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YY 0600.5-2011

Chinese Standard: 'YY 0600.5-2011'
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YY 0600.5-2011English599 Add to Cart Days<=5 Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 5: Gas-powered emergency resuscitators Valid YY 0600.5-2011
YY 0600.5-2011Chinese42 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID YY 0600.5-2011 (YY0600.5-2011)
Description (Translated English) Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 5: Gas-powered emergency resuscitators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 43,435
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard GB 3100; GB 3102.1; GB 3102.2; GB 3102.3; GB 3102.4; GB 3102.5; GB 3102.6; GB 3102.7; GB 3102.8; GB 3102.9; GB 3102.10; GB 3102.11; GB 3102.12; GB 3102.13; GB 4208-2008; GB/T 4999-2003; GB 7144-1999; GB 9706.1-2007; GB 15382-2009; GB 19633; YY/T 0316-2008; YY 0461; YY 0466.1-2009; YY/T 0753.1-2009; YY/T 0753.2-2009; YY/T 0799; YY 0801.1; YY/T 0802-2010; YY 1040.1; YY 1040.2; ISO 10524-1; ISO 10524-3
Adopted Standard ISO 10651-1-2006, IDT
Drafting Organization Shanghai Medical Device Testing
Administrative Organization National Standardization Technical Committee of Anaesthetic and respiratory equipment
Regulation (derived from) State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Proposing organization National Standardization Technical Committee of anesthesia and respiratory equipment (SAC/TC 116)
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the use of first responders who left with a pneumatic resuscitation for the basic safety and essential performance requirements. The device for emergency spaces, in normal use, continuous monitoring by the operator. YY 0600 This part also provides for recovery of component (3. 22) requirements. YY 0600 This part does not apply to electric resuscitators.

YY 0600.5-2011
Lung ventilators for medical use.Particular requirements for basic safety and essential performance.Part 5. Gas-powered emergency resuscitators
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 0600.5-2011/ISO 10651-5..2006
Dedicated to basic safety and main performance of medical ventilator
Requirements Part 5. Pneumatic First Aid Resuscitator
(ISO 10651-5..2006, IDT)
2011-12-31 release
2013-06-01 Implementation
Published by the State Food and Drug Administration
Contents
Foreword I
Introduction Ⅱ
1 * range 1
2 Normative references 1
3 Terms and definitions 2
4 General requirements 4
4.1 Overview 4
4.2 Other test methods 5
4.3 Acceptance Criteria 5
5 Structural requirements 5
5.1 Overview 5
5.2 Connector 6
6 Operating requirements 7
6.1 Overview 7
6.2 Environmental resistance 8
6.3 Resistance to typical use 8
6.4 Dimensions and quality 9
6.5 Air source 9
7 Performance 10
7.1 Ventilation requirements 10
7.2 * Ventilation performance 11
8 Identification, marking and documentation 14
8.1 Overview 14
8.2 Mark 14
8.3 Operation and maintenance information provided by the manufacturer 16
Appendix A (Informative) Basic Principles 19
Appendix B (Normative) Test Method 24
Appendix C (informative) Relationship between this part of YY 0600 and CPR guidelines 33
Appendix D (informative) Clause 34 of this part of YY 0600 that discusses basic principles
Appendix E (Informative) Terminology-Index of Defined Terms 36
References 38
YY 0600.5-2011/ISO 10651-5..2006
Foreword
YY 0600 `` Special Requirements for Basic Safety and Main Performance of Medical Ventilators '' is divided into five 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 5 of YY 0600.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is equivalent to ISO 10651-5..2006 "Special requirements for basic safety and main performance of medical ventilators. Part 5. Pneumatics
First Aid Resuscitator.
Compared with ISO 10651-5..2006, this section has the following editorial changes.
--- The introduction of ISO 10651-5..2006 was modified into the introduction of this part;
--- The international standards quoted in ISO 10651-5..2006 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 ISO 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 Fu Guoqing.
YY 0600.5-2011/ISO 10651-5..2006
introduction
Resuscitation committees and associations point out that for patients at risk of life
Perform on-site cardiopulmonary resuscitation and start a series of continuous ambulances until the patient can get professional medical care and will get the most effective
Ambulance results. To improve possible ambulances at an early stage, experts and organizations train non-professionals in key locations, such as
Where they gather or where danger arises, they can provide a higher level of ambulance in the shortest possible time.
There is increasing awareness that the use of basic equipment can greatly improve efficiency, such as avoiding mouth-to-mouth contact while providing ventilation
device of. Simply put, pneumatic rescue resuscitators can deliver controlled ventilation, and this section specifies the standard indicators required to achieve safety.
