YY 0671.1-2009 English PDF

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY 0671.1-2009 (Self-service in 1-minute)
Historical versions (Master-website): YY 0671.1-2009
Preview True-PDF (Reload/Scroll-down if blank)

YY 0671.1-2009: Sleep apnoea breathing therapy. Prat 1: Sleep apnoea breathing therapy devices
YY 0671.1-2009
Sleep apnoea breathing therapy.Prat 1. Sleep apnoea breathing therapy devices
ICS 11.040.10
C46
People 's Republic of China Pharmaceutical Industry Standard
Sleep apnea treatment
Part 1. Sleep apnea treatment equipment
(ISO 17510-1..2002, MOD)
2009-06-16 release
2010-12-01 implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 range
2 Terms and definitions 1
3 General requirements 3
4 General requirements for testing 3
Category 3
Identify, mark and file 3
7 input power 5
8 basic security type 5
9 Removable protective device 5
Environmental conditions 5
11 does not use 6
12 does not use 6
13 Overview 6
14 Requirements for classification 6
15 voltage and/or energy limit 6
16 housing and shield 6
17 isolation 6
18 protection earthing, functional grounding and potential equalization 6
19 continuous leakage current and patient auxiliary current 6
20 dielectric strength 6
21 Mechanical strength 6
22 moving parts 7
23 faces, horns and sides 7
Determine when used normally
25 splash 7
Vibration and noise
27 Pneumatic and hydraulic power 7
28 Suspension 7
29 X-ray radiation 7
30 α, β, λ neutron radiation and other particle radiation
31 microwave radiation
32 optical radiation (including laser) 8
33 Infrared radiation 8
34 UV radiation 8
35 sound energy (including ultrasound) 8
36 Electromagnetic compatibility
37 Location and basic requirements 8
38 logo, random file 8
Common requirements for AP and APG equipment
Requirements and tests for AP equipment and its components and components
Requirements and tests for APG - type equipment and their components and components
42 overtemperature 8
Fireproof 9
44 overflow, liquid spill, leak, moisture, feed, cleaning, disinfection, sterilization and compatibility 9
45 pressure vessel and pressure receiving parts
46 does not use 9
47 electrostatic charge 9
Biocompatibility 9
49 Power supply disruption 9
50 Accuracy of working data 10
51 Prevention of dangerous output 10
52 abnormal operation and fault status 10
Environmental Test 10
54 Overview 10
55 housing and cover
Components and components
57 power supply parts, components and wiring 12
58 protection ground --- terminals and connections 12
Structure and wiring
Appendix AA (informative) Basic principles 13
Appendix BB (informative) Glossary 16
References 17
Preface
YY 0671 "sleep apnea treatment" consists of the following components.
- Part 1. Sleep apnea treatment equipment;
- Part 2. Face mask and application attachments.
This part is part 1 of YY 0671.
This part of the revision using the international standard ISO 17510-1..2002 "sleep apnea treatment Part 1. sleep apnea treatment
equipment".
The main differences between this section and ISO 17510-1..2002 are as follows.
This section adjusts ISO 17510-1..2002, Chapter 2, "normative reference documents" to 1.101; translates Chapter 3, "Terminology and Definitions"
The whole chapter is the same as the common standard number.
This part is based on GB 9706.1-2007 "Medical electrical equipment Part 1. General requirements for safety" (general standard) of the special standard
Quasi-use with GB 9706.1-2007.
Section 36 Electromagnetic Compatibility and YY 0505-2005 (IEC 60601-1-2..2001, IDT) "Medical Electrical Equipment Section 1-2
Points. safety requirements - parallel standard. electromagnetic compatibility - requirements and testing "implementation of the same period.
Section 56 of this section refers to EN556 "Medical Device Sterilization" Medical Device Requirements for "Sterilization" Labels, PrEN737-6..1998
"Medical gas piping systems Part 6. Compressed medical gas and vacuum terminal equipment plugs", EN739 "Low pressure flexible soft for medical gases
Pipe fittings ", ENISO 8185" General requirements for humidifiers for medical humidifiers ", ENISO 9360-1" Anesthesia and respiratory equipment for
Humidification of Respiratory Gas in Patients with Respiratory Gas Part 1. Moisture Reliefs with a Minimum Tidal Volume of 250 mL ", in these standard conversions
For the national standards or industry standards after the implementation of the same period, and in the preparation of explanations to be explained.
