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YY 0600.3-2007

Chinese Standard: 'YY 0600.3-2007'
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YY 0600.3-2007English649 Add to Cart Days<=5 Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 3: Emergency and transport ventilators Valid YY 0600.3-2007
YY 0600.3-2007Chinese22 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID YY 0600.3-2007 (YY0600.3-2007)
Description (Translated English) Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 3: Emergency and transport ventilators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 27,284
Date of Issue 2007-01-31
Date of Implementation 2008-02-01
Quoted Standard GB/T 2423.6-1995; GB/T 2423.8-1995; GB/T 2423.10-1995; GB/T 4999-2003; GB/T 5332-1985; GB 7144-1999; GB 9706.1; GB 9706.28-2006; YY 0461-2003; YY 0505-2005; YY 0574.1-2005; YY 0574.2-2005; YY 1040.1-2003; ISO 5356-2-1987; ISO 5359-1989; ISO 5362-1986; ISO 9170-1990; IEC 68-8-36
Adopted Standard ISO 10651-3-1997, MOD
Drafting Organization Beijing Science and Technology Development Co., Ltd. Yi Metroplex
Administrative Organization National Standardization Technical Committee of Anaesthetic and respiratory equipment
Regulation (derived from) Chinese industry standards for record 2007 of 4 (total of 88)
Summary This standard specifies in case of emergency and patient transport used when the portable ventilator requirements. This section is based on GB 9706. 1 "Medical electrical equipment Part 1: General requirements for safety, " the specific standard. As the 1. 3 GB 9706. 1 expressed, the requirements of this than the relevant requirements of GB 9706. 1 more effective. If this part of the statement of GB 9706. 1 certain conditions apply, it refers only to the terms of the demands made by the considered first aid and the use of ventilator-associated transfer when applicable. This section and GB 9706. 28 "Medical electrical equipment Part 2: Safety requirements for treatment of ventilator ventilator" There is a common requirement. GB 9706. 1-2007 given in Chapter 1 Scope and purpose are applicable. First aid and transferred using a portable ventilator (hereinafter referred to as "breathing machine") is often installed in ambulances or other emergency vehicles, but also outside of the vehicle must be used by the operator or other personnel onboard the occasion. These devices are often highly trained personnel to varying degrees outside the hospital or home use. This section also applies to be permanently installed in the ambulance or aircraft ventilator. This section does not apply artificial respiration (such as artificial resuscitator).

YY 0600.3-2007
Lung ventilators for medical use.Particular requirements for basic safety and essential performance.Part 3. Emergency and transport ventilators
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 060.3-2007
Medical ventilator
Specific requirements for basic safety and main performance
Part 3. Respirators for emergency and transport
(ISO 10551-3..1997, MOD)
2007-01-31 released
2008-02-01 implementation
Published by the State Food and Drug Administration
Contents
Foreword III
Introduction IV
First article overview 1
1 Scope 1
2 Terms and definitions 2
3 General requirements 3
4 General requirements for testing 3
5 Classification 3
6 Identification, marking and documentation 3
7 Input power 6
Part II Environmental Conditions 6
8 Basic safety type 6
9 Removable protective device 6
10 Environmental Conditions 6
11 Not used 6
12 Not used 6
Chapter III Protection against electric shock hazards 7
13 Overview 7
14 Requirements for classification 7
15 Limitation of Voltage and/or Energy 7
16 Housing and protective cover 7
17 Isolation 7
18 Protective earth, functional earth and potential equalization 7
19 Continuous leakage current and patient auxiliary current 7
20 Dielectric strength 7
Chapter 4 Protection against Mechanical Hazards 7
21 Mechanical strength 7
222 Moving parts 8
23 Faces, corners and edges 8
24 Stability during normal use 8
25 Splash 8
26 Vibration and noise 8
27 Pneumatic and Hydraulic Power 8
28 Hanging objects 8
Chapter 5 Protection against Unwanted or Excessive Radiation Hazards 8
29 X-Ray Radiation 8
30 α, β, γ, neutron radiation and other particle radiation 9
31 microwave radiation 9
YY 060.3-2007
32 Light radiation (including laser radiation) 9
33 Infrared radiation 9
34 ultraviolet radiation 9
35 sound energy (including ultrasound) 9
36 Electromagnetic Compatibility 9
Chapter 6 Protection against the danger of ignition of flammable anesthetic mixtures 9
37 Location and basic requirements 9
38 mark, random file 9
39 Common requirements for AP and APG equipment 9
40 Requirements and tests for AP-type equipment and its parts and components
41 Requirements and tests for APG-type equipment and its parts and components
Chapter 7 Protection against overtemperature and other dangers 10
42 over temperature 10
43 fire protection 10
44 Overflow, liquid spill, leak, dampness, ingress of liquid, cleaning, disinfection and sterilization
45 Pressure vessels and pressure parts 10
46 Human error 10
47 electrostatic charge 11
48 Materials for application parts in contact with the patient's body 11
49 Power supply interruption 11
Chapter 8 Accuracy of Work Data and Prevention of Dangerous Outputs 11
50 Accuracy of working data 11
51 Prevention of Dangerous Outputs 11
Chapter IX Abnormal Operation and Failure State; Environmental Test 13
52 Abnormal operation and fault status 13
53 Environmental Test 13
Chapter 10 Structural Requirements 13
54 Overview 13
55 Housing and cover 14
56 Components and Assemblies 14
57 network power supply parts, components and wiring 15
58 Protective Earth --- Terminals and Connections 15
59 Structure and wiring 15
Appendix 16
Appendix AA (Informative) Basic Principles 16
Appendix BB (informative) Reference 19
Appendix CC (informative appendix) The chapter number in this part is compared with ISO 10651-3..1997 chapter number
YY 060.3-2007
Foreword
The general title of Y600 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. Respirators for emergency and transport.
