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YY/T 1543-2017Nasal oxygen cannula (English PDF)

鼻氧管

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 2, 2017

Implementation date

April 1, 2018

Scope

YY/T 1543-2017 is the English-translated version of 鼻氧管.

YY/T 1543-2017 is the Chinese pharmaceutical industry standard for the nasal oxygen cannula, the tube that delivers medical oxygen, oxygen 93 percent or another oxygen-enriched medical gas to a breathing patient.

It sets the requirements and the test methods, covering the dimensions and the flow resistance of the tubing and the prongs, the strength of the joints and of the connector, the freedom from leakage and occlusion, the materials and their biological evaluation, and the marking and packaging. Issued on 2 May 2017, it has applied since 1 April 2018.

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Document preview — YY/T 1543-2017

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Foreword4
1 Scope5
2 Normative References5
3 Terms and Definitions5
3.1 Nasal Oxygen Cannula5
3.2 Oxygen-enriched Air (oxygen 93 percent)5
3.3 Oxygen Source Connector6
4 Materials6
5 Length6
6 Appearance6
7 Connection6
8 Physical Properties7
9 Chemical Properties7
10 Biological Properties8
11 Microbiological Requirements of Nasal Oxygen Cannula8
12 Cleaning, Disinfection or Sterilization9
13 Marking9
14 Information Provided by Manufacturer10
Appendix A (normative) Airflow Resistance Test Method12
Appendix B (normative) Flattening Resistance Test Method14
Bibliography16

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.

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... 5

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.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 19633

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