Source: https://www.chinesestandard.net/PDF/English.aspx/YY0671.2-2011
Timestamp: 2020-08-13 03:06:40
Document Index: 433211027

Matched Legal Cases: ['art 2', 'art 2', 'art 1', 'art 1', 'art 1', 'art 1']

YY 0671.2-2011 PDF.
Chinese Standard: 'YY 0671.2-2011'
YY 0671.2-2011 English 389 Add to Cart Days<=4 Sleep apnoea breathing therapy. Part 2: Masks and application accessories Valid YY 0671.2-2011
YY 0671.2-2011 Chinese 28 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]
Standard ID YY 0671.2-2011 (YY0671.2-2011)
Description (Translated English) Sleep apnoea breathing therapy. Part 2: Masks and application accessories
Word Count Estimation 28,260
Quoted Standard GB/T 3767-1996; GB/T 4999-2003; GB 9706.1-2007; GB 9706.15-2008; GB/T 14574; GB/T 16886.10; GB/T 16886.11; GB/T 16886.1; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16; GB/T 16886.17; GB/T 16886.18; GB/T 16886.19; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.9; GB/T 19974; YY/T 0316-2008; YY/T 0466.1-2009; YY 0671.1-2009; YY/T 0753.1-2009; YY/T 0753.2-2009; YY/T 0802-2010; YY 1040.1; YY 1040.2; IEC 61672-1-2002
Adopted Standard ISO 17510-2-2007, IDT
Drafting Organization Beijing Aerospace Changfeng Co., Ltd.
Summary This standard applies to mask its fixed and is used to connect the device to treat sleep apnea patients attachments. It sets out in detail the requirements for masks and accessories, covers for any necessary connection parts, which include both sleep apnea therapy equipment interfaces and patient information are required when connecting part, including sleep apnea treatment process Use the part such as a nasal mask, the exhaust port and headband. Tetsuya stopped treatment for sleep apnea equipment requirements see YY 0671 Part 1. For YY 0671 standard two-part deals with typical components see Figure A. 1. This section does not include oral appliance requirements.
Types, such as medical electron accelerators, high-frequency surgical equipment, hospital beds, etc.
Gas port and headband.
GB 9706.1-2007 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988 Amd1..1991
YY/T 0466.1-2009 Medical devices. Symbols used for labeling, marking and providing information of medical devices. Part 1. General requirements
Note. For the sake of convenience, this standard gives a list of the source of all the terms defined in alphabetical order in Appendix L.
Note. Appendix H includes a guide to help readers find the identification and labeling requirements contained in other clauses of this part of YY 0671.
Warning of negative performance impact.
m) Provide methods to minimize the risk of repeated breathing (see 5.3).
4.2 Where applicable, identification of packaging labels, masks or accessories, and/or accompanying documents shall include the following information.
Touch to evaluate. In addition, for components and materials that are not inserted into the oral cavity or nasal cavity, airway materials should be evaluated as not in contact with the tissue. For expectation
Mask materials, including headbands, that come into contact with the patient's head should be evaluated for skin contact.
All materials should be considered as classified as persistent contact types as specified in GB/T 16886.
Note. The classification of persistent exposure is due to the cumulative use of sleep apnea devices and their accessories for longer than 30 days.
Latex should not be used on masks and accessories.
Compliance is checked by applying GB/T 16886.
5.3 * Protection against repeated breathing
Under normal conditions and single fault conditions, methods should be provided to minimize the risk of repeated breathing. Under normal conditions, at the minimum amount
At a constant pressure, 5hPa (5cmH2O) and 10hPa (10cmH2O), the relative concentration of CO2 should not increase by more than 20%. In single fault state
Under these conditions, the relative increase in CO2 concentration should not exceed 60%.
Compliance is checked by the tests described in Appendix F.
5.4 Cleaning, disinfection and sterilization
The mask and all accessories, whether used for a single patient or for repeated use of multiple patients, should be designed to maximize staining characteristics
Small and easy to clean by the operator.
Masks and all accessories, including their parts, intended for repeated use by multiple patients should be manufactured in a form that can be disinfected or disinfected.
The method of reprocessing or reprocessing of the mask should include the number of times that it can be cleaned or disinfected to indicate the expectation of the mask
In the instruction manual for the mask and all its accessories, including its components, the instructions for sterilization or reprocessing should be in accordance with
YY/T 0802 and ISO 14937 requirements. Masks marked as sterile and all their accessories shall be properly and effectively as defined in ISO 14937
Method for sterilization.
