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Delivery: <= 8 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 27420-2018: Conformity assessment -- Application guide for evaluation and expression of uncertainty in biological sample measurement Status: Valid
Basic dataStandard ID: GB/T 27420-2018 (GB/T27420-2018)Description (Translated English): Conformity assessment -- Application guide for evaluation and expression of uncertainty in biological sample measurement Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A00 Classification of International Standard: 03.120.20 Word Count Estimation: 62,652 Date of Issue: 2018-05-14 Date of Implementation: 2018-12-01 Regulation (derived from): National Standards Announcement No. 6 of 2018 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 27420-2018: Conformity assessment -- Application guide for evaluation and expression of uncertainty in biological sample measurement---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. Conformity assessment--Application guide for evaluation and expression of uncertainty in biological sample measurement ICS 03.120.20 A00 National Standards of People's Republic of China Evaluation of Measurement Uncertainty of Conformity Assessment Biological Samples And presentation application guide Published on.2018-05-14 2018-12-01 implementation State market supervision and administration China National Standardization Administration issued ContentForeword III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 conventions and symbols 6 5 Measurement Overview 6 5.1 Metrological traceability of measurement results 6 5.2 Uncertainty of measurement results 6 6 Measurement uncertainty measurement method 7 6.1 Overview of assessment methods 7 6.2 Class A and Class B assessment of measurement uncertainty components 8 6.3 Synthesis uncertainty and representation 9 7 Uncertainty evaluation and representation of measurement results of reference measurement procedures 10 7.1 Requirements for measurement uncertainty assessment 10 7.2 Potential sources and control requirements for measurement uncertainty 10 7.3 Measurement uncertainty assessment strategy 11 7.4 Measurement results and uncertainty representation 11 7.5 Review of the measurement uncertainty program 12 8 Uncertainty evaluation and representation of measurement results of routine measurement procedures 12 8.1 Requirements for measurement uncertainty assessment 12 8.2 Potential sources and control requirements for measurement uncertainty 12 8.3 Measurement uncertainty assessment strategy 13 8.4 Measurement results and uncertainty representation 13 8.5 Review of the measurement uncertainty procedure 14 Appendix A (informative) Conventions and symbols used in this standard 15 Appendix B (informative) Commonly used inclusion probability p value, inclusion factor k value and t value 19 Appendix C (informative) Calculation of the degree of freedom of the standard uncertainty component of Class B assessment 21 Appendix D (informative) Example of measurement uncertainty assessment 22 Reference 55ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Certification and Accreditation Standardization Technical Committee (SAC/TC261). This standard was drafted. China National Accreditation Center for Conformity Assessment, Beijing Aerospace General Hospital, Nantong University Affiliated Hospital, Shenzhen Entry and Exit Inspection Inspection and Quarantine Bureau, China Institute of Metrology, Beijing Medical Device Inspection Institute, Shanghai Clinical Laboratory Center, National Environmental Analysis Test Xin, Beijing Institute of Technology, Aussie Analytical Testing (Shanghai) Co., Ltd., Beijing Continental Star Quality Certification Center Co., Ltd., Zhongsheng North Control Biotechnology Co., Ltd., Shanghai Fosun Long March Medical Science Co., Ltd. The main drafters of this standard. Lu Jing, Chen Baorong, Wang Huimin, Dong Fuyin, Shi Guanghua, Sun Huiying, Ji Youyan, Wang Jun, Li Yuwu, Yang Yuanhua, Shi Changyan, Ju Yi, Zhou Taogeng, Jiang Fang, Jiang Lin, Wu Jie.IntroductionThe complete measurement results should include information that characterizes the dispersion of the results, ie measurement uncertainty, which has become a consensus in the measurement field. Used for the measurement of biological samples. An understanding of the measurement uncertainty helps to more accurately interpret and apply the measured values, especially when the measured values are When a certain decision limit is close, at the same time, measurement uncertainty is also an important indicator of measurement quality. At present, the basic document of the internationally announced uncertainty assessment is the Guide to Measurement Uncertainty (ISO /IEC Guide 98-3. GuidetotheExpressionofUncertaintyinMeasurement, GUM..1995), GUM explains in principle that the measurement is not The degree of certainty and its principle of assessment. Common methods include. bottom-up methods, top-down methods, and Monte Carlo method. Biological sample