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YY/T 1195-2011 English PDF

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YY/T 1195-2011: Reference measurement procedure of total protein in serum
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PDF similar to YY/T 1195-2011


Standard similar to YY/T 1195-2011

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Basic data

Standard ID YY/T 1195-2011 (YY/T1195-2011)
Description (Translated English) Reference measurement procedure of total protein in serum
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 19,172
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard GB/T 6682-2008; JJF 1059-1999
Regulation (derived from) Industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to the total protein content in serum quantitative measurements.

YY/T 1195-2011: Reference measurement procedure of total protein in serum

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Reference measurement procedure of total protein in serum ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Serum total protein reference measurement procedures Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the State Food and Drug Administration. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. Beijing Leadman Biochemistry Co., Ltd., Beijing Medical Device Testing, Shanghai Fuxing Changzheng Medical Science Ltd., BIOSINO Biotechnology Co., Ltd.. The main drafters of this standard. Wanglan Zhen, Wang Jun, Wu Jie, Qi Lili, Yang Zongbing, Duhai Ou.

Introduction

Biuret method for measuring serum total protein has been nearly a hundred years of history, in this process, many researchers measured their system Optimized 1974 American Association for Clinical Chemistry (AACC) total protein study group this method was more in-depth studies, the establishment Serum total protein reference measurement procedures and findings in the American Journal of ClinicalChemistry continuously published. The final Senate Test methods recognized standards agency and became the Joint Commission Laboratory Medicine Traceability (JCTLM, JointCommitteefor TraceabilityinLaboratoryMedicine) Recommended total serum protein reference measurement procedures. This standard is based on this reference measurement procedures Making. Serum total protein reference measurement procedures

1 Scope

This standard is used for quantitative measurement of serum total protein content.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. Laboratory use specifications and test methods GB/T 6682-2008 Analysis JJF1059-1999 Evaluation and Expression of Uncertainty in Measurement

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Sensitivity analysis analyticalsensitivity The sensitivity of the measurement program sensitivityofameasurementprocedure Measurements indicating values divided by the corresponding change of the measured value quotient. Note 1. The sensitivity of the measurement procedure is likely to be dependent on the measured value. Note 2. To investigate the changes must be greater than the measured value resolution. Note 3. a measuring system sensitivity analysis is the slope of the calibration curve. Note 4. The analytical sensitivity should not be used to indicate the limit of quantification or detection limit, and should not be confused with the diagnostic sensitivity. [ISO 18113-1.2009, defined A3.3] 3.2 Linearityofameasuringsystem linear measuring system Linear linearity Values are given in the sample to be measured is directly measured value of the ability to scale. Note 1. For in vitro diagnostic medical devices, linear and linear measurement calibration or indication of a given measurement result of the measurement interval related. Note 2. Linear assessed by measuring the recipe which contains known or known relative relationship (not necessarily absolute knowledge) is measured samples. Relative is measured when the measurement result Absolute or relative value is plotted, the curve of the line plan that is a measure of degree of compliance linearity. [ISO 18113-1.2009, defined A3.21] 3.3 Influence quantity influencequantity In direct measurement, does not affect the actual amount to be measured, but the amount of influence between the indication and the measurement result of the relationship. Example 1. direct measurement of hemoglobin concentration in human plasma bilirubin concentrations. Example 2. measurement of the background pressure in the mass spectrometer ion source in a fraction of the amount of substance. Note 1. Indirect Measurement combination comprising direct measurements, wherein each measurement can be affected by the amount of impact. Note 2. In the GUM, the concept is defined as the amount of influence a previous version of VIM, covering not only the amount of influence the measuring system, as defined above, but also that These affect the actual amount was measured quantity. Further, in the GUM this concept is not limited to direct measurement.

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