Packaging systems for non-sterile instruments should be designed so that products that need to be sterilized before use can maintain their expected cleanliness
Compliance is checked by verification of the processing method, including confirmation that the mask and all its accessories, including its parts, are still compliant after repeated processing
According to the product's characteristic description and inspection instruction manual.
5.5 * Breathing during a single failure
Means should be provided to limit the resistance to inhalation and exhalation in a single fault condition. When the flow is 50L/min, the air resistance should not exceed 10hPa
(10cmH2O)/(L/s) (measured at the patient connection port).
If an anti-asphyxia valve is provided, the opening pressure connected to the atmosphere should be less than the minimum rated pressure of the mask. Opening and closing pressure
The instructions should be listed separately.
Compliance is checked by the tests described in Appendix D and Appendix E.
5.6 Respiratory filtration
Any respiratory filtration should follow YY/T 0753.1-2009 and YY/T 0753.2-2009.
Compliance is checked by applying the requirements of YY/T 0753.1-2009 and YY/T 0753.2-2009.
The A-weighted sound power level caused by masks and accessories shall be in accordance with GB/T 14574 and GB/T 3767-1996.
Measured by the process test method and indicated in the instruction manual. Comply with GB/T 14574 and GB/T 3767- at a distance of 1m from the equipment
The A-weighted sound pressure level required in.1996 should also be indicated in the instruction manual.
Note. When measuring the mask and all accessories, it is necessary to ensure that the sound measurement is not disturbed by the noise emitted by the breathing circuit and equipment.
Compliance is checked in accordance with Annex G.
This appendix provides the rationale for the important requirements of this section.It is for those who are familiar with the main content of the standard but have not participated in the development of the standard.
Prepared. Understanding the reasons for these main requirements is important for proper application. Moreover, with the advancement of clinical practice and technology,
The required principles will assist in the revision of this section.
Figure A.1 is an example of a typical series of components of the YY 0671 standard. Can help strengthen sleep apnea treatment facilities
The combination of equipment and masks and application accessories, as well as the scope of the YY 0671 standard.
The clause numbers in this appendix are based on the corresponding national and industry standard clauses, so the numbering is discontinuous.
1 --- headband;
2--mask;
3--connector (optional);
4--patient connection port;
5 --- breathing circuit;
6 --- air outlet connector;
7 --- Sleep apnea treatment equipment with or without humidifier.
a YY 0671.2 specified range.
b YY 0671.1 specified range.
Note. The exhaust port can be located at connector 3 or mask 2.
Figure A.1 Relationship between sleep apnea treatment equipment and masks and application accessories with specified components of YY 0671
Sleep apnea therapy devices are often used in combination with masks and application accessories made by different manufacturers. However, most sleep
The respiratory therapy device is pressure adjustable at the patient end, and all connection accessories and masks are located outside the pressure control area. Therefore, these masks and
The attachment has a direct impact on the stress received by the patient. Sleep apnea treatment device benefits patients by increasing throat cross section
It is an important principle to reduce the collapse of the upper respiratory tract. Apnea therapy device for communicating to patients through masks and accessories
Hand over a cure for stress.
The air blockage of the mask and accessories connected to the sleep apnea treatment device depends on the breathing flow. Especially high inspiratory peak flow
The amount may cause a significant pressure drop between the patient's connection port and the patient's airway. As a result, the patient cannot get the pressure needed for treatment, obstruction
The probability of sexual apnea increases, and the purpose of treatment will not be achieved. Moreover, sleep apnea treatment devices rely on
The design of the stopping treatment device thus minimizes the risk of suffocation.
Awaken to avoid possible injury. Therefore, this standard extends the performance standards of sleep apnea treatment equipment to ensure delivery of treatment
Stress and prevent suffocation.
These requirements and testing methods provide users and operators with the right sleep apnea treatment equipment, face masks, accessories and attachments
Provides guidance and provides guidance on ensuring compatibility between masks and accessories and sleep breathing therapy equipment.
3.7 Sleep apnea therapy device Respiratory airway patient connection port is connected to the patient interface (such as a mask and/or application accessory) or connected to the test
Test instrument interface.
4.1c) Exhaust volume includes flow through all holes in the mask and accessories (including exhaust ports).