measurements have more complex sources of uncertainty, such as imperfect definition of analytes, unstable samples, and inability to trace Source to SI unit, measuring the "activity" of the substance, complex matrix, and usually taking the value of a single measurement in the field of medical inspection as a result Etc., which leads to the uncertainty of assessing the measurement results of biological samples. In actual work, it is difficult to meet the method requirements as easily as chemical analysis. The ideal conditions or their complexity are in conflict with the detection needs. This standard is based on the classification of biological sample metrology traceability, according to the conventional The different characteristics of the measurement method and the reference measurement method, and the strategies, methods and steps for the uncertainty assessment that can be taken under different conditions are given. Application guide. The content of this standard mainly relates to the uncertainty assessment of biological sample measurement process, without involving biological variation, pre-measurement and post-measurement. The effect of the process on the dispersion of results, and this does not mean that they are not important. In order to better explain and utilize the measurement results, the laboratory should combine practical work. Make a demand, focus on its potential impact on the outcome, and explore ways to properly control and express its impact. Evaluation of Measurement Uncertainty of Conformity Assessment Biological Samples And presentation application guide1 ScopeThis standard is an application guide for the assessment and presentation of the uncertainty of quantitative measurements of biosourced samples in the field of conformity assessment. This standard applies to the assessment of the uncertainty of test results related to the measurement process, but does not include biological variation, pre-measurement and post-measurement. The effect of the process on the measurement results.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 8170 Numerical Rounding Rules and Representation and Determination of Limit Values GB/T 19702 Description of the reference measurement procedure for the measurement of the amount of biological samples of in vitro diagnostic medical devices GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation Source GB/T 21919 Requirements for Laboratory Medical Reference Measurement Laboratory GB/T 22576 Medical laboratory quality and capacity requirements General requirements for GB/T 27025 testing and calibration laboratory capabilities GB/T 27407 laboratory quality control using statistical quality assurance and control chart technology to evaluate the performance of analytical measurement systems GB/T 27411 Test Laboratory Commonly Used Uncertainty Evaluation Method and Representation ISO 80000-1 Quantity and Units Part 1. General (Quantitiesandunits-Part 1. General)3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Measured measurand The amount to be measured. 3.2 Metrological traceability Through the uninterrupted calibration chain specified in the document, the measurement results are linked to the reference object, and each calibration in the calibration chain will Introduce measurement uncertainty. 3.3 Measuring principle measurementprinciple Used as a basis for measurement. 3.4 Measurement method measurementmethod A general description of the logical arrangement given for the operations used in the measurement process. 3.5 Measuring procedure measurementprocedure Based on one or more measurement principles and a given measurement method, based on the measurement model and the calculations required to obtain the measurement results, A detailed description of the amount. 3.6 Reference measurement program referencemeasurementprocedure When calibrating or setting a standard substance, the measurement procedure used to provide the measurement results is suitable for evaluation by the same amount of other The measurement accuracy of the measured magnitude obtained by the measurement procedure. 3.7 Primary reference measurement program primary referencemeasurementprocedure Primary reference program primary referenceprocedure A reference measurement procedure used to obtain measurements that are not related to the same type of measurement standard. 3.8 General measurement program regularmeasurementprocedure The measurement procedure used to test samples, whose measurements usually require metrology traceability. 3.9 Measuring system measuringsystem A set of one or more measuring instruments that are assembled and adapted to give a measured amount of information within a specified interval, usually including He is equipped with devices such as reagents and power supplies. 3.10 Matrix effect Sample characteristics that affect the measurement and measurable values independent of the presence of the analyte. 