YY/T 1522-2017 (YY/T1522-2017, YYT 1522-2017, YYT1522-2017) & related versions
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Flow-metering devices for connection to terminal units of medical gas pipeline systems
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YY/T 1522-2017
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YYT 1522-2017
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YY/T 1522-2017: PDF in English (YYT 1522-2017)
YY/T 1522-2017
Flow-metering devices for connection to terminal units of medical gas pipeline systems
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Connected to medical gas pipeline
System terminal flow measuring device
(ISO 15002.2008, MOD)
Released on.2017-03-28
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 2
4 Flow measurement system and device configuration 3
5 General requirements 3
6 Test method 8
7 Logo, color identification and packaging 9
8 Information provided by the manufacturer 11
Appendix A (informative) Basic Principles 12
Appendix B (informative) Configuration of flow measurement systems and devices 13
Appendix C (informative) Environmental issues 16
Reference 17
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the redrafting method to modify the flow measurement device connected to the terminal of the medical gas pipeline system using ISO 15002.2008.
Set" (English version).
The technical differences between this standard and ISO 15002.2008 and their reasons are as follows.
--- Regarding the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory References”, and the specific adjustments are as follows.
● Replace ISO 32 with GB 50751-2012 (see Table 2);
● Replace ISO 5359 with YY/T 0799 (see 5.4.1.1, Table 2);
● Replace ISO 15001 with YY/T 0882 (see 5.3.1, 5.5.1);
● Replace ISO 14971 with YY/T 0316 (see 5.1, 5.2);
● Replace ISO 9170-1 with YY 0801.1 (see 5.4.1.1);
● Added normative reference document GB/T 1226-2010 (see 5.4.7.5.1).
Compared with ISO 15002.2008, this standard makes the following editorial changes.
--- "This International Standard" is replaced by the word "this standard";
---Involving numbers with the decimal symbol "." instead of the symbol ",";
--- Removed the preface of ISO 15002.2008;
--- Removed from 1.2" Note. Certain regional or national regulations may allow oxygen connectors to be used in oxygen-enriched air."
--- Removed 5.2, 5.3.2, 5.3.6, 5.4.1.2, 5.4.6.2, 5.4.6.3, 5.4.7.2, 5.4.7.3, 5.4.7.5.1, 5.4.8.2, 5.4.8.3.1 ,
5.5.1, 5.5.2, 5.5.3 “Note. Certain regional or national regulations may require an authoritative authority or assessment agency with decision
Provision of evidence (such as the reporting body of the EEA). ”
--- Removed the word ''oil ban'' in 7.1.1 from the relevant national language."
--- The international standards involved in the references are correspondingly adopted as national standards and industry standards. This standard is based on the corresponding national standard.
Standard and industry standards are used as references.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This standard was drafted. Shanghai Medical Device Testing Institute, Shanghai Dräger Medical Devices Co., Ltd., Jierui Enterprise (Shanghai) Co., Ltd.
the company.
The main drafters of this standard. Li Min, Ding Deping, Hu Yuegang.
introduction
Flow measuring devices are widely used to deliver medical gases provided by medical gas supply systems to patients. These devices need to be at different temperatures
Provides accurate gas flow under conditions of inlet and inlet pressure. Therefore, it is important to specify the operating characteristics and test methods of the flow measuring device.
Special attention to this standard.
---Safety (safe handling of mechanical strength, overpressure, fire protection);
--- Gas specificity;
---clean;
---Material suitability;
---Accuracy;
---test;
--- Identification;
---Information provided.
Appendix A contains some of the basic principles required by this standard. Numbered with an asterisk (*), with a corresponding base in Appendix A
This principle, the basic principle is added to provide additional annotations to explain the reasons for this requirement and recommendations. Generally believe that know
The reasons for these requirements not only contribute to the correct application of this standard, but will also accelerate the subsequent revision of this standard.
Connected to medical gas pipeline
System terminal flow measuring device
1 Scope
1.1 This standard applies to.
--- at the end of the medical gas pipeline system, connected or disconnected by the operator directly or through a flexible connection assembly, for adjustment,
a flow measuring device for measuring flow rate and transporting medical gas;
--- A flow measuring device that is connected and disconnected by an operator at a gas-specific connection point of a device (eg, a pressure regulator).
1.2 This standard applies to.
1) Flow measuring device for the following medical gases.
---oxygen;
--- nitrous oxide (laughing gas);
---medical air;
---carbon dioxide;
--- Oxygen/nitrous oxide (laughing gas) mixture [50%/50% (volume fraction)];
--- A specific mixture of the above gases.