Exhaust volume and its pressure flow curve are important indicators of the mask, which can help medical staff evaluate the compatibility of the mask and other equipment.
The relationship between the pressure provided to the patient and the amount of exhaust should be measured and included in the label.
For the selection of curve test points, see Table K.1.
4.1l) Total air resistance of sleep apnea treatment equipment and masks and application accessories includes air resistance and mask applications before the patient interface
Attachment from the patient connection to the patient's air resistance.
The air resistance before the patient connection is defined in the YY 0671.1 device design. Mask and application from patient connection port to patient
Accessory air resistance is an important indicator to help health care workers evaluate the compatibility of masks and application accessories with other equipment.
The air resistance of the mask and application accessories changes as the flow changes, and this relationship depends on the design. Therefore, a single measurement point
is not enough. Two typical flow values should be taken at the patient connection to measure air resistance (50L/min and 100L/min).
Air resistance is provided as a pressure drop, not a calculated air resistance. The pressure drop is more useful for the user (diagnostic).
Specifying air blockage for masks and application accessories helps healthcare professionals design compatible sleep apnea treatment devices.
4.1o) Explain in detail that the inhalation resistance of the mask's anti-asphyxia valve at a very low flow rate will help medical personnel understand sleep apnea treatment
Medical equipment compatibility so that the valve closes when needed. See Appendix E.
Specifying the expiratory resistance of the mask anti-asphyxia valve will help medical staff understand the compatibility of sleep apnea treatment equipment, and
The valve closes when needed. See Appendix E.
5.3 Masks and other patient interfaces used for sleep apnea therapy should be vented without an active exhalation valve
mouth. The exhaust port is used to exhaust the exhaled gas in a passive way to minimize repeated breathing.
A key issue to consider is whether the residual exhaled CO2 in the machine-patient airflow through the exhaust port is reduced to an acceptable level
Most sleep apnea treatment equipment is equipped with a single circuit air path to achieve a dual purpose, namely to achieve the inspiratory/exhaling function and serve as
exhaust vent. The problem of CO2 rebreathing will be a function of several variables. Such as.
--- the type of breathing accessory --- mask, nasal mask, full face mask or nasal congestion;
--- the size and location of the exhaust port;
--- average flow rate at minimum CPAP pressure;
Note. Refer to Appendix K for the measurement method of average flow rate, and record it in Table K.1 for medical personnel to evaluate the potential risk of repeated breathing.
--- During patient exhalation.
If the design and location of the exhaust port is not appropriate, there is a great potential risk for clinically significant CO2 rebreathing. because
Therefore, the design and construction of sleep apnea treatment equipment and its masks and accessories have an important impact on CO2 rebreathing, which in turn affects
Inhaled oxygen concentration.
The industry's largest recommended time-weighted average of CO2 inhalation is 1%. 1% CO2 inhalation will increase the test pressure in Appendix F
Force of 1013.25Pa, and will lead to test results of 1013.25Pa 5066.25Pa or 6079.5Pa. This indicates an increase in CO2 content
Based on this, the Commission chose a 20% increase in CO2 content as a limit. Similarly, limiting the increase in CO2 content in a single fault condition is
60% indicates a time-weighted amount of CO2 inhalation of 3%.
5.5 When sleep apnea therapy equipment stops providing airflow, for patient safety, the mask and its accessories need to have the following characteristics.
--- When only the patient's breathing air flows through the mask, enough CO2 can be taken away to achieve an acceptable level of repeated breathing. see
--- Limit the inhalation and exhalation resistance to an acceptable range.
One way to meet the above requirements is to provide an anti-asphyxia valve while providing the exhaust port. To prevent suffocation under normal conditions
The effect of the valve will not weaken the effect of the mask, which should have the following characteristics.
--- Closing pressure. The anti-asphyxia valve needs to be closed under the proper pressure to ensure the treatment for the patient;
--- Opening pressure. The anti-asphyxia valve needs to be opened at a suitable pressure to ensure that the patient's inspiratory and expiratory resistance is safe, and
Provide safe repetitive breathing levels when not being treated;
--- Anti-open during normal use. In order to ensure that the treatment is provided to the patient, the anti-asphyxia valve should be maintained while the sleep apnea treatment device is running.
Exhaust airflow test procedure
The purpose of this test is to determine the relationship between the pressure provided to the patient and the measured exhaust flow.