3.11 Reference material (standard sample, reference material) referencematerial; RM Substances with specific properties that are sufficiently uniform and stable, whose properties have proven to be suitable for the intended use in measurement or nominal property inspection. 3.12 Certified reference material certified referencematerial; CRM A document issued by an authority that provides one or more characteristics of uncertainty and traceability obtained using an effective procedure The standard substance of the quantity. 3.13 Calibration calibration The first step in a set of operations under specified conditions is to determine the relationship between the magnitude provided by the measurement standard and the corresponding indication. Then, this information is used to determine the relationship between the measurement results obtained by the indication value, where the measurement value provided by the measurement standard and the corresponding indication value have inaccurate measurement. Degree. 3.14 Measurement accuracy;accuracyofmeasurement Accuracy The degree to which the measured value is measured and its true value. 3.15 Measurement accuracy; truenessofmeasurement Correctness trueness Infinitely repeated measures the degree of agreement between the average of the magnitudes obtained and a reference magnitude. 3.16 Measuring precision measurementprecision Precision precision Under the specified conditions, the measured value or the degree of agreement between the measured values is repeated for the same or similar object to be measured. 3.17 Measuring repeatability measurerepeatability Repetitive repeatability Measurement precision under a set of repetitive measurement conditions. 3.18 Repeatability measurement condition measurementrepeatabilityconditionofmeasurement Repeatability condition repeatabilitycondition Same measurement procedure, same operator, same measurement system, same operating conditions and same location, and the same or similar in a short time A set of measurement conditions that are like repeated measurements by the measured object. Note. In chemistry, the term "intra-sequence precision measurement conditions" is sometimes used to mean "repetitive measurement conditions." 3.19 Measuring reproducibility measurementreproducibility Reproducibility Measurement precision under reproducible measurement conditions. 3.20 Reproducibility measurement condition reproducibilityconditionofmeasurement Recurrence condition reproducibilitycondition A set of measurement conditions for different locations, different operators, different measurement systems, and repeated measurements of the same or similar objects. 3.21 Precise measurement precisionmeasurementprecision Period precision intermediate precision Measurement precision under precision measurement conditions during a set of periods. 3.22 Preciseness measurement condition intermediateprecisionconditionofmeasurement Period precision condition intermediateprecisioncondition Except for the same measurement procedure, the same location, and a set of measurements that repeat measurements on the same or similar subject over a longer period of time In addition to the quantitative conditions, other conditions involving changes may also be included. 3.23 Indoor recurrence within-laboratoryreproducibility Measurement precision under reproducible measurement conditions in the same laboratory. 3.24 Indoor recurrence condition within-laboratoryreproducibilitycondition Reproducible measurement conditions in the same laboratory. Note 1. Indoor reproducibility conditions are the measurement conditions for the greatest variation in precision in the same laboratory. Note 2. For some laboratories, there may not be multiple measurement systems, and the precision may indicate the maximum possible imprecision measurement conditions. Note 3. Indoor reproducibility conditions and period precision conditions are not strictly defined. When applied, the description of conditions should include changed and unchanging conditions and How much has actually changed. 3.25 Measurement error; errorofmeasurement Error error The measured magnitude is subtracted from the reference magnitude. 3.26 Measuring offset measurementbias Offset bias An estimate of the system measurement error. 3.27 Measurement uncertainty measurementuncertainty Uncertainty Based on the information obtained, a non-negative parameter that imparts dispersibility to the measured value is characterized. Note 1. Measurement uncertainty includes components caused by system influences, such as components related to corrections and measurement criteria, and defined uncertainties. Sometimes the estimated system impact is not corrected, but treated as an uncertainty component. Note 2. This parameter can be such as the standard deviation (or its specific multiple) called the standard measurement uncertainty, or the interval half width including the probability. Note 3. Measurement uncertainty generally consists of several components. Some of these components can be based on a statistical distribution of a series of measurements, according to the class A of measurement uncertainty. The assessment was assessed and characterized by experimental standard deviation. Other components can be estimated based on the probability distribution of experience or other information. The Class B assessment of certainty is assessed and also characterized by standard deviation. Note 4. Generally, for a given set of information, the measurement uncertainty corresponds to the amount of magnitude assigned to the measurement. A change in this value will result in a corresponding inaccuracy The change in the degree. 