The clauses marked with an asterisk (*) in this part of YY 0600 have basic principles in Appendix A.
YY 0600.5-2011/ISO 10651-5..2006
Dedicated to basic safety and main performance of medical ventilator
Requirements Part 5. Pneumatic First Aid Resuscitator
1 Scope
This part of YY 0600 specifies the basic safety and main performance requirements of human emergency rescue resuscitators used by first responders.
This device is used in emergency places and is continuously monitored by the operator during normal use.
This part of YY 0600 also specifies requirements for resuscitator components (3.22).
This part of YY 0600 does not apply to electric resuscitators.
Note. YY 0600.3 contains the contents of ventilator for emergency and transportation.
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 3100 international unit system and its application (ISO 1000)
GB 3102 (all parts) Quantities and units [ISO 31 (all parts)]
GB 4208-2008 enclosure protection level (IP code) (IEC 60529..2001, IDT)
GB/T 4999-2003 Anesthesia breathing equipment term (ISO 4135..2001, IDT)
GB 7144-1999 cylinder color code
GB 9706.1-2007 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988 A1..1991 A2.
(1995, IDT)
GB 15382-2009 General technical requirements for gas cylinder valves
GB 19633 Packaging for final sterilized medical devices (GB/T 19633-2005, ISO 11607..2003, IDT)
YY/T 0316-2008 Application of medical device risk management to medical devices (ISO 14971..2007, IDT)
YY 0461 Breathing circuit for anesthesia machine and ventilator (YY 0461-2003, ISO 5367..2000, IDT)
YY 0466.1-2009 Medical devices. Symbols for labelling, marking and providing information of medical devices. Part 1. General requirements
(ISO 15223-1..2007, IDT)
YY/T 0753.1-2009 Respiratory filters for anesthesia and breathing. Part 1. Salt test method for evaluating filtration performance
(ISO 23328-1..2003, IDT)
YY/T 0753.2-2009 Respiratory filters for anesthesia and breathing Part 2. Non-filtering aspects (ISO 23328-2.
(2002, IDT)
YY/T 0799 Medical Gas Low Pressure Hose Assembly (YY/T 0799-2010, ISO 5359..2008, MOD)
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, MOD)
YY/T 0802-2010 Information provided by sterilization manufacturers of medical devices for handling re-sterilizable medical devices (ISO 17664.
(2004, IDT)
YY 1040.1 Conical joints for anesthesia and breathing equipment-Part 1. Taper heads and sleeves
1..1996, IDT)
YY 1040.2 Conical joints for anesthesia and breathing equipment-Part 2. Threaded load-bearing joints
YY 0600.5-2011/ISO 10651-5..2006
(2006, IDT)
ISO 10524-1 Pressure regulators for medical gases. Part 1. Pressure regulators and pressure regulators with flow meter
(Pressureregulatorsforusewithmedicalgases-Part 1. Pressureregulatorsandpressureregulators
withflow-meteringdevices)
ISO 10524-3 Pressure Regulators for Medical Gases Part 3. Pressure Regulators with Gas Cylinder Valves (Pressureregulators
forusewithmedicalgases-Part 3. Pressureregulatorsintegratedwithcylindervalves)
3 terms and definitions
GB/T 4999-2003, GB 9706.1-2007 and the following terms and definitions apply to this document. Appendix E gives
Source of all terms in this section.
3.1
Random filesaccompanyingdocuments
Documents included with the resuscitator or resuscitator assembly, including information for the user, operator, installer or assembler
It is all important information, especially information about security.
Note. Rewrite GB 9706.1-2007, definition 2.1.4.
3.2
Automatic pressure-cycle resuscitator
After the pressure set by the control device is reached, the resuscitator is switched from inspiratory phase to expiratory phase.
3.3
Automatictime-cycledresuscitator
A resuscitator that automatically controls the cycle between inspiratory and expiratory phases at time intervals set by the control device.
3.4
Automatic volume-cycle resuscitator
After the delivery capacity set by the control device is reached, the resuscitator is switched from inspiratory phase to expiratory phase.
3.5
Cardiopulmonary resuscitation cardiopulmonaryresuscitation
A combination of breathing assistance and chest compressions for patients who are judged to be cardiac arrest.
[AHA CPR and First Aid Guide]
3.6
Clearly legible
Can make the operator or related personnel with normal vision see clearly.
Note. See 8.2.1.
3.7
* Delivered volume delivered volume
Vdel
The volume of gas delivered through the patient connection during the inspiratory phase.
3.8
On-demand valve
A component of the resuscitator that delivers the pressure-related airflow caused by the patient at the patient connection.
3.9
First responder
Trained personnel to provide initial response to respiratory emergencies.
