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YY/T 1675-2019 PDF English

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YY/T 1675-2019: Reference measurement procedure for determination of electrolytes(Potassium, sodium, calcium and magnesium)in serum (Ion chromatography)
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YY/T 1675-2019English499 Add to Cart 5 days [Need to translate] Reference measurement procedure for determination of electrolytes(Potassium, sodium, calcium and magnesium)in serum (Ion chromatography)

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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 25,266
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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