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YY 0786-2010: Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
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Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
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Basic data | Standard ID | YY 0786-2010 (YY0786-2010) | | Description (Translated English) | Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 42,417 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB/T 3767-1996; GB/T 4999-2003; GB/T 5332-2007; GB 9706.1-2007; GB 11243-2008; YY 0461-2003; YY 0505-2005; YY 1040.1-2003; YY 0709-2009; YY/T 0735.1; YY/T 0735.2; ISO 7396-1-2002; ISO 10524-1-2006; IEC 60601-1-6-2004 | | Adopted Standard | ISO 8185-2007, IDT | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the humidification system's basic safety and essential performance requirements. Humidification system also includes the use of certain independent devices such as breathing circuit heating (breathing pipe heating wire) and the breathing circuit heating control device (breathing circuit heating controller). Breathing circuits other aspects of security and performance requirements refer to YY 0461. This standard also includes an active HME (heat and moisture exchanger) requirements, namely through active heated humidification to increase interest rates by HME gas delivered to the humidity level of the device. This standard does not apply to passive HMEs, namely in the inspiratory phase as part of the patient exhaled moisture and heat again to return to the breathing circuit without increasing the moisture and heat of the device. YY/T 0735. 1 and YY/T 0735. 2 provides passive HMEs safety and performance requirements, and performance test methods are described. Breathing tube humidifier can be pneumatic, electric or a combination of both. However, this standard applies to based on GB 9706. 1 based on a specific standard, which takes into account all of the general requirements for safety, not just electrical safety, but also including non-electric humidifier for many of the requirements. This standard specifies GB 9706. 1 shall apply in a wet system means that only relevant when considering the needs of the application of that section to save, This standard does not apply to commonly referred to as "indoor humidifier" those devices, or use the heating, ventilation and air conditioning systems humidification, does not apply to infant incubator has been integrated into the humidifier. This standard does not apply to patients with drug delivery atomizer. | YY 0786-2010: Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
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Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
YY 0786-2010/ISO 8185..2007
Medical respiratory tract humidifier
Specific requirements for respiratory humidification systems
(ISO 8185..2007, IDT)
Published on December 27,.2010
2012-06-01 Implementation
Published by the State Food and Drug Administration
Contents
Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 General requirements and test requirements 3
5 Classification 4
6 Identification, marking and documentation 4
7 Input power 5
8 Basic safety type 5
9 Removable protective device 5
10 Ambient conditions 5
11 No general requirements 6
12 No general requirements 6
13 Overview 6
14 Classification requirements 6
15 Limitations of voltage and/or energy 6
16 Housing and protective cover 6
17 Isolation 6
18 Protective earth, functional earth and potential equalization 6
19 Continuous Leakage Current and Patient Auxiliary Current 6
20 Dielectric strength 6
21 Mechanical strength 6
22 Moving parts 6
23 Faces, corners and edges 7
24 Stability during normal use 7
25 Splash 7
26 Vibration and noise 7
27 Pneumatic and hydraulic power 7
28 Hanging 7
29 X-ray radiation 7
30 α, β, γ, neutron radiation and other particle radiation 7
31 Microwave radiation 7
32 Optical radiation (including laser) 7
33 Infrared radiation 7
34 UV radiation 7
35 Acoustic energy (including ultrasound) 7
36 Electromagnetic compatibility 8
YY 0786-2010/ISO 8185..2007
37 Location and basic requirements 8
38 Logo, random file 8
39 Common requirements for AP and APG equipment 8
40 Requirements and tests for AP-type equipment, its parts and components 8
41 Requirements and tests for APG equipment and its parts and components 8
42 over temperature 8
43 * Fire 8
44 Overflow, liquid spills, leaks, moisture, ingress, cleaning, disinfection, sterilization and compatibility
45 Pressure vessels and pressure parts 9
46 Human error 9
47 Electrostatic Charge 9
48 Biocompatibility 10
49 Power supply interruption 10
50 Accuracy of working data 10
51 * Prevention of Dangerous Outputs 10
52 Abnormal operation and fault conditions 11
53 Environmental test 11
54 Overview 11
55 Housings and covers 11
56 Components and Components 11
57 Network power supply section, components and wiring 12
58 Protective Earth--Terminals and Connections 12
59 Structure and wiring 12
101 * Humidification System Output 13
102 Water storage tank 13
103 Alarm system 13
Appendix AA (Informative) Basic Principles 14
Appendix BB * (Normative Appendix) Measurement of Display Temperature Accuracy 19
Appendix CC (informative) Specific enthalpy calculation 20
Appendix DD (Normative) Temperature Sensors and Interfaces 24
Appendix EE (Normative) Determination of Humidification System Output 25
Appendix FF * (Normative) Standard temperature sensor 27
Appendix GG (informative) Environmental aspects 28
Appendix HH (Informative) Basic Principles of Safety and Performance 30
Appendix II (Informative) Terminology-Index 32
References 33
YY 0786-2010/ISO 8185..2007
Foreword
This standard is equivalent to ISO 8185..2007 "Special Requirements for Respiratory Humidification Systems for Medical Respiratory Humidifiers" (English version).