YY 0600.5-2011/ISO 10651-5..2006
Example 1. firefighter
Example 2. First responder
3.10
Gas-poweredemergencyresuscitator
Resuscitator
Portable type that uses compressed gas as the power source and is expected to be used urgently to provide lung ventilation for resuscitated persons
device.
3.11
Unexpected positive end-expiratory pressure inadvertentpositiveend-expiratory pressure
Unexpected PEEP inadvertentPEEP
Unexpected positive pressure at the connection port of the end-expiratory patient.
3.12
Intermediatehose
A pipeline that transfers gas between resuscitator components.
3.13
Manual-cycledresuscitator
The inspiratory phase and the expiratory phase are controlled by the operator by repeatedly operating the resuscitator.
Note. In this document, on-demand valves that can be controlled by manual triggers are classified as "manual circulation resuscitators containing on-demand valves", rather than
These countries commonly define "on-demand valves."
3.14
Minutevolume
Volume of gas inhaled or exhaled by the patient's lungs per minute.
3.15
Operator
Man operating a resuscitator.
Note. GB 9706.1-2007 was rewritten to define 2.12.17.
3.16
Patient-triggeredresuscitator
The cycle from expiration to inspiration is a resuscitator triggered by the patient's inspiration.
3.17
Patient-triggering
At the patient connection port, a pressure drop generated by the patient initiates a set inspiratory operation mode.
3.18
Patient valve
A valve in the breathing system of a resuscitator directs gas into the lungs during inhalation and directs gas from the lungs into the atmosphere during expiration.
3.19
Pressure-limiting device
A device that defines the maximum pressure in the respirator's respiratory system.
3.20
Resuscitator breathing system
Respiratory system bounded by low-pressure gas inlet, gas inlet and patient connection port, if provided, plus fresh gas inlet and
The exhaust is bounded by the respiratory system.
YY 0600.5-2011/ISO 10651-5..2006
3.21
Resuscitator dead space
The volume of gas that was previously exhaled in the respirator's respiratory system and delivered to the patient during the subsequent inspiratory phase.
3.22
Resuscitatorset
All necessary components to enable the resuscitator to be transported to an emergency ambulance and ready for immediate use.
3.23
Safety hazard
Potentially harmful effects directly on the patient, other people, animals, or the environment caused by the resuscitator.
Note. Rewrite GB 9706.1-2007, definition 2.12.18.
3.24
Single fault condition
In the resuscitator, only one safety-related dangerous protective measure fails, or only one external abnormality occurs.
Note. Rewrite GB 9706.1-2007, definition 2.10.11.
4 General requirements
4.1 Overview
Transport, storage, installation, normal use and maintenance according to random documents.Under normal conditions and single failure conditions, the resuscitator should not
Causes reasonably foreseeable hazards, and does not cause safety hazards that are not related to the intended application purpose.
A risk management process in accordance with YY/T 0316 shall be implemented.
When implementing YY/T 0316.
a) The term "medical equipment" should be considered equivalent to a resuscitator.
b) The term "fault state" referred to in YY/T 0316 shall include, but shall not be limited to, a single fault as defined in this part of YY 0600
status.
c) Where YY 0600 specifies the measurable requirements for specific risks and meets these requirements, the requirements of these requirements
Residual risk should be considered acceptable unless there is objective evidence to the contrary.
This part of YY 0600 specifies requirements that can generally be applied to risks related to resuscitators and is expected to be used as a tool in the risk management process.
用 用。 Use. This risk management process identifies not only those safety aspects mentioned in this part of YY 0600, but also all safety aspects
Hazards, and their associated risks and risk control measures.
Conditions or faults that can cause dangerous risks in safety have been pointed out in the clauses of YY 0600. In these cases, it is often necessary
A risk management process is performed to determine what the actual safety hazard is and testing is required to show the known safety hazards
Does not appear under specified conditions.
For each constituent component of a resuscitator, such as patented components, non-medical subsystems and legacy components, the manufacturer may not be able to
Conforms to all procedures indicated in this part of YY 0600. In this case, the manufacturer should specifically consider whether additional risk control is needed
制 Measures.
The requirements in this part of YY 0600 involve that if there is no unacceptable risk, the manufacturer decides the risk according to its acceptable risk regulations.
Acceptability or unacceptability of risks.
Compliance is checked by inspection of risk management documents. If the manufacturer.
--- A risk management process has been established,
--- an acceptable level of risk has been established, and
--- It has been proven that the residual risk is acceptable (according to the regulations that determine acceptable risk).
Then the requirements of this chapter and all requirements related to risk management documents in this part of YY 0600 are considered to be in compliance.
