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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]

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Detail Information of 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: 28,219
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
People's Republic of China pharmaceutical industry standards
YY 0671.2-2011/ISO 17510-2:2007
Sleep Apnea Treatment
Part 2: Masks and application of Annex
Part 2: Masksandapplicationaccessories
(ISO 17510-2:2007, IDT)
Issued on: 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 2 Information supplied by the manufacturer
5 4 structural requirements
5.1 Mask header 4
5.2 biocompatible 4
5.3 * to avoid duplication of respiratory protection 4
5.4 cleaning, disinfection and sterilization 4
Respiratory failure during a single 5.5 * 4
5.6 Respiratory filter 5
6 vibration and noise 5
Appendix A (informative) Basic principles 6
Appendix B (normative) exhaust airflow test program 9
Annex C (normative) air resistance (pressure drop) 10
Annex D (normative) anti-suffocation valve pressure test 11
Determination of the inspiratory and expiratory breathing resistance --- Appendix E (normative) under a single fault condition 13
Appendix F (Normative Appendix) CO2 rebreathing 14
Annex G (normative) Noise and vibration 16
Information Guide Appendix H (informative) provided by the manufacturer 17
The basic principle involved in Annex I (informative) 18
Appendix J (informative) environment 20
Annex K (normative) Maximum flow rate measuring method 21
Annex L (informative) terms --- alphabetical index of defined terms 22
References 23
YY 0671.2-2011/ISO 17510-2:2007
YY 0671 "sleep apnea treatment" is divided into two parts:
--- Part 1: Sleep apnea therapy equipment;
--- Part 2: Masks and application accessories.
This is Part 2 YY 0671 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section identical with the international standard ISO 17510-2:2007 "Sleep apnea treatment - Part 2: Masks and application of Annex" (English
Chinese Version). This part of ISO 17510-2:2007 compared to editorial changes made the following:
--- ISO 17510-2:2007 Introduction Introduction The conversion of this Part;
--- ISO 17510-2: ISO 2007 international standard referenced, has been adopted as the corresponding national standards and industry standards, this section
In reference to these national standards and industry standards for use as a specification; no correspondence now been adopted as national standards and industry standards, the
To ISO international standard cited as a standard use;
--- ISO 17510-2:2007 in reference relates to ISO 17510-1:2007 Annex CC direct reference to an appendix of this Part K, this
Appendix K postpone any original part of Appendix L.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part of the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) and focal points.
This section is drafted: Beijing Aerospace Changfeng Co., Ltd., Beijing Jardine Ka Yip Medical Technology Co., Ltd. Shanghai Medical Devices
The main drafters of this section: Qiao Lian, ZHUANG Zhi, Fu Guoqing, Zhaopeng Li, Chen Xingwen, Liang Chen.
YY 0671.2-2011/ISO 17510-2:2007
Sleep apnea is a breathing normally occur clinically significant intermittent missing during sleep. In recent years, along with sleep apnea
Significantly increased risk awareness to stop, sleep apnea therapy equipment use has become increasingly common. This section covers the use of process equipment
Protection of basic safety and essential performance requirements of patients.
YY 0671 is based on GB 9706.1-2007 "Medical Electrical Equipment Part 1: General requirements for safety," the specific standard,
GB 9706.1-2007 referred to herein as "Common Criteria." Common Criteria is using or monitoring patients in the usual care and the environment by qualified personnel
Basic standards of medical electrical equipment safety, it also includes a number of relevant and reliable operation to ensure safety.
General Standard and Collateral standard and application-specific standard combination. Collateral Standard including special technical requirements and/or hazards and apply
All applications, such as medical electrical systems, EMC, diagnostic X-ray equipment protection software. Specific standards for special equipment
Type, such as medical electron accelerators, high frequency surgical equipment, hospital beds and the like.
Note: The parallel standard and proprietary standards are described in sections 1.5 GB 9706.1-2007 and A.2.
This part of the bid with an asterisk (*) in terms of basic principles described in Appendix A.
YY 0671.2-2011/ISO 17510-2:2007
Sleep Apnea Treatment
Part 2: Masks and application of Annex
1 Scope
YY 0671 this section applies to mask their fixed and is used to connect devices to treat sleep apnea patients annex. It details
Finely specifies requirements for masks and accessories covering for any necessary connection components that include both sleep apnea treatment
Part of the required interfaces to connect patients and patient equipment, including some sleep apnea treatment used, such as a nasal mask, row
Air intake and headband.
Sleep apnea therapy equipment requirements, see Part 1 YY 0671 of. Typical two-part standard of YY 0671 involved
Member see Figure A.1.
This section does not include oral appliance requirements.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
Determination of sound power levels of noise sources reflecting plane free field engineering method GB/T 3767-1996 Acoustics sound pressure
(ISO 3744:1994, eqv)
GB/T 4999-2003 term anesthesia breathing equipment (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
Seek (IEC 60601-1-1:2000, IDT)
Declaration and verification of GB/T 14574 Acoustics machinery and equipment noise emission values (GB/T 14574-2000, ISO 4871:1996,
GB/T 16886 (all parts) Biological evaluation of medical devices (ISO 10993 all parts)
Characteristics of GB/T 19974 Sterilization of health care products and medical equipment sterilization factors set sterilization process, validation and routine control
General requirements (ISO 14937, IDT)
YY/T 0316-2008 Medical Device Risk Management in Medical Devices (ISO 14971:2007, IDT)
Symbols - Part 1 YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information: General To
Demand (ISO 15223-1:2007, IDT)
YY 0671.1-2009 sleep apnea treatment - Part 1: Sleep apnea therapy equipment (ISO 17510-1:2002,
Salt Test Method for Evaluating filter characteristics: YY/T 0753.1-2009 anesthesia and respiratory respiratory filters - Part 1
(ISO 23328-1:2003, IDT)
YY/T 0753.2-2009 anesthesia and respiratory breathing system filters - Part 2: Non-filtration aspects (ISO 23328-2:
2002, IDT)
Sterilization processing Manufacturer YY/T 0802-2010 medical devices provide repeatable information sterilized medical devices
(ISO 17664:2004, IDT)
YY 0671.2-2011/ISO 17510-2:2007
Related standard:   YY 0671.1-2009  YY/T 0339-2019
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