This Standard specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination (referred to as “receptacle”). This Standard also applies to receptacles containing media for blood culture. This Standard does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This Standard does not specify requirements and test methods for single-use receptacles intended for the collection of specimens, other than blood.
Basic Data
Standard ID
YY 0314-2007 (YY0314-2007)
Description (Translated English)
[Including YY 0314-2013XG] Single-use containers for venous blood specimen collection
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C31
Classification of International Standard
11.040.20
Word Count Estimation
21,276
Date of Issue
2007-07-02
Date of Implementation
2008-08-01
Older Standard (superseded by this standard)
YY 0314-1999
Quoted Standard
GB/T 1962.1; GB/T 6682-1992
Adopted Standard
EN 14820-2004, MOD
Regulation (derived from)
China Food and Drug Administration Announcement 2013 No.34
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard provides for in vitro diagnostic tests, manufacturers are expected to disposable human blood samples collection tube (referred to as "mining vessel") requirements and test methods. This standard also applies to culture medium containing blood collection tube. This standard does not specify peripheral arterial blood collection tubes or sample collection requirements. This standard does not provide for one-time use of non-blood sample collection tubes Requirements and test methods.
