Some standard content:
All clauses in Chapter 4 of this standard are mandatory clauses. Foreword
This standard is a revised version of YY91107-1999 "Buoy-type oxygen inhaler". YY 1107-2003
According to the standard conversion requirements of "Notice on Issuing the Results of Cleaning Up and Rectifying National and Industry Standards for Medical Devices and Abolishment of Professional Standards" No. 110 of the National Medical Equipment Administration [1999], the professional standard ZBC46007-1989 "Buoy-type oxygen inhaler" has been adjusted to an industry standard since March 1, 1999, and the standard number has been given a corresponding transition number: YY91107-1999. This standard is a revision of YY91107-1999.
The main technical differences between this standard and YY91107-1999 are as follows: the structural composition of the product has been removed from the classification, and the naming regulations have been added. The specifications and varieties of oxygen pressure gauges have been modified for selection. The pressure resistance value of the dehumidification bottle has been revised, and a liquid level indicator line has been added. The process requirement for the inhaler to be free of grease has been removed from the standard. Multiple appearance requirements for the inhaler have been merged into a clause. The structural strength requirements of the high-pressure part of the pressure reducer of the original standard inhaler have been removed from the inspection rules and placed in the requirements chapter. The test equipment and test environment conditions of this standard have been revised. The test methods for multiple requirements such as oxygen pressure gauge have been added. The factory inspection of the inspection rules has been changed from the percentage sampling of the original standard to the provisions of GB/T2828, and the type inspection content has been enriched.
The contents of the two chapters on marking, instruction manual and packaging, transportation and storage have been modified. This standard replaces YY91107-1999 from the date of implementation, and YY91107-1999 is abolished at the same time. This standard is proposed and managed by the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment of the State Food and Drug Administration. The drafting units of this standard: Medical Equipment Factory of Shanghai Medical Device Co., Ltd. and Shanghai Medical Device Testing Institute. The main drafters of this standard are Gu Dapeng, Yu Hongyi and Zhang Yanping. The previous versions of the standards replaced by this standard are: ZBC46007-1989;
-YY 91107--1999.
1 Scope
Floating oxygen inhaler
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This standard specifies the classification and naming, requirements, test methods, inspection rules, marking, instruction manual and packaging, transportation and storage of buoy-type oxygen inhalers.
This standard is applicable to buoy-type oxygen inhalers (hereinafter referred to as inhalers) with an output pressure of 0.20MPa~0.30MPa after decompression. This product is used for emergency oxygen supply in medical units and oxygen inhalation for hypoxic patients. 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version applies to this standard. GB/T191 Pictorial marking for packaging storage and transportation
GB/T2828 Count sampling procedures and sampling tables for batch inspection (applicable to inspection of continuous batches) GB/T2829 Count sampling procedures and tables for periodic inspection (applicable to inspection of process stability) GB9969.1 General provisions for instructions for use of industrial products JB/T9271 Pressure gauges for welding, cutting and similar processes 3 Classification and naming
3.1 Classification
According to the product type, the inhaler is divided into float indicating type. 3.2 Naming
The naming of the inhaler product shall be expressed as follows:
4 Requirements
4.1 Appearance
Buoy-type oxygen inhaler
Product name
Product code
The appearance of the inhaler shall be smooth, with uniform color and clear and consistent patterns. There shall be no defects that obviously affect the appearance, such as exposed bottom, delamination, blistering, peeling, cracking, whitening, etc.
4.2 Working pressure
When the high-pressure part of the inhaler inputs a pressure of 12MPa~~15MPa, it shall be able to drop to a pressure range of 0.20MPa~0.30MPa after decompression.
4.3 Flow range and basic error
The flow range of the inhaler shall be at least 1L/min~10L/min, and its basic error shall be ±4% of the maximum indication. 4.4 Exhaust pressure of safety valve
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When the output pressure of the inhaler rises to 0.35MPa±0.05MPa, the safety valve will automatically exhaust. 4.5 Oxygen pressure gauge
The oxygen pressure gauge shall comply with the provisions of JB/T9271, with an accuracy of 2.5. The nominal diameter of the gauge shell and the thread size of the joint can be selected from Table 1.