Annexes AA and Appendix BB of this section are informative.
This section is proposed by the National Standardization Technical Committee on Anesthesia and Respiratory Equipment.
This part of the drafting unit. Henan Pfizer Medical Devices Co., Ltd., Beijing Oriental Wan Tai Technology Development Co., Ltd.
This part of the main drafters. Wu Yaoyu, Shi Jie, Zhang Xiaomin, Zhou Juan.
introduction
YY 0671 this part is based on GB 9706.1-2007 "medical electrical equipment Part 1. general requirements for safety" special standard
Standard, GB 9706.1-2007 is referred to herein as the "General Standard". The generic standard is all in the general medical and patient environment by qualified personnel
Use or monitor the safety of medical equipment based on the basic standards, it also includes some reliable operation to ensure the safety requirements.
Common standards are used in conjunction with side-by-side standards and proprietary standards. The juxtaposition criteria include special technical and/or dangerous requirements and are applicable
There are application equipment, such as medical systems, EMC, diagnostic X-ray equipment, ray protection, software and so on. Special standards apply to special equipment types, examples
Such as medical electronic accelerator, high frequency electric knife, bed and so on.
Note. The parallel standard and the description of the specific standards are described in GB 9706.1-2007 1.5 and A. Chapter 2.
YY 0671 part of the chapter, chapter and article number consistent with the common standards. Changes to the common standard text and the complementarity of the parallel standards
Charge, by using the following words.
--- "Replace" means that the chapter or clause of the generic standard is completely replaced by the text of this part.
- "Increased" means that the relevant text in this section is new content (eg, bar, column item, note, table, figure) attached to the common standard.
--- "Modification" means that the common content of the common standard is partially modified.
In order to avoid confusion with the modified version of the generic standard itself, the YY 0671 part of this chapter increases the number of chapters, bars, tables and figures starting from 101;
Charge the column to the letter aa), bb) number; supplementary appendix to AA, BB and other numbers.
This part is marked with an asterisk
) Are described in Appendix AA.
Sleep apnea treatment
Part 1. Sleep apnea treatment equipment
1 range
The scope given in Chapter 1 of GB 9706.1-2007 is applicable with the following additions.
This part of YY 0671 specifies the specific requirements for sleep apnea treatment equipment suitable for use in the home and health care sectors.
YY 0671 this part does not apply to GB 9706.28 standards involved in a variety of equipment.
YY 0671 this part does not consider high-frequency jet ventilator, high-frequency oscillation ventilator.
The second part of YY 0671 sets out requirements for masks and application accessories.
This part of YY 0671 does not apply to the in vitro breathing apparatus described in GB/T 4999-2003.
1.101 normative reference document
The terms of this document are the terms of this part of the terms of this part of YY 0671. Any reference to the date of the document,
Any subsequent amendments (not including corrigenda) or revisions shall not apply to this part, however, it is encouraged to enter into an agreement under this Part
Of the parties to study whether the latest version of these documents can be used. For undated references, the latest edition applies to this section.
GB/T 3767-1996 Acoustic vocal pressure method for the determination of noise sources at sound power level.
(Eqv ISO 3744-94)
Electrical and acoustic performance of sound level meter GB/T 3785-1983 and test method
GB/T 4999-2003 Terminology for anesthetic breathing equipment (ISO 4135..2001, IDT)
Test method for ignition temperature of flammable liquids and gases (IEC 60079-4. 1975, IDT) GB/T 5332-2007
GB 7144-1999 Cylinder color mark
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 18278-2000 Sterilization of medical and health care products and routine control requirements Industrial damp heat sterilization (idt ISO 11134.
