YY/T 1550.2-2019: Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 2: Leachable known - Substance

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Scope

This Part of YY/T 1550 gives the method for study on known leachable
substance in the process of single-use infusion equipment in contact with
pharmaceutical products under clinical infusion conditions or simulated clinical
actual infusion conditions.
This Part applies to the study of known leachable substance with specific
infusion equipment and pharmaceutical product to be infused or a simulated
solvent selected after demonstration.

Basic Data

Standard ID	YY/T 1550.2-2019 (YY/T1550.2-2019)
Description (Translated English)	Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 2: Leachable known - Substance
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.30
Word Count Estimation	6,620
Date of Issue	2019
Date of Implementation	2020-08-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the research methods for known leachables in the process of single-use infusion set in contact with drugs under clinical infusion conditions or simulating actual clinical infusion conditions. This standard applies to the study of known leachables with a specific infusion device and a drug to be infused or a simulated solvent selected for justification.