Table 1 Basic dimensions of oxygen pressure gauge
Standard code
JB/T9271
4.6 Connection between inhaler and oxygen cylinder
Nominal diameter of gauge shell/mm
Thread size of joint/mm
The thread size of the tightening nut connecting the inhaler and oxygen cylinder is G5/8\. 4.7 Oxygen output connector
The oxygen output is connected to the gas transmission pipe through a tapered connector. The outer diameter of the largest part of the tapered connector is 9mm±0.5mm. 4.8 Flow tube
The flow tube of the inhaler should be colorless and transparent, the numbers and scales should be clear, the scale intervals should be even, and the minimum scale value should not exceed 1L/min. 4.9 Flow regulation
The flow regulating valve of the inhaler should be easy to adjust and the tightness should be appropriate; the float in the flow tube should move up and down flexibly and smoothly; the flow regulating valve rotates clockwise to reduce the flow, and rotates counterclockwise to increase the flow. There should be a mark to indicate that there should be no oxygen output when the flow regulating valve is closed. 4.10 Sealing
The connecting parts of the inhaler should be sealed and should not leak under working pressure. 4.11 Tidal bottle
The tidal bottle of the inhaler should be colorless, transparent or translucent, and marked with the highest and lowest liquid level indicator lines; it should not break under a pressure of not less than 0.40MPa.
4.12 Structural strength
After the high-pressure part of the pressure reducer of the inhaler is subjected to a water pressure test of 22.5MPa for 3min, the high-pressure part shall not have permanent deformation. 5 Test method
5.1 Test equipment
The test equipment shall include:
a) 0MPa～0.6MPa pressure gauge (oil-free), accuracy level 2.5; b) standard push flow meter, accuracy level 1;
c) oxygen source: oxygen pressure shall not be less than 12MPa. 5.2 Test environment conditions
Test temperature: 20℃±5℃.
5.3 Appearance
Observe visually, and the result shall comply with the provisions of 4.1. 5.4 Working pressure
Let the high pressure part of the inhaler pass through the oxygen pressure of 12MPa~15MPa, and connect the 0MPa~0.6MPa pressure gauge to the output port of the inhaler to measure the output working pressure of the inhaler. The result shall meet the requirements of 4.2. High pressure oxygen input》
5.5 Flow range and basic error
Inhaler
Flow regulating valve
》》Low pressure oxygen output
Figure 1 Flow regulation test
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According to Figure 1, connect the output port of the inhaler with the input port of the standard flow meter with a rubber tube, open the flow regulating valve of the inhaler flow meter to the maximum, adjust the flow regulating valve of the standard flow meter, adjust the standard flow to 1L/min, 5L/min, 10L/min three calibration points for flow value calibration, calculate the basic error of flow according to the following formula, and the result shall meet the requirements of 4.3. = [(Q-Qn)/Qmax × 100%
Wherein:
8——Basic flow error,%;
Q——Flow indication of the aspirator, in liters per minute (L/min); Qn—Standard flow indication, in liters per minute (L/min); Qmax—Maximum flow value of the aspirator, in liters per minute (L/min). 5.6 Exhaust pressure of safety valve
Connect a pressure gauge to the output port of the aspirator, and adjust the output pressure to 0.35MPa±0.05MPa. The safety valve can automatically exhaust the air, and the result should comply with the provisions of 4.4.
5.7 Oxygen pressure gauge
Check the quality certificate of the oxygen pressure gauge within the validity period of the past year and inspect it with a general measuring tool. The result should comply with the provisions of 4.5. 5.8 The connection between the inhaler and the oxygen cylinder
Use a special measuring tool to check the thread size of the tightening nut, and the result should comply with the provisions of 4.6. 5.9 The oxygen output connector
Use a general measuring tool to check, and the result should comply with the provisions of 4.7. 5.10 The flow tube
Use visual observation, and the result should comply with the provisions of 4.8. 5.11 Flow regulation
Observe visually, the result should meet the requirements of 4.9. 5.12 Sealing
The sealing test of the inhaler can be carried out together with the working pressure test. The connection method of the test is in accordance with 5.4. The pressure of the high-pressure part shall not be lower than 12MPa, the working pressure of the low-pressure part is 0.20MPa~~0.30MPa, the flow rate is adjusted to 10L/min, and each connection part is coated with fat-free soapy water for 20s. There should be no leakage, and the result should meet the requirements of 4.10. 5.13 Dehumidification bottle
Remove the dehumidification bottle of the inhaler, and perform a water pressure test on the dehumidification bottle with a pressure of 0.40MPa for 20s. Observe visually, the result should meet the requirements of 4.11.