1 --- tested masks and accessories;
2 --- patient connection port;
3--flow source;
4 --- manometer;
5 --- Flowmeter.
a Exhaust flow.
b Intake air flow.
Figure B.1 Exhaust air flow test equipment installation
Follow these requirements.
a) Install the mask or accessories and test equipment as shown in Figure B.1.
b) To measure only the exhaust flow, ensure that the test instrument meets the following requirements.
--- Exclude the influence of the flow source (3) in the measurement system (from the flow generator to the patient connection port) (for example. the flow meter can be placed in the
On the patient connection port);
--- Place the flow meter (5) at the patient connection (2);
--- Close the interface between the mask and the patient to exclude the influence of the flow source (3) at the patient interface. Ensure that the patient interface is sealed.
c) In order to measure the pressure applied to the patient, ensure that the pressure sensor measures the pressure next to the patient's nose/mouth.
d) Adjust the flow rate to the minimum value of the rated pressure range and measure the flow rate at this time.
e) Repeat the steps from b) to d) at 1/4, 1/2, 3/4 of the rated pressure range (rounded to the nearest decimal place) and the maximum rated pressure point.
Air resistance (pressure drop)
The purpose of this test is to measure the pressure drop from the patient connection port to the patient at a flow rate of 50L/min and 100L/min.
4--manometer 2;
5 --- manometer 1;
6 --- Flowmeter.
a Airflow to the atmosphere.
b Exhaust flow.
c Intake air flow.
Figure C.1 Test device for air resistance (pressure drop)
Perform the test as follows.
a) Install the mask or accessory and instrument as shown in Figure C.1. If necessary, open the patient end to the atmosphere to reach the set flow rate.
b) The first pressure test point is located at the patient connection port, and the second pressure test point is next to the patient's nose/mouth.
c) Adjust the flow rate to 50L/min, measure the pressure drop (pressure gauge 1 minus pressure of pressure gauge 2), expressed in hPa (cmH2O).
d) Repeat steps b) and c) at a flow rate of 100 L/min.
Anti-asphyxia valve pressure test
The purpose of this test is.
--- Determine the pressure when the anti-asphyxia valve is opened and connected to the atmosphere;
--- Measure the pressure when the anti-asphyxia valve is closed and disconnected from the atmosphere.
This test is designed to assess those who limit breathing resistance and avoid excessive repetitive breathing if the sleep apnea treatment device does not have enough airflow
Some safe ways.
The pressure when the anti-asphyxia valve is opened and connected to the atmosphere should be lower than the minimum rated pressure of the sleep apnea treatment device.
Note. If the pressure when the anti-asphyxia valve is opened and connected to the atmosphere is not lower than the minimum rated pressure of the sleep breathing therapy device, the anti-asphyxia valve will be invalid.
D.2 Opening pressure
Perform the opening test as follows.
a) Install a test device as shown in Figure D.1 to generate airflow in the breathing gas path, while ensuring that the anti-asphyxia valve is closed and the atmosphere
b) Slowly reduce the flow from the flow source until the anti-asphyxia valve is activated and begins to open.
c) Record the mask pressure when the anti-asphyxia valve begins to open.
1 --- tested anti-asphyxia valve;
a Anti-asphyxia valve flow.
Figure D.1 Determination of opening pressure and closing pressure of anti-asphyxia valve
D.3 Closing pressure
Perform the shutdown test as follows.
a) As shown in Figure D.1, air flow is generated in the breathing gas path, and at the same time, the anti-asphyxia valve (1) is opened and connected to the atmosphere.
b) Slowly increase the flow from the flow source (3) until the anti-asphyxia valve is completely closed.
c) Record the mask pressure when the anti-asphyxia valve is fully closed.
Respiration in a single failure state-determination of inspiratory and expiratory resistance
The purpose of this test is to determine the inhalation and exhalation resistance in a single fault state at a flow rate of 50 L/min, such as when the anti-asphyxia valve is open
Time (connected to the atmosphere).
a) Connect a variable pressure source capable of generating sub-atmospheric pressure to a flow measurement device (see Figure E.1).
1 --- patient connection port;
2--Tested anti-asphyxia valve;
3--air simulation head;
4--flow source;
5--manometer;
b Expiratory flow.
c Inspiratory flow.
