GB 9706.28-2006 English PDF
Basic dataStandard ID: GB 9706.28-2006 (GB9706.28-2006)Description (Translated English): Medical electrical equipment -- Part 2: Particular requirements for the safety of lung ventilators -- Critical care ventilators Sector / Industry: National Standard Classification of Chinese Standard: C46 Classification of International Standard: 11.040.10 Word Count Estimation: 53,556 Date of Issue: 2006-07-25 Date of Implementation: 2007-05-01 Adopted Standard: IEC 60601-2-12-2001, MOD Regulation (derived from): Announcement of Newly Approved National Standards No. 9, 2006 (No. 96 overall) Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China Summary: This Chinese standard applies to the treatment of ventilator (defined by 2. 1. 125) security. This standard does not apply to special continuous positive airway pressure (CPAP) devices, sleep apnea therapy equipment, strengthen ventilator, anesthesia ventilator, emergency ventilator, high-frequency and high-frequency jet ventilator oscillating ventilator does not include hospital used only as increasing patient ventilation equipment. GB 9706.28-2006
Medical electrical equipment.Part 2. Particular requirements for the safety of lung ventilators.Critical care ventilators
ICS 11.040.10
C 46
National Standards of People's Republic of China
Medical electrical equipment
Part 2. Specific requirements for ventilator safety
Therapeutic ventilator
2006-07-25 posted
2007-05-01 Implementation
First overview
Except for the following, the chapters and clauses of this chapter of the General Standard apply.
1 * Scope and purpose
Except for the following, this chapter of the general standard applies.
1.1 Application
increase.
This specific standard applies to the safety of therapeutic ventilators (as defined in 2.1.125).
This specific standard does not apply to CPAP equipment, sleep apnea therapy equipment, boosters, anesthesia breathing
Machine, emergency ventilator, high-frequency jet ventilator and high-frequency oscillatory ventilator
device.
1.2 * Purpose
increase.
The purpose of this special standard is to specify special safety requirements for therapeutic ventilator.
1.3 * Specific standards
increase.
This special standard refers to GB 9706.1.1995 "Medical Electrical Equipment Part 1. General Safety Requirements" and supplements IEC
60601-1. 1988 "Medical Electrical Equipment Part 1. General Requirements for Safety" Amendment 2 (1995).
When GB 9706.1-1995 is referred to in this special standard, it is referred to as "general standard" for short. For the standard GB 9706.15-1999
(IEC 60601-1-1..1995X (Medical electrical equipment Part 1. General safety requirements 1. Collateral standard. Medical electrical system safety
"Qiu" is referred to as "parallel standard".
The term "wood standard" includes wood-specific standards and common and juxtaposed standards used in conjunction with them.
The numbers of chapters, chapters, and bars of wood-specific standards correspond to the numbers of general standards. Modifications to the text of the General Standard require the use of the following terms.
"Replace". means that the chapter or section of the general standard is completely replaced by the text of this special standard;
"Increase". means that the wood standard for wood is added to the requirements of the general standard;
“Modification”. means that the chapter or section of the general standard is modified by the text of this special standard.
The bars, diagrams and tables added to the general standard are numbered from 101 to 101, the appendixes are AA, BB, etc., and the additions are aa), bb), etc.
Chapters and articles that have been prepared are marked with "
The standard normative part, which only provides additional information, it is not the object of the test.
This special standard does not mention the general standards, corresponding chapters, chapters, and articles. These articles, chapters, and articles of the general standard are applicable without modification.
(Although it may not be relevant); some part of the general standard, although it may be relevant, is not applicable and is clearly specified in the wood-specific standard.
The requirements of wood-specific standards take precedence over the requirements of general standards.
increase.
1.5 tied standards
In the series of safety requirements for medical electrical equipment, the collateral standards indicate that the general safety requirements apply to.
These preparations are described in informative appendix AA. Appendix AA is not a wood-specific sign.
A group of medical electrical equipment (for example. radiological equipment);
A special feature (eg electromagnetic compatibility) of all medical electrical equipment not specified in the general safety standards;
A juxtaposed standard is applicable to a special standard, then the special standard takes precedence over this juxtaposed standard.