1994)
GB 18279-2000 Sterilization and routine control of ethylene oxide for medical devices (idt ISO 11135..1994)
GB 18280-2000 Sterilization of medical and health care products and routine control requirements Radiation sterilization (idt ISO 11137..1995)
YY 1040.1-2003 Anesthesia and respiratory equipment - Conical joints - Part 1. Conical and taper sleeves (ISO 5356-1..1996);
YY 1040.2-2008 Anesthesia and respiratory equipment - Conical joints - Part 2. Threaded load - bearing joints (ISO 5356-2..2006,
IDT)
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests
(IEC 60601-1-2..2001, IDT)
YY 0466-2003 Symbols for medical devices for labeling, marking and providing information on medical devices (ISO 15223..2000, IDT)
EN556 medical device sterilization with "sterilization" label for medical device requirements
Pren737-6..1998 Medical gas piping systems - Part 6. Compressed medical gas and vacuum terminal equipment plugs
Low pressure flexible hose assemblies for medical gases
General requirements for humidification systems for medical humidifiers ENISO 8185
ENISO 9360-1 Anesthesia and respiratory equipment - Humid heat exchangers for humidifying respiratory gases in patients - Part 1. Minimum tidal volume
For 250 ml of heat and moisture exchangers
2 terms and definitions
GB 9706.1-2007, GB/T 4999-2003 and the following terms and definitions apply to this part of YY 0671.
increase.
2.1.5
Add the following items.
--- It is expected to be connected to all parts of the patient or ventilation system.
2.101
In the breathing cycle, it is expected that two positive pressure levels are produced at the patient interface.
2.102
Sleep apnea treatment 2) equipment ventilation system to low pressure gas inlet, gas inlet and patient connection for the boundaries, if new
Fresh gas inlet and outlet, should also include fresh gas inlet and outlet.
NOTE. As long as the requirements of this standard are met, the breathing valve can be installed in the ventilation system or in any position relative to the port.
2.103
Throughout the breathing cycle, it is expected that a continuous positive airway pressure will be generated at the patient connection port.
2.104
To the gas of the ventilation system. Does not include the following.
A) gas entering from the emergency air inlet;
B) gas leaked by the ventilation system;
C) the patient exhaled the gas.
2.105
In addition to the emergency air intake, the device or patient draws fresh gas into the gas inlet of the equipment ventilation system (see 2.102
Note).
2.106
Under normal operating conditions, excess gas and/or exhaust gases are discharged to the ports through which the atmosphere or anesthetic gas purification system flows.
2.107
With the breathing pressure through the ventilation system piping, transmission of gas to the patient connection port of the device output port.
2.108
With the breathing pressure through the ventilation system piping, the transmission of gas from the patient connection port back to the device connection port.
2.109
Enter a gas inlet with a supply pressure greater than 100 kPa.
2.110
Used for text or graphic information on medical devices or their containers or packaging.
2.111
Enter a gas inlet with a supply pressure of no more than 100 kPa.
2.112
Permanent affixed to the medical device of the text or symbolic information.
2.113
In the normal state and single failure state, the maximum pressure of the patient connection port.
2.114
Means for removing bacteria, microorganisms or particulates in the air stream.
2.115
A ventilation system port that can be connected to a patient.
2.116
When used, ventilation can be automatically adjusted according to the patient's need to adjust the air pressure.
Note. This device can be tuned to one or more pressure levels.
2.117
Respiratory therapy equipment for relieving the symptoms of sleep apnea, suitable for use in health care departments and families, without the need for professionals
The custody of the guard.
2.118
The change in the respiration pressure setting over time and the change due to changes in the environment (eg, temperature, aging).
2.119
The difference between the actual reading of the respiratory pressure during the breathing cycle and its set value.
3 General requirements
GB 9706.1-2007 Chapter 3 applies.
4 General requirements for testing
GB 9706.1-2007 Chapter 4 applies.
5 classification
GB 9706.1-2007 Chapter 5 applies.
Note. A device can have different types of applications.
6 identification, marking and documentation
GB 9706.1-2007 Chapter 6 applies, with the following modifications and additions.
6.1 External marking of equipment or equipment parts
Replace [replace j] the first paragraph].
J) input power
The rated input should be expressed in amperes.
Increase (after 6.1).
Aa) For any operator accessible to the direction of the air flow sensitive components, should be marked on the component indicates the direction of the air flow is clear
Read and permanently affixed to the arrow.
Bb) All high-voltage input ports shall be marked with a gas name or symbol in accordance with GB 7144-1999 and shall be marked with a pressure range
(KPa) and rated maximum flow (L/min) requirements.
Cc) Operator-accessible ports should be marked. Use the following terms.
--- fresh gas inhalation. "fresh gas inhalation";
--- ...