YY 0600.5-2011/ISO 10651-5..2006
4.2 Other test methods
If the same level of safety is available, the manufacturer may use a different type test method than detailed in this part of YY 0600. however
In case of dispute, the methods specified in this section should be used as a reference method.
4.3 Acceptance criteria
Many of the test clauses in this part of YY 0600 set acceptance criteria for performance. These acceptance criteria should always be met.
When the performance level specified by the manufacturer in the random file is higher than the performance level specified in this part of YY 0600, the manufacturer specifies
The level is the acceptance level and should be met.
5 Structural requirements
5.1 Overview
5.1.1 Structural materials
When selecting the constituent materials of all gas transmission components, consideration should be given to what is mentioned in the random file.
--- Can be managed by a resuscitator, and
--- Chemical and physical characteristics of any substance that can be used to clean, disinfect or sterilize the resuscitator.
Compliance is checked by examining risk management documents.
5.1.2 Faces, corners and edges
Damaged rough surfaces, sharp corners, open ends and sharp edges of tubular components should be avoided or covered. Special attention should be paid to hair
Clearance of thorns.
Compliance is checked by inspection.
5.1.3 Material filtration
Resuscitators and components should be designed and manufactured in such a way as to pose the greatest health risks in use as a result of leaching from substances in the resuscitator or its components
small. Particular attention should be paid to the toxicity of materials and the compatibility of materials and substances in contact with gases during normal use.
Compliance is checked by examining risk management documents.
5.1.4 Breathing circuit
Breathing tubes used for the respirator breathing system with an internal diameter greater than 18mm should meet the requirements of YY 0461.
Compliance is checked according to the requirements of YY 0461.
5.1.5 Supply of sterile components
If the product is declared to be sterile on the label, it should be in accordance with GB 18278, GB 18279, GB 18280, GB 18281 or GB/T.19974
Sterilize by an appropriate and validated method specified in.
The packaging of aseptically supplied resuscitators or components should meet the requirements of GB 19633. Such packages should not be sealed once opened,
Otherwise it should be clearly stated that the packaging has been opened.
Non-sterile packaging systems should be designed to maintain sterilized products at the expected cleanliness level before use, and should be designed to keep microorganisms
Harm caused by pollution is minimal.
Compliance is checked by examining the methods of sterilization and disinfection in the random documentation and by examining the relevant verification reports.
YY 0600.5-2011/ISO 10651-5..2006
5.1.6 * Respiratory filter
Any respiratory system filter, whether integrated with the resuscitator or specified in the accompanying documentation for the resuscitator, shall meet
Applicable parts in YY/T 0753.1 and YY/T 0753.2.
Compliance is checked according to the requirements of YY/T 0753.1 and YY/T 0753.2.
5.1.7 Function Arrangement
Any single fault condition shall not cause any monitoring or alarm system function and related ventilation control specified in this part of YY 0600
Control function is a failure in which the monitoring or alarm system function fails at the same time, and thus the function of the monitored resuscitator cannot be checked.
Failure.
Compliance is checked by simulating a single fault condition and visual inspection.
5.1.8 Protection against accidental adjustment
Means should be provided to prevent accidental changes to control settings including on-off switches, such as locks, guards, damping and braking
And other mechanical technologies.
Compliance is checked by visual inspection according to the instruction manual.
5.1.9 Selector switch/control
For non-continuous adjustment control, measures should be provided to prevent the selector from staying in the middle position.
Example 1. "On-Off" switch.
Example 2. Oxygen concentration selector.
Example 3. Preset selector, discrete value of transmission capacity or frequency.
Compliance is checked by inspection.
5.1.10 Accuracy of working data
When the resuscitator is used normally, the gas should be delivered with the accuracy indicated in the instruction manual. See 8.3.2.2.
Compliance is checked by the appropriate test methods in this part of YY 0600.
5.1.11 * Resuscitator assembly
The resuscitator should be provided with the resuscitator assembly, or the resuscitator assembly should be recommended in the accompanying documents, including compliance with this part of YY 0600
Medical gas supply system in accordance with relevant requirements.
Compliance is checked by inspection.
5.2 Connector
5.2.1 Connection to the medical gas supply system
If a removable hose assembly is provided to connect the resuscitator and the medical gas supply system, it shall comply with YY/T 0799. If the hose assembly
It is permanently connected to the resuscitator and connected to the medical gas supply system in the following way.
--- Inserts in accordance with YY 0801.1, or
--- Permanent connector.
Note. A permanent joint is a joint that can only be separated using a tool.
Compliance is checked by inspection.
5.2.2 Connection to high pressure gas input
The connection of the hose to the high pressure gas inlet of the resuscitator should be as follows.
YY 0600.5-2011/ISO 10651-5..2006
--- Non-interchangeable threaded joints in accordance with YY/T 0799,
--- Inserts in accordance with YY 0801.1, or
--- Permanent connector.
