This Part of YY 0326 specifies the requirements for containers for plasma used together with hemostix specified in YY 0328, plasma tubing specified in YY 0326.2 and plasma centrifuge bowl specified in YY 0326.1.The plasma collected and stored in containers for plasma specified in this Part is used to prepare blood products. It cannot be used for clinical blood transfusion.
Basic Data
Standard ID
YY 0326.3-2005 (YY0326.3-2005)
Description (Translated English)
Plasmapheresis centrifuge apparatus for single use - Part 3: Containers for plasma
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C31
Classification of International Standard
11.040.20
Word Count Estimation
17,162
Date of Issue
2005-12-07
Date of Implementation
2006-12-01
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies requirements and YY 0326. 1 plasma separation cup, YY 0326. 2 prescribed plasma lines and YY 0328 supporting the use of prescribed blood plasma bags requirements. As provided in this section plasma bags stored plasma collected for the preparation of blood products, can not be used for clinical transfusion.