2) Flow measuring device for the following gases.
---Oxygen-enriched air;
---氦气;
--- Helium.
1.3 This standard does not apply to electrical or electronic flow measuring devices.
1.4 This standard does not apply to gases that drive surgical instruments.
2* Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 50751-2012 Technical specification for medical gas engineering
GB/T 1226-2010 general pressure gauge
YY/T 0316 Medical Device Risk Management for Medical Devices (YY/T 0316-2008, ISO 14971.2007, IDT)
YY/T 0799 Medical gas low pressure hose assembly (YY/T 0799-2010, ISO 5359.2008, MOD)
YY 0801.1 Medical gas pipeline system terminal - Part 1. Terminals for compression of medical gases and vacuum (YY 0801.1-
2010, ISO 9170-1.2008, MOD)
YY/T 0882 Compatibility of anesthesia and respiratory equipment with oxygen (YY/T 0882-2013, ISO 15001.2003, IDT)
ISO 7396-1.2007 Medical gas pipeline systems - Part 1. Pipe systems for compression of medical gases and vacuums (Medical
gaspipelinesystems-Part 1. Pipelinesystemsforcompressedmedicalgasesandvacuum)
Gas cylinders and valves - Gas and gas - Part 3. s.
Transportablegascylinders-Compatibility ofcylinderandvalve materials with gas
contents-Part 3.Autogenousignitiontestinoxygenatmosphere)
ISO 19054 Rail system for supporting medical equipment (Railsystemsforsupportingmedicalequipment)
EN837-1.1996 Pressure gauges Part 1. Bourdon tube pressure gauges dimensions, measurements, requirements and tests (Pressuregauges-
Part 1. Bourdontubepressuregauges-Dimensions, metrology, requirementsandtesting)
EN1089-3.2004 Removable gas cylinders for gas cylinder identification (except LPG) Part 3. colour identification [Transportablegas
cylinders-Gascylinderidentification(excludingLPG)-Part 3.Colourcoding]
EN13544-2 Breathing apparatus - Part 2. Catheters and joints (Respiratorytherapyequipment-Part 2.
Tubingandconnectors)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
DISS connector DISSconnector
Diameter limit safety system connector diameterindexsafetysystemconnector
A set of inner and outer joint assemblies of different diameters that match each specific gas or facility to maintain gas specificity.
3.2
Flow meter flowgauge
A device that measures pressure and is calibrated to flow units.
Note. This flow meter does not measure flow. It indicates flow by measuring the upstream pressure of a fixed orifice.
3.3
Flow meter flowmeter
A device that measures and indicates a specific gas flow rate.
3.4
Flow measuring device flow-meteringdevice
A device with an inlet and an outlet connection and containing one of the following.
a) a flow meter with a flow control valve;
b) flow meter, fixed orifice with flow control valve;
c) One or more fixed orifices with flow selection mechanism.
Note. Typical examples of flow measurement systems and devices are given in Figure B.1 and Figure B.2.
3.5
Gas-specific gas-specific
Features to prevent cross-connections, allowing design to be used with only one gas or only vacuum.
3.6
Special gas connection port gas-specificconnectionpoint
A portion of the socket for receiving a dedicated gas insert.
3.7
Hose insert body hoseinsert
The part that is inserted into the lumen of the hose and fastened to the fitting on the hose.
3.8
Manufacturer manufacturer
A natural or legal person responsible for the design, manufacture, packaging, and identification of the device before the device is listed in its name, whether or not
I or a third party acting on his behalf.
3.9
Medical gas pipeline system medicalgaspipelinesystem
Central supply system with control equipment, including piping systems and terminals providing medical gas or vacuum, or any other
A device with a permanent piping system, but a medical source with a pressure regulator.
3.10
Medical gas supply system medicalgassupplysystem
a) a medical gas piping system, or
b) Non-permanent piping systems, but with a device for a medical gas supply with a pressure regulator.
3.11
NIST connector NISTconnector
Non-interchangeable threaded joint non-interchangeablescrew-threadedconnector
a set of outer and inner joints of different diameters and having left-hand or right-handed threads, respectively associated with mating joints of specific gases
Connect to maintain the specificity of the gas.
3.12
Insert probe
A gas-specific insert assembly designed to be inserted and secured in a socket.
3.13
Rated intake pressure ratedinletpressure
P1
The flow measuring device is designed to operate with maximum intake pressure.
3.14
Single fault condition singlefaultcondition
There is only one safety hazard in the equipment that fails, or only one external abnormal condition.