Compliance is checked by inspection.
5.2.3 Patient connection port connector
The patient connector of the resuscitator should be a 15mm/22mm coaxial connector in accordance with YY 1040.1.
Compliance is checked according to the requirements of YY 1040.1.
5.2.4 Mask connector
The mask should have a 22mm inner conical joint or 15mm outer conical joint that matches the corresponding joint specified in YY 1040.1.
Compliance is checked according to the requirements of YY 1040.1.
5.2.5 * Exhaust port connector
If an exhaust connection is provided, it should be.
--- 30mm outer conical joint in accordance with YY 1040.1; or
--- Incompatible with YY 1040.1 and YY 0801.1, and has the ability to prevent any breathing in accordance with YY 1040.1 or YY 1040.2
The accessory is connected to a dedicated connector in its cavity.
Compliance is checked by inspection and in accordance with the requirements of YY 1040.1, YY 1040.2 and YY 0801.1.
5.2.6 Resuscitator suction branch joint
Resuscitator suction branch joints, if conical, should meet the requirements of YY 1040.1 and YY 1040.2.
Non-conical joints should not be matched with conical joints in accordance with YY 1040.1 and YY 1040.2. Unless it meets YY 1040.1
Engagement, disengagement and leakage requirements in YY 1040.2.
Compliance is checked by inspection.
5.2.7 Emergency air intake
The emergency air intake should.
---provide;
--- Meet the requirements of 7.1.2.2 and 7.1.2.3; and
--- Does not match any connector that meets YY 1040.1 or YY 1040.2.
Compliance is checked by inspection.
6 Operating requirements
6.1 Overview
6.1.1 * Patient valve function after vomit contamination
When the resuscitator is tested according to the method described in B.3.1, the time for cleaning and restoring to normal function shall not exceed 20s, and shall comply with
Meet the requirements specified in Chapter 7. The housing of the valve should be constructed so that the operator can observe the operation of the mechanical device, such as through a transparent housing.
Note. Observing the function mechanism of the patient valve can help the operator detect abnormal operation.
Compliance is checked in accordance with the methods of B.3.1 and Chapter 7.
YY 0600.5-2011/ISO 10651-5..2006
6.1.2 Washing, sterilizing or disinfecting
In normal use and in the simulated single fault state listed in B.3.10, those that can be contaminated by the patient's exhaled gas are in a random file
Indicate that all parts and accessories that can be reused should be capable of being cleaned, sterilized or disinfected.
Parts and accessories marked as sterilizable shall meet the requirements of YY/T 0802-2010.
Compliance is checked by inspection.
6.1.3 * Functional test after reassembly
6.1.3.1 Reassembly
The resuscitator (e.g., cleaning) intended to be disassembled by the operator should be designed to incorrectly reload when using only the parts provided with the resuscitator assembly.
The risk of a new assembly is minimal.
Compliance is checked by inspection.
6.1.3.2 Functional test
The accompanying documentation should indicate the functional tests that can be performed by the operator after reassembly using only the components provided with the resuscitator assembly
Procedure to prove that the resuscitator has been properly reassembled.
Compliance is checked by the method of B.3.2.
6.1.4 Flow direction sensitive component connector
Any operator-removable, flow-sensitive components should be designed so that they cannot be installed in such a way that there is a safety aspect for the patient
Danger.
Compliance is checked by inspection.
6.2 Environmental resistance
6.2.1 * Storage and working conditions
6.2.1.1 Storage
After storage at a temperature of -40 ° C to 60 ° C and a relative humidity of 40% to 95%, the resuscitator and resuscitator assembly should meet
Requirements of 5.1.10, 7.2.2, 7.2.4 and 7.2.6.
Compliance is checked by the method of B.3.3.
6.2.1.2 Working conditions
In the entire range of relative humidity from 5% to 95% and.
--- The temperature ranges from -18 ℃ ~ 50 ℃, or
--- If given the working range [see 8.3.2.4i)], within the temperature range specified in the random file,
The resuscitator and resuscitator assembly shall meet the requirements of 5.1.10, 7.2.2, 7.2.4, and 7.2.6.
Compliance is checked according to the method in B.3.3.
6.3 Resistance to typical use
6.3.1 Mechanical vibration
6.3.1.1 * Drop test
After the resuscitator components and detachable parts are tested in accordance with B.3.4, the resuscitator shall remain functional, and the tolerance shall
YY 0600.5-2011/ISO 10651-5..2006
Within the range.
Compliance is checked according to the method in B.3.4.
6.3.2 Splashproof
The resuscitator should be splash-proof and classified as IPX4 according to GB 4208.