Other parts of Y600 will be formulated one after another.
--- Part 4. artificial breathing equipment;
--- Part 5. Pneumatic first aid resuscitation equipment.
This part is the third part of Y0600. It is modified to adopt the international standard ISO 10651-3..1997 "Medical ventilator --- Part 3.
Specific requirements for ventilator for emergency and transfer ", the main differences between this part and ISO 10651-3..1997 are as follows.
--- This section adjusts ISO 10651-2..2004 Chapter 2 "Normative Reference Documents" to 1.101; Chapter 3 "Terms and Definitions"
Adjusted to Chapter 2, consistent with the general standard number;
--- Article 10.2.1a) The ambient temperature range is modified to "unless stated otherwise by the manufacturer, the ambient temperature range is -18 ° C to + 50 ° C".
The main reason for revising this article is that it is difficult to implement this article at the current domestic level, but it is not appropriate to modify the original standard technology.
Technical parameters, so be sure to add "unless otherwise specified by the manufacturer" in this clause;
--- Article 36.202.2.1 was amended to "Unless the manufacturer indicates otherwise, the level will be changed from 3V/m to 30V/m". This article is amended
The main reason is that the original standard requires an order of magnitude greater than general medical device products, making it difficult to achieve at the current domestic level.
Large, but it is not appropriate to modify the technical parameters of the original standard, so it is determined to add "unless stated otherwise by the manufacturer" in this clause
Expression.
This section is based on GB 9706.1-2007 (IEC 60601-1. 1988 + Amd1..1991 + Amd2..1995, IDT) "Medical Electrical
Equipment Part 1. Special requirements for general safety requirements (common standards), used in conjunction with GB 97.16.1, and with GB 976.1-
2007 (IEC 60601-1. 1988 + Amd1..1991 + Amd2..1995, IDT) was implemented in the same period.
Chapter 36 of this part is juxtaposed with Z05505-2005 "Medical Electrical Equipment Part 1-2. General Safety Requirements
Standard. Electromagnetic Compatibility-Requirements and Tests "implemented concurrently.
Appendix AA, Appendix BB, and Appendix CC of this section are informative appendices.
This part is proposed and managed by the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment.
This section was drafted. Beijing Yi'an Meida Technology Development Co., Ltd., Shanghai Dräger Medical Devices Co., Ltd.
The main drafters of this section. Li Yunfei, Ding Deping, Deng Yongru, Li Li.
YY 060.3-2007
introduction
This part of the Q600 is specific requirements for portable ventilator for emergency and transport. These devices must meet breathing
Machine definitions (automatically augmenting or providing ventilation to a patient's lungs), but they are more often medically trained by people with varying degrees of training
Out-of-hospital or home use.
This part of Y600 is a special standard based on GB 9701.1 "Medical Electrical Equipment Part 1. General Safety Requirements."
GB 970.1 is referred to herein as the "common standard." Common standards are all used or monitored by qualified personnel in general medical and patient environments
The basic standard for the safety of medical electrical equipment, it also includes some requirements for reliable operation to ensure safety.
Common standards are used in combination with side-by-side and proprietary standards. Tiered standards include special technical and/or hazardous requirements and apply to all
There are application equipment, such as medical systems, EMC, radiation protection for diagnostic X-ray equipment, software, etc. Specific standards apply to special equipment types, such as
Such as medical electron accelerator, high frequency electric knife, hospital bed and so on.
For a description of the parallel and special standards, see GB 9.76.1-2007 in Chapter 1.5 and Chapter A2, respectively.
The numbering of chapters, chapters, and articles in this part of Y0600 is consistent with the general standards. Changes to the text of the General Standard and supplements to the Parallel Standard
Charge, specified by using the following words.
--- "Replace" means that the chapter or section of the general standard is completely replaced by the text of this section.
--- "Additional" means that the relevant text in this section is new content (for example, bar, column item, note, table, figure) attached to the general standard.
--- "Modified" means that the existing content of the general standard has been partially modified.
In order to avoid confusion with the revised version of the General Standard itself, the chapters, bars, tables and figures added to this part of Q6000 are numbered starting from 101;
The supplementary columns are numbered by the letters aa) and bb); the supplementary appendixes are numbered by AA, BB, etc.
