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Reference measurement procedure for determination of electrolytes(Potassium, sodium, calcium and magnesium)in serum (Ion chromatography)
| Valid |
YY/T 1675-2019
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PDF similar to YY/T 1675-2019
Basic data | Standard ID | YY/T 1675-2019 (YY/T1675-2019) | | Description (Translated English) | Reference measurement procedure for determination of electrolytes(Potassium, sodium, calcium and magnesium)in serum (Ion chromatography) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 25,235 | | Date of Issue | 2019 | | Date of Implementation | 2020-10-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard is applicable to the quantitative measurement of potassium ion, sodium ion, total calcium and total magnesium content in serum. |
YY/T 1675-2019: Reference measurement procedure for determination of electrolytes(Potassium, sodium, calcium and magnesium)in serum (Ion chromatography) ---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Reference measurement procedure for determination of electrolytes (Potassium, sodium, calcium and magnesium) in serum (Ion chromatography)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Reference measurements of serum electrolytes (potassium, sodium, calcium, magnesium)
Procedure (ion chromatography)
Published on October 23,.2019
2020-10-01 implementation
Published by the State Drug Administration
Contents
Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Abbreviations 2
5 Measurement principle and method 3
6 Reagent 3
6.1 Reagent material information 3
Serum Electrolyte References Recommended by the Joint Committee for Traceability in Laboratory Medicine (JCTLM)
Measurement procedure. Based on this standard, the detection conditions and sample preparation methods of the ion chromatograph are optimized, and reference is made to ISO 15193.
2009 "In-vitro diagnostic medical device biological source sample measurement of reference measurement and expression requirements and content requirements" Appropriate increase or decrease
content.
Reference measurements of serum electrolytes (potassium, sodium, calcium, magnesium)
Procedure (ion chromatography)
1 Scope
This standard applies to the quantitative measurement of potassium, sodium, total calcium, and total magnesium in serum.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 29791.1-2013/ISO 18113-1..2009 Information (marking) provided by manufacturers of in vitro diagnostic medical devices
Section. Terminology, definitions and general requirements
GB/T 6682-2008 Analytical laboratory water specifications and test methods
JJF1135-2005 Uncertainty Evaluation for Chemical Analysis
ISO 15193..2009 in vitro diagnostic medical devices for the measurement of quantities in biologically-derived samples
Requirements (Invitrodiagnosticmedicaldevices-Measurementofquantitiesinsamplesofbiologicalorigin-
Requirementsforcontentandpresentationofreferencemeasurementprocedures)
3 terms and definitions
The following terms and definitions apply to this document.
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