Figure E.1 Determination of inhalation and exhalation resistance of anti-asphyxia valve
b) Connect the flow measurement device to an artificial head with an artificial airway or other suitable item that can seal the mask.
c) Connect the pressure gauge to the mask.
d) Close the patient connection port of the mask or any known flow port (such as a pressure port) on the mask that will not open during normal operation.
e) Open all normal access to air.
f) Set the variable flow rate to -50L/min.
g) Read the suction pressure at the pressure gauge.
h) Set the variable flow rate to 50L/min.
i) Read the expiratory pressure at the manometer.
CO2 repeated breathing
Considering the possibility of CO2 rebreathing, the purpose of the CO2 rebreathing test is to measure the
Effectiveness of other parts in contact with the patient.
Exhaust ports should be provided for masks used in positive airway conditions and other parts in contact with the patient without an active exhaust valve. row
The vent function is to expel the exhaled air in a passive way to minimize repeated breathing. If the exhaust vent design and placement is not appropriate,
Add the risk of clinically significant CO2 rebreathing. Because the position of the exhaust port can affect repeated breathing, only the exhaust port pressure/flow is measured
Quantitative characteristics may not be sufficient to guarantee the required performance. This test directly measures the CO2 produced during the simulated breathing process to obtain
Repeated breathing conditions for masks and other patient-contact devices in both normal and single failure conditions
F.2 Test procedure
a) Assemble the components according to Figure F.1.
Note 1. During initial installation, the mask and the simulated patient's head are not fixed.
Note 2. The simulated patient's airway between the gas sampling port and the nose/mouth of the simulated patient's head requires an internal volume of approximately 30 mL.
b) Set the parameters of the breathing simulator.
1) Tidal volume = 0.5L;
2) Frequency = 15 times/min;
3) I. E = 1. 2;
4) Sine waveform.
c) Connect the CO2 detector and the gas sampling port through the sampling tube.
d) Connect a CO2 source with a concentration greater than 99% to the lung simulator through the flow meter. Make sure the flow rate is constant.
e) Start the lung and breathing simulator while slowly increasing the airflow until the end-expiratory CO2 peak reading reaches approximately 5% (volume fraction).
Require sufficient time for the analog state to reach equilibrium and the readings to be stable.
Note. 5% (volume fraction) simulates normal metabolism of CO2 products.
1 --- Airflow source;
2 --- 1.9m ± 0.15m breathing circuit;
3--mask, if applicable, including attachments;
4 --- simulate the patient's head;
5 --- CO2 detector;
6 --- Dead space 140mL ± 5mL;
7 --- test lung simulator (driven ventilator breathing simulator);
8 --- CO2 constant flow source.
Note 1. To ensure sufficient mixing, it is recommended to use a lung with an active mixing fan and a cavity volume of approximately 10L.
Note 2. Adapted from reference [3].
Figure F.1 CO2 Repeated Breath Test Instrument
f) Record the end-expiratory CO2 concentration.
Note. A time greater than 3 times the time constant is sufficient (for example, 3 times the ratio of the volume of the lung cavity to the simulated alveolar ventilation of the lung).
g) Put the test mask on the head to simulate normal use. Confirm that the mask is completely closed between the face of the simulated patient and no intention
Outside leaks.
h) Set a pressure source to generate the minimum rated pressure of the mask including any connected parts.
i) Allow sufficient time for the simulation to reach equilibrium and stabilize the CO2 reading, and then record the end-expiratory CO2 concentration.
j) Calculate the relative CO2 increase by the percentage difference between the beginning and end CO2 concentration, for example, after 100 times the difference between i) value and f) value
Divide by the f) value.
k) Set a pressure source to generate a pressure of approximately 5 hPa (5 cmH2O).
l) Repeat e) ~ j).
m) Set a pressure source to generate a pressure of approximately 10 hPa (10 cmH2O).
n) Repeat e) ~ j).
o) Simulate the following single faults, one at a time.
--- blocked breathing circuit (simulated by blocking the patient connection port);
--- The device that generates the flow is malfunctioning (by connecting one end of the breathing circuit to the patient connection port, and the other end is open to the atmosphere
Pass to simulate).
p) Repeat e) ~ j).
a) Seal the patient end of the mask or accessory and place the mask and all accessories on the acoustically reflective surface.
b) Install the breathing circuit in accordance with the method provided or recommended by the manufacturer.
c) If the equipment provides a humidifier, the test process should include a humidifier.
d) adopt appropriate methods to isolate the sound of breathing ducts and equipment outside the test area.
