Standard No.:	YY/T 1550.2-2019
English Name:	Guidance of study on the compatibility of infusion equipments and pharmaceutical products―Part 2:Leachable known―Substance
Chinese Name:	一次性使用输液器具与药物相容性研究指南 第2部分：可沥滤物研究 已知物
Chinese Classification:	C31    General and microsurgical devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by:	National Medical Products Adminstration
Issued on:	2019-07-24
Implemented on:	2020-8-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	3500 words
Price(USD):	105.00
Delivery:	via email in 1~3 business day

本标准给出了在临床输注条件下或模拟临床实际输注条件下，一次性使用输液器具与药物接触过程中可沥滤物中已知物的研究方法。本标准适用于特定输液器具与拟输注的药物或经论证所选择的模拟溶剂进行的已知可沥滤物研究。