The main differences between this standard and ISO 8185..2007 are as follows.
--- The IEC and ISO international standards cited in ISO 8185..2007 have been converted into national standards and industry standards.
China standards are cited as normative use; if there is no corresponding translation into national standards and industry standards, the cited IEC
And ISO international standards are used as norms.
--- ISO 7396-1..2002 "Medical Gas Piping System Part 1 Medical Compressed Gas and Vacuum Piping" has been adopted internationally
ISO 7396-1..2007 replaces, so this standard directly references ISO 7396-1..2007.
--- The original standard of this standard 14.6 was “B-type, BF-type and CF-type equipment”. According to the adjusted definition of GB 9706.1-2007,
Changed to "B-type, BF-type and CF-type application part".
Chapter 36 of this standard is compatible with YY 0505-2005 "Medical Electrical Equipment-Part 1-2. General Safety Requirements"
Standard. Electromagnetic Compatibility Requirements and Tests "implemented simultaneously.
Appendix BB, Appendix DD, Appendix EE, and Appendix FF of this standard are normative appendixes, Appendix AA, Appendix CC, Appendix GG,
Appendix HH and Appendix II are informative appendices.
This standard was proposed and managed by the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This standard was drafted. Beijing Yi'an Medical System Co., Ltd.
The main drafters of this standard. Kou Liqiang and Li Yunfei.
YY 0786-2010/ISO 8185..2007
Introduction
This standard 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 all medical devices used or monitored by qualified personnel in general medical and patient settings
The basic standard for electrical equipment safety, it also includes some requirements for reliable operation to ensure safety. Common and side-by-side standards
Combined with proprietary standards. The collateral standard includes requirements for specialized technology and/or hazards, and applies to all applications, such as medical systems
System, EMC, radiation protection for diagnostic X-ray equipment, software, etc. Specific standards apply to specialized equipment types, such as medical electron accelerators,
Frequency surgical equipment, hospital beds, etc.
Note. For the explanation of the parallel standard and the special standard, please refer to 1.5 of the first part of GB 9706.1-2007 and Chapter A.2 of Appendix A, respectively.
This standard is consistent with the structure of ISO 8185.Therefore, the numbering of individual chapters, chapters, and articles is different from the general standard.
The chapters are consistent with the general standards, and the specific differences are shown in the following table.
Chapter This Standard General Standard (GB 9706.1-2007)
1 Scope Application and purpose
2 Normative references documents terms and definitions
3 General requirements for terms and definitions
4 General requirements and general requirements for testingGeneral requirements for testing
101 Humidification System Output-
102 Liquid container-
103 Alarm System-
Changes and additions to the text of the General Standard are specified by using the following words.
--- "Replace" means that the chapter or section of the general standard is completely replaced by the text of this standard.
--- "Add" means that the relevant text of this standard is new content added to the general standard.
--- "Modified" means that the existing content of the general standard has been partially modified.
To avoid confusion with the revised version of the General Standard itself, the chapters, bars, tables and figures added to this standard are numbered starting from 101;
Font size aa), bb) number. Supplementary appendixes are numbered AA, BB, etc.
The following typographical fonts are used in this standard.
--- Requirement, determine its compliance, definition, use Song font.
--- Notes and examples. the smaller one.
--- Description and test method of document adjustment type. italics.
--- Terms defined in the General Standard and this standard. bold.
In this standard, the text marked with an asterisk (*) provides an explanation of the principle in Appendix AA.
Humidifiers are used to increase the humidity of the gas delivered to a patient. Gases used for medical purposes do not contain sufficient moisture.
Injuries or irritation to the respiratory tract or upper respiratory tract are thickened by secretions from patients with bypass. Reduced relative humidity at patient connection port may cause trachea
Or it may cause the tracheobronchial secretion at the tracheotomy and intubation to be thick and dense, which may cause the airway to narrow or even block. Heating can increase wetness
Vapor output from the carburetor.