The clauses marked with an asterisk () in this section are described in Appendix AA.
YY 060.3-2007
Medical ventilator
Specific requirements for basic safety and main performance
Part 3. Respirators for emergency and transport
First overview
1 Scope
Note. See instructions in Appendix AA.
This section is a special standard based on GB 97.16.1 "Medical Electrical Equipment-Part 1. General Safety Requirements". As in GB 970.1
As stated in 1.3, the requirements of this section are more effective than the relevant requirements of GB 9706.1. If GB 97016.1 is declared in this section
The application of a provision means that the provision applies only if the request made is relevant to the ventilator for emergency and transport in question.
This section has common features with GB 9706.28 "Medical Electrical Equipment Part 2. Ventilator Safety Specific Requirements Treatment Ventilator"
Claim.
The scope and purpose given in Chapter 1 of GB 970.1-2007 are applicable, but 1.1 shall be modified as follows.
This section specifies requirements for portable ventilators used in emergency situations and when transporting patients. Emergency breathing and transport portable breathing
(Hereinafter referred to as "ventilator") is often installed in ambulances or other rescue vehicles, but it is also often used outside the vehicle and must be operated by
Occasions where personnel or other persons carry them. These devices are often used outside the hospital or at home by trained personnel. this
Some also apply to ventilators that are fixedly mounted on ambulances or aircraft.
This section does not apply to artificial respirators (such as artificial resuscitators).
1.101 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this section. For dated references,
All subsequent amendments (excluding errata) or revisions are not applicable to this standard, however, it is encouraged to reach agreement in accordance with this section
The parties studied whether the latest versions of these documents could be used. For undated references, the latest edition applies to this section.
GB/T 243.6-1995 Environmental test for electric and electronic products Part 2. Test method Test Eb and guidelines Collision
(IEC 68-2-29. 1987, IDT)
GB/T 243.8-1995 Environmental test for electric and electronic products Part 2. Test method test Ed Free fall
(IEC 68-2-2..1990, IDT)
GB/T 2423.10-1995 Environmental test for electric and electronic products Part 2. Test method Test Fc and guideline vibration
(Sine) (IEC 68-2-6. 1982, IDT)
GB/T.1999-2003 Terms for Anesthesia and Respiratory Equipment (ISO 4135..2001, IDT)
GB/T 5332-1985 Test method for ignition temperature of flammable liquids and gases (IEC 61979-4. 1975, EZV)
GB 7144-1999 cylinder color code
GB 97016.1 Medical electrical equipment Part 1. General safety requirements (GB 9706.1-2007, IEC 60601-1. 1988+
Amd1..1991 + Amd2..1995, IDT)
GB 9706.28-2006 Medical electrical equipment. Part 2. Special requirements for ventilator safety. Therapeutic ventilator (IEC 60601- 2-
12..2001, MOD)
YY0461-2003 Breathing circuit for anesthesia machine and ventilator (ISO 5367..2000, IDT)
YY0555-2005 Medical electrical equipment Part 1-2. General requirements for safety and safety Standards EMC requirements and tests
Inspection (IEC 60601-1-2..2001, IDT)
YY 060.3-2007
YY0574.1-2005 Alarm signals for anesthesia and respiratory care Part 1. Visual alarm signals (ISO 9703-1..1992, IDT)
YY 054.2-2005 Alarm signals for anesthesia and respiratory care Part 2. Audible alarm signals (ISO 9703-2..1992, IDT)
YY1040.1-2003 Conical joints for anesthesia and breathing equipment-Part 1. Taper head and sleeve (ISO 5356-1..1996, IDT)
ISO 5356-2. 1987 Conical connection devices for anesthesia and breathing equipment. Part 2. Load-bearing threaded connection devices
ISO 5359. 1989 Low-pressure flexible connecting parts for medical gas systems
ISO 5362. 1986 Anesthesia Airbag
ISO 9170..1990 Terminal devices for medical gas piping systems
IEC 68-2-2-36 Environmental test for electric and electronic products --- Part 2. Test method --- Test Fdb. Broadband random vibration ---
Medium reproducibility
2 Terms and definitions
Except for the following definitions, 1.3 of GB 9706.28-2006 and Chapter 2 of GB 9706.1-2007 apply.
The definition in 2.1.5 of GB 970.1 should be modified as follows.
2.1.5 
The breathing apparatus is connected to the patient or any part of the respiratory system.
Part of the equipment, during normal use.
--- The part in which the function must be in direct contact with the patient, or
--- the part that may be used to contact the patient; or
--- need to be touched by the patient, or
--- All parts that can be connected to the respiratory ventilation system.
Note. See instructions in Appendix AA.
The definition in GB 9.706.28-2007, 1.19 should be amended to.
1.3.19
Gas inlet with a pressure greater than 500kPa.
Note. Please pay attention to the definition in GB/T 4999.
The following definitions also apply.
2.101
It is mainly used for portable ventilator for respiratory rescue outside the hospital.
2.102
Equipment for reducing bacteria and particles in gas systems.
