
Resuscitator and resuscitator kit (if available) should be arbitrarily relative between -40 ℃ ~ 60 ℃ and relative humidity 40% ~ 95%
YY 0600.4-2013/ISO 10651-4..2002
After storage under humidity, it still meets the requirements of Chapter 6 except for 6.6 (dead space).
7.2 * Operating conditions
Test according to the method described in A.4.13, the resuscitator should be in the entire relative humidity range of 15% to 95% relative humidity, and in the following
Meet the requirements of Chapter 6 in one of the temperature ranges.
---- 18 ° C ~ 50 ° C; or
--- If given a specific operating range (see 9.2 and Chapter 10), it must be within the entire temperature range declared by the manufacturer.
8 Requirements for resuscitators or components in aseptic packaging
8.1 Aseptic guarantee
Resuscitators or components marked "sterile" should meet the requirements of EN556-1..2001 to ensure the sterility required to make this statement.
8.2 Aseptic packaging of resuscitators or components
Packaging should meet EN868-1 and should effectively block the entry of microorganisms and particulate matter.
Such packaging should not be sealed once opened, otherwise it should be clearly stated that the packaging has been opened.
9 Mark
9.1 General
The marking, packaging, inserts and information provided by the manufacturer of the resuscitator or applicable parts shall comply with EN1041.
Note. Some requirements of Chapter 9 can be met by using the corresponding symbols given in ISO 15223-1.
9.2 Indication of operating conditions
If the resuscitator cannot work normally between -18 ℃ ~ 50 ℃ specified in 7.2, there should be a warning mark on the device.
Note. Examples of warnings.
--- "For use only between ℃ ~ ℃"; or the symbol shown in Figure 1.
Figure 1 Symbols indicating operating conditions between -10 ° C and 50 ° C
YY 0600.4-2013/ISO 10651-4..2002
9.3 Indication of pressure limit system settings
If the pressure limiting system equipped with the resuscitator is set to a fixed pressure, the nominal set pressure should be marked on the resuscitator.
10 Information to be provided by the manufacturer in the operation and maintenance instructions
10.1 General
Manufacturers are required to provide operation and maintenance instructions. These instructions should be sized and shaped to fit in the resuscitator box.
10.2 Content
In addition to the requirements of EN1041, if applicable, the operation and maintenance instructions shall include the following.
a) warn of the danger of incorrect use of the resuscitator;
b) instructions on how to operate the resuscitator in all expected modes of operation;
c) Information detailing the following information about the resuscitator and its recommended accessories (if any).
1) Suitable weight range for resuscitator;
2) Operating environment restrictions;
3) Storage environment restrictions;
4) All contents that can be delivered by the resuscitator except air (e.g. oxygen, volatile anesthetic);
5) The oxygen concentration that can be delivered under various test conditions;
6) Range of gas capacity;
7) Dead space, backward leakage and forward leakage of the resuscitator;
8) expiratory impedance, inspiratory impedance and impedance added using any recommended accessories;
9) The end-expiratory pressure generated during normal use of the resuscitator should be stated if it is greater than 0.2kPa (≈ 2cmH2O);
10) If there is a pressure limiting system and an override device, the details should be stated;
11) If the resuscitator is equipped with a control or indicating device, its accuracy should be stated;
12) external dimensions of the resuscitator and resuscitator box (if any);
13) the quality of the resuscitator and resuscitator box (if any);
d) instructions for disassembly and assembly of certain components for cleaning (including cleaning of vomitus), instructions for sterilization (if applicable), and assembly
Detailed description of the performance test after operation.
Note. These instructions can also be given in schematic form.
e) recommended methods for cleaning, disinfecting or sterilizing resuscitators, components, and accessories (if applicable);
f) functional tests to be performed before use;
g) operator-replaceable parts list;
h) maintenance requirements;
i) Recommendations for use in hazardous or explosive environments, including if the resuscitator mixes with air or allows the patient to inhale from the atmosphere
A warning that gas may be harmful if used in a contaminated environment (unless it is not mixed into the atmosphere). If applicable, the manufacturer shall describe
How to prevent contamination or inhalation of contaminated gases, such as the use of filters;
j) Under high oxygen concentration conditions, smoke and open flames can cause danger warnings and warnings against the use of grease in resuscitators;
k) The sterile resuscitator or component shall indicate the sterilization method used.
YY 0600.4-2013/ISO 10651-4..2002
Appendix A
(Normative appendix)
experiment method
A.1 General test conditions
Unless otherwise specified, the ambient temperature of the test should be between 20 ° C and 25 ° C, and the relative humidity should be between 45% and 75%.
A.2 Instrument
A.2.1 General
Typical test instruments are shown in Figures A.1 to A.5; test instruments with equal or better accuracy can also be used.
A.2.2 Simulated lung (see Figure A.4 and Figure A.5 for examples), with appropriate compliance and impedance characteristics (see Table A.1 and Table A.2).
A.2.3 Flow resistance if the simulated lungs are not provided together.
A.2.4 Instruments for measuring and recording pressure, flow and capacity.
A.2.5 Temperature measuring instrument.
A.2.6 Instrument for measuring dead space (see A.3 for a typical example).
A.2.7 graduated cylinder, at least.200mL volume.
A.2.8 Oxygen analyzer.
A.2.9 A large enough pool to completely submerge the resuscitator.
A.2.10 Environmental test box, which can maintain the temperature at -40 ℃ ± 1 ℃ ~ 70 ℃ ± 1 ℃, and maintain the relative humidity at 15% ~ 95%.
Hold for up to 7d.
A.3 Condition adjustment and reference conditions
A.3.1 Condition adjustment of resuscitator and test equipment
Unless otherwise stated in a particular test, place the resuscitator and test...
......
| Standard ID | YY 0600.4-2013 (YY0600.4-2013) | | Description (Translated English) | Lung ventilators for medical use-Particular requirements for basic safety and essential performance. Part 4: Coperator-powered resuscitators | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 23,262 | | Quoted Standard | GB/T 4999-2003; YY/T 0615.1-2007; YY 0810.1; YY 1040.1; EN 148-1; EN 868-1; EN 1041; PREN 13544-2-2000 | | Adopted Standard | ISO 10651-4-2002, IDT | | Drafting Organization | Shanghai Medical Device Testing | | Administrative Organization | National Standardization Technical Committee anesthesia and respiratory devices | | Regulation (derived from) | State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC 116) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the special requirements apply to all ages of portable artificial resuscitation device used to provide breathing lung ventilation is not sufficient. For infants, children, artificial resuscitator according to weight ranges and thei |
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