YY/T 1416.4-2016 English PDF (YYT1416.4-2016)

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YY/T 1416.4-2016: Test method for additive in single-use containers for human venous blood specimen collection--Part 4: Fluoride
YY/T 1416.4-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.20
C 48
Test method for additive in single-use containers
for human venous blood specimen collection –
Part 4. Fluoride
ISSUED ON. JULY 29, 2016
IMPLEMENTED ON. JUNE 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3 
Introduction .. 4 
1 Scope .. 5 
2 Normative references . 5 
3 Test section . 5 
4 Test report . 7 
Foreword
YY/T 1416 “Test method for additive in single-use containers for human venous blood
specimen collection” consists of 4 parts.
- Part 1. Ethylene diamine tetraacetic acid (EDTA) salt;
- Part 2. Sodium citrate;
- Part 3. Heparin.
- Part 4. Fluoride.
This Part is Part 4 of YY/T 1416.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some contents of this document may involve patents. The issuing
agency of this document does not assume responsibility for identifying these patents.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee of Infusion
Equipment for Medical Use Standardization (SAC/TC 106).
Main drafting organizations of this Part. Shandong Quality Supervision and Testing
Center for Medical Device Product AND Guangzhou Improve Medical Science and
Technology Co., Ltd.
Main drafters of this Part. Xu Kai, Zhang Limei and Sun Bangfu.
Test method for additive in single-use containers
for human venous blood specimen collection –
Part 4. Fluoride
1 Scope
This Part of YY/T 1416 specifies the experiment method of using ion chromatography
method to determine the amounts of additives in single-use containers for human
venous blood specimen collection (abbreviated as blood-collecting vessel, whose
additives have fluoride).
This Part applies to the blood-collecting vessels whose additives are fluoride/oxalate,
fluoride/EDTA and fluoride/heparin. They can separately determine the amount of
fluoride, oxalate and EDTA. For the blood-collecting vessel which contain the additive
of fluoride/heparin, the amount of heparin can be determined by the methylene blue
spectrophotometric method in YY/T 1416.3.
2 Normative references
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this standard.
GB/T 6682 Water for analytical laboratory use - Specification and test methods
YY/T 1416.3 Test method for additive in single-use containers for human venous
blood specimen collection - Part 3. Heparin
3 Test section
3.1 Test principle
This Part uses ion chromatography method to determine the fluoride ion, EDTA ion
and oxalate ion in blood-collecting vessel. Using the retention time to determine the
quality and using the peak area to determine the quantity, the contents of the fluoride
ion, EDTA ion and oxalate ion in blood-collecting vessel can be determined.