In addition, many humidifiers use breathing tube heating to improve conversion efficiency and reduce water and heat losses. At this time, the
The breathing circuit of ventilator and anesthesia machine may not be able to withstand the heat generated by the humidifier and the heating device of the breathing circuit.
Many humidifier manufacturers use off-the-shelf electrical connectors to power their electrically heated breathing circuits, so different manufacturers choose similar electrical connections
When the connector is used on its electric heating breathing circuit with different power, although the interface is the same, it is not interchangeable in electrical performance. Choose not
YY 0786-2010/ISO 8185..2007
Properly heating the breathing circuit can cause overheating, circuit fusing, burns to patients and operators, and fire. No need to specify a different system
Necessity of electrical connector interface compatibility between manufacturer's humidifier and breathing circuit.
The safe use of the humidifier is based on the interaction between the humidifier and various accessories, so this standard establishes the performance requirements of the entire system.
Requirements, optional accessories, such as. breathing circuit (both heated and unheated), temperature sensor and
Device.
YY 0786-2010/ISO 8185..2007
Medical respiratory tract humidifier
Specific requirements for respiratory humidification systems
1 Scope
In addition to the following, Chapter 1 of GB 9706.1-2007 applies.
Modifications (added at the end of 1.1).
This standard specifies the basic safety and basic performance requirements of humidification systems (see definition in 3.6). It also includes special features used in humidification systems.
Specific independent devices, such as breathing tube heating (breathing tube heating wire) and control devices for breathing tube heating (breathing tube heating control)
Note. The breathing circuit heating device belongs to medical electrical equipment and should comply with the regulations in GB 9706.1.
* This standard also includes the requirements for active HME (heat and humidity exchanger), which is to improve the delivery of HME to patients by actively heating and humidifying
Device for the humidity level of a gas. This standard does not apply to passive HMEs, that is, a portion of the moisture and heat that is exhaled by the patient during the inspiration phase
A device that returns to the breathing circuit without adding moisture and heat. YY/T 0735.1 and YY/T 0735.2 specify passive HMEs
The safety and performance requirements are described, and the methods of performance testing are described.
The breathing circuit humidifier can be pneumatic, electric or a combination of both. However, this standard is based on GB 9706.1
A special standard that takes into account all the general requirements for safety, not just electrical safety, but also non-electric but applicable
Due to many requirements of the humidifier. This standard specifies that the application of a clause in GB 9706.1 means that it is only applied when the requirements related to the humidification system
Consider the application of this clause.
This standard does not apply to those devices commonly referred to as "indoor humidifiers" or for humidification of heating, ventilation and air conditioning systems.
Not suitable for humidifiers that have been integrated into the incubator.
This standard does not apply to atomizing devices that deliver drugs to patients.
When planning and designing a product in accordance with this standard, consideration should be given to the environmental impact of the product throughout its life cycle. About Ring
Please refer to Appendix GG for environmental impact.
Note. Please refer to YY 0316 for additional information on environmental impact.
2 Normative references
The clauses in the following documents have become the clauses of this standard after being referenced. For dated references, all subsequent documents
The amendments (excluding the content of errata) or revisions are not applicable to this section. For undated references, the latest version (package
Including any modifications) apply to this standard.
GB/T 3767-1996 Acoustics Engineering method for measuring sound power level of noise source by approximating free field by sound pressure method
(eqv, ISO 3744..1994)
GB/T 4999-2003 Anesthesia breathing equipment term (ISO 4135..2001, IDT)
GB/T 5332-2007 Test method for ignition temperature of flammable liquids and gases (ISO 60079-4. 1975, IDT)
GB 9706.1-2007 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 11243-2008 Medical electrical equipment Part 2. Particular requirements for the safety of infant incubators (IEC 60601-2-19..1990,
IDT)
YY 0461-2003 Breathing circuit for anesthesia machine and ventilator (ISO 5367..2000, IDT)
YY 0505-2005 Medical electrical equipment. Part 1-2. General requirements for safety. Parallel standards. EMC requirements and tests.
(IEC 60601-1-2..2001, IDT)
YY 1040.1-2003 Conical joints for anesthesia and breathing equipment-Part 1. Taper heads and sleeves (ISO 5356-1..1996, IDT)
YY 0786-2010/ISO 8185..2007
YY 0709-2009 Medical electrical equipment. Part 1-8. General requirements for safety. Collateral standard. General requirements for medical electrical equipment.
