YY/T 1898-2024 Intravascular catheter and guidewire - Testing method for fastness of the hydrophilic coating
1 Scope
This document describes the testing methods for coating fastness of medical intravascular catheters and guidewires with hydrophilic lubricant coatings, including four methods: visual inspection, friction test, particulate test, and chemical property test.
The hydrophilic lubricant coatings referred to in this document refer specifically to those prepared from polymers that are chemically bonded to the surface of the substrate, excluding other types of coatings such as drug-eluting coatings, and degradable coatings.
This document is applicable to intravascular catheters and guidewires with hydrophilic lubricant coatings.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY/T 1556 Test methods for particle contamination of infusion, transfusion and injection equipments for medical use
Pharmacopoeia of the People's Republic of China (Edition 2020, Volume IV)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
hydrophilic lubricant coating
hydrophilic substance with lubricating function that is firmly attached to the surface of catheters and guidewires through a certain strong bonding force
3.2
coating lubricity
ease of sliding of the coating during contact with human tissues, organs, as well as devices used in conjunction or combination
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3.3
coating fastness
degree of bonding between the coating and the substrate of the medical device, manifested as the integrity and durability of the coating
4 Testing methods for coating fastness
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Testing methods for coating fastness
4.1 General
4.2 Visual inspection method
4.3 Friction test method
4.4 Particulate test method
4.5 Chemical property test method
5 Test report
Annex A (Informative) Visual inspection method (staining test)
Annex B (Informative) Friction test method
Annex C (Informative) Simulated vascular models
Annex D (Informative) Particulate test method (Immersion method)
Annex E (Informative) Particulate test method (Vascular model friction method)
Annex F (Informative) Chemical property test method
Bibliography