2.103
Related to infants weighing less than 5kg.
2.104
Passive portable medical equipment that provides breathing for patients with impaired breathing in emergency situations.
2.105
It is related to children weighing between 5kg and 40kg.
YY 060.3-2007
2.106
A ventilator for transporting to and from a hospital and between patients.
3 General requirements
GB 970.1-2007 Chapter 3 applies and adds the following.
All parts of the ventilator should be designed and manufactured in such a way that substances filtered out or leaked from the device bring health to the patient when the device is in use
The risk is minimized.
increase.
3.6 犪 犪) The applicable single fault conditions include.
a) Open or short circuits or circuits that cause temperature rise (see Chapter 7).
b) Output errors caused by software errors.
Note. See also 54.1.
3.6 犫 犫) Illumination of 215 lx shall be provided. The measurement of environmental illuminance should be completed by the control board facing the measuring subject. Inspector
The visual acuity (or corrected visual acuity) of the operator reached 5.0.
4 General requirements for testing
GB 9706.1-2007 Chapter 4 applies.
5 classification
Chapter 9 of GB 970.1-2007 is applicable.
Note. A ventilator may have different types of application parts.
6 Identification, marking and documentation
Chapter 9 of GB 970.1-2007 is applicable, and the following contents are added and modified.
If applicable, the address of the manufacturer and/or authorized representative should also be marked.
Add the following clause after 6.1 (i).
6.1)) Any element that is sensitive to the direction of the airflow (except that the direction of flow can be exchanged) shall be accessible to
The pieces are marked with clear, easy-to-read and permanently attached arrows indicating the direction of the airflow.
6.1 犫 犫) All high-pressure gas input ports shall be marked with the gas name or gas symbol and pressure range of the gas in accordance with GB 7144.
And maximum flow requirements.
6.1 犮 犮) If there is an interface accessible to the operator, the interface shall be marked. The following terms should be at least Chinese or operator
Marked in mother tongue. In addition, the symbols listed and explained in the instruction manual can also be used.
1) Drive gas input port. marked with the text "drive gas input".
2) Fresh gas suction port. marked with the text "Fresh gas suction".
3) Emergency air intake. marked with the text "Warning. Emergency air intake-blocking is strictly prohibited".
4) Manual ventilation port. marked with the text "airbag".
5) Air outlet. marked with the text "Air Out".
6) Air return port. marked with the text "Air Return".
7) Exhaust port. marked with the text "Exhaust".
8) Pressure measurement port. marked with the text "pressure measurement" and marked with easy-to-read arrows.
YY 060.3-2007
Electronic display such as CRT.
1) Special storage and/or operation instructions;
2) Special instructions for use;
3) any special warnings and/or warnings related to the direct operation of the ventilator;
4) The specified weight range of the ventilator is applicable.
1) Description of contents;
2) "SINGLE USE ONLY", "NO USE USE", or
The symbol 3.2 in Y0466-2003;
3) If applicable, "Sterile" or any of the symbols 3.20 to 3.24 in Y0466-2003;
4) the names or trademarks and addresses of manufacturers, suppliers and authorized representatives;
5) Recommended cleaning, disinfection and sterilization methods;
6) Type identification, or symbol 3.15 in Z046.6-2003;
7) batch or serial number identification, or the symbol 3.14 or 3.16 in Z046.6-2003;
8) The weight of the ventilator and any accompanying equipment (such as cylinders, batteries, regulators, packing boxes, etc.).
Note. The recommended use of some breathing accessories can be included in the instruction manual.
Period of use.
6.8.2 i) Add the following.
The instruction manual should be attached as follows.
1) Expected working hours and working environment
a) If the ventilator is equipped with an internal power supply, the ventilator shall meet the requirements specified by the manufacturer under normal conditions of use.
Minimum working hours of the indicator;
b) in the case of a pneumatic ventilator, the range of air pressure to be supplied (see 10.2);
c) If the ventilator is equipped with a backup power source, the function of the ventilator after the switch to the backup power source should be described.
2) Unless the introduction of air can be prevented, the use of a ventilator in a hazardous or explosive atmosphere should be given.
Methods, including warning users that if the ventilator is not tightly sealed, it is dangerous to use it in a contaminated air environment
of. If available, the manufacturer should explain how to avoid mixing in or inhaling air, such as using a filter.
3) Before connecting the respiratory system to the patient, test the following alarms.
a) high voltage alarm;
b) breathing circuit integrity alarm (if provided);
c) power failure alarm;
d) High and low oxygen alarms (if provided).
4) Applicable scope of ventilator (for example, adult, newborn, weight range);
5) If the ventilator is equipped with a gas mixing system, the manufacturer should provide the necessary information for safe operation;
6) Recommendations on the use of alternative breathing methods.
Instructions for use should provide methods for cleaning or disinfecting the patient or the delivery part of the breathing gas.
6.8.3 i) Add the following.
YY 060.3-2007
The given requirements apply while adding the following.