3.28 Standard uncertainty standarduncertainty Standard measurement uncertainty standardmeasurementuncertainty;standarduncertaintyofmeasurement Measurement uncertainty expressed in standard deviation. 3.29 Class A assessment of measurement uncertainty TypeAevaluationofmeasurementuncertainty Class A assessment TypeAevaluation The measurement uncertainty component is evaluated by the statistical analysis method for the measured value under the specified measurement conditions. Note. The specified measurement conditions refer to repetitive measurement conditions, period precision measurement conditions, or reproducibility measurement conditions. 3.30 Class B assessment of measurement uncertainty TypeBevaluationofmeasurementuncertainty Class B assessment TypeBevaluation The measurement uncertainty component is evaluated by a method different from the measurement uncertainty class A assessment. Example. The rating is based on the following information. ---The amount of authority issued by the authority; --- The amount of certified reference material; --- Calibration certificate; --- Instrument drift; --- The accuracy level of the measured measuring instrument; --- Limit values inferred based on personnel experience, etc. 3.31 Synthetic standard uncertainty combinedstandarduncertainty Synthetic standard measurement uncertainty combinedstandardmeasurementuncertainty The standard measurement uncertainty of the output obtained from the standard measurement uncertainty for each input in a measurement model. Note. In the case of input quantities related in the measurement model, the covariance must be considered when calculating the synthetic standard uncertainty. 3.32 Extended uncertainty expandeduncertainty Extended measurement uncertainty expandedmeasurementuncertainty The composite standard uncertainty is the product of a numerical factor greater than one. Note 1. This factor depends on the type of probability distribution of the output in the measurement model and the selected inclusion probability. Note 2. The term “factor” in this definition refers to the inclusion factor. 3.33 Contains interval coverageinterval An interval containing a measured set of magnitudes determined based on the available information, the measured value falling within the interval with a certain probability. Note 1. The inclusion interval is not necessarily centered on the selected measured value. Note 2. The inclusion interval should not be called a “confidence interval” to avoid confusion with statistical concepts. Note 3. The inclusion interval can be derived from the extended measurement uncertainty. 3.34 Contains probability coverageprobability The probability of including a measured set of magnitudes within a specified inclusion interval. Note 1. To avoid confusion with statistical concepts, inclusion probabilities should not be called confidence levels. Note 2. The inclusion of probability in GUM is also called "level of confidence". Note 3. The inclusion probability replaces the “confidence level” that has been used. 3.35 Include factor coveragefactor To obtain extended uncertainty, a number greater than one that is multiplied by the synthetic standard uncertainty. Note. The inclusion factor is usually indicated by the symbol k. 3.36 Probability distribution probabilitydistribution Give a (random variable) function that takes a random variable to take any given value or the probability of a given set. 3.37 Distribution function distributionfunction For each threshold, a function is given for the probability that the random variable X is less than or equal to ξ. GX(ξ)=Pr(X ≤ξ) 3.38 Probability density function probabilitydensityfunction; PDF The derivative of the distribution function, if the derivative exists, then gX(ξ)=dGX(ξ)/dξ, where GX(ξ) is the distribution function and X is the random variable. 3.39 Normal distribution normaldistribution The probability distribution of the continuous random variable X, whose probability density function is gX(ξ)= σ 2π Exp - Ξ-μ 2é Êê Úú ,-¥< ξ< ¥ Where μ is the expectation of X and σ is the standard deviation. 3.40......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 27420-2018_English be delivered?Answer: Upon your order, we will start to translate GB/T 27420-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 5 ~ 8 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 27420-2018_English with my colleagues?Answer: Yes. 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