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YY 0671.2-2011

Chinese Standard: 'YY 0671.2-2011'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0671.2-2011English389 Add to Cart Days<=4 Sleep apnoea breathing therapy. Part 2: Masks and application accessories Valid YY 0671.2-2011
YY 0671.2-2011Chinese28 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID YY 0671.2-2011 (YY0671.2-2011)
Description (Translated English) Sleep apnoea breathing therapy. Part 2: Masks and application accessories
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 28,260
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
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.
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 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.

YY 0671.2-2011
Sleep apnoea breathing therapy.Part 2. Masks and application accessories
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 0671.2-2011/ISO 17510-2..2007
Sleep apnea treatment
Part 2. Masks and application accessories
(ISO 17510-2..2007, 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 Information provided by the manufacturer 2
5 Structural requirements 4
5.1 Mask connector 4
5.2 Biocompatibility 4
5.3 * Protection against repeated breathing 4
5.4 Cleaning, disinfection and sterilization 4
5.5 * Breathing during a single failure 4
5.6 Respiratory filtration 5
6 Vibration and noise 5
Appendix A (Informative) Basic Principles 6
Appendix B (Normative Appendix) Exhaust Airflow Test Procedure 9
Appendix C (Normative) Air Resistance (Pressure Drop) 10
Appendix D (Normative) Pressure Test of Anti-asphyxia Valve 11
Appendix E (Normative Appendix) Breathing in a Single Failure State-Determination of Inspiratory and Expiratory Resistance 13
Appendix F (Normative) CO2 Repeated Breathing 14
Appendix G (Normative) Vibration and Noise 16
Appendix H (informative) Guidance for information provided by the manufacturer 17
Appendix I (Informative) Basic Principles Covered 18
Appendix J (informative) Environmental aspects 20
Appendix K (Normative Appendix) Maximum Velocity Measurement Method 21
Appendix L (Informative) Terminology-Index of Terms Defined Alphabetically 22
References 23
YY 0671.2-2011/ISO 17510-2..2007
Foreword
YY 0671 Sleep Apnea Treatment is divided into two parts.
--- Part 1. Sleep apnea treatment equipment;
--- Part 2. Masks and application accessories.
This part is Part 2 of YY 0671.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is equivalent to adopting the international standard ISO 17510-2..2007 "Sleep apnea treatment part 2. masks and application accessories" (English
Text version). Compared with ISO 17510-2..2007, this section has the following editorial changes.
--- The introduction of ISO 17510-2..2007 is transformed into the introduction of this part;
--- The ISO international standards cited in ISO 17510-2..2007, which have been adopted as national standards and industry standards, this section
Use these national standards and industry standards as normative use; if there is no corresponding adoption as national standards and industry standards,
Use quoted ISO international standards as norms;
--- Appendix CC in ISO 17510-2..2007 that refers to ISO 17510-1..2007 is directly cited in Appendix K of this section.
The original appendix K in the section has been postponed to appendix L.
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. Beijing Aerospace Changfeng Co., Ltd., Beijing Yihe Jiaye Medical Technology Co., Ltd., Shanghai Medical Devices
Testing institute.
The main drafters of this section. Qiao Li'an, Zhuang Zhi, Fu Guoqing, Zhao Pengli, Chen Xingwen, Liang Chen.
YY 0671.2-2011/ISO 17510-2..2007
introduction
Sleep apnea is a clinically significant intermittent loss of normal breathing during sleep. In recent years, with the
The awareness of the risk of stopping has increased significantly, and the use of sleep apnea treatment equipment has become more and more common. This section covers the use of equipment
Requirements for protecting patients' basic safety and primary performance.
YY 0671 is a special standard based on GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Safety Requirements",
GB 9706.1-2007 is referred to herein as the "common standard". Common standards are used or monitored by qualified personnel in the usual medical and patient environment
The basic standard of medical electrical equipment safety, 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 requirements for special technologies and/or hazards and apply
All application equipment, such as medical electrical systems, EMC, radiation protection for diagnostic X-ray equipment, software, etc. Special standards apply to special equipment
Types, such as medical electron accelerators, high-frequency surgical equipment, hospital beds, etc.
Note. For the explanation of the parallel standard and the special standard, see 1.5 and A.2. In GB 9706.1-2007, respectively.
