This part of YY/T 1651 specifies the absorbance method for hemolysis and the hemoglobin concentration for hemolysis. This section applies to the evaluation of hemolysis by medical devices/materials.
Basic Data
Standard ID
YY/T 1651.1-2019 (YY/T1651.1-2019)
Description (Translated English)
Tests for hemolysis of medical devices - Part 1: Material induced hemolysis assay
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
11.040.01
Word Count Estimation
10,136
Date of Issue
2019
Date of Implementation
2020-06-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the hemolysis method for the determination of absorbance and the determination of hemoglobin concentration. This standard applies to the evaluation of hemolysis mediated by medical devices/materials.
