YY 0671-2021_English: PDF (YY0671-2021)
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(Medical equipment sleep apnea treatment mask and application accessories)
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YY 0671-2021
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| Standard ID | YY 0671-2021 (YY0671-2021) | | Description (Translated English) | (Medical equipment sleep apnea treatment mask 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 | 30,319 | | Date of Issue | 2021-09-06 | | Date of Implementation | 2024-05-01 | | Summary | This standard applies to masks and accessories that connect sleep apnea therapy devices to patients. This standard specifies requirements for face masks and accessories, including connecting the patient connection port on the sleep apnea treatment device to any connections required for the patient undergoing sleep apnea treatment (such as nasal masks, exhaust ports, and headgear) . See the standard YY 9706.270 (ISO 80601-2-70) for the requirements for sleep apnea treatment equipment. This standard and YY 9706.270 (ISO 80601-2-70) constitute two parts of the sleep apnea treatment system. This standard does not include requirements for oral appliances. | YY 0671-2021
(Medical equipment sleep apnea treatment mask and application accessories)
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0671.2-2011
Medical Devices Sleep Apnea Treatment
Face shields and application accessories
(ISO 17510.2015, MOD)
Published on 2021-09-06
2024-05-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction V
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Information provided by the manufacturer3
4.1 Overview 3
4.2 Marking on protective packaging3
4.3 Accompanying Documents 3
5 Structural Requirements 4
5.1 Mask connector 4
5.2 Biocompatibility 4
5.3 *Protection against repeated breathing 5
5.4 Cleaning, Disinfection and Sterilization5
5.5 * Breathing 6 in a single fault condition
5.6 Respiratory system filters 6
6 Vibration and noise6
Appendix A (Informative Appendix) Rationale 7
Appendix B (Normative Appendix) Exhaust Flow Test Procedure 10
Appendix C (Normative Appendix) Air Resistance (Pressure Drop) 12
Appendix D (Normative Appendix) Anti-Asphyxia Valve Pressure Test 13
Appendix E (normative) Breathing under a single fault condition - Determination of inspiratory and expiratory resistance 15
Appendix F (normative) Rebreathing of CO2 17
Appendix G (Normative Appendix) Vibration and Noise 19
Appendix H (Informative) Manufacturer's Information Guide 20
Appendix I (informative appendix) covers the basic principles21
Reference 23
foreword
All technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0671.2-2011 "Sleep Apnea Treatment Part 2.Masks and Application Accessories", and YY 0671.2-
Compared with.2011, the main technical changes except editorial changes are as follows.
--- Removed the test for the nasal mask rebreathing single fault condition, because the patient can breathe through the mouth in this environment (see
5.3.2);
--- The standard for sleep apnea treatment equipment used in conjunction with this standard has been changed from YY 0671.1 to YY 9706.270 (see Section 1
chapter).
This standard uses the redrafted method to modify and adopts ISO 17510.2015 "Medical Devices Sleep Apnea Treatment Masks and Application Attachments
Piece".
The technical differences between this standard and ISO 17510.2015 and their reasons are as follows.
--- Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows.
● Replace IEC 61672-1.2013 with GB/T 3785.1 which is equivalent to adopting international standards;
● Replace ISO 4135.2001 with GB/T 4999, which is equivalent to adopting international standards;
● Replaced IEC 60601-1.2005 Amd1.2012 with the revised international standard GB 9706.1;
● Replace ISO 4871.1996 with GB/T 14574 which is equivalent to adopting international standards;
● Replace ISO 10993-1.2009 with GB/T 16886.1 which is equivalent to adopting international standards;
● Replace ISO 14937.2009 with GB/T.19974 which is equivalent to adopting international standards;
● Replacing ISO 23328-1.2003 with YY/T 0753.1 which is equivalent to adopting international standards;
● Replacing ISO 23328-2.2002 with YY/T 0753.2 which is equivalent to adopting international standards;
● Replacing ISO 17664.2004 with YY/T 0802-2020 which has been modified to adopt international standards;
● Replacing ISO 5356-1.2015 with YY/T 1040.1 which is equivalent to adopting international standards;
● Replacing ISO 5356-2.2012 with YY 1040.2 which is equivalent to adopting international standards;
● Replacing ISO 80601-2-70.2015 with YY 9706.270 which has been modified to adopt the international standard.
This standard has made the following editorial changes.
--- Deleted Appendix J;
--- Fixed editorial errors in ISO 17510.2015.