Unless otherwise stated, all parameters are considered to have been proposed at ambient temperature and drying pressure (ATPP) conditions. If appropriate
The technical description should be appended as follows.
1) The following pressure information.
--- The range of volume values where the maximum working pressure is established and methods to ensure the maximum working pressure (eg pressure cycles, limits
pressure);
--- State whether negative pressure (less than atmospheric pressure) can be obtained during the exhalation phase. If there is a device that provides negative pressure during the exhalation phase, such as
Applicable, the extreme and generated pressures in the exhalation and inspiratory phases should be listed;
--- The volume range where the minimum working pressure is established and the method to ensure the minimum working pressure.
2) The range of the following parameters (if adjusted or adjusted in advance to a value greater than the ambient pressure).
--- circulating pressure;
--- end-expiratory pressure;
--- Provided oxygen concentration.
3) A description of the trigger method.
4) The purpose, type, range and sensor position of all measurement and display devices, whether integrated on the ventilator or controlled
Manufacturer recommends use on ventilator.
5) All the conditions (such as ATPD, BTPS) corresponding to the flow rate, volume, and ventilation volume measured or displayed and the corresponding sensors in the air
The condition and composition of the body, so that the displayed information meets the accuracy requirements specified in 51.9.
6) For the alarm used by the emergency ventilator, the type, performance, alarm detection principle, missed or delayed report of the alarm should be described
(If applicable), and battery life expectancy and appropriate backup batteries.
7) The size and type of the battery, how to replace the battery and precautions.
8) The internal volume recommended by the manufacturer for breathing accessories or other components placed between the patient connection and the patient. As used
The user requests that the manufacturers of these components should disclose their testing methods.
9) The instruction manual should include the entire ventilator breathing system (including all breathing accessories or other parts recommended by the manufacturer).
Components such as humidifiers or microbiological filters), compliance, internal capacity and other performance indicators, and
Distinguishing marks of the respiratory system components of the crew. Inhalation and exhalation resistance should be in accordance with the corresponding adult 60L/min, children
A flow rate of 30 L/min and neonatal 5 L/min was used. It should also be stated that the operator must ensure that
The breathing accessories or other components fully comply with the provisions of 56.16, and the above specified values will not be exceeded.
10) Where applicable, the performance of the microbial filter shall be indicated.
11) Pneumatic schematics and schematics of each ventilator breathing system (provided by the supplier or recommended by the manufacturer).
12) Explain in detail each restriction condition in accordance with the order of the internal components of the ventilator's breathing system, such as where the airflow direction exists
Sensitive parts.
13) Interdependence of control devices.
14) Indicate the accuracy, deviation, range of displayed value and accuracy index of the calibrated control device.
Note. The accuracy index should use the maximum zero error (the appropriate unit can be directly used) plus the sensitivity error (such as the percentage of the read value can be used)
Form to express. Principle description. If the variable passes the zero point or covers a range, it needs to be expressed by zero error plus sensitivity error.
The value is only a fraction of the maximum.
15) Explain how the tidal volume or minute ventilation and oxygen concentration provided are affected by the barometric pressure at the patient connection. particular
It should be given that when the average pressure is 0.5 kPa, 1.5 kPa, 3.0 kPa, and 6.0 kPa, these parameters are calibrated or given.
The maximum offset of the setting value.
16) When the gas cylinder is filled to the rated pressure and the ventilator is operating under normal settings, the approximate time that the gas can be supplied can be expressed by
YY 060.3-2007
Time/liter capacity "to indicate the need to indicate the selected pressure value and ventilator setting conditions.
Add the following clause after 6.8.3 d).
The manufacturer should declare that when the environment or gas supply conditions are outside the range allowed in Chapter 10 (change one parameter at a time while other parameters remain
How the ventilator will respond within the range given in Chapter 10 and under the conditions given by the manufacturer).
The ventilator treats patients and operates when environmental or supply conditions
There should be no potential safety hazards.
Note. The ventilator may continue to operate beyond the specified range of variation.
7 Input power
GB 9706.1-2007 Chapter 7 applies.
Environmental conditions
8 Basic safety types
Chapter 9 of GB 970.1-2007 is applicable.
9 removable protection device
GB 9706.1-6.1 (6) of.2007) apply.
10 Environmental conditions
GB 970.1-2007 Chapter 10 applies, and the following are added and modified.
10.2.1
a) Unless otherwise specified by the manufacturer, the ambient temperature range is -18 ° C to + 50 ° C.
b) The relative humidity ranges from 15% to 95%.
c) The atmospheric pressure ranges from 70kPa to 110kPa.
10.2.2 犪 犪) The ventilator should still function normally within the following fluctuation ranges of internal or external power supply.
--- AC voltage. -25% to + 15% of the rated value.
--- DC voltage. -15% to + 25% of the rated value.
--- AC frequency. -5% to + 5% of the rated value.
Note. Ventilator powered by an external DC power supply should be designed with noise in mind.
10.2.21 External power supply
The ventilator should maintain the calibration error within the tolerance range specified by the manufacturer.