3.15
Socket socket
The pluggable part of the terminal, which can be either a part of the terminal as a whole or a terminal of the terminal through a dedicated gas interface
on. This section includes a dedicated gas connection.
3.16
Terminal terminalunit
The output port assembly of the medical gas supply system (in the case of a vacuum) is connected and disconnected by the operator.
4 Flow measurement system and device configuration
See Appendix B for a typical example of a flow measurement system.
5 General requirements
Note. Unless otherwise specified, the pressure in this standard is expressed in gauge pressure (for example, atmospheric pressure is defined as 0).
5.1 Security
The flow measuring device shall be in the normal state and single fault when transported, stored, installed, used and maintained according to the manufacturer's instructions.
In this state, there is no risk of higher than YY/T 0316 risk management program acceptance levels, and there is no risk associated with the intended application.
5.2 Alternative equipment
The material or structure used is different from this section (except for the size and distribution of DISS and NIST joints and inserts as inlet joints)
The flow measuring devices and components or components thereof, if they can be proved to be equivalent in safety, should be recognized (eg risk has been
Lowering to an acceptable level can be considered as meeting the requirement) unless the opposite objective evidence is available.
Note 1. Objective evidence may be obtained during post-marketing surveillance.
Evidence of equivalent security levels should be provided by the manufacturer upon request.
Note 2. Risk management refers to YY/T 0316 and the international standards being developed by ISO /TC210.
5.3 Materials
5.3.1* In the temperature range specified in 5.3.3, materials in contact with the medical gases listed in 1.2 shall have resistance under normal conditions of use.
Corrosive, and compatible with oxygen, other medical gases and their mixtures.
Note 1. Corrosion resistance includes resistance to humidity and surrounding materials.
Note 2. Compatibility with oxygen includes flammability and flammability. Materials that burn in air will burn violently in pure oxygen. Many do not burn in the air
The material will also burn in pure oxygen, especially under certain pressure. Similarly, materials that can be ignited in air cost less in oxygen.
The amount can be ignited. When such high pressure oxygen is quickly input into an initially low pressure system, many of these materials are subject to friction or insulation with the valve seat.
Compressed and ignited.
Note 3. YY/T 0882 provides information on the selection of metals and non-metals as well as other information on the oxygen compatibility of the equipment.
5.3.2* For flow measuring devices applied to all gases, non-metallic parts in contact with gases, including sealing materials and lubricants (if
Use), its auto-ignition temperature should not be lower than 160 °C.
Evidence that meets this requirement should be provided by the manufacturer on demand.
The auto-ignition temperature should be determined in accordance with ISO 11114-3.
Note. The maximum operating temperature of the test material should be 100 ° C lower than the auto-ignition temperature at the corresponding oxygen pressure. Safety margin is necessary because of operating temperature
Unexpected growth, auto-ignition temperature is not a constant value. The value of the auto-ignition temperature always depends on the test method used, and the test method may
Not all possible operating conditions are simulated exactly.
5.3.3 In the temperature range of -20 ° C ~ 60 ° C, the flow measuring device and its components should meet the requirements of 5.4 (except
5.4.6.3, 5.4.7.3 and 5.4.8.2).
5.3.4 When the transported and stored packaging is opened, the flow measuring device shall meet the requirements of 5.4 under the environmental conditions specified by the manufacturer.
5.3.5 Springs, highly tensioned parts and parts that are subject to wear and contact with gases shall not be plated.
Note. The coating may fall off.
5.3.6 Evidence that meets the requirements of 5.3.1~5.3.5 shall be provided by the manufacturer upon request.
5.4 Design requirements
5.4.1 Gas input port
5.4.1.1 Entrance
The gas inlet should be one of the following.
a) an insert that conforms to YY 0801.1 and is permanently attached to the flow measuring device [see Figure B.2a)];
b) a nut and mastoid connection that meets the DISS or NIST requirements of YY/T 0799 and is permanently attached to the flow measuring device
Head [see Figure B.2b)];
c) use an insert conforming to YY 0801.1 as the inlet joint and a flow measuring device as the outlet joint
Low pressure hose assembled by YY/T 0799 [see Figure B.2c)];
d) Use a nut and mast joint that meets DISS or NIST specifications in YY/T 0799 as the inlet fitting and use a flow rate
The measuring device acts as an outlet joint for the low pressure hose assembled according to YY/T 0799 [see Figure B.2d)].
5.4.1.2 Filtering
The gas inlet should be equipped with a filter and the following requirements should be met.
a) replaceable;
b) There are small holes or equivalent filters of no more than 100 μm.
