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WS/T 407-2012 PDF English

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WS/T 407-2012: Guideline for comparability verification of quantitative results within one health care system
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WS/T 407-2012English419 Add to Cart 3 days [Need to translate] Guideline for comparability verification of quantitative results within one health care system

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Basic data

Standard ID WS/T 407-2012 (WS/T407-2012)
Description (Translated English) Guideline for comparability verification of quantitative results within one health care system
Sector / Industry Health Industry Standard (Recommended)
Classification of Chinese Standard C50
Classification of International Standard 11.100
Word Count Estimation 16,135
Quoted Standard WS/T 406; CLSI EP9-A2; CLSI EP15-A2
Regulation (derived from) ?Health-Communication (2012) 23; Industry Standard Filing Announcement 2013 No.2 (Total No.158)
Issuing agency(ies) National Health and Family Planning Commission of the People's Republic of China
Summary This standard provides a quantitative test for multiple detection systems project implementation results to verify the comparability requirements, including conditions comparable validation protocol and application, verification methods and procedures, ve

WS/T 407-2012: Guideline for comparability verification of quantitative results within one health care system




---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.
Guideline for comparability verification of quantitative results within one health care system ICS 11.100 C50 People's Republic of China health industry standards Medical institutions within the quantitative test results Comparability verification guide Posted on.2012-12-25 2013-08-01 implementation Ministry of Health of People's Republic of China released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard proposed by the Ministry of Health Clinical Laboratory Standards Committee. This standard was drafted. Ministry of Health Clinical Laboratory, Beijing Union Medical College Hospital, Beijing Capital Medical University, Beijing Tiantan Hospital. Drafters of this standard. Peng Mingting, Xie Bo, Li Chenbin, Gu Xiaolin, Lu Hong, Su Bingnan, Su Wei, Yuexiu Ling. Medical institutions within the quantitative test results Comparability verification guide

1 Scope

This standard specifies the requirements for the comparability verification of the results of multiple inspection systems of quantitative test items, including the comparability verification scheme The conditions of use and application, verification methods and procedures, verification results do not meet the requirements of the measures. This standard applies to the same medical institutions within the clinical laboratory.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. WS/T 406 clinical hematology routine testing project analysis of quality requirements CLSIEP9-A2 Methodological Alignment and Bias Assessment with Patient Samples. Method comparison andbiasestimationusingpatientsamples. Approvedguideline-Secondedition) User Verification of CLSIEP15-A2 Precision and Accuracy Performance. Approval Guide - Second Edition (Userverificationof performanceforprecisionandtrueness. Approvedguideline-Secondedition)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Comparability Different measurement procedures are used to determine the consistency of test results obtained with an analyte. The difference between the results does not exceed the required Accept the standard, the results can be considered comparable. 3.2 Commutability Interchangeability Replacement When measuring the substance with different measurement procedures, the numerical relationship between the measurement results obtained by each measurement procedure and those measured by these measurement procedures The actual number of clinical specimens when measuring the numerical relationship between the degree of agreement. 3.3 Precision precision Under the conditions specified, the consistency between independent test results, the measure of precision is usually expressed in imprecision. 3.4 Imprecision imprecision The same laboratory uses the same method to analyze the discreteness of results obtained from the same sample in multiple independent tests. ...

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