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GB/T 19703-2020 English PDF

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GB/T 19703-2020: (In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content)
Status: Valid

GB/T 19703: Evolution and historical versions

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GB/T 19703-2020English319 Add to Cart 4 days [Need to translate] (In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content) Valid GB/T 19703-2020
GB/T 19703-2005English679 Add to Cart 3 days [Need to translate] In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Description of reference materials Obsolete GB/T 19703-2005

PDF similar to GB/T 19703-2020


Standard similar to GB/T 19703-2020

GB/T 16886.9   GB/T 16886.6   GB/T 19702   GB/T 21666   

Basic data

Standard ID GB/T 19703-2020 (GB/T19703-2020)
Description (Translated English) (In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content)
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C30
Word Count Estimation 17,176
Date of Issue 2020-11-19
Date of Implementation 2021-12-01
Older Standard (superseded by this standard) GB/T 19703-2005
Regulation (derived from) National Standard Announcement No. 26 of 2020
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 19703-2020: (In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content)


---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.
(In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content) ICS 11.040 C30 National Standards of People's Republic of China Replace GB/T 19703-2005 In Vitro Diagnostic Medical Devices Measurement of amount in biological samples Requirements for certified reference materials and supporting document content (ISO 15194.2009, IDT) Released on 2020-11-19 Implemented on 2021-12-01 State Administration for Market Regulation Issued by the National Standardization Management Committee

Table of contents

Preface Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Systematic format of document characteristics supported by certified reference materials 3 4.1 Characteristic format 3 4.2 Structure of System Naming 4 4.3 Popular names 4 5 The characteristics, production and value of certified reference materials 4 5.1 Level 4 5.2 Features 4 5.3 Production and valuation 5 6 Contents of supporting documents 5 6.1 Supporting documents 5 6.2 Label 5 6.3 Certificate 5 6.4 Valuation report 5 Appendix A (informative appendix) Nominal characteristics or ordinal quantities of certified reference materials 12 Reference 13

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces GB/T 19703-2005 "In Vitro Diagnostic Medical Device Biological Source Samples Measurement Reference Substances" Ming Dynasty, compared with GB/T 19703-2005, the main technical changes are as follows. ---Introduced ISO 5725-2, ISO 17511.2003, ISO 18153, ISO Guide31, ISO Guide34, ISO Guide35, ISO /IEC Guide98-3.2008, ISO /IEC Guide99.2007 content; ---Added the terms and definitions of "internationally agreed calibrators", "reference materials" and "certified reference materials" (see 3.3, 3.4, 3.5); ---Added the content of "5 Characteristics, production and value of certified reference materials" (see Chapter 5); --- "5 Description of Reference Substances" is revised to "6.4 Fixed Value Report"; --- Deleted the content of the "rationality of choice" clause (see 5.6 of the.2005 edition); --- "5.9 Verification" is changed to "6.4.8 Fixed value"; --- "5.12 Supplier" is amended to "6.4.11 Development Organization"; --- Deleted the content of the "Packaging Insert" clause (see Chapter 8 of the.2005 edition). The translation method used in this standard is equivalent to ISO 15194.2009 "In vitro diagnostic medical device biological sample measurement Requirements for the content of certified reference materials and supporting documents. The Chinese documents that have a consistent correspondence with the international documents cited in this standard are as follows. ---GB/T 3102 (all parts) quantity and unit [(ISO 31 (all parts)]; ---GB/T 6379.2-2004 Measurement method and accuracy of results (accuracy and precision) Part 2.Determine standard measurement The basic method of measurement method repeatability and reproducibility (ISO 5725-2.1994, IDT); ---GB/T 15000.3-2008 Guidelines for the Work of Standard Samples (3) General principles and statistical methods for the determination of standard samples (ISO Guide35.2006,IDT); ---GB/T 15000.4-2019 Standard Sample Work Guidelines Part 4.The content of certificates, labels and accompanying documents (ISO Guide 31.2015, IDT); ---GB/T 15000.7-2012 Guidelines for Standard Sample Work (7) General Requirements for the Ability of Standard Sample Producers (ISO Guide 34.2009, IDT); ---GB/T 27418-2017 Measurement Uncertainty Evaluation and Expression (ISO /IEC Guide98-3.2008, MOD); ---GB/T 27419-2018 Evaluation and Expression of Measurement Uncertainty Supplementary File 1.Distribution based on Monte Carlo method (ISO /IEC Guide98-3/Suppl.1.2008,IDT); ---YY/T 0638-2008 In Vitro Diagnostic Medical Device Biological Samples Measurement of calibrators and enzyme catalysis in control substances Metrological traceability of concentration assignment (ISO 18153.2003, IDT). This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this standard. Beijing Institute of Medical Device Inspection, Chinese Academy of Metrology, Zhongsheng Beikong Biotechnology Co., Ltd., National Health Commission Clinical Laboratory Center, Beijing Leadman Biochemical Co., Ltd. The main drafters of this standard. Li Shengmin, Wu Liqing, Jin Ling, Zhang Tianjiao, Ren Yikun. The previous versions of the standard replaced by this standard are as follows. ---GB/T 19703-2005.

