YY/T 1416.4-2016Test method for additive in single-use containers for human venous blood specimen collection - Part 4: Fluoride (English PDF)
一次性使用人体静脉血样采集容器中添加剂量的测定方法第4部分:氟化物
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1416.4-2016 is the English-translated version of 一次性使用人体静脉血样采集容器中添加剂量的测定方法第4部分:氟化物.
YY/T 1416.4-2016 is the Chinese pharmaceutical industry standard that gives the ion chromatographic method for determining the amounts of the additives in a single-use venous blood collection container.
It is the fourth part of the YY/T 1416 series and sets out the eluent and the column, the preparation of the sample from the tube, the separation and detection of the ions and the calculation of the amount of each additive per container. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1416.4-2016
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Test section5
- 4 Test report7
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.
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.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
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Related Standards
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
YY/T 1416.3-2016 — Test method for additive in single-use containers for human venous blood specimen collection - Part 3: Heparin
YY/T 1416.5-2021 — Test method for additive in single-use containers for human venous blood specimen collection - Part 5: Glycine
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YY/T 1416.4-2016
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