YY/T 1898-2024: Intravascular catheter and guidewire - Testing method for fastness of the hydrophilic coating

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Scope

This document describes test methods for assessing the coating fastness of medical
catheters and guidewires featuring hydrophilic lubricant coatings intended for
intravascular use, comprising four methods. visual inspection method, friction testing
method, particulate testing method, and chemical property testing method.
The hydrophilic lubricant coatings addressed in this document refer exclusively to
coatings prepared using polymers that are chemically bonded to the substrate surface.
They do not encompass other types of coatings, such as drug-eluting coatings or
biodegradable coatings.
This document applies to intravascular catheters and guidewires with hydrophilic
lubricant coatings.

Basic Data

Standard ID	YY/T 1898-2024 (YY/T1898-2024)
Description (Translated English)	Intravascular catheter and guidewire - Testing method for fastness of the hydrophilic coating
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	18,141
Date of Issue	2024-02-07
Date of Implementation	2025-03-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the coating firmness test method for medical catheter guidewires with hydrophilic lubricating coating used in blood vessels, including four methods: appearance inspection method, friction test method, insoluble particle test method, and chemical performance test method. The hydrophilic lubricating coating mentioned in this document only refers to the hydrophilic lubricating coating prepared by using polymers and chemically combined with the surface of the substrate, and does not include other types of coatings, such as drug-loaded coatings, degradable coatings, etc. This document applies to intravascular catheters and guidewires with hydrophilic lubricating coatings.