If the ventilator is expected to be connected to a medical gas source (whether a medical gas piping system that meets the prEN737-3 standard or a prEN 73.8-
Standard pressure regulator), then it should meet and comply with the pressure range of the power source in GB 9706.28-2006.
Requirements from 280kPa to 600kPa, and guarantee that there is no potential safety hazard under a single fault condition when the input pressure reaches 1,000kPa
harm. When the pressure is 280 kPa, the weighted average of the ventilator's stable flow rate measured at the gas inlet exceeding 10s should not exceed
60mL/min. The short-term flow velocity of the air source required by the ventilator within 3s should not exceed the equivalent of.200mL/min.
10.101 The ventilator should still function normally under extreme conditions or the combined conditions declared by the manufacturer in 6.8.3e).
11 Not used
12 Not used
YY 060.3-2007
Chapter III Protection against electric shock hazards
13 Overview
GB 970.1-2007 Chapter 13 applies.
14 Requirements for classification
Chapter 14 of GB 970.1-2007 is applicable.
15 Limitation of voltage and/or energy
GB 970.1-2007 Chapter 15 applies.
16 Housing and protective cover
GB 970.1-2007 Chapter 16 applies.
17 Isolation
GB 970.1-2007 Chapter 17 applies.
18 Protective earth, functional earth, and potential equalization
GB 970.1-2007 Chapter 18 applies.
19 Continuous leakage current and patient auxiliary current
GB 97.16.1-2007 Chapter 19 applies, and the following are modified.
19.4 Test
Add the following to Article h).
Note. See also Appendix AA in this section.
Patient leakage currents should be measured at the ventilator's inlet, outlet, and other application sites as defined in this section. Besides connecting to
Except for the components on the protective ground terminal, all application parts of the same type shall be electrically connected together, and the protective ground part shall be tested separately.
20 Dielectric strength
GB 970.1-2007 Chapter 20 applies.
Chapter 4 Protection against mechanical hazards
21 mechanical strength
GB 970.1-2007 Chapter 21 applies, and the following are added and modified.
21.6 Replace the existing content with the following.
The ventilator should be able to withstand the stress caused by rude operation during the work, and should be carried out in accordance with 21.6a) to d).
test.
During and after the test, the ventilator should continue to operate within the fluctuation range specified by the manufacturer for normal operating conditions.
21.6 犪) Vibration (sinusoidal curve) in accordance with GB/T 2423.10-1995 test Fc
--- Frequency range. 10Hz ~ 1000Hz;
--- Amplitude/acceleration. 0.35mm/49m · s-2;
YY 060.3-2007
--- Number of scanning cycles. 4 times per axis;
--- Scanning speed. 1 octave/min, ± 10%.
21.6 犫) Wide-band random vibration
--- Medium reproducibility conforms to IEC 68-2-2-36 test Fdb;
--- Duration/axis/base. 30min.
21.6 犪 犪) The crash test is in accordance with GB/T 2243.6-1995 test Ed
--- Pulse duration. 6ms;
--- Number of collisions. 4,000 times;
--- Direction. vertical (the ventilator is in the normal working position).
21.6 犫 犫) The free fall test conforms to the first procedure of GB/T 243.8
--- Falling height. 0.75m;
--- Number of drops. Each of the 6 surfaces drops once.
22 moving parts
GB 970.1-2007 Chapter 22 applies.
23 faces, corners and edges
GB 970.1-2007 Chapter 23 applies.
24 Stability during normal use
GB 970.1-2007 Chapter 24 applies.
25 spatter
GB 970.1-2007 Chapter 25 applies.
26 Vibration and noise
GB 970.1-2007 Chapter 26 applies.
27 Pneumatic and hydraulic power
GB 970.1-2007 Chapter 27 applies.
28 suspension
GB 970.1-2007 Chapter 28 applies.
Chapter 5 Protection against unwanted or excessive radiation risks
29 X-ray radiation
GB 970.1-2007 Chapter 29 applies.
YY 060.3-2007
30 α, β, γ, neutron radiation and other particle radiation
GB 970.1-2007 Chapter 30 applies.
31 microwave radiation
GB 970.1-2007 Chapter 31 applies.
32 light radiation (including laser radiation)
GB 970.1-2007 Chapter 32 applies.
33 infrared radiation
GB 970.1-2007 Chapter 33 applies.
34 ultraviolet radiation
GB 970.1-2007 Chapter 34 applies.
35 sound energy (including ultrasound)
GB 970.1-2007 Chapter 35 applies.
36 electromagnetic compatibility
GB 970.1-2007 Chapter 36 applies.
36 犪 犪) The ventilator should continue to work and meet the requirements of this section when tested in accordance with YY0505-2005 as modified below, or
Can stop without causing a safety hazard.
If an unexpected situation occurs, such as display interruption, alarm, etc., the ventilator should be able to return to normal within 30 seconds after the occurrence of electromagnetic interference
run.
Note. The silence of the active status alarm should not be considered a fault.
36 犫 犫) The requirements of 0055-2005 are applicable, and the following modifications are made.