During and after the test according to the provisions of GB 4208, according to random documents, under the most unfavorable working conditions, the resuscitator should maintain its function.
Yes, the tolerance is within the tolerance range of normal use and should not cause safety hazards.
Compliance is checked by inspection and in accordance with the requirements in GB 4208.
6.3.3 * Water immersion
After immersion in water according to the method described in B.3.5, the resuscitator should remain functional and the tolerance should be within the tolerance range of normal use.
Compliance is checked according to the method in B.3.5.
6.4 Size and quality
6.4.1 * Size
The resuscitator assembly provided or recommended in the accompanying documentation should be able to pass through a 300mm x 600mm rectangular opening.
Compliance is checked by inspection.
6.4.2 * Quality
The mass of the resuscitator assembly with all recommended items (including any gas filled cylinders) should not exceed 5 kg.
The resuscitator component including the patient connection port should be lighter than 0.3 kg.
Compliance is checked by inspection.
6.5 Air supply
6.5.1 Gas cylinders and cylinder valves
The contents of the cylinders provided or recommended in the accompanying documents shall comply with GB 7144.
The gas cylinder valve provided or recommended in the accompanying documents shall be in compliance with the requirements of GB 15382. Stingy with special connector
Bottles can sometimes be used on special occasions.
Compliance is checked by inspection.
6.5.2 Controlled cylinder valve key
If the handwheel, key or other parts used to open the cylinder valve are detachable, they should pass a static load that can withstand not less than.200N (20kg).
A chain or similar attachment that is loaded without breaking to hold it under control.
Compliance is checked by inspection.
6.5.3 Gas cylinder regulator
To match the type of cylinder provided or recommended as part of the medical gas supply system (see 5.1.11) of the resuscitator assembly,
Pressure regulators provided or recommended in the accompanying documentation shall meet the requirements of ISO 10524-1 or ISO 10524-3.
Compliance is checked by inspection.
6.5.4 External Supply
If the resuscitator has an operator connected to a medical gas supply system (e.g. pressure regulator in accordance with ISO 10524 series, or
YY 0600.5-2011/ISO 10651-5..2006
Inserts (see 5.2.1 on the terminal of the ambulance) (see 5.2.1), should be able to work in the whole range of air source pressure from 280kPa to 600kPa
And meet the requirements of this part of YY 0600, and the single failure condition of the medical gas supply that the input pressure rises to 1000kPa
It should not pose a safety hazard.
Compliance is checked by a functional test.
6.5.5 Permanently connected resuscitator
If the resuscitator does not have an insert connected to the medical gas supply system by the operator, the
Within the rated gas range, it should be able to work and meet the requirements of this part of YY 0600, and the gas pressure at the input port rises to 1000kPa.
A single fault condition of the bottle pressure regulator should not pose a safety hazard.
Compliance is checked by a functional test.
6.5.6 * Intermediate pipe
Intermediate piping between any resuscitator parts that can be connected by the operator should not be fitted with joints on piping complying with YY/T 0799.
Replace the connector, and should not allow incorrect connection between the parts of the resuscitator.
Compliance is checked by inspection.
6.5.7 Gas supply capacity
Any resuscitator assembly provided or recommended in the accompanying documentation shall be capable of being equipped with one or
Multiple cylinders. When tested in accordance with B.3.6, the resuscitator assembly should contain sufficient gas to enable the resuscitator to deliver oxygen to the patient.
At least 100 l of gas with a volume fraction greater than 85%.
Compliance is checked according to the method in B.3.6.
7 Performance
7.1 Ventilation requirements
7.1.1 * Transport oxygen concentration
The resuscitator should deliver at least 85% volume fraction concentration of oxygen.
Compliance is checked according to the method in B.3.7.
7.1.2 * spontaneous breathing impedance
7.1.2.1 Overview
Accessible accessories or optional features provided for specified purposes, temporary use, but increasing inhalation and exhalation resistance during use
Yes, if a warning such as 8.3.2.3d) is specified in the random file, it shall not be used when testing that meets the following requirements.
Compliance is checked by inspection.
7.1.2.2 Inspiratory impedance when resuscitator exhales
In the expiratory phase, for resuscitators intended for patients weighing more than 10 kg, at an inspiratory flow of 60 l/min, it is expected to be used for
For resuscitators with a size of 10 kg, the negative pressure at the connection port of the patient should not be greater than 6hPa (6cmH2O) at an inspiratory flow of 6l/min.
Compliance is checked by the method of B.3.8.1.
7.1.2.3 Spontaneous breathing when the gas input pressure exceeds the rated range
When the gas input pressure exceeds the rated range, the deviation between the delivery capacity and the inspiratory time of the resuscitator during the inspiratory phase should be within the normal range.