The clauses marked with an asterisk (*) in this section are described in Appendix A.
YY 0671.2-2011/ISO 17510-2..2007
Sleep apnea treatment
Part 2. Masks and application accessories
1 Scope
This part of YY 0671 applies to the mask and its attachments and accessories used to connect sleep apnea treatment equipment to the patient. Detailed
Detail requirements for masks and accessories, covering components for any necessary connections, including both sleep apnea treatment
The patient interface of the device and the parts needed to connect with the patient, including the parts used during sleep apnea treatment, such as nasal masks, drainage
Gas port and headband.
For requirements on sleep apnea treatment equipment, see Part 1 of YY 0671. Typical of the two parts of the YY 0671 standard
For parts, see Figure A.1.
This section does not include requirements for oral appliances.
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 edition (including all amendments) applies to this document.
GB/T 3767-1996 Acoustic sound pressure method for measuring sound power levels of noise sources near the free field engineering method
(ISO 3744..1994, eqv)
GB/T 4999-2003 Anesthesia breathing equipment term (ISO 4135..2001, IDT)
GB 9706.1-2007 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988 Amd1..1991
Amd2..1995, IDT)
GB 9706.15-2008 Medical electrical equipment. Part 1-1. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems.
Seeking (IEC 60601-1-1..2000, IDT)
GB/T 14574 Identification and verification of noise emission values of acoustic machines and equipment (GB/T 14574-2000, ISO 4871..1996,
eqv)
GB/T 16886 (all parts) Biological evaluation of medical devices (all parts of ISO 10993)
GB/T.19974 Characteristics of sterilization factor of medical care products and setting, confirmation and routine control of sterilization process of medical devices
General Requirements (ISO 14937, IDT)
YY/T 0316-2008 Application of medical device risk management in medical devices (ISO 14971..2007, IDT)
YY/T 0466.1-2009 Medical devices. Symbols used for labeling, marking and providing information of medical devices. Part 1. General requirements
Seeking (ISO 15223-1..2007, IDT)
YY 0671.1-2009 Sleep apnea treatment part 1. Sleep apnea treatment equipment (ISO 17510-1..2002,
MOD)
YY/T 0753.1-2009 Respiratory filters for anesthesia and breathing. Part 1. Salt test method for evaluating filtration characteristics
(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 0802-2010 Information provided by sterilization manufacturers of medical devices for handling re-sterilizable medical devices
(ISO 17664..2004, IDT)
YY 0671.2-2011/ISO 17510-2..2007
YY 1040.1 Conical connector for anesthesia breathing equipment-Part 1. Taper head and sleeve (YY 1040.1-2003, ISO 5356-1.
(1996, IDT)
YY 1040.2 Conical joints for anaesthetic breathing equipment-Part 2. Threaded load-bearing joints (YY 1040.2-2008, ISO 5356-
2..2006, IDT)
IEC 61672-1..2002 Electroacoustics Sound Level Meters Part 1. Specifications (Electroacoustics-Soundlevelmeters-
Part 1. Specifications)
3 terms and definitions
For the purpose of this standard, GB 9706.1-2007, GB 9706.15-2008, GB/T 4999-2003, YY 0671.1-2009,
The terms and definitions defined in ISO 17664..2004, YY/T 0753.2-2009 and the following apply to this document.
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.
3.1
Anti-asphyxia valve
The on-off valve used in the nasal mask, when the sleep apnea treatment device cannot provide sufficient pressure on the mask end, the valve opens to connect with the atmosphere
When the sleep apnea treatment device can provide sufficient pressure at the end of the mask, the valve closes and disconnects from the atmosphere.
3.2
Exhaust flow
Airflow to the atmosphere from a mask or application accessory, excluding leaks due to improperly sealed faces.
Note 1. Exhaust flow can pass through openings in the mask, connecting parts and masks, or through anti-asphyxia valves to the atmosphere.
Note 2. Exhaust flow releases exhaled air to the atmosphere to reduce CO2 rebreathing.
3.3
Headgear
This section is used to secure the mask to the patient.
3.4
Mask
This section is used to connect the patient and patient interface.
Note. According to the application of masks, masks can be divided into. nasal masks, masks and oronasal masks.
3.5
Multi-patientre-use
Can be used multiple times by multiple patients.