36.202.1 Change the specified test voltage to 8kV (contact discharge) and 15kV (air discharge).
When there are unexpected situations such as display interruption, alarm, and silence of activated alarm, if the ventilator resumes normal operation within 30s,
It should not be considered a malfunction.
36.202.2.1 Unless otherwise specified by the manufacturer, change the rating from 3V/m to 30V/m.
Considering the purpose of anti-radiation test, the ventilator should not be defined as connected to the patient in accordance with 2.202 of.2005-2005.
device.
Chapter 6 Protection against the danger of ignition of flammable anesthetic mixture
37 Location and basic requirements
GB 970.1-2007 Chapter 37 applies.
38 marks, random files
GB 970.1-2007 Chapter 38 applies.
39 Common requirements for AP and APG equipment
GB 970.1-2007 Chapter 39 applies.
YY 060.3-2007
40 Requirements and tests for AP-type equipment and its parts and components
GB 970.1-2007 Chapter 40 applies.
41 Requirements and tests for APG equipment and its parts and components
GB 970.1-2007 Chapter 41 applies.
Chapter 7 Protection against overtemperature and other dangers
42 over temperature
GB 970.1-2007 Chapter 42 applies.
43 fire prevention
GB 970.1-2007 Chapter 43 applies and adds the following.
43.1 In order to reduce the risk to patients, others or the environment caused by a fire, under normal and single failure conditions, combustible materials are enriched in oxygen.
Conditions must not meet the following conditions.
--- the temperature of the material is raised to its lowest ignition temperature; and
--- The presence of oxidants.
According to GB/T 5332-1985, the minimum ignition temperature is determined using the oxygen conditions that exist under normal and single fault conditions.
In the normal state and single fault state, the compliance is checked by determining the temperature rise of the material.
43.2 If sparks can occur under normal conditions and single fault conditions, the material should not ignite due to sparks under oxidizing conditions.
Compliance is checked by observing whether the material is ignited under the most unfavourable combination of normal and single fault conditions
Claim.
44 Overflow, spilled liquid, leakage, dampness, ingress of liquid, cleaning, disinfection and sterilization
GB 970.1-2007 Chapter 44 applies, and the following are modified.
44.4 Leaks
Add the following.
Emergency ventilator should be splash-proof.
44.6 Into the liquid
amend as below.
Emergency ventilator should be splash-proof. During the test specified in GB 4970-6.4.4 of.2007 and after the test, it is at 4.6a)
The emergency ventilator in this state should be able to continue to operate within the fluctuation range specified by the manufacturer for normal use conditions without generating a safety hazard.
44.7 Cleaning, disinfection and sterilization
Add the following.
Accessories and parts of the ventilator breathing system that come into contact with the exhaled breath and are intended to be reused shall be structurally removable for cleaning.
Wash, disinfect and sterilize.
45 Pressure vessels and pressure parts
GB 970.1-2007 Chapter 45 applies.
46 human error
Not adopted.
YY 060.3-2007
47 electrostatic charge
Not adopted.
48 Materials for application parts that come into contact with the patient's body
GB 970.1-2007 Chapter 48 applies.
49 Power supply interruption
GB 970.1-2007 Chapter 49 applies and amends the following.
49.101 Spontaneous breathing during energy supply interruptions
The ventilator should be designed to allow the patient to breathe spontaneously when electrical or pneumatic energy is interrupted.
During the energy interruption, the resistance of the inspiratory and air outlets should not exceed 0.6 kPa for adult patients at a flow rate of 30 L/min.
For pediatric patients, the flow rate cannot exceed 0.6 kPa at a flow rate of 15 L/min, and for neonatal patients, the flow rate cannot exceed 0.6 kPa
0.6kPa.
This test should be performed without the use of attachable accessories, otherwise the resistance to inhalation and exhalation will be affected. And manufacturers
It shall be described in the technical description in accordance with the requirements of 6.8.3 of GB 97.16.1-2007.
Means should be provided to prevent unintentional switch-off.
A ventilator used in a hazardous environment is outside the scope of this requirement.
Chapter 8 Accuracy of Work Data and Prevention of Dangerous Outputs
50 Accuracy of working data
GB 970.1-2007 Chapter 50 applies and adds the following.
50.101 Display of monitoring data
When the emergency ventilator is in normal use and tested under the working conditions given in Chapter 10, all monitoring data displays should be made at the time of manufacture.
The accuracy range specified by the supplier.
51 Prevention of Dangerous Output
GB 970.1-2007 Chapter 51 applies and adds the following.
51.101 Power failure alarm
51.101.1 Electric or pneumatic energy
When the supply of electric or pneumatic energy does not reach the value specified by the manufacturer, the energy failure alarm of the ventilator should be issued in accordance with
YY 054.2 required audible alarm signal for at least 7s.
Compliance is checked by simulating an energy supply (electrical/or pneumatic) below the required usage purpose.
51.101.2 Backup energy supply (if provided)
When the energy supply is switched (automatically or manually) to backup energy, this should be explained.
Note. Examples of backup energy supply are.
