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YY 0671.2-2011

YY 0671.2-2011_English: PDF (YY0671.2-2011)
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YY 0671.2-2011English554 Add to Cart Days<=4 Sleep apnoea breathing therapy. Part 2: Masks and application accessories YY 0671.2-2011 Valid YY 0671.2-2011
 

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