This Standard specifies the classification, requirements, test methods, marking, labeling, use instructions, as well as packaging, transportation and storage requirements for medical centrifuges (hereinafter referred to as centrifuges). This Standard is applicable to the design, production and inspection of medical centrifuges. This Standard does not apply to ultracentrifuges (rotational speed higher than 30000 r/min).
Basic Data
Standard ID
YY/T 0657-2008 (YY/T0657-2008)
Description (Translated English)
Medical centrifuge
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
8,836
Date of Issue
2008-04-25
Date of Implementation
2009-06-01
Older Standard (superseded by this standard)
YY 91046-1999; YY 91100-1999
Quoted Standard
GB/T 191; GB 4793.1; GB 4793.7; GB/T 14710
Regulation (derived from)
SFDA [2008] No. 192
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the Medical Centrifuge (hereinafter referred to as centrifuges) product classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage requirements. This standard applies to medical centrifuge design, production and testing. This standard does not apply to ultracentrifuge (speed above 30000r/min),
