YY/T 1543-2017 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1543-2017 | English | 130 |
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YY/T 1543-2017: Nasal Oxygen Cannula---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1543-2017
PHARMACEUTICAL INDUSTRY STANDARD
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
8 Physical Properties... 7
9 Chemical Properties... 7
10 Biological Properties... 8
11 Microbiological Requirements of Nasal Oxygen Cannula... 8
12 Cleaning, Disinfection or Sterilization... 9
13 Marking... 9
14 Information Provided by Manufacturer... 10
Appendix A (normative) Airflow Resistance Test Method... 12
Appendix B (normative) Flattening Resistance Test Method... 14
Bibliography... 16
Foreword
This Standard was drafted in accordance with the rules in GB/T 1.1-2009.
Please be noted that certain content in this document might involve patents. The
institution that issues this document does not undertake the responsibility of identifying
these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee 116 on
Anesthetic and Respiratory Equipment of Standardization Administration of China
(SAC/TC 116).
The drafting organizations of this Standard. Shanghai Medical Equipment Testing
Institute; Guangzhou Well Lead Medical Co., Ltd.; Zhejiang Institute of Medical Device
Testing; Henan Tuoren Medical Device Co., Ltd.
The main drafters of this Standard. Fu Guoqing, Huang Kaigen, Zhang Guyin, Wang
Yanchen, Wangwei, Wusong.
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.
4 Materials
4.1 Nasal oxygen cannula shall choose medical polymer materials without biological
or chemical hazards.
5 Length
The length of nasal oxygen cannula shall be marked with the nominal full length
measured at rest in a horizontal plane. It shall be expressed in millimeter.
6 Appearance
6.1 Nasal oxygen cannula shall have uniform color and smooth surface. There shall
be no clearly visible impurities, foreign matters or bubble defects.
6.2 There shall be no obvious raw edges, burrs or sharp plastic flow defects.
7 Connection
7.1 Connector
7.1.1 Oxygen source connector of nasal oxygen cannula should adopt inner cone
connector.
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.
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.
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
method stipulated in GB/T 14233.1-2008, conduct the test.
9.2 Heavy Metal Content
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
method stipulated in GB/T 14233.1-2008, conduct the test.
9.3 pH Value
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.
9.4 Evaporation Residue
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.
10 Biological Properties
10.1 The cytotoxicity of nasal oxygen cannula shall be not more than Level 1.
10.2 The difference between the average score of the nasal oxygen cannula test
sample and the solvent control shall be not more than 1.0 (intradermal reaction).
11 Microbiological Requirements of Nasal Oxygen Cannula
11.1 Sterility
Nasal oxygen cannula designated with “STERILE” shall comply with the requirements
in 4.1 in YY/T 0615.1-2007.
11.2 Packaging of Sterilely Supplied Nasal Oxygen Cannula
Nasal oxygen cannula designated with “STERILE” shall adopt independent package.
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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