● Change the 6 in parentheses after "Sleep Apnea Treatment Equipment" in the note to Figure A.1 to 7;
● Refer to Appendix C of YY 9706.270-2021 for the measurement method of 5.3 "Note. Average flow rate in Appendix A.2, and its records in
"Table C.1" is changed to "Note. Refer to.201.12.1.103 of YY 9706.270-2021 for the measurement method of the average flow rate, and its record parameters refer to
See Table.201.104";
● Adjust the correspondence between the letter number and content under 4.3 in Appendix A.2, that is, adjust the content of p) to r), and adjust the content of q)
The content of r) is adjusted to p), and the content of r) is adjusted to q), so as to correspond to the content of the text;
● In D.4b), change the 3 in parentheses after "traffic source" to 4.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee of Anesthesia and Respiratory Equipment (SAC/TC116).
This standard was drafted by. Tianjin Yihe Jiaye Medical Technology Co., Ltd., Shanghai Medical Device Testing Institute.
The main drafters of this standard. Zhuang Zhi, Zhao Weidong, Zhou Mingzhao, Wang Wei, Jia Wenxiang, Xu Chang.
The previous editions of the standard replaced by this standard are as follows.
---YY 0671.2-2011.
introduction
Sleep apnea is a clinically significant intermittent loss of normal breathing during sleep. In recent years, with the development of sleep apnea
With the significant increase in risk awareness, the use of sleep apnea treatment equipment has become more and more common. This standard covers the use of equipment during
Basic safety and essential performance requirements for masks and other applied accessories used to protect patients.
For the rationale of chapters, clauses and definitions marked with an asterisk (*), see Appendix A. Complies with safety and security as shown in ISO 16142.2006
See Appendix I for basic principles of energy.
Medical Devices Sleep Apnea Treatment
Face shields and application accessories
1 Scope
This standard applies to masks and accessories that connect sleep apnea therapy devices to patients. This standard specifies face shields and accessories in detail.
requirements, including the need to connect the patient connection port on the sleep apnea therapy device to the patient undergoing sleep apnea therapy
Any attachments (such as nasal masks, exhaust vents, and headgear).
See YY 9706.270 for the requirements for sleep apnea treatment equipment. This standard and YY 9706.270 constitute sleep apnea treatment
The two parts of the system, the typical components involved are shown in Figure A.1.
This standard 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 3785.1 Electroacoustic Sound Level Meter Part 1.Specification (GB/T 3785.1-2010, IEC 61672-1..2002, IDT)
GB/T 4999 Terminology of Anesthesia and Respiratory Equipment (GB/T 4999-2003, ISO 4135.2001, IDT)
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance (GB 9706.1-2020,
IEC 60601-1.2012, MOD)
GB/T 14574 Marking and Verification of Noise Emission Values of Acoustic Machinery and Equipment (GB/T 14574-2000, eqvISO 4871.
1996)
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process (GB/T 16886.
1-2011, ISO 10993-1.2009, IDT)
GB/T.19974 Characterization of Sterilization Factors for Sterilization of Healthcare Products and Development, Validation and Routine Control of Sterilization Processes for Medical Devices
General requirements for (GB/T.19974-2018, ISO 14937.2009, IDT)
YY/T 0466.1-2016 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements
Seek (ISO 15223-1.2012, IDT)
YY/T 0753.1 Respiratory system filters for anesthesia and respiration - Part 1.Salt test method for evaluating filtration performance
(YY/T 0753.1-2009, ISO 23328-1.2003, IDT)
YY/T 0753.2 Respiratory system filters for anesthesia and respiration Part 2.Non-filtering aspects (YY/T 0753.2-2009,
ISO 23328-2.2002, IDT)
YY/T 0802-2020 Handling of medical devices Information provided by medical device manufacturers (ISO 17664.2017, MOD)
YY/T 1040.1 Conical joints for anesthesia and respiratory equipment Part 1.Cone head and conical sleeve (YY/T 1040.1-2015,
ISO 5356-1.2004, IDT)
YY 1040.2 Conical joints for anesthesia and respiratory equipment Part 2.Threaded load-bearing joints (YY 1040.2-2008, ISO 5356-
2.2006)
YY 9706.270 Medical Electrical Equipment Part 2-70.Special Purpose for Basic Safety and Basic Performance of Sleep Apnea Treatment Equipment
Requirements (YY 9706.270-2021, ISO 80601-2-70.2015, MOD)
ISO 3744.2010 Acoustic sound pressure method for the determination of sound power levels of noise sources and engineering measurements of approximate free fields above reflecting surfaces for sound energy levels
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