Testing and guidance of alarm systems in medical equipment and medical electrical systems (IEC 60601-1-8..2003, IDT)
YY/T 0735.1 Heat and humidity exchangers (HMEs) for anesthesia and breathing equipment for humidifying human breathing gas. Part 1. Use
HMEs with tidal volume above 250mL (YY/T 0735.1-2009, ISO 9360-1..2000, IDT)
YY/T 0735.2 Heat and humidity exchangers (HMEs) for anesthesia and breathing equipment for humidifying human breathing gas. Part 2. Use
HMEs with a tidal volume above 250 mL for tracheostomy patients (YY/T 0735.2-2009, ISO 9360-2..2001, IDT)
ISO 7396-1..2002 Medical gas piping systems. Part 1. Medical compressed gas and vacuum piping
ISO 10524-1..2006 Pressure regulators for medical gases. Part 1. Pressure regulators and pressure regulators with flowmeter equipment
Section
IEC 60601-1-6..2004 Medical electrical equipment. Part 1-6. General requirements for safety. Collateral standard. Usability
3 terms and definitions
The following terms and definitions established in GB 9706.1-2007, GB/T 4999-2003 and YY 0709-2009 apply to this
standard.
Note. For ease of reading, the sources of terms and definitions cited in this standard are provided in Appendix II.
3.1
Accessible surface temperature
In normal use, including when the humidifier is filled or refilled with liquid, the temperature at which the surface can be reached with the palm or fingers.
3.2
Active HME activeHME
A device that actively replenishes water, steam, or heat to the HME to increase the humidity of the gas delivered from the HME to the patient.
3.3
Delivered gas temperature
The temperature of the gas, or aerosol, or a mixture of the two at the patient connection port.
3.4
Breathing tube heating controller heatedbreathingtubecontroler
Device that controls temperature or heating in the breathing circuit.
Note. The controller can be independent or integrated in the humidifier.
3.5
Humidification chamber
Vaporization or atomization in a humidifier.
3.6
Humidification system
Complete system including humidifier and accessories.
Note. The accessories should include breathing circuit (with or without heating), breathing circuit heater, breathing circuit heating controller and temperature sensor.
3.7
Humidification system output
Under normal human temperature (37 ° C), standard atmospheric pressure [101.3kPa (760mmHg)] and saturated water vapor conditions (BTPS),
The total water content (in the form of liquid and water vapor) per unit volume of gas at the connection port.
3.8
Humidifier
A device that increases the moisture inhaled by atomization, or steam, or a mixture of the two.
Note. This term includes evaporation, through-bubble and ultrasonic humidifiers and active HMEs.
YY 0786-2010/ISO 8185..2007
3.9
Liquidcontainer
Humidifier for liquid storage.
Note 1. The water storage tank should be accessible by breathing gas.
Note 2. The water storage tank should also be part of the humidification chamber.
Note 3. The water storage tank should be removable when filling.
3.10
Liquidreservoir
Part of the humidifier as a supplement to the water storage tank.
3.11
Maximum operating pressure
The maximum pressure in the humidification chamber.
3.12
Measured gas temperature
The temperature of the gas or aerosol or both measured by the humidification system, if applicable, can be used for display.
3.13
Relative humidity
At a certain temperature, the ratio of the water vapor pressure to the saturated water vapor pressure expressed as a percentage.
3.14
Settemperature
The temperature of the measured gas is maintained at the temperature expected by the humidification system.
Note. The set temperature should be adjustable by the operator.
4 General requirements and test requirements
Except for the following parts, chapters 3 and 4 of GB 9706.1-2007 apply.
3.6
increase.
aa) The humidifier is operated without any liquid;
bb) If the humidifier includes a temperature sensor, any single fault condition of the temperature sensor, such as.
--- The temperature sensor is open all the way;
--- The temperature sensor is short-circuited all the way;
--- the temperature sensor is detached from the humidity control system; or
--- The temperature sensor has come off from the breathing tube or humidifier.
cc) Safety hazards due to software errors (such as thermal damage to the patient).
4.1 Other conditions
increase.
aa) The test gas should be medical air, medical oxygen or a mixture of both;
Note. Adjust the test gas to BTPS state (37 ℃, relative humidity is 100%, 101kPa).
bb) Unless otherwise required, if provided, the test shall be performed at the temperature of the test environment at the start of the test with distilled water as required in the instructions.