--- Replace the power grid drive with a power storage device;
--- Use gas cylinders instead of gas supply pipe drive devices;
--- When the air supply fails, use oxygen as the driving energy.
Means should be provided to enable the operator to determine the status of the backup energy source before and during its use.
51.102 Pressure limit
The maximum ultimate pressure at the connection port of the patient, whether in normal use or in a single failure state, cannot be greater than 10 kPa
(100cmH2O) or 120% of the maximum working pressure.
YY 060.3-2007
51.103 Equipment for measuring respiratory pressure
Diversion machines should provide equipment for measuring respiratory pressure. The accuracy of the values read by the operator from the equipment should be within ± (full
Within 2% of the scale reading + 8% of the actual reading).
Compliance is checked by inspection and accuracy verification.
51.104 High voltage alarm
A high-voltage alarm should be provided. When the suction pressure reaches the alarm value, an audible alarm signal should be issued.
The setting of the pressure alarm value should not be greater than the maximum limit pressure allowed by the pressure limit described in 51.6.
When performing controlled breathing tests on the test lungs (see Figure 1 and Table 1), by setting a exceeded alarm value in the respiratory system
Limit the breathing pressure, and simulate the corresponding single fault state to verify compliance.
1 --- ventilator;
2 --- the capacity measuring device to be tested;
3 --- airflow resistance;
4 --- test the lungs;
5 --- pressure sensor;
6 --- Recorder (pressure as a function of time), its accuracy is ± 2% of the actual reading value, used to verify the accuracy of the capacity measurement device;
7 --- respiratory system;
8 --- Exhalation valve.
Note. The volume measuring device (2) can be placed anywhere in the respiratory system.
Figure 1 Typical configuration of detection equipment for measuring exhaled volume
Table 1 Expiratory volume measurement conditions
Adjustable parameter
Test conditions
For pediatrics and infants
Tidal volume [T] [Measured by pressure sensor mounted on experimental lung
I/E ratio is about 1/2 or about 1/2 or about 1/2
Resistance R/kPa (L/s)-1 0.5 ± 10% 2 ± 10% 5 ± 10%
Compliance C/mL · kPa-1 500 ± 5%.200 ± 5% 10 ± 5%
Note. The accuracy of C and R applies to the entire measurement range.
51.105 Exhaled volume measuring equipment
If equipment is provided to measure exhaled tidal volume and minute ventilation, when tidal volume is greater than 100mL or minute ventilation is greater than 2L/min
The accuracy requirement should be within ± 20% of the actual reading. The accuracy when the tidal volume is less than 100mL should be in the instruction manual
Instructions.
You can verify accuracy by visual inspection and accuracy verification with the instrument shown in Figure 1.
YY 060.3-2007
51.106 Respiratory system integrity alarm
If a respiratory integrity alarm is provided, it should be able to generate an audible alarm signal in accordance with Z054.2. Should provide
The method of turning off the alarm sound is described in 51.12.
Compliance with requirements can be checked by performing a controlled breath test by disconnecting the patient connection. Operate the instrument to receive the test lung
Up and follow the instruction manual. An audible alarm should sound within 20 seconds after the connection is disconnected. If using IMV breathing method, report
The alarm delays the time between two IMV cycles, but cannot exceed 45 s.
51.107 High and low oxygen alarm
If high and low oxygen alarms are provided, they should meet the requirements of ISO 7767.
Compliance is checked by visual inspection and by a functional test that simulates oxygen concentrations above or below a preset alarm value.
51.108 Alarm
a) The manufacturer shall inform the full performance of any audible alarm. If there is a visual alarm, it shall meet the requirements of Z054.1. sound
The audible alarm shall comply with the requirements of YY574.2.
Note. The performance of the alarm should be suitable for the intended use, such as on an ambulance, between hospital departments, on a helicopter, etc.
b) The audible alarm can be muted for up to 120 seconds.
c) When performing the following tests, the visual indicator on the ventilator and its position should be clearly visible from the operator's position.
Marking and warning.
Keep the test operator at a distance of 500 mm from the ventilator. If he can correctly distinguish all the controls of the ventilator and
The indicator confirms all quantitative and qualitative information, and can see all warnings, then the test passes.
51.109 Prevention of misadjustment
Means should be provided to prevent erroneous adjustments that may produce hazardous outputs.
Note. Mechanical control techniques, such as locking, shielding, damped loading and braking, are considered appropriate methods of protection. For pressure-sensitive touch pads, capacitive touch
For switches and "soft" controllers with microprocessors, it is appropriate to develop a specific switching sequence.
Compliance is checked by inspection according to the instruction manual.
Chapter IX Abnormal Operation and Failure State; Environmental Test
52 Abnormal operation and fault conditions
GB 970.1-2007 Chapter 52 applies.
53 Environmental Test
GB 970.1-2007 Chapter 53 applies. ...
Related standard:   YY 0600.4-2013  YY 0600.5-2011
Related PDF sample:   YY/T 0506.4-2016  YY/T 0506.5-2009
   
 
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