2 terms and definitions
Except for the following, this chapter of the general standard applies.
2.1 Equipment parts, accessories and accessories
2.1.5
Applied part
replace.
Part of the normal used equipment.
A part of the body that should be in contact with the patient in order to perform the function of the device; or
-Parts that may be used to reach the patient; or
-The part that needs to be touched by the patient.
increase.
Or the ventilator 屮 any part connected to the respiratory system.
replace.
2.1.7
F-type isolated (floating) applied part (hereinafter referred to as F-type applied part)
The insulation of the application part that is isolated from the rest of the device should be such that when an unexpected voltage appears on the external device connected to the patient,
There should be no current between the application part and ground that is higher than the allowable value for patient leakage current in a single fault condition.
The F-type application part is a BF-type application part or a CF-type application part.
2.1.15
Patient circuit
Any electrical circuit that contains one or more patient connections.
Patient circuits include all conductive parts (see Chapter 20) that are not insulated with
Isolation of the connected part of the conductive part that does not meet the creepage distance and clearance requirements (see 57.10).
Add definition.
2.1.2 3
Patient connection
In the normal state or single fault state, each part of the application through which current can flow between the patient and the device is independent
section.
2.1.2 4
Type B applied part
Protection against electric shock in accordance with the wood standard 屮, especially the application part regarding the allowable leakage current requirements, use Appendix D 屮 Table D2
Mark with the symbol 1.
Note. The Type B application section is not intended for direct use on the heart.
2.1.2 5 *
Type BF applied part
In accordance with the requirements of this standard, the degree of protection against electric shock is one level higher than that of the type B application part. The type F application part uses the appendix.
D Table D2 is marked with the symbol 2.
Note. The BF type application part is not suitable for coiled connection to the heart.
2.1.2 6
Type CF applied part
Meet the requirements specified in this standard, the degree of protection against electric shock is higher than that of the BF-type application part of the F-type application part, using the appendix
D Table D2 is marked with the symbol 3.
2.1.27 s
Defibrillation-proof applied part
A part of the application that protects the patient against defibrillation discharge effects.
Add definition.
2.1.101
Bacteria filter
Device for removing airborne germs and particles.
bacterial filter
2.1.102
Clearly legible
The visual attribute of the device display content, this attribute enables the operator to qualitatively or quantitatively identify (or identify) the device in a specific group
Value or function under ambient conditions.
2.1.103
Emergency air intake port
Special air inlet for inhaling air when fresh gas supply is insufficient and/or pressurized gas is insufficient
2.1.104
Flovv-direction-sensitive component
Airflow should flow in a specific direction to ensure proper functioning and/or patient safety.
2.1.105
Fresh gas
Breathable gas delivered to the respiratory system.
2.1.106
Fresh-gas intake port
Except for the emergency air intake, the ventilator or the patient's intake of fresh gas
2.1.107
Exhaust port
Excess gas and/or exhaust gas is discharged to the port through which the atmosphere or anesthetic gas purification system flows.
2.1.108
Intake port
An interface through which the ventilator or patient can draw gas.
2.1.109
Gas output port
The ventilator interface, so the gas is input to the patient-end interface through the pipeline at breathing pressure.
2.1.110
Gas return port
The ventilator is connected to U, and the gas is thereby discharged from the patient through the tube at a breathing pressure.
2.1.111
0 high-pressure input port
Able to input gas with supply pressure greater than 100 kPa to U.
2.1.112
Pressurized gas
The fresh gas that drives the ventilator can also supply air to the patient.
2.1.113
Pressurized gas input port
Input interface for pressurized gas.
Note. The gas supplied by n is passed through this connection under the pressure driving. The gas may be supplied under a controlled pressure or under a controlled stream S.
2.1.114
Disable (disabled)
A state in which an alarm system or part of an alarm system cannot issue an alarm signal.
Note 1. Disabled applies to individual alarm environments, group alarm environments, or the entire alarm system of a device.
Note 2. Disabled can be used by the operator or by the device (for example, in heating mode K or when no patient is connected).
Note 3. The duration of disabling is usually uncertain. The disabling can only be stopped by the operator directly or by the operator changing the setting.