The manufacturer shall provide evidence of compliance with the requirements as required.
5.4.2 Air outlet connector
The air outlet connector should be one of the following.
a) a fixed mastoid joint in accordance with EN13544-2;
b) threaded joints in accordance with EN13544-2;
c) An exclusive accessory that can be fitted with or without a hose.
Compliance is checked by visual inspection.
5.4.3* Mechanical strength
The flow measuring device shall be in accordance with the pressures of 1000 kPa for 5 min and shall comply with 5.4.4, 5.4.6.3, 5.4.7.3 and 5.4.8.2.
Claim.
The mechanical strength test is given in 6.2.
5.4.4 Leakage
After the mechanical strength and accuracy test, when the flow control valve is closed with a torque of 0.4 N·m (or with multiple fixed orifices)
The flow measuring device is set to zero) and the total internal leakage should not exceed 0.3 mL/min (corresponding to 0.0303 kPa·L/min) under P1.
After mechanical strength and accuracy testing, the total external leakage (to the atmosphere) should not exceed 0.5 mL/min under P1 (equivalent to
0.0506 kPa·L/min).
The leak test is given in 6.3.
5.4.5 Connection to the rail system
If the flow measuring device fitted with a gas inlet complying with 5.4.1.1c) or d) is designed by the manufacturer to comply with ISO 19054
If the rail system is supported, then it should be equipped with one of the following devices in accordance with ISO 19054.
---rail clamp;
--- Equipment floor;
--- Equipment floor pin.
5.4.6 Requirements for flow measuring devices containing flow meters with flow control valves
5.4.6.1 Scales and indications
The flow meter should be used in liters per minute (L/min) or in milliliters per minute (mL/min) for flow rates equal to or less than 1 L/min.
For the unit.
The flow meter indication should be visible at all flows and contain zero flow.
Compliance is checked by visual inspection.
5.4.6.2 Readability
Under the illumination of 215lx, for the visual acuity of 1.0 (corrected if necessary), the operator of the flowmeter 1m should indicate the value of the flowmeter.
It is clear and easy to recognize.
5.4.6.3 Flow accuracy
When the gas is directed to the ambient atmosphere and corrected to the reference conditions (see 6.1.3), for any flow with a maximum flow greater than 1 L/min
The flow accuracy of 10%~100% of the full scale should be within ±10% or ±0.5L/min of the indicated value, whichever is greater.
When the gas is directed to the ambient atmosphere and corrected to the reference conditions (see 6.1.3), for any one of the maximum flows equal to or less than 1 L/min
Flowmeter, flow accuracy should be within ±10% of full scale.
When the gas is directed to the ambient atmosphere, the accuracy test shall include the entire range of inlet pressures specified by the manufacturer. This test should be in mechanical strength
After the test is completed.
The manufacturer shall provide evidence of compliance with the requirements as required.
In order to improve accuracy and reduce the risk of electrostatic discharge, it is recommended to provide a method of minimizing the electrostatic charge inside, outside and outside the flow tube.
5.4.6.4 Flow control valve
Note. The flow control valve can be located downstream or upstream of the flow meter [see Figure B.1a) and B.1b)]. In different supply pressures and outlet resistance
The position at which the flow control valve is installed affects the flow measurement accuracy.
5.4.6.4.1 The flow control knob and valve stem should be well fixed and can not be removed without tools.
Try not to use the tool to remove the knob and stem to verify compliance.
5.4.6.4.2* The flow control valve shall be designed to increase flow when rotated counterclockwise.
Compliance is checked by visual inspection.
5.4.7 Requirements for flow measuring devices containing flow meters, fixed orifices and flow control valves
5.4.7.1 Scale
5.4.7.1.1 The maximum scale value of the flow meter shall be at least 33% higher than the maximum flow specified by the manufacturer.
5.4.7.1.2 The flow meter shall be marked in increments per minute (L/min).
Visual inspection should be performed to verify compliance.
5.4.7.2 Readability
Under the illumination of 215lx, for the visual acuity of 1.0 (corrected if necessary), the operator of the flowmeter 1m should indicate the value of the flowmeter.
It is clear and easy to recognize.
5.4.7.3 Flow accuracy
When the gas is discharged to the ambient atmosphere and corrected to the reference conditions (see 6.1.3), on the scale of 10%~100% of the full scale of the flow meter
The flow accuracy should be within ±10% or ±0.5L/min of the indicated value, whichever is greater.