YY 0600.5-2011/ISO 10651-5..2006
The delivery volume and inspiratory time produced within the range of ± 25% during use, or the resuscitator should be designed to allow spontaneous breathing.
Under spontaneous breathing conditions, for resuscitators intended for patients weighing more than 10 kg, at a flow rate of 30 l/min, it is expected to be used for
For patients with a maximum weight of 10 kg, the pressure at the connection port of the patient should not exceed atmospheric pressure ± 6 hPa at a flow rate of 3 l/min.
(6cmH2O).
Example 1. The inlet pressure drops below the minimum rated working pressure of the resuscitator, for example. when the gas contained in the cylinder is exhausted.
Example 2. The inlet pressure exceeds the maximum rated working pressure of the resuscitator, for example. the regulator fails.
Compliance is checked by the method of B.3.8.2.
7.1.2.4 Exhalation impedance
When there is no removable PEEP valve or with a full positive end expiratory pressure function and is set to its minimum value,
Resuscitators for patients weighing more than 10 kg are expected to be used for resuscitation of patients weighing up to 10 kg at an inspiratory flow of 60 l/min.
The pressure of the patient's connection port should not exceed 6hPa (6cmH2O) at 6l/min inspiratory flow. (See 8.3.2.2h)
Compliance is checked according to the method of B.3.8.3.
7.1.3 * Unexpected PEEP
The positive expiratory pressure at the end of the expiratory phase should not exceed 2hPa (2cmH2O).
Compliance is checked by the method of B.3.9.
7.1.4 * Unexpected continuous expiratory pressure
Means shall be provided to prevent the establishment of a continuous positive pressure exceeding 2 hPa (2 cmH2O).
Compliance is checked according to the method of B.3.10.
7.1.5 * Dead space of resuscitator and airway accessories
The dead space of the resuscitator should not exceed 5.5% of the minimum delivery capacity in the resuscitator.
For resuscitators delivering more than 300ml, any combination of accessories recommended for resuscitators (e.g. masks, filters, artificial ventilation
The dead space of the tube), together with the dead space of the resuscitator, should not exceed 100ml. For resuscitators delivering 300ml and below, the dead space should not exceed
Use 30% of the minimum delivery capacity indicated in the instructions.
Compliance is checked by physical or water measurements.
7.2 * Ventilation performance
7.2.1 Overview
When the resuscitator is used by only one operator, all tests in this part of YY 0600 should be performed.
Resuscitators are classified into one or more of the following categories. Resuscitators should meet the relevant requirements of 7.2.
7.2.1.1 Manual circulation resuscitator
Manual circulation resuscitators shall meet the requirements specified in 7.2.2 ~ 7.2.8.
7.2.1.2 Automatic pressure cycle resuscitator
The automatic pressure cycle resuscitator shall meet the requirements specified in 7.2.2 ~ 7.2.7.
7.2.1.3 Automatic time cycle or volume cycle resuscitator
Automatic time cycle or volume cycle resuscitators shall meet the requirements specified in 7.2.2 ~ 7.2.7.
YY 0600.5-2011/ISO 10651-5..2006
7.2.1.4 Resuscitator with patient trigger function
Resuscitators with patient-triggered functions should meet the requirements specified in 7.2.10, and should also meet the requirements of relevant automatic resuscitator functions.
7.2.1.5 Resuscitator with on-demand valve
The on-demand valve as a component of the resuscitator shall meet the requirements of 7.2.9, and in addition shall meet the requirements of the relevant functions of the resuscitator.
7.2.2 * Conveying capacity (Vdel)
The resuscitator should deliver the delivery capacity specified for the design weight, as shown in Table 1, using the given compliance and impedance values, such as
Tune, using both the given breath-in ratio and frequency. The delivery capacity range of any operator-adjustable delivery volume resuscitator shall include the specified
Weight range limit (as stated in the random file). The specific method is shown in the following table.
Compliance is checked according to the method of B.3.11.
Table 1 Requirements for transport capacity and test conditions
Parameter test conditions
Compliance/(l/hPa) 0.001 0.01 0.02
Impedance/[hPa/(l/s)].200 20 20
Breathing ratio a ± 20% 1. 1 1. 2 1. 2
Frequency a/(times/min) 60 ± 6 20 ± 2 12 ± 1
Typical descriptive name
(If used)
Specified weight or range
Gas delivery requirements under given test conditions
ml
Adult (preset volume) mb≥40kg--Vdel≥600
Adult (adjustable air volume)
mmax≥40kg
mminc
-Vdel <7 × mmax Vdel> 600
Adult/Child
mmax≥40kg
mminc
-Vdel <7 × mmax Vdel> 600
Newborn/Child
mmax
mminc≤5kg
Vdel <20 Vdel> 15 × mmin-
Newborn m≤5kg Vdel≤20--
a This setting applies only to resuscitators whose delivery capacity can be set independently.
bm is body weight, expressed in kg, specified in the instruction manual.
c Weight is specified in the instruction manual, mmin is the minimum weight, and mmax is the maximum weight. (See 8.3.2.2a).