2.1.115
Low-pressure input port
Gas input connection with supply pressure not exceeding 100 kPa.
2.1.116
Manual ventilation port
A ventilator interface that can be connected to a manual compression device.
2.1.117
Maximum ultimate pressure
Maximum pressure of the patient's connection U during normal use and single fault conditions.
limited pressure, /? lim, maxjPlim.maximum
2.1.118
Working pressure pw,
The maximum pressure that can be reached by the patient connection port during the inhalation phase when the ventilator is operating normally.
Note. Even if it is not adjustable, this maximum working pressure is not greater than the maximum ultimate pressure.
working pressure, /? w.maximum
2.1.119
Minimum ultimate pressure plim,
Minimum pressure at the patient connection during normal use and single fault conditions
Note. This pressure can be lower than atmospheric pressure.
limited pressure, plim.
2.1.120
Minute volume
Volume of gas inhaled or exhaled from the patient's lungs every minute.
2.1.121
Operator's position
According to the user manual, the operator's position relative to the device during normal use.
2.1.122
Patient connection port
An interface to the ventilator breathing system of a patient or test instrument.
Note. Interface between ventilator breathing system and patient.
2.1.123
Respiratory pressure
The pressure difference between the minimum working pressure and the maximum T. working pressure.
2.1.124
Suspended
The operator temporarily disables all audible alarms or all audible and visual alarms of the alarm system within a set time interval.
status.
2.1.125
Ventilator-critical care ventilator
Pivoting device designed to increase or supply patient ventilation.
2.1.126
Ventilator breathing system, VBS
Respiratory system, including low-pressure gas inlets, gas inlets and patient connections. If fresh gas inlets and outlets,
Including fresh gas inlet I4 and outlet U1
2.2 Equipment Type (Classification)
2.2.7
Direct cardiac application
Replace "device" with "application part" in the text.
2.2.9 Not used.
2.2.15
Medical electrical equipment [hereinafter referred to as equipment]
Add a second paragraph to the definition.
The equipment includes those accessories specified by the manufacturer as necessary for the equipment to function properly.
2.2.20 Not used.
2.2.24 x Not used.
2.2.25 Not used.
2.2.26 s Not used.
2.2.28 Not used.
2.6.4
Functional earth terminal
Add an asterisk after the terms.
2.9.13
Thermostat
replace.
Temperature-sensitive controller, used to keep the temperature between two specified values during normal operation, and may have a device set by the operator.
3 General requirements
Except for the following, this chapter of the general standard applies.
3.r increase.
Any failure that can cause harm but will not be detected by inherent testing methods or regular inspections (such as oxidant leaks, software failures), should be
Treated as a normal condition rather than a single fault condition.
3.4 Added.
The security risk analysis method shall be carried out in accordance with the provisions of YY/T 0316-2003.
3.6 ^ The following single fault conditions have specific requirements and experiments in this standard.
Replace e) to j).
e) Leakage of flammable anesthetic gas mixture with oxygen or nitrous oxide (see Chapter 6)
0 Liquid leakage (see 44.4).
g) Failure of electrical components that may cause safety hazards (see Section 9).
h) Failure of mechanical parts that may cause safety hazards (see Section 4).
6.1 External marking of equipment or equipment parts
e) Production and supply units
Add after the original sentence. "The manufacturer's address or the name and address of an authorized representative should also be marked."
k) Network power output
replace.
If one (several) auxiliary network power outlets are provided, the maximum allowable output should be indicated on the output port in amps or volts.
Out value.
l) Classification
笫 The first pair of parentheses in two dashes. replace "(1, 4 or 7), with" (1 to 8) "
In the second dashed line, delete the second pair of parentheses and their contents, and delete the symbols 11, 12, and 13 in Appendix D, Table D1.
Replace the content of the = dash line.
-For B, BF and CF application parts, the application part symbols are classified according to the degree of protection against electric shock (see Appendix D, Table D2, Symbols
1, 2, and 3).
In order to be clearly distinguished from the symbol 2, the symbol 1 should not be used as a mark surrounded by a box.
If the equipment has more than one application part with different degree of protection against electric shock, on these application parts, the corresponding output U
Or near the output (connection point), the relevant mark should be clearly marked.
