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YY/T 1543-2017 English PDF (YYT1543-2017)

YY/T 1543-2017 English PDF (YYT1543-2017)

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YY/T 1543-2017: Nasal oxygen cannula

This Standard stipulates the requirements of nasal oxygen cannulas intended to deliver medical oxygen, oxygen-enriched air (oxygen 93 percent) and other oxygenated medical gases for breathing to patients. This Standard is applicable to all the nasal oxygen cannulas, either independent nasal oxygen cannulas or nasal oxygen cannulas used to connect to humidification bottles and masks.
YY/T 1543-2017
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.10
C 46
Nasal Oxygen Cannula
?????????
ISSUED ON: MAY 2, 2017
IMPLEMENTED ON: APRIL 1, 2018
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 5
3.1 Nasal Oxygen Cannula ... 5
3.2 Oxygen-enriched Air (oxygen 93 percent) ... 5
3.3 Oxygen Source Connector ... 6
4 Materials ... 6
5 Length ... 6
6 Appearance ... 6
7 Connection ... 6
7.1 Connector ... 6
7.2 Bonding and Connection Firmness ... 7
8 Physical Properties ... 7
8.1 Airflow Resistance ... 7
8.2 Flattening Resistance ... 7
8.3 Bending Resistance ... 7
8.4 Leakage ... 7
8.5 Compressive Strength ... 7
9 Chemical Properties ... 7
9.1 Reducing Substance ... 7
9.2 Heavy Metal Content ... 8
9.3 pH Value ... 8
9.4 Evaporation Residue ... 8
10 Biological Properties ... 8
11 Microbiological Requirements of Nasal Oxygen Cannula ... 8
11.1 Sterility ... 8
11.2 Packaging of Sterilely Supplied Nasal Oxygen Cannula ... 9
11.3 Ethylene Oxide Residue ... 9
12 Cleaning, Disinfection or Sterilization ... 9
13 Marking ... 9
13.1 Marking of Nasal Oxygen Cannula ... 9
13.2 Single Packaging Marking ... 10
14 Information Provided by Manufacturer ... 10
Appendix A (normative) Airflow Resistance Test Method ... 12
Appendix B (normative) Flattening Resistance Test Method ... 14
Bibliography ... 16
Nasal Oxygen Cannula
1 Scope
This Standard stipulates the requirements of nasal oxygen cannulas intended to deliver medical oxygen, oxygen-enriched air (oxygen 93 percent) and other oxygenated medical gases for breathing to patients.
This Standard is applicable to all the nasal oxygen cannulas, either independent nasal oxygen cannulas or nasal oxygen cannulas used to connect to humidification bottles and masks.
2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods
GB/T 19633 (all parts) Packaging for Terminally Sterilized Medical Devices [ISO 11607 (all parts)]
YY/T 0615.1-2007 Requirements for Medical Devices to be Designated STERILE - Part 1: Requirements for Terminally Sterilized Medical Devices
3 Terms and Definitions
The following terms and definitions are applicable to this Standard.
3.1 Nasal Oxygen Cannula
Nasal oxygen cannula refers to a cannula which can transport medical oxygen or oxygen-enriched air (oxygen 93 percent) and other oxygen-containing medical gases for breathing to patients?€? nasal cavity after being connected to the oxygen supply system.
3.2 Oxygen-enriched Air (oxygen 93 percent)
Oxygen-enriched air refers to air generated by oxygen concentrator with the oxygen concentration of not lower than 90%.
---Connected with nasal or facial mask.
7.2 Bonding and Connection Firmness
7.2.1 The various bonding parts of nasal oxygen cannula shall be firmly bonded; the various bonding areas shall be able to sustain 30 N of axial direction of static tension; maintain for 15 s; there shall be no rupture.
7.2.2 Nasal oxygen cannula, and the various components that are connected to nasal oxygen cannula shall be firmly connected. The various connected areas shall be able to sustain 30 N of axial direction of static tension; maintain for 15 s; there shall be no falling-off.
8 Physical Properties
8.1 Airflow Resistance
When the test is conducted in accordance with Appendix A, pressure increase per meter of cannula shall not exceed 2.0 kPa.
8.2 Flattening Resistance
When the test is conducted in accordance with Appendix B, flow decrease of nasal oxygen cannula shall not exceed 25% of the initial flow.