7.2.3 * Continuity of conveying capacity
If the resuscitator is intended for patients weighing more than 40kg, then when the resuscitator is set to deliver more than 85% by volume per cycle
The oxygen and the compliance and impedance are changed according to B.3.12 (If the delivery capacity is not automatically controlled, the resuscitator settings are not changed.
Setting or manual triggering frequency), the deviation to the delivery capacity of the simulated lung should not exceed 150ml.
Compliance is checked according to the method of B.3.12.
7.2.4 Pressure limits under normal use
The pressure at the connection port of the patient should not exceed 60hPa (60cm H2O) during normal use. For specific patients, higher than 60hPa
YY 0600.5-2011/ISO 10651-5..2006
The setting of a pressure limiting device is useful, although the choice of such a setting requires your doctor's advice.
Compliance is checked according to the method of B.3.13.
7.2.5 Pressure limit under single fault conditions
The maximum pressure that can be reached at the connection port of the patient under single fault conditions should not exceed 80hPa (80cmH2O).
Simulate the relevant single fault state and check whether it meets the requirements according to the method of B.3.13.
7.2.6 * Pressure limit activation alarm signal
Means shall be provided to detect the operation of the pressure limiting device required by 7.2.4 (7.2.5 for pressure-triggered resuscitators). Due to pressure limit
The action of the control device, or when the set inspiratory pressure limit level is reached, an audible signal should be triggered to indicate the interruption of the delivery capacity.
With reference to 7.2.4 (7.2.5 for pressure-triggered resuscitators), it should not be possible to set an inspiratory pressure alarm limit based on the pressure limit method
Control exceeds the maximum allowable pressure.
Note. Transient pressure (such as coughing) from a patient cannot trigger an alarm signal.
Close the patient connection port and the controlled ventilation device that simulates the lungs according to the method of B.3.13 to check the compliance.
7.2.7 * Inspiratory flow
With a preset flow function, it is expected to be used in resuscitators for patients weighing more than 40kg (adults), when the set delivery oxygen concentration is greater than
At 85%, for free flow at atmospheric pressure and 20hPa (20cmH2O) back pressure, the suction flow rate delivered should be 25l/min ~
Between 40l/min. The adjustment range of the resuscitator with operator adjustable flow function should cover this range.
Compliance is checked by the method of B.3.14.
7.2.8 Manually triggered operation on manual circulation resuscitator
If the resuscitator provides a method of manual circulation, the operator (normal adult rescuer) should be able to operate the function with one finger while using
The International Resuscitation Guide [15] [16] recommends methods such as head-up and double-handed jaws to keep the mask sealed.
Compliance is checked according to the method of B.3.15.
7.2.9 On-demand valve
7.2.9.1 Overview
The requirements in 7.2.9.2 ~ 7.2.9.4 apply only to on-demand valves included in the resuscitator as part of the complete machine, if provided.
7.2.9.2 Threshold pressure for traffic initiation
The negative pressure at the patient connection required to initiate gas flow from the on-demand valve should be no greater than 2hPa (2cmH2O).
Perform a functional test in accordance with the method of B.3.16 to verify compliance with the requirements.
7.2.9.3 Peak inspiratory flow
In the case where the negative pressure at the patient connection port is not greater than 8hPa (8cmH2O), the minimum peak inspiratory flow should be 100l/min and
Maintain at least 2s. This flow should be reached within 250 ms.
Perform a functional test in accordance with the method of B.3.16 to verify compliance with the requirements.
7.2.9.4 Termination pressure
When the pressure at the connection port of the patient is equal to the atmospheric pressure or the positive pressure specified in the random file, the on-demand airflow should be terminated. (See 8.3.2.2q).
Perform a functional test in accordance with the method of B.3.16 to verify compliance with the requirements.
YY 0600.5-2011/ISO 10651-5..2006
7.2.10 * Patient triggered resuscitator
If the random file indicates that the function of the resuscitator or resuscitator can be triggered by the patient, then when the pressure at the patient connection port drops to
When the negative pressure is not greater than 2.5hPa (2.5cmH2O), it should be within 250ms ...
Related standard:   YY 0600.4-2013  YY 0600.1-2007
Related PDF sample:   YY/T 0506.2-2016  YY/T 0506.4-2016
   
 
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