Introduction

In scientific, technical, and routine service work, a reference measurement system is required to obtain useful and reliable measurement results to make it comparable And finally traceable in metrology to the measurement standards and/or measurement procedures with the highest metrological level. Reference substances are substances or equipment used to obtain metrological traceability across time and space and between different measurement procedures. A certified reference material is required for the calibration level sequence of the quantity level. A designated certified reference material should have a supporting document, which includes the source, description, measurement results, metrology traceability of the material Performance, instructions for use, stability data and storage conditions, and health and safety warnings. This standard specifies the content of such substances and supporting documents Requirements. Reference substances are used for one of the three main purposes. a) Calibrate the indication value of a measurement system or be used for the assignment of other reference materials; b) Verify or control the accuracy of the values measured by a designated laboratory or batch of laboratories; Note. In ISO terminology, "correctness" is related to "bias", "system effect" and "system error", while "accuracy" is related to "correctness" and "precision". "Precision" is related to "standard deviation", "coefficient of variation", "random effect" and "random error". c) Evaluate the performance of a new measurement procedure. The maximum acceptable measurement uncertainty of a reference substance assignment result depends on the measurement procedure including the reference substance. Requirement of quantity. Since the correct use of a reference material depends on its description, it is necessary to specify the documentation of the reference material. The advantages of having standards available are listed in ISO /IEC Guide15. In Vitro Diagnostic Medical Devices Measurement of amount in biological samples Requirements for certified reference materials and supporting document content

1 Scope

This standard specifies the requirements for the content of certified reference materials and supporting documents, so that they can be considered to be consistent with GB/T 21415-2008. The result is a higher level of metrology. This standard applies to all types of certified reference materials, including primary measurement standards, secondary measurement standards and calibration Or an internationally agreed calibrator for accuracy control. This standard also provides how to collect data for setting value, and how to express the result of setting value and Its measurement uncertainty requirements. This standard is applicable to certified reference materials whose assignment result is differential value or proportional value. Appendix A provides relevant nominal characteristics and order Amount of information. This standard does not apply to reference materials that are part of the in vitro diagnostic measurement system, but many elements may help it.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 21415-2008 Measurement of calibrator and control substance assignment in biological samples of in vitro diagnostic medical devices Academic traceability (ISO 17511.2003, IDT) ISO 31 (all parts) 1) Quantities and units (Quantities and units) 1) At present, the ISO 31 series of standards have been replaced by the ISO 80000 series of standards and the IEC 80000 series of standards. ISO 5725-2 Measurement methods and accuracy of results (correctness and precision) Part 2.Repeatability and accuracy of standard measurement methods The basic method of reproducibility determination [Accuracy(truenessandprecision)ofmeasurementmethodsandresults- Part 2.Basicmethodforthedeterminationofrepeatabilityandreproducibilityofastandardmeasure- mentmethod] ISO 18153 In Vitro Diagnostic Medical Device Biological Samples Measurement of Enzyme Catalytic Concentration Assignment in Calibrators and Control Substances Metrology traceability (Invitrodiagnosticmedicaldevices-Measurementofquantitiesinbiologicalsamples- Metrologicaltraceabilityofvaluesforcatalyticconcentrationofenzymesassignedcalibratorsandcon- trol) The content of the ISO Guide31 standard material standard sample certificate and label (Referencematerials-Contentsofcertifi- catesandlabels) ISO Guide34 Standard Material/Standard Sample Producer Competence Criteria (General requirements for the competenceofreferencematerialproducers) ISO Guide35 General principles and statistical methods for the determination of standard samples (Referencematerials-Generalandsta- tisticalprinciplesforcertification) ISO /IEC Guide98-3.2008 Guidelines for the expression of uncertainty in measurement (Guidetotheexpressionofuncertaintyin measurement)(GUM.1995) ISO /IEC Guide99.2007 Common concepts and related terms (International Metrology Vocabulary Foundation)

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