Reservoir and water reservoir are added to maximum capacity.
cc) In order to check compliance with this standard, the measurement point of the temperature of the transmitted gas in the breathing circuit is not more than the patient connection port
50mm. (See Appendix BB).
YY 0786-2010/ISO 8185..2007
5 Categories
GB 9706.1-2007 Chapter 5 applies.
6 Identification, marking and documentation
Except for the following parts, Chapter 6 of GB 9706.1-2007 applies.
6.1 External marking of equipment or equipment parts
modify.
g) * Connection to power
Note. The breathing tube heating connector connected to the humidifier or breathing tube heating controller should be marked when connected to the power line.
Amendments (added at the end of this article)
p) output
Note. The electrical connector of the application part connected to the humidifier for heating the breathing circuit should be labeled with the output.
increase.
aa) The external marking should also include the following.
1) If the correct use of the humidifier is affected, the maximum and minimum liquid levels should be marked on it;
2) If there are components on the humidifier or humidification system that are sensitive to the airflow direction, the airflow direction should be marked;
3) If a pressure relief device is provided, the opening pressure shall be marked on the pressure relief device or the nearest position;
4) * If the humidifier is driven by compressed gas, the required flow rate and pressure range of the compressed gas should be marked;
5) If applicable, the humidification system and its components shall be marked for proper disposal.
6.8.2 Instruction Manual
a) General content
Modification (added after the last dash)
The instruction manual should also include the following information.
1) * For humidifiers, specify at least one set of accessories and a ventilator necessary for the intended use (if applicable)
Potentially unsafe warnings when using non-specified matching humidifier breathing circuits, accessories, and ventilator.
2) At least one set of breathing tubes or other accessories used in the expected humidification system meets the requirements of this standard.
3) * It should be mentioned that there is a potential unsafe condition when using the matching breathing circuit or accessories with non-designated humidifier and ventilator.
Warning.
4) * If the humidifier draws in air to dilute oxygen, the following information should be provided.
i) It should be stated that when auxiliary equipment is used, the concentration of oxygen will be affected when the humidifier is partially blocked downstream;
i) It is recommended to measure oxygen concentration at the patient's delivery end.
5) The intended use of the humidification system, whether the humidification system is intended for patients with bypassed upper airways.
6) * If the humidifier is expected to be used in patients with bypass of the upper airway, the humidification system should meet the minimum output of 33mg/L
Under the conditions, the range and setting of the gas flow rate adjustment.
7) The maximum volume of water that can be used for evaporation in the water storage tank and water reservoir (if provided), expressed in mL.
8) If the humidifier is driven by compressed gas, the rated flow rate and air supply pressure range, and the method of pipe connection shall be stated.
9) Maximum working pressure of the humidifier.
10) * If applicable, specify the inspiratory and expiratory pressure drop as the flow rate passes through the humidification system or individual components. Measurement of pressure drop should be
According to YY 0461 or other equivalent methods. The pressure drop of active HMEs should be based on YY/T 0735.1 and YY/T 0735.2
Standard test.
11) If applicable, leakage of the humidification system or its individual components at the maximum working pressure. Leak testing should be based on YY 0461 or
Equivalent method. The leakage of active HMEs should be tested according to YY/T 0735.1 and YY/T 0735.2 standards.
YY 0786-2010/ISO 8185..2007
12) * Internal compliance of the humidification system or individual components, if applicable. If internal compliance is affected by the liquid contained in the humidifier, then
No maximum and minimum compliance values should be provided. Internal compliance measurements should be based on YY 0461 or other equivalent methods. Active
For non-patient-contact parts, methods suitable for cleaning these parts should be listed.
7 Input power
GB 9706.1-2007 Chapter 7 applies.
8 Basic safety types
GB 9706.1-2007 Chapter 8 applies.
9 removable protection
Chapter 9 of GB 9706.1-2007 applies.
10 Ambient conditions
Except for the following parts, Chapter 10 of GB 9706.1-2007 applies.
10.2.1 Environment
replace.
a) Within the working ambient temperature range specified in the random documents.
increase.
10.2.101 Driving air source
If the humidifier is expected to be connected to a medical gas supply system (medical gas piping system in accordance with ISO 7396-1 or
ISO 10524-1 pressure regulator), should be able to operate normally within the range of air source pressure 280kPa ~ 600kPa, and meet the requirements of this standard
begging. And when the pressure of the medical gas source reaches 1000kPa in a single failure state, it should not cause any safety danger.
YY 0786-2010/ISO 8185..2007
11 No general requirements
12 No general requirements
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