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YY/T 1898-2024: Intravascular catheter and guidewire - Testing method for fastness of the hydrophilic coating
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| YY/T 1898-2024 | English | 379 |
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Intravascular catheter and guidewire - Testing method for fastness of the hydrophilic coating
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YY/T 1898-2024
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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 & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 18,126 | | 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. | YY/T 1898-2024: Intravascular catheter and guidewire - Testing method for fastness of the hydrophilic coating
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.20
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Durability of hydrophilic coating on intravascular catheter guidewires
experiment method
hydrophilic coating
2025-03-01 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Coating fastness test method 1
4.1 General 1
4.2 Visual inspection method 2
4.3 Friction Test Method 2
4.4 Particle Test Method 2
4.5 Chemical performance test method 3
5 Test report 3
Appendix A (Informative) Appearance Inspection Method (Dyeing Method) 4
Appendix B (Informative) Friction Test Method 5
Appendix C (Informative) Simulated Blood Vessel Model 8
Appendix D (Informative) Particle Test Method (Immersion Method) 9
Appendix E (Informative) Particle Test Method (Blood Vessel Model Friction Method) 10
Appendix F (Informative) Chemical Performance Test Methods 11
Reference 12
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Jiangsu Baisaifei Biotechnology Co., Ltd., Suzhou Su
The Institute of Health and Environmental Technology Co., Ltd., Lepu (Beijing) Medical Devices Co., Ltd., Poco International Medical Trading (Shanghai) Co., Ltd.
Company, Dingke Medical Technology (Suzhou) Co., Ltd., Jianshi Medical Equipment (Wuxi) Co., Ltd., and Medtronic (Shanghai) Management Co., Ltd.
The main drafters of this document are. Chen Hong, Wan Min, Ai Chongchong, Fang Jingyi, Yang Tingru, Cui Yongping, Weng Yulin, Wang Rui, Kong Fanzhi, Nie Jiaqi,
Liu Ye and Han Lei.
Durability of hydrophilic coating on intravascular catheter guidewires
experiment method
1 Scope
This document describes the coating fastness test method for medical catheter guidewires with hydrophilic lubricating coatings for intravascular use, including visual inspection.
There are four methods. friction test method, particle test method and chemical property test method.
The hydrophilic lubricating coatings mentioned in this document refer only to the hydrophilic lubricating coatings prepared by polymers and chemically bonded to the surface of the substrate, and do not include
Other types of coatings, such as drug-loaded coatings, biodegradable coatings, etc.
This document applies to intravascular catheters and guidewires with hydrophilic lubricating coatings.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
YY/T 1556 Test method for particle contamination of medical infusion, blood transfusion and injection equipment
Pharmacopoeia of the People's Republic of China (2020 Edition, Volume 4)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
A hydrophilic substance with lubricating function that is fixed on the surface of the catheter guide wire through a certain strong bonding force.
3.2
coating lubricity
The ease with which a coating slides when in contact with human tissues, organs, and associated or combined devices.
3.3
coating fastness
The degree of bonding between the coating and the medical device substrate is reflected in the integrity and durability of the coating.
4 Coating fastness test method
4.1 General
This document provides four test methods for characterizing the fastness of coatings, including appearance inspection method, friction test method, and particle test method.
And chemical performance test methods. Appropriate methods can be selected according to the clinical use of the product and the purpose of the test.
NOTE. Other validated methods may also be used.
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