YY 0671.2-2011Sleep apnoea breathing therapy - Part 2: Masks and application accessories (English PDF)

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

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

YY 0671.2 covers the masks and accessories used in sleep apnoea therapy, the interface between a CPAP machine and the patient's face. The mask is where the therapy usually fails: a leak drops the pressure that holds the airway open, pressure on the bridge of the nose causes ulceration, and discomfort leads a patient to abandon treatment altogether, which is the commonest reason CPAP does not work. This standard sets the requirements such masks and accessories have to meet and the test methods that verify them, covering the fit and seal, the leak characteristics, the carbon dioxide washout that prevents rebreathing, the biocompatibility of the skin-contacting materials and the connections. Compliance is compulsory in China.

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)

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).

--- 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.

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 pati...