Standard No.:	DB32/T 4768-2024
English Name:	Identification and leaching amount determination of common fluorescent substances in PVC-based medical devices
Chinese Name:	聚氯乙烯医疗器械中常见荧光物质识别及浸出量的测定
Chinese Classification:	C31    General and microsurgical devices
Professional Classification:	DB    Provincial Standard
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by:	Jiangsu Adminstration of Market Regulation
Issued on:	2024-05-16
Implemented on:	2024-6-16
Status:	valid
Language:	English
File Format:	PDF

本文件描述了以聚氯乙烯为原料制成的医疗器械。在模拟实际使用条件下。对OB、OB-1、OB-2、KSN、CBS-127、ER-1六种常见荧光物质进行识别及浸出量的测定。
本文件中极限浸提法适用于心血管介入器械等高风险医疗器械，模拟浸提法适用于相对风险较低的医疗器械。
本文件不适用于医用输液器和输血器中荧光物质的识别及浸出缱的测定。