8.3 Bending Resistance
Under the most unfavorable working environment specified by the manufacturer, repeatedly bend nasal oxygen cannula for 10 times, the cannula shall not rupture; the inner wall of the cannula shall not be bonding.
8.4 Leakage
Under the pressure of 100 kPa, nasal oxygen cannula shall not have any leakage. 8.5 Compressive Strength
Under the pressure of 200 kPa, or two times of the maximum working pressure specified by the manufacturer, take the larger value between them; nasal oxygen cannula shall not rupture.
9 Chemical Properties
9.1 Reducing Substance
In accordance with the stipulations of test solution preparation method 8 in Table 1 in GB/T 14233.1-2008, conduct the preparation of test solution. In accordance with the in 4.1 in YY/T 0615.1-2007.
Nasal oxygen cannula shall go through the process of sterilization validation and routine control, so that the products can be sterile.
NOTE 1: please refer to GB 18278-2000, GB 18279-2000 and GB 18280-2000 for appropriate sterilization validation and routine control.
NOTE 2: GB/T 14233.2-2005 stipulates sterility test method, which is applicable to type inspection, not exit-factory inspection.
11.2 Packaging of Sterilely Supplied Nasal Oxygen Cannula
Nasal oxygen cannula designated with ?€?STERILE?€? shall adopt independent package. The package shall comply with GB/T 19633 and become an effective barrier that prevents penetration by microorganisms and particulate matters. The package shall be able to sterilely remove the contents and cannot be resealed after opening, otherwise, there shall be obvious traces of opening.
11.3 Ethylene Oxide Residue
If ethylene oxide residue is adopted for sterilization, the residue of ethylene oxide shall be not more than 10 ??g/g.
In accordance with the method stipulated in GB/T 14233.1-2008, conduct the test; it shall comply with the requirements.
12 Cleaning, Disinfection or Sterilization
Non-disposable nasal oxygen cannula shall be designed to be suitable for cleaning, disinfection or sterilization in accordance with the method described in accompanying documents. After 30 times of cleaning, disinfection or sterilization in accordance with the method described in accompanying documents, nasal oxygen cannula shall comply with the requirements in 7.2, and 8.1 ~ 8.5.
13 Marking
13.1 Marking of Nasal Oxygen Cannula
Nasal oxygen cannula shall have the following marking:
a) The name and/or trademark of manufacturer or supplier;
b) In terms of nasal oxygen cannula that is intended for non-repetitive use, indicate ?€?DISPOSABLE?€? or equivalent marking.
Appendix A
(normative)
Airflow Resistance Test Method
A.1 Instruments
A.1.1 Flow measuring instrument, accuracy shall be not lower than Level 2.5. A.1.2 Pressure measuring instrument, accuracy shall be: ?? 0.025 kPa.
A.2 Test Conditions
A.2.1 Air supply pressure: 200 kPa ?? 10 kPa.
A.2.2 Flow: rated flow specified by the manufacturer.
A.3 Procedures
A.3.1 Place the test nasal oxygen cannula in the test environment at 23 ??C ?? 2 ??C for 1 h; conduct state adjustment.
A.3.2 In accordance with Figure A.1, connect the test device. However, do not connect the nasal oxygen cannula. Adjust the flow to the rated flow specified by the manufacturer, then, observe the pressure gauge. Wait till the value indicated by the pressure gauge becomes stable, record the pressure value P1 on the pressure gauge at that moment, which shall be the airflow resistance of the test device. A.3.3 Connect the nasal oxygen cannula to the air outlet (7 in Figure A.1) of the test device; make it naturally straight. Adjust the flow to the rated flow specified by the manufacturer, then, observe the pressure gauge. Wait till the value indicated by the pressure gauge becomes stable, record the pressure value P2 on the pressure gauge at that moment.
A.3.4 Through Formula (P2 - P1), calculate the airflow resistance of the nasal oxygen cannula.

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