YY 0671-2021_English: PDF (YY0671-2021)
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(Medical equipment sleep apnea treatment mask and application accessories)
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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. | | Standard ID | YY/T 0671-2021 (YY/T0671-2021) | | Description (Translated English) | Medical devices-Sleep apnoea breathing therapy- Masks and application accessories | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 30,352 | | Date of Issue | 2021-09-06 | | Date of Implementation | 2024-05-01 | | Drafting Organization | Tianjin Yihe Jiaye Medical Technology Co., Ltd., Shanghai Medical Device Testing Institute | | Administrative Organization | National Standardization Technical Committee on Anesthesia and Respiratory Equipment (SAC/TC 116) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard applies to masks and their accessories for connecting sleep apnea therapy equipment to patients. This standard specifies requirements for masks and accessories, including any connections required to connect the patient connection port on the sleep apnea therapy device to a patient receiving sleep apnea therapy (such as nasal masks, vents, and headgear) . See standard YY 9706.270 (ISO 80601-2-70) for requirements on sleep apnea therapy equipment. This standard and YY 9706.270 (ISO 80601-2-7 | | Standard ID | YY 0671.1-2009 (YY0671.1-2009) | | Description (Translated English) | Sleep apnoea breathing therapy. Prat 1: Sleep apnoea breathing therapy devices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 23,253 | | Date of Issue | 2009-06-16 | | Date of Implementation | 2010-12-01 | | Quoted Standard | EN 556; EN 739; EN ISO 8185; EN ISO 9360-1; GB 18278-2000; GB 18279-2000; GB 18280-2000; GB 7144-1999; GB 9706.1-2007; GB/T 3767-1996; GB/T 3785-1983; GB/T 4999-2003; GB/T 5332-2007; PREN 737-6-1998; YY 0466-2003; YY 0505-2005; YY 1040.1-2003; YY 1040.2-2008 | | Adopted Standard | ISO 17510-1-2002, MOD | | Drafting Organization | Pfizer Medical Devices Co., Ltd., Henan | | Administrative Organization | National Standardization Technical Committee of Anaesthetic and respiratory equipment | | Regulation (derived from) | Industry standard filing Notice 2009 No. 9 | | Proposing organization | National Standardization Technical Committee of anesthesia and respiratory equipment | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard provides for the family and the health care sector sleep apnea therapy equipment requirements for. YY 0671 does not apply to this part of the standard GB 9706. 28 involved in various devices. YY 0671 does not consider this part of high frequency jet ventilation, high frequency oscillatory ventilator. YY 0671 Part 2 of the application for masks and accessories made requests. YY 0671 This part does not apply to GB/T 4999-2003 as described in the in vitro respiratory equipment. |
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
......
YY/T 0671-2021: Medical Device Sleep Apnea Therapy Mask and Application Accessories
ICS 11:040:10
C46
Pharmaceutical Industry Standard of the People's Republic of China
YY 0671-2021
Replace YY 0671:2-2011
Medical Devices Sleep Apnea Therapy
Masks and Application Accessories
(ISO 17510:2015, MOD)
According to the State Drug Administration medical device industry
Standard Announcement (No: 76 of 2022), this standard is from
From September 7, 2022, it will be converted into a recommended standard, no
Enforce it again:
Released on 2021-09-06 Implemented on 2024-05-01
Released by the State Drug Administration
table of contents
Preface III
Introduction V
1 Range 1
2 Normative references 1
3 Terms and Definitions 2
4 Information provided by the manufacturer3
4:1 Overview 3
4:2 Markings on the protective packaging3
4:3 Attached Document 3
5 Structural Requirements 4
5:1 Mask connector 4
5:2 Biocompatibility4
5:3 * Protection against rebreathing 5
5:4 Cleaning, disinfection and sterilization5
5:5 * Breathing in single fault condition 6
5:6 Breathing system filter 6
6 Vibration and noise 6
Appendix A (Informative) Basic Principles 7
Appendix B (Normative Appendix) Exhaust Flow Test Procedure 10
Appendix C (Normative) Air Resistance (Pressure Drop) 12
Appendix D (Normative) Anti-asphyxia valve pressure test 13
Appendix E (Normative Appendix) Breathing under a single fault state --- Determination of inspiratory and expiratory resistance 15
Appendix F (Normative Appendix) Rebreathing of CO2 17
Appendix G (Normative Appendix) Vibration and Noise 19
Appendix H (informative appendix) Information guide provided by the manufacturer 20
Appendix I (informative appendix) involves basic principles 21
Reference 23
YY 0671-2021
foreword
All technical contents of this standard are mandatory:
This standard is drafted in accordance with the rules given in GB/T 1:1-2009:
This standard replaces YY 0671:2-2011 "Sleep Apnea Therapy Part 2: Masks and Application Accessories", and YY 0671:2-
Compared with:2011, the main technical changes except editorial modifications are as follows:
--- The test for the single failure condition of nasal mask rebreathing has been deleted, because the patient can breathe through the mouth in this environment (see
5:3:2);