Anti-defibrillation application parts shall be marked with corresponding symbols (see Appendix D, Table D2, symbols 9, 10 and 11).
Add the fourth dashed line as follows.
-If some patient cables are protected against the effects of defibrillation discharge, near the corresponding output U1, it should be marked with Appendix D table
The symbol 14 in D1.
n) ^ fuse
Add an asterisk after the item number.
q) Physiological effects (symbols and warnings)
If appropriate, add between the first and second paragraphs. "There should be a warning sign for the use of rubber."
v) Protective packaging
Add the second paragraph as follows.
Sterile packaging of equipment or accessories should be labeled "sterile".
Addition.
aa) All high-pressure gas inlets should be marked with the gas name or gas symbol in accordance with the provisions of GB 7144-1999, and should be marked with
Supply pressure range and rated maximum flow requirements. If a gas-specific color marking is used on the flow controller or flexible hose,
In accordance with the provisions of GB 7144.1999.
bb) If there is an interface accessible to the operator, the interface shall be marked with the following terms.
-Pressurized gas input. "Pressurized gas input";
Manual vent. "Qi Xiang,
-Gas output U. "gas output";
-Return air port. "Return air";
-Exhaust port. "Exhaust";
The above interface can also choose other terms or symbols, which should be explained in the instruction manual
-Emergency air intake. "Warning. Emergency air intake-Do not block."
cc) Any storage and/or shipping mark.
del) Any special warnings and/or warnings related to the direct operation of the ventilator.
ee) Where applicable, the life of the equipment or accessory shall be marked in years and months where appropriate.
Note. When appropriate, the symbol number 3.12 in YY/T 0466-2003 can be used.
ff) The packaging of single-use breathing accessories should clearly indicate the following.
-Content description;
-"Single use" and "Do not reuse" words, where appropriate, the serial number in GB/T 16273.1-1996 should be used
The graphic symbol of 123 or the symbol number 3.2 in YY/T 0466-2003;
-If applicable, the words "sterilized" or, where appropriate, the ones numbered 3.20 ~ 3.24 in YY/T 0466-2003 should be used
symbol;
The name and address of the manufacturer or authorized representative;
-The identification mark of the product category, or, where appropriate, the symbol number 3.15 in YY/T 0466-2003 should be used;
-The identification mark of the product batch or serial number, or, where appropriate, the number 3.14 in YY/T 0466-2003 or
3.16 symbol;
-The word "rubber" should be clearly marked on the package containing rubber.
gg) The packaging of reusable breathing accessories should clearly indicate the following.
Content description
-The name and address of the manufacturer or authorized representative;
-The identification mark of the product category, or, where appropriate, the symbol number 3.15 in YY/T 0466-2003 should be used;
The identification number of the product batch or serial number, or, where appropriate, the number 3.14 in YY/T 0466-2003 or
3.16 symbol;
-Recommended cleaning, disinfection and sterilization methods;
Note. The instructions for use may include recommended methods for cleaning, disinfecting, and sterilizing breathing accessories. See also 6.8.2 d)
-The word "rubber" should be clearly marked on the package containing rubber.
hh) All components that are sensitive to the direction of the air flow, if the operator can move them without using any tools, the components should be marked with
Clearly identifiable and permanently attached arrows indicate the direction of the air flow.
6.2 Equipment or markings inside the equipment
a) The last line of the first paragraph. Replace "6.1 z)" with "6.1".
d) Add a new paragraph as follows.
For batteries not intended to be replaced by the operator and batteries that can only be replaced when using tools, use a document
The identification mark mentioned in the
Add an asterisk after item e).
6.3 Control device and instrument marking
replace.
f) The functions of the operator controls and indicators shall be recognizable.
In the last line, after "Pass Inspection", add "and apply the durability test of 6.1."
Addition.
g) The numerical indication of the parameters shall be expressed in the International System of Units specified in GB 3100-1993 and the following combined units.
Units available outside the international system on the device.
[Plane] Angle unit.
• revolutions,
• taper,
• degrees,
• [Angle] minutes,
[Angle] seconds;
-time unit.
?Minute,
......
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