YY/T 1898-2024
Intravascular catheter guidewires - Test method for firmness of hydrophilic coatings (English Version)

Standard No.

YY/T 1898-2024

Language

Chinese, Available in English version

Release Date

2024

Published By

Professional Standard - Medicine

Latest

YY/T 1898-2024

Introduction

Analysis of the core content of the standard

YY/T 1898-2024 is my country's first test method standard specifically for the firmness of hydrophilic lubricating coatings on intravascular catheters and guidewires. It stipulates four complementary test method systems:

Test method	Detection principle	Applicable scenarios	Sensitivity
Appearance inspection method	Coating morphology observation	Initial quality screening	Macro defects
Friction test method	Lubrication performance degradation analysis	Dynamic use evaluation	Micron-level changes
Particle test method	Quantification of detached particles	Biological safety verification	≥10μm particles
Chemical performance test method	Molecular level dissolution analysis	Total quality evaluation	Nano-level changes

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Detailed explanation of key technical requirements

1. Key points for the implementation of friction test method

The test device recommended by the standard must meet the following requirements: clamping force control accuracy ≥ 0.01N, silicone sheet hardness Shore A55±10, surface roughness Ra0.6±0.2μm. The following should be controlled during the test:

• Water temperature 37±2℃ to simulate physiological environment
• Lifting speed 200-600mm/min
• At least 10 cycles of testing

2. Key Controls of Particle Test Method

When using the vascular model friction method, please note:

1. Model selection should comply with ASTM F2394 or YY/T 0807 specifications
2. Number of pushes ≥3 times to ensure clinical relevance
3. Parallel tests ≥3 groups to ensure data reliability

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Recommendations for the implementation of the standard

Principles of test plan design

Test methods should be combined according to the clinical use of the product:

• Neurointerventional catheters: Friction test + particle test combination is preferred
• Coronary guidewires: Appearance inspection + chemical performance test combination is recommended
• Peripheral vascular stent delivery system: Four-method full test is recommended

Equipment validation requirements

The laboratory needs to perform IQ/OQ/PQ validation on the test equipment, with special attention to:

1. Sensor calibration of friction test device
2. Particle detection environment cleanliness control
3. Specificity validation of chemical analysis methods

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Technological evolution and standard value

This standard fills the gap in my country's evaluation of vascular intervention device coatings. Its technical features are reflected in:

• Innovatively proposed the friction ratio analysis method (formula: D=F_{last 5 times}/F_{first 5 times}×100%)
• Introduced the three-level vascular model system (straight/single bend/multiple bends)
• Established a multi-index correlation evaluation of chemical properties (reducing substances + ultraviolet absorption + evaporation residue)

The implementation of this standard will significantly improve the coating process level and product quality control capabilities of my country's vascular interventional devices.