When the gas is vented to the ambient atmosphere, the accuracy test shall include the entire range of inlet pressures specified by the manufacturer. This test should be strong in mechanical
After the test is completed.
The manufacturer shall provide evidence of compliance with the requirements as required.
5.4.7.4 Flow control valve
Note. The flow control valve can be located downstream or upstream of the flow meter. In the case of different supply and outlet resistances, the position of the installation will affect the measurement
Precision.
5.4.7.4.1 The flow control knob and stem should be well fixed and must not be removed without tools.
Try not to use the tool to remove the knob and stem to verify compliance.
5.4.7.4.2* The flow control valve shall be designed to increase the flow rate in the counterclockwise direction.
Compliance is checked by visual inspection.
5.4.7.5 Flow Meter
5.4.7.5.1 If a Bourdon flow meter is used, it shall comply with EN837-1 (except for the minimum nominal size) or
GB/T 1226-2010, and shall comply with the requirements of 5.4.7.1, 5.4.7.2, 5.4.7.5.2 and 5.4.7.5.3. 5.4.7.1, 5.4.7.2, 5.4.7.5.2
The requirements of 5.4.7.5.3 and 5.4.7.5.5 also apply to other types of flow meters.
5.4.7.5.2 If the fitting of the flow meter is threaded, the thread shall comply with EN837-1 or GB/T 1226-2010.
5.4.7.5.3 The flow meter shall be of class 2.5 or higher specified in EN837-1 or GB/T 1226-2010.
5.4.7.5.4 The flow meter shall be calibrated to the fixed orifice as intended.
5.4.7.5.5 The manufacturer shall provide evidence in accordance with the requirements of 5.4.7.5.1 to 5.4.7.5.4 as required.
5.4.8 Requirements for flow measuring devices with one or more fixed orifices and flow selection mechanisms
5.4.8.1 Readability
Under the illumination of 215lx, for the visual acuity of 1.0 (corrected if necessary), the operator of the fixed orifice 1m, the fixed orifice
The indication value should be clear and easy to recognize.
5.4.8.2 Flow accuracy
If the flow rate is greater than 1.5L/min, the actual flow rate should be within ±20% of the specified value.
If the flow rate is equal to or less than 1.5L/min, the actual flow rate shall be within ±30% of the specified value.
When the gas is vented to the ambient atmosphere, the accuracy test shall include the entire range of inlet pressures specified by the manufacturer. This should be measured in mechanical strength
After the test.
The manufacturer shall provide evidence of compliance with the requirements as required.
5.4.8.3 Traffic Settings
5.4.8.3.1 If there are multiple holes, when the flow selection mechanism is from "closed" and from one position to another, it acts on the most
The tangential force at a large radius should be no less than 5N and no higher than 50N.
The manufacturer shall provide evidence of compliance with the requirements as required.
5.4.8.3.2* The flow selection mechanism should automatically center at each flow set point and should minimize the possibility of being in a no-flow position (eg
Between adjacent set points), unless it is a 0 flow set point.
Compliance is checked by functional testing.
5.4.8.3.3* If a flow measuring device containing multiple fixed orifices can be placed between adjacent gears so that there is no flow at the outlet,
Set a warning for this result on the device.
5.4.8.4 Removal of fixed orifices
The removal of the fixed orifice requires the use of tools.
Try removing the fixed orifice without using a tool and verify that it meets the requirements.
5.4.8.5* Traffic Selection Mechanism
The flow selection mechanism should be well fixed and cannot be removed without tools.
Try to remove the traffic selection mechanism without using a tool to verify compliance.
If the flow selection mechanism is rotating, it should be designed to increase flow when rotated counterclockwise.
Compliance is checked by visual inspection.
5.5 Assembly requirements
5.5.1* Cleaning
Flow measuring devices in contact with medical gases during normal use shall comply with the cleaning requirements specified in YY/T 0882.
The manufacturer shall provide evidence of compliance with the requirements as required.
5.5.2* Lubricant
If a lubricant is used, the lubricant should be capable of reacting with oxygen, other at a test pressure of 1000 kPa and within the temperature range specified in 5.3.......
......
| Standard ID | YY/T 1522-2017 (YY/T1522-2017) | | Description (Translated English) | Flow-metering devices for connection to terminal units of medical gas pipeline systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 21,215 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Shanghai Medical Device Testing Institute, Shanghai Draeger Medical Devices Co., Ltd., Jie Rui Enterprise (Shanghai) Co., Ltd. | | Administrative Organization | National Anesthetic and Respiratory Equipment Standardization Technical Committee (SAC/TC 116) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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