1. Background of standard revision

The old version YY/T 1543-2017 provided a basic quality basis for the domestic nasal cannula industry. With the release of the international standard ISO 23368:2022, in order to achieve internationalization of technical requirements and enhance global competitiveness of products, the new version of the standard has emerged, fully absorbing advanced technical content from international standards and adjusting reference standards in combination with the actual situation of China's medical industry.

2. Key technological changes

Adjust the scope description and terminology definition to more accurately define the applicable scenarios of low flow nasal cannula for oxygen therapy.

Add a section on general requirements to strengthen the foundation of quality control throughout the product lifecycle.

Integrate the content of length, appearance, connection, physical performance, etc. from the original standard into a unified "Design Requirements" chapter, and optimize the standard structure.

Delete clauses related to chemical and biological properties from the original standard, and focus on core physical properties and safety of use.

Adjust the requirements for manufacturers to provide information and enhance the standardization of product use and traceability.

Adopting domestic standards such as GB/T 4999 and YY/T 1778.1 to replace international standards and adapt to China's technical conditions.

1. Full coverage of testing indicators

The NOC-02 nasal oxygen tube performance tester needs to accurately match the core performance indicators specified in the new standard, including airflow resistance, anti collapse, leakage protection, pressure resistance, and smoothness, to ensure no testing blind spots.

2. Accuracy and reliability requirements

The pressure measurement accuracy of NOC-02 nasal oxygen tube performance tester needs to reach ± 0.025 kPa or above, meeting the requirements for detecting small pressure differences under low flow conditions.

The flow measurement accuracy shall not be less than ± 1% FS, covering a wide flow testing range of 0.5-30 L/min.

Having stable pressure control capability, it can accurately maintain a leakage test pressure of 100 kPa and a pressure test pressure of 200 kPa.

3. Compliance and Traceability

The testing process of NOC-02 nasal oxygen tube performance tester must strictly follow the operating steps specified in the appendix of the new standard to ensure compliance with the testing method.

Support automatic recording, storage, and export of test data to meet GMP and quality traceability requirements.

Equipped with user permission management function to ensure the standardization and data security of the testing process.

1. Overall design architecture

The tester adopts a modular design, integrating five core units: pneumatic control system, mechanical testing module, high-precision sensing system, intelligent control system, and data processing platform, to achieve the integrated testing capability of "one machine for multiple uses", avoiding efficiency loss and error accumulation caused by equipment switching.

2. Core functions

Test procedures that meet standard testing requirements

Procedure for low flow nasal cannula straight:

A. 4.1 For adult size, child size, and newborn size, set the flow rate of the low flow nasal cannula equipped with a connector to (4 ± 0.2) L/min, (3 ± 0.2) L/min, and (2 ± 0.2) L/min, respectively.

A. 4.2 Verify if the flow resistance is within 6.2 1 and 6 two Within the scope specified in 2.

Procedure for low flow nasal cannula treatment of bent tubing

A. 5.1 Determine the pressure drop required to maintain a low flow nasal cannula flow rate of (4 ± 0.2) L/min (adult size), 3 L/min (child size), and 2 L/min (newborn size).

A. 5.2 When bending the low flow nasal cannula treatment tubing into a semicircle with a diameter three times its minimum outer diameter, maintain this pressure.

A. 5.3 Verify that the traffic meets 6.2 Requirement 3.