---The sleep apnea treatment equipment standard 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 revise and adopt ISO 17510:2015 "Medical Device Sleep Apnea Therapy Mask and Application Accessories
pieces":
The technical differences between this standard and ISO 17510:2015 and their reasons are as follows:
--- Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the adjustment situation
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 the international standard;
● Replaced ISO 4135:2001 with GB/T 4999, which is equivalent to the international standard;
● 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 the international standard;
● Replaced ISO 10993-1:2009 with GB/T 16886:1, which is equivalent to the international standard;
● Replaced ISO 14937:2009 with GB/T:19974, which is equivalent to the international standard;
● Replaced ISO 23328-1:2003 with YY/T 0753:1, which is equivalent to the international standard;
● Replaced ISO 23328-2:2002 with YY/T 0753:2, which is equivalent to the international standard;
● Replaced ISO 17664:2004 with YY/T 0802-2020, which adopts international standards;
● Replaced ISO 5356-1:2015 with YY/T 1040:1, which is equivalent to the international standard;
● Replaced ISO 5356-2:2012 with YY 1040:2, which is equivalent to the international standard;
● Replace ISO 80601-2-70:2015 with YY 9706:270, which adopts international standard:
This standard has made the following editorial changes:
--- Deleted Appendix J;
--- Corrected editorial errors in ISO 17510:2015:
● Change 6 in parentheses after "sleep apnea treatment equipment" in the note of Figure A:1 to 7;
● Refer to 5:3 "Note: For the measurement method of average flow rate, refer to Appendix C of YY 9706:270-2021 in Appendix A:2, and refer to the
Table C:1" is changed to "Note: Refer to:201:12:1:103 in YY 9706:270-2021 for the measurement method of the average flow rate, and its record reference
See Table:201:104";
● Adjust the corresponding relationship between the letter number and the content under 4:3 in Appendix A:2, that is, adjust the content of p) to r) and the content of q)
Adjust the content to p), and adjust the content of r) to q) so as to correspond to the content of the text;
● Change the 3 in brackets after “traffic source” in D:4b) to 4:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents:
YY 0671-2021
This standard was proposed by the State Drug Administration:
This standard is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116):
This standard was drafted: 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 releases of the standards replaced by this standard are as follows:
---YY 0671:2-2011:
YY 0671-2021
introduction
Sleep apnea is a clinically significant intermittent absence of normal breathing during sleep: Sleep apnea
Risk awareness has increased significantly, and the use of sleep apnea therapy devices has become more common: This standard covers the use of equipment
Basic safety and essential performance requirements for face shields and other applied accessories for patient protection:
See Appendix A for the rationale for chapters, clauses and definitions marked with an asterisk (*): Conforms to safety and security as indicated in ISO 16142:2006
See Appendix I for the basic principles of performance:
YY 0671-2021
Medical Devices Sleep Apnea Therapy
Masks and Application Accessories
1 Scope
This standard applies to masks and their accessories for connecting sleep apnea therapy equipment to patients: This standard specifies the face shields and accessories
requirements, including those required to connect the patient connection port on the sleep apnea therapy device to a patient receiving sleep apnea therapy:
Any attachments (such as nasal masks, vents, and headgear):
See YY 9706:270 for requirements on sleep apnea therapy 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 indispensable for the application of this document: For dated references, only the dated version applies to this document
pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 3785:1 Electroacoustic sound level meters Part 1: Specifications (GB/T 3785:1-2010, IEC 61672-1:2002, IDT)
GB/T 4999 Terminology of anesthesia breathing equipment (GB/T 4999-2003, ISO 4135:2001, IDT)
GB 9706:1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (GB 9706:1-2020,
IEC 60601-1:2012, MOD)
GB/T 14574 Marking and verification of noise emission values of acoustic machines and equipment (GB/T 14574-2000, eqvISO 4871:
1996)
GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process (GB/T 16886:
1-2011, ISO 10993-1:2009, IDT)
GB/T:19974 Sterilization characteristics of healthcare products and development, validation and routine control of sterilization process for medical devices
General requirements for (GB/T:19974-2018, ISO 14937:2009, IDT)
YY/T 0466:1-2016 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices 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 Breathing 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 respiration equipment Part 1: Cone head and cone 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: Particulars for Basic Safety and Essential Performance of Sleep Apnea Therapy 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 sound energy levels Approximate free-field engineering measurements above reflecting surfaces
YY 0671-2021
......