3.6
Oral appliance oralappliance
A device that maintains the airway of the mouth by mechanical means, which can work independently of sleep apnea treatment equipment.
3.7
* Patient connection port
Connect the breathing air circuit to the interface of the mask.
3.8
Single-patientreuse
Can be used multiple times by the same patient.
4 Information provided by the manufacturer
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.
YY 0671.2-2011/ISO 17510-2..2007
4.1 The label on the packaging, the identification on the mask or accessories, and/or the accompanying documents shall contain the following information.
a) The name (or trademark) and address of the manufacturer and the name and address of the manufacturer or importer's authorized representative or responsible person.
b) Characteristics and use of the mask and all application accessories.
c) * Pressure flow curve of exhaust gas flow in the working pressure range specified in Appendix B.
d) Rated pressure range of the mask (including all parts).
e) if reusable.
--- If sterilized, the information specified in 3.9 of YY/T 0802-2010;
--- The cleaning frequency, cleaning method, use of detergent or the number of processing cycles are not
Warning of negative performance impact.
f) any special storage and/or handling conditions.
g) any special operating instructions.
h) any special warnings and/or precautions to be taken.
i) If the package contains multiple parts, the necessary instructions for correct assembly of these parts.
j) Information provided to users (physicians) so that they can inform patients of any potential adverse effects and any precautions that may need to be taken
Preventive measures.
k) Warning to prevent any blockage of the exhaust.
l) * At the flow rate of 50L/min and 100L/min, measured by measuring the pressure drop between the mask and the patient connection port
Air resistance, refer to Appendix C.
m) Provide methods to minimize the risk of repeated breathing (see 5.3).
n) Declaration of proper disposal of masks and accessories at the end of their useful life.
o) * When the anti-asphyxia valve is opened and connected to the atmosphere, the air resistance of the mask inhaling and exhaling is determined by referring to Appendix E.
p) Expected life of any mask and accessory.
q) details of any further handling and handling required before use of the mask and accessories.
r) Information necessary to verify that the masks and accessories are properly installed and used correctly and safely, and that they are safe and correct at all times
Use the required details about calibration and maintenance content and maintenance intervals.
s) Information on the content and cycle of regular maintenance of the mask or accessory, including the risk of wearing parts during the expected life of the mask or accessory
Replace information.
Compliance is checked by inspection of random files.
4.2 Where applicable, identification of packaging labels, masks or accessories, and/or accompanying documents shall include the following information.
a) Serial number (or the symbol specified in 5.16 in YY/T 0466.1-2009), or batch number (or in YY/T 0466.1-2009
5.14 symbols).
b) The safe use period of the mask and all application accessories (or the symbol specified in 5.12 of YY/T 0466.1-2009), in months and months
Means.
c) Description of changes in mask performance when used with other medical devices, such as medical humidifiers, nebulizers, heat and moisture exchange
Filters, filters, two-level positive pressure equipment, self-regulating equipment, or additional oxygen supply ports or any exhaust ports.
d) If it is aseptic packaging, it should meet the requirements of symbols 5.20 ~ 5.24 in YY/T 0466.1-2009.
e) necessary instructions for details of the method of sterilization packaging (material) damage and repeated sterilization.
Compliance is checked by inspection of random files.
YY 0671.2-2011/ISO 17510-2..2007
5 Structural requirements
5.1 Mask connector
If the mask joint is conical, it should meet the 15mm or 22mm outer cone joint of YY 1040.1 or YY 1040.2.
Non-conical mask joints should not engage with joints that meet YY 1040.1 or YY 1040.2 unless they meet YY 1040.1
Or YY 1040.2 requirements on locking, non-locking and leakage.
Compliance is checked by inspection of random files.
5.2 Biocompatibility
Under normal conditions, parts and/or materials used in contact with the patient or the patient's airways should comply with GB/T 16886.
The nasal mask attachment or the part of the mask used to insert the mouth, the surface material of the nasal insert or mask insertion part should be adhered to the mucosa
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
Service life.
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
The risk of contamination is minimized.
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).
YY 0671.2-2011/ISO 17510-2..2007
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.
6 Vibration and noise
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.
YY 0671.2-2011/ISO 17510-2..2007
Appendix A
(Informative appendix)
Fundamental
A.1 Introduction
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.
The main components.