5.14 Structural strength
Use 22.5MPa pressure to conduct a 3-minute hydraulic test on the high-pressure part of the pressure reducer of the inhaler, and then inspect the size and shape changes of the tested part. The results should comply with the provisions of 4.12. 6 Inspection rules
6.1 General
Inhalers should be inspected by the quality department of the manufacturer and can only be submitted for acceptance after passing the inspection. 6.2 Inspection classification
Inhaler inspection is divided into factory inspection and type inspection. 6.3 Factory inspection
6.3.1 Factory inspection must be carried out before the inhaler leaves the factory, and it can only leave the factory after passing the inspection. 6.3.2 Sampling plan: Factory inspection shall be carried out in accordance with the provisions of GB/T2828. 6.3.3 Inspection items: The factory inspection adopts a normal inspection and one-time sampling plan. Its non-conforming classification, inspection items, inspection level and qualified quality level (AQL) are as specified in Table 2, and the number of non-conforming products is used for judgment. Table 2 Factory Inspection
Non-conforming classification
Non-conforming classification group
Inspection items
Inspection level
Qualified quality level (AQL)
6.4 Type inspection
Type inspection should be carried out in any of the following situations: before product registration or when old products are converted to production; B
Products in continuous production, no less than once every two years; when the interval is more than two years before re-production;
Product structure, materials, and processes have changed significantly, and the factory inspection results are significantly different from the last type inspection; e)
The national quality supervision agency proposes type inspection requirements. C
Sampling plan: Type inspection shall be carried out in accordance with the provisions of GB/T2829. Factory inspection should be carried out before type inspection. The sampling method for trial production registration inspection in 6.4.2
of type inspection is sample delivery, and the quantity is 3 units; other inspections in type inspection are sampled from the qualified batch of factory inspection for type inspection.
6.4.3 Inspection items: Type inspection adopts a single sampling plan, and its unqualified classification, inspection items, discrimination level, judgment array and unqualified quality level (RQL) are as specified in Table 3, and the number of unqualified units is used for judgment. Table 3 Type inspection
Non-conformity classification
Non-conformity classification group
Inspection items
Discrimination level
Discrimination group
Non-conformity quality level (RQL)
4. 24. 11,4. 12
[A.=0 R,=1]
Except for 6.4.1a), d), and f), 4.12 is only performed once and will not be repeated later. I
[A. =1 R. =2]
7 Marking, Instructions for Use
7.1 Marking
7.1.1 Each inhaler shall have the following markings in an appropriate and obvious position: a) Manufacturer’s name;
Product name, model, trademark;
c) Product production date and number;
Product standard number and registration number;
e) Metrology license number.
Each inhaler shall be packed in a box, and the box shall have the following markings: a) Manufacturer’s name and address;
Product name, model;
Product production date and number;
Product standard number and registration number;
e) Metrology license number.
The quantity of inhalers to be packed shall be as specified in the order contract. The following marks shall be on the box: a)
Manufacturer name and address;
Product name and model;
Net weight and gross weight;
Volume (length x width x height);
Quantity;
Product date and serial number;
Words or marks such as "fragile", "upward", "afraid of rain"; Product standard number and registration number;
Metrology license number;
Shipment and receipt marks.
The words and marks on the box shall comply with the provisions of GB/T191 and shall not be blurred due to long-term use. 7.2 Instructions for Use
The instructions for use shall comply with the requirements of GB9969.1, and shall also include the following: a) manufacturer's name, address, postal code and contact number; b) product scope of application and relevant precautions, storage and preservation conditions; c) product standard number, registration number and measurement license number; d) publication date.
8 Packaging, transportation and storage
8.1 Packaging
8.1.1 Moisture-proof
The container of the inhaler shall be equipped with moisture-proof measures to ensure that the product is not damaged by nature. 8.1.2 Random Documents
Each inhaler in the packaging box shall be accompanied by a product certificate, instruction manual and packing list. 8.1.3 Product certificate
The product certificate should include:
a) Manufacturer's name;
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Product name and model;
Inspection date;
Inspector code.
2 TransportationwwW.bzxz.Net
Transportation requirements According to the order contract, the packaged inhaler should be stored in a room with a relative humidity not exceeding 90%, no corrosive gas and good ventilation. 8.4 Others
If the packaged inhaler fails to work normally within one and a half years from the date of leaving the factory (the service life is one year) under the conditions of complying with the storage and use regulations, the manufacturer shall repair or replace it for the user free of charge. 63 Inspection items: The type inspection adopts a single sampling plan. Its non-conforming classification, inspection items, discrimination level, judgment array and non-conforming quality level (RQL) shall be as specified in Table 3, and the number of non-conforming items shall be used for judgment. Table 3 Type inspection
Non-conforming classification
Non-conforming classification group
Inspection items
Discrimination level
Determination array
Non-conforming quality level (RQL)
4. 24. 11,4. 12
[A.=0 R,=1]
Except for 6.4.1a), d), and f), 4.12 is only performed once and the test will not be repeated later I
[A. =1 R. =2]
7 Marking, Instructions for Use
7.1 Marking
7.1.1 Each inhaler shall have the following markings in an appropriate and obvious position: a) Manufacturer’s name;
Product name, model, trademark;
c) Product production date and number;
Product standard number and registration number;
e) Metrology license number.