The sound will not affect the sound measurement of the mask and any other accessories.
Note. Isolation should ensure that the noise from the breathing circuit and equipment or the noise from the airflow does not affect the sound measurement of the mask and accessories.
e) Set the device to a continuous pressure of 10 hPa (10 cmH2O) at the patient connection.
f) According to 7.2 of GB/T 3767-1996, draw a half radius of 1m with the geometric center of the mask and accessories as the center of the sphere.
Ball, and using a sound level meter's microphone, measure the sound pressure level at ten points on this hemisphere. The sound level meter must meet
Requirements for Class 1 equipment as specified in IEC 61672-1.
g) Calculate the A-weighted average sound pressure level of the measurement surface in accordance with 8.1 of GB/T 3767-1996.
h) Calculate A-weighted sound power level according to 8.6 of GB/T 3767-1996.
i) Ensure that the A-weighted background level of external noise is at least 6 dB lower than the measured value during the test.
j) According to the provisions of GB/T 3767-1996, use a sound level meter in the free field above the reflecting surface, and use the frequency characteristic A weighting and time
The characteristic F is weighted for measurement.
Information guide provided by the manufacturer
The manufacturer's request for information follows Chapter 4. Additional requirements are listed in Table H.1.
Table H.1 Flags
Processing or reprocessing 5.4
If provided, pressure value when anti-asphyxia valve opens to atmosphere is 5.5
If provided, anti-asphyxia valve closes to atmospheric pressure 5.5
Sound power level level 6
Sound pressure level level 6
The basic principles involved
This part of YY 0671, masks and accessories for sleep apnea treatment equipment according to ISO /T R16142 regarding safety and sexuality
Support the basic principles of performance. The purpose of this section is to make it meet the conformity assessment.
Compliance with this part of YY 0671 proves that it also complies with the specific provisions of ISO /T R16142. Other methods may also prove
Bright. The correspondence between the clauses of YY 0671 and the basic principles of ISO /T R16142 is given in Table I.1.
Table I.1 Correspondence between this part and basic principles
ISO /T R16142..2006 Basic Principles
A.1, A.2, A.3 all
A.7.1 5.2, 5.4
A.7.2 5
A.7.3 5.2, 5.4
A.7.4-Not applicable
A.7.5 5
A.7.6 5
A.8.1 5.4, 5.6
A.8.1.1-Not applicable
A.8.1.2-Not applicable
A.8.2 5.4
A.8.3 5.4
A.8.4 5.4
A.8.5 4.1e)
A.8.6 4.2d)
A.9.1 4.1c), d), l), o), 4.2c)
A.9.2 5.3, 5.5
A.9.3-Not applicable
A.10.1-Not applicable
A.10.2-Not applicable
A.10.3-Not applicable
A.11.1.1-Not applicable
A.11.2.1-Not applicable
Table l.1 (continued)
A.11.2.2-Not applicable
A.11.3.1-Not applicable
A.11.4.1-Not applicable
A.11.5.1-Not applicable
A.11.5.2-Not applicable
A.11.5.3-Not applicable
A.12.1-Not applicable
A.12.2-Not applicable
A.12.3-Not applicable
A.12.4-Not applicable
A.12.5-Not applicable
A.12..6-Not applicable
A.12.7-Not applicable
A.12.7.1-Not applicable
A.12.7.2 6
A.12.7.3 6
A.12.7.4 5.1
A.12.7.5-Not applicable
A.12.8.1 5.5
A.12.8.2 5.3, 5.5
A.12.8.3-Not applicable
A.13.1 4
A.14.1-
The masks and accessories of sleep apnea treatment equipment affect the environment mainly through the following events.
--- The normal use process has an impact on the local environment;
--- Consumable use, cleaning and disposal during testing and normal use;
--- Scrap at the end of the product life cycle.
In order to emphasize the importance of reducing the environmental burden, this section puts forward the following requirements and recommendations to reduce the importance of masks and accessories at different stages.
Environmental impact caused by the above aspects.
The corresponding relationship between the life cycle of the mask and accessories of the sleep breathing therapy equipment on the environment is shown in Table J.1.