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
A.2 General requirements
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
YY 0671.2-2011/ISO 17510-2..2007
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
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
YY 0671.2-2011/ISO 17510-2..2007
Add 20%.
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
5.3;
--- 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.
Hold off.
YY 0671.2-2011/ISO 17510-2..2007
Appendix B
(Normative appendix)
Exhaust airflow test procedure
B.1 Introduction
The purpose of this test is to determine the relationship between the pressure provided to the patient and the measured exhaust flow.
The main components.
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
B.2 Procedure
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.
Line test.
YY 0671.2-2011/ISO 17510-2..2007
Appendix C
(Normative appendix)
Air resistance (pressure drop)
C.1 Introduction
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.
The main components.
1 --- tested masks and accessories;
2 --- patient connection port;
3--flow source;
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)
C.2 Procedure
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.
pressure.
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.
YY 0671.2-2011/ISO 17510-2..2007
Appendix D
(Normative appendix)
Anti-asphyxia valve pressure test
D.1 Introduction
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
disconnect.
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.
The main components.
1 --- tested anti-asphyxia valve;
2 --- patient connection port;
3--flow source;
4 --- manometer;
5 --- Flowmeter.
a Anti-asphyxia valve flow.
b Intake air flow.
Figure D.1 Determination of opening pressure and closing pressure of anti-asphyxia valve
YY 0671.2-2011/ISO 17510-2..2007
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.
YY 0671.2-2011/ISO 17510-2..2007
Appendix E
(Normative appendix)
Respiration in a single failure state-determination of inspiratory and expiratory resistance
E.1 Introduction
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).
E.2 Procedure
Follow these steps.
a) Connect a variable pressure source capable of generating sub-atmospheric pressure to a flow measurement device (see Figure E.1).
The main components.
1 --- patient connection port;
2--Tested anti-asphyxia valve;
3--air simulation head;
4--flow source;
5--manometer;
6 --- Flowmeter.
a Anti-asphyxia valve flow.
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.
YY 0671.2-2011/ISO 17510-2..2007
Appendix F
(Normative appendix)
CO2 repeated breathing
F.1 Introduction
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
Compare.
F.2 Test procedure
Perform the following tests.
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.
YY 0671.2-2011/ISO 17510-2..2007
The main components.
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).
YY 0671.2-2011/ISO 17510-2..2007
Appendix G
(Normative appendix)
Vibration and noise
Perform the test as follows.
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.
YY 0671.2-2011/ISO 17510-2..2007
Appendix H
(Informative appendix)
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
Information description
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
YY 0671.2-2011/ISO 17510-2..2007
Appendix I
(Informative appendix)
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.4 5
A.5-
A.6-
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
YY 0671.2-2011/ISO 17510-2..2007
Table l.1 (continued)
ISO /T R16142..2006 Basic Principles
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-
YY 0671.2-2011/ISO 17510-2..2007
Appendix J
(Informative appendix)
Environmental aspect
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
Environmental aspect
(Input and output)
Product life cycle
Pre-production
Phase A
Distribution (including packaging)
Phase B
use
Phase C
throw away
Phase D
Related Terms
1 Resource usage----
2 Energy consumption----
3 Air emissions--
4.1e)
4.1n)
4.1p)
4 Water discharge 5.4-4.1e) 4.1e)
5 Waste 5.4-
4.1e)
4.1n)
4.1e)
4.1n)
6 Noise 6-6-
7 Introduction of hazardous substances 5.2-5.2 5.2
8 Soil Impact---4.1n)
Accidents and misuse
Environmental risks
---4.1n)
YY 0671.2-2011/ISO 17510-2..2007
Appendix K
(Normative appendix)
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
project
Test pressure
pmin
pmin
1/4 (pmax-pmin)
pmin
1/2 (pmax-pmin)
pmin
3/4 (pmax-pmin)
pmax
At the patient connection
Measured pressure/hPa
At the patient connection
Measured average flow rate/(L/min)
YY 0671.2-2011/ISO 17510-2..2007
Appendix L
(Informative appendix)
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
YY 0671.2-2011/ISO 17510-2..2007
references
[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
YY 0671.2-2011/ISO 17510-2..2007
Related standard:   YY 0671.1-2009  YY/T 0339-2019
Related PDF sample:   YY 0671.1-2009  YY/T 0506.4-2016
   
 
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