Each inhaler shall be packed in a box, and the box shall have the following markings: a) Manufacturer’s name and address;
Product name, model;
Product production date and number;
Product standard number and registration number;
e) Metrology license number.
The quantity of inhalers to be packed shall be as specified in the order contract. The following marks shall be on the box: a)
Manufacturer name and address;
Product name and model;
Net weight and gross weight;
Volume (length x width x height);
Quantity;
Product date and serial number;
Words or marks such as "fragile", "upward", "afraid of rain"; Product standard number and registration number;
Metrology license number;
Shipment and receipt marks.
The words and marks on the box shall comply with the provisions of GB/T191 and shall not be blurred due to long-term use. 7.2 Instructions for Use
The instructions for use shall comply with the requirements of GB9969.1, and shall also include the following: a) manufacturer's name, address, postal code and contact number; b) product scope of application and relevant precautions, storage and preservation conditions; c) product standard number, registration number and measurement license number; d) publication date.
8 Packaging, transportation and storage
8.1 Packaging
8.1.1 Moisture-proof
The container of the inhaler shall be equipped with moisture-proof measures to ensure that the product is not damaged by nature. 8.1.2 Random Documents
Each inhaler in the packaging box shall be accompanied by a product certificate, instruction manual and packing list. 8.1.3 Product certificate
The product certificate should include:
a) Manufacturer's name;
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Product name and model;
Inspection date;
Inspector code.
2 Transportation
Transportation requirements According to the order contract, the packaged inhaler should be stored in a room with a relative humidity not exceeding 90%, no corrosive gas and good ventilation. 8.4 Others
If the packaged inhaler fails to work normally within one and a half years from the date of leaving the factory (the service life is one year) under the conditions of complying with the storage and use regulations, the manufacturer shall repair or replace it for the user free of charge. 63 Inspection items: The type inspection adopts a single sampling plan. Its non-conforming classification, inspection items, discrimination level, judgment array and non-conforming quality level (RQL) shall be as specified in Table 3, and the number of non-conforming items shall be used for judgment. Table 3 Type inspection
Non-conforming classification
Non-conforming classification group
Inspection items
Discrimination level
Determination array
Non-conforming quality level (RQL)
4. 24. 11,4. 12
[A.=0 R,=1]
Except for 6.4.1a), d), and f), 4.12 is only performed once and the test will not be repeated later I
[A. =1 R. =2]
7 Marking, Instructions for Use
7.1 Marking
7.1.1 Each inhaler shall have the following markings in an appropriate and obvious position: a) Manufacturer’s name;
Product name, model, trademark;
c) Product production date and number;
Product standard number and registration number;
e) Metrology license number.
Each inhaler shall be packed in a box, and the box shall have the following markings: a) Manufacturer’s name and address;
Product name, model;
Product production date and number;
Product standard number and registration number;
e) Metrology license number.
The quantity of inhalers to be packed shall be as specified in the order contract. The following marks shall be on the box: a)
Manufacturer name and address;
Product name and model;
Net weight and gross weight;
Volume (length x width x height);
Quantity;
Product date and serial number;
Words or marks such as "fragile", "upward", "afraid of rain"; Product standard number and registration number;
Metrology license number;
Shipment and receipt marks.
The words and marks on the box shall comply with the provisions of GB/T191 and shall not be blurred due to long-term use. 7.2 Instructions for Use
The instructions for use shall comply with the requirements of GB9969.1, and shall also include the following: a) manufacturer's name, address, postal code and contact number; b) product scope of application and relevant precautions, storage and preservation conditions; c) product standard number, registration number and measurement license number; d) publication date.
8 Packaging, transportation and storage
8.1 Packaging
8.1.1 Moisture-proof
The container of the inhaler shall be equipped with moisture-proof measures to ensure that the product is not damaged by nature. 8.1.2 Random Documents
Each inhaler in the packaging box shall be accompanied by a product certificate, instruction manual and packing list. 8.1.3 Product certificate
The product certificate should include:
a) Manufacturer's name;
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Product name and model;
Inspection date;
Inspector code.
2 Transportation
Transportation requirements According to the order contract, the packaged inhaler should be stored in a room with a relative humidity not exceeding 90%, no corrosive gas and good ventilation. 8.4 Others
If the packaged inhaler fails to work normally within one and a half years from the date of leaving the factory (the service life is one year) under the conditions of complying with the storage and use regulations, the manufacturer shall repair or replace it for the user free of charge. 6
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