Table J.1 YY 0671 Environmental provisions of this section
Distribution (including packaging)
1 Resource usage----
2 Energy consumption----
3 Air emissions--
4.1n)
4.1p)
4 Water discharge 5.4-4.1e) 4.1e)
5 Waste 5.4-
6 Noise 6-6-
7 Introduction of hazardous substances 5.2-5.2 5.2
8 Soil Impact---4.1n)
---4.1n)
Maximum flow velocity measurement method
Test the maximum flow rate method.
a) Connect a breathing tube with a length of 1.9m ± 0.15m to the sleep apnea device;
b) Connect a pressure measuring device and flow meter to the patient connection port;
c) adding an adjustable valve to the patient connection;
d) Set the pressure to its minimum setting value pmin, and open the adjustable valve until the measured pressure value is lower than the pressure setting value 1hPa ±
0.1hPa. Read out the corresponding measured pressure value and flow rate value;
e) Repeat step d) 10 times and record the average of the 10 measurements;
f) repeat step e) according to the pressure requirements mentioned in Table K.1;
g) Record the results in Form K.1.
Table K.1 Performance of Sleep Apnea Apnea Therapy Device at Set Pressure
1/4 (pmax-pmin)
1/2 (pmax-pmin)
3/4 (pmax-pmin)
At the patient connection
Measured pressure/hPa
Measured average flow rate/(L/min)
Terminology --- Index of terms defined alphabetically
Annex GB 9706.1-2007, 2.1.3
Random file GB 9706.1-2007, 2.1.4
Anti-asphyxia valve 3.1
Bi-level positive airway pressure equipment YY 0671.1-2009, 2.101
Respiratory airway ISO 17510-1..2007, 3.3
Respiratory system filter YY/T 0753.2-2009,3.1
Ventilation pipe GB/T 4999-2003, 4.1.2
Cleaning YY/T 0802-2010, 2.2
Disinfection YY/T 0802-2010, 2.3
Equipment GB 9706.1-2007, 2.2.11
Exhaust flow 3.2
Exhaust port GB/T 4999-2003, 4.2.1.6
Fresh gas outlet GB/T 4999-2003, 3.2.8
Headband 3.3
Mask 3.4
Medical electrical equipment GB 9706.1-2007, 2.2.15
Medical electrical system GB 9706.15-2008, 2.203
Multiple patients reuse 3.5
Normal state GB 9706.1-2007, 2.10.7
Normal use GB 9706.1-2007, 2.10.8
Operator GB 9706.1-2007, 2.12.17
Oral appliance 3.6
Patient GB 9706.1-2007, 2.12.4
Patient connection port 3.7
Patient environment GB 9706.15-2008, 2.204
Handle YY/T 0802-2010, 2.6
Rated GB 9706.1-2007, 2.12.8
Repeated breathing GB/T 4999-2003, 4.1.4
Risk YY 0316-2008, 2.13
Automatic adjustment ISO 17510-1..2007, 3.6
Single fault state GB 9706.1-2007, 2.10.11
Single patient reuse 3.8
Sleep apnea treatment equipment YY 0671.1-2009, 2.117
User GB 9706.1-2007, 2.12.13
[1] ISO /T R16142, Medicaldevices-Guidanceontheselectionofstandardsinsupportof
recognizedessentialprinciplesofsafetyandperformanceofmedicaldevices
[2] AAMITIRNo. 12-1994, Designing, Testing and Labeling ReusableMedicalDevicesfor
ReprocessinginHealthCareFacilities, AGuideforDeviceManufacturers
[3] ASTMF1246-91..2005, StandardSpecificationforElectricallyPoweredHomeCareVent-
ilators, Part 1. Positive-PressureVentilatorsandVentilatorCircuits
[4] FARRE, R., MONTSERRAT, JM, BALLESTER, E.andNAVAJAS, D.Potential
RebreathingAfterContinuousPositiveAirwayPressureFailureDuringSleep, Chest, 121, pp186-
200,.2002
[5] GUILHERME, PP, SCHETTINO, SC, HESS, DRandKACMAREK, R, M.Posi-
tionofexhalationportandmaskdesignaffectCO2rebreathingduringnon-invasivepositivepressure
ventilation, CritCareMed31 (8), pp2178-2182,.2003
Related standard: YY 0671.1-2009 YY/T 0339-2019
Related PDF sample: YY 0671.1-2009 YY/T 0506.4-2016