YY 0671.1-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Sleep apnoea breathing therapy –
Part 1. Sleep apnoea breathing therapy devices
(ISO 17510-1.2002, MOD)
ISSUED ON. JUNE 16, 2009
IMPLEMENTED ON. DECEMBER 1, 2010
Issued by. China Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically &
immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 6
Introduction ... 8
1 Scope* ... 9
2 Terms and definitions ... 10
3 General requirements ... 13
4 Test general requirements ... 13
5 Classification ... 13
6 Identification, marks and files ... 13
7 Input power ... 17
8 Basic safety type ... 17
9 Removable protective device ... 17
10 Ambient conditions ... 17
11 Not used ... 18
12 Not used... 18
13 Overview ... 18
14 Requirements for classification ... 18
15 Voltage and/or energy limits ... 18
16 Shell and enclosure ... 18
17 Isolation ... 19
18 Protection earthing, functional grounding and potential equalization ... 19
19 Continuous leakage current and patient auxiliary current ... 19
20 Dielectric strength ... 19
21 Mechanical strength ... 19
22 Moving parts ... 19
23 Face, corner and side ... 20
24 Certainty during normal use ... 20
25 Splash ... 20
26 Vibration and noise ... 20
27 Pneumatic and hydraulic power ... 21
28 Suspension ... 21
29 X-ray radiation ... 21
30 Α, β, λ neutron radiation and other particle radiation ... 21
31 Microwave radiation ... 21
32 Optical radiation (including laser) ... 22
33 Infrared radiation ... 22
34 Ultraviolet radiation ... 22
35 Sound energy (including ultrasound) ... 22
36 Electromagnetic compatibility ... 22
37 Location and basic requirements ... 22
38 Signs, random files ... 22
39 Common requirements for AP and APG devices ... 22
40 Requirements and tests for AP device and its components and elements 23
41 Requirements and tests for APG device and its components and elements
... 23
42 Over-temperature ... 23
43* Fire protection ... 23
44 Overflow, liquid spill, leak, moisture, liquid injection, cleaning, disinfection,
sterilization and compatibility ... 24
45 Pressure vessel and pressured parts ... 24
46 Not used... 24
47 Static charge ... 24
48 Biocompatibility ... 25
49 Power supply interruption... 25
50 Accuracy of work data ... 25
51 Hazardous output prevention ... 25
52 Abnormal operation and fault status ... 26
53 Ambient test ... 26
54 Overview ... 26
55 Shell and enclosure ... 27
56 Components and elements ... 27
57 Network power parts, components and wiring ... 30
58 Protective ground - terminals and connections ... 30
59 Structure and wiring ... 30
Annex ... 30
Annex A (Informative) Basic principles ... 31
Annex B (Informative) Glossary ... 37
Bibliography ... 38
Foreword
YY 0671 Sleep apnoea breathing therapy consists of the following parts.
-- Part 1. Sleep apnoea breathing therapy devices;
-- Part 2. Masks and application accessories.
This Part is the first part of YY 0671.
The modification of this Part uses the International Standard ISO
17510-1.2002 Sleep apnoea breathing therapy -- Part 1. Sleep apnoea
breathing therapy devices.
The main difference between this Part and ISO 17510-1.2002 is as follows.
This Part modified Clause 2 “Normative references” of ISO 17510-1.2002 to
sub-clause 1.101, Clause 3 “Terms and definitions” to Clause 2, so as to be
consistent with the common standard number.
This Part is a special standard based on GB 9706.1-2007 Medical electrical
equipment - Part 1. General requirements for safety (a general standard). It
shall be used together with GB 9706.1-2007.
Clause 36 Electromagnetic compatibility of this Part shall be implemented
concurrently with YY 0505-2005 (IEC 60601-1-2.2001, IDT) Medical electrical
equipment - Part 1-2. General requirements for safety - Collateral standards.
Electromagnetic compatibility - Requirements and tests.
Clause 56 of this Part referred to EN 556 Sterilization of medical devices.
Requirements for medical devices to be designated "STERILE", PrEN
737-6.1998 Medical gas pipeline systems - Part 6. Dimensions of probes for
terminal units for compressed medical gases and vacuum, EN 739
Low-pressure hose assemblies for use with medical gases, EN ISO 8185
Humidifiers for medical use - General requirements for humidification
systems, EN ISO 9360-1 Anaesthetic and respiratory equipment -- Heat and
moisture exchangers (HMEs) for humidifying respired gases in humans --
Part 1. HMEs for use with minimum tidal volumes of 250 ml. It shall be
implemented concurrently with these standards after they are converted to
national or industry standards. It shall be explained in the preparation
instructions.
Annex AA and Annex BB of this Part are informative.
This Part was proposed by a...
......
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