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Delivery: <= 10 days. True-PDF full-copy in English will be manually translated and delivered via email. JJF 1343-2022: Characterization, Homogeneity and Stability Assessment of Reference Materials Status: Valid JJF 1343: Historical versions
Basic dataStandard ID: JJF 1343-2022 (JJF1343-2022)Description (Translated English): Characterization, Homogeneity and Stability Assessment of Reference Materials Sector / Industry: Metrology & Measurement Industry Standard Word Count Estimation: 116,158 Date of Issue: 2022-04-29 Date of Implementation: 2022-10-29 Issuing agency(ies): State Administration for Market Regulation JJF 1343-2022: Characterization, Homogeneity and Stability Assessment of Reference Materials---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.Characterization, Homogeneity and Stability Assessment of Reference Materials National Metrology Technical Specifications of the People's Republic of China Valuation, homogeneity and stability evaluation of reference materials Released on 2022-04-29 Implementation on 2022-10-29 Released by the State Administration for Market Regulation Valuation of standard substances and Uniformity, Stability Evaluation Characterization, Homogeneity Replace JJF 1343-2012 Responsible unit. National Standard Substance Metrology Technical Committee Main drafting unit. China Institute of Metrology Participating in the drafting unit. Beijing Institute of Technology Steel Research Nanoco Testing Technology Co., Ltd. This specification entrusts the National Standard Substance Metrology Technical Committee to be responsible for interpretation The main drafters of this specification. Lu Xiaohua (National Institute of Metrology) Wang Bin (National Institute of Metrology) Zhou Taogeng (Beijing Institute of Technology) Li Hongmei (National Institute of Metrology) Tang Benling (Steel Research Nanoco Testing Technology Co., Ltd.) Participating drafters. Kan Ying (National Institute of Metrology) Wang Yang (National Institute of Metrology) Table of contentsIntroduction (Ⅲ) 1 Scope(1) 2 Normative references (1) 3 Terms and Definitions(1) 3.1 Synchronous Stability Research (1) 4 Overview(2) 4.1 Project Design(2) 4.2 Procurement of raw materials (2) 4.3 Feasibility study (3) 4.4 Processing and preparation of reference materials (3) 4.5 Uniformity Evaluation (3) 4.6 Stability assessment (3) 4.7 Selection of measurement procedures (3) 4.8 Metrological traceability (3) 4.9 Fixed value measurement(4) 4.10 Interchangeability assessment(4) 4.11 Assignment (4) 4.12 Stability monitoring (4) 4.13 Transportation(4) 4.14 Production of duplicate batches of reference materials (4) 5 Homogeneity Evaluation(5) 5.1 Basic requirements (5) 5.2 The need for experimental research (6) 5.3 Properties to be studied (6) 5.4 Number of extracted units and number of repeated measurements (6) 5.5 Sampling plan(8) 5.6 Choice of measurement procedure for homogeneity studies (8) 5.7 Implementation of measurement procedures for homogeneity studies (9) 5.8 Homogeneity study design (10) 5.9 Evaluation of inter-unit homogeneity (12) 5.10 Evaluation method when the repeatability of the measurement procedure is not good(18) 5.11 Evaluation of intra-element homogeneity (18) 5.12 Confirmation of homogeneity (20) 5.13 Uncertainty introduced by inhomogeneity(20) 6 Stability assessment and monitoring (21) 6.1 Basic requirements (21) 6.2 Stability assessment (22) 6.3 Classification of Stability Experimental Studies (23) 6.4 Procedures for Stability Experimental Studies (26) 6.5 Evaluation of the results of stability experiments (27) 6.6 Actions to take when a significant trend is found in a stability study (33) 6.7 Uncertainty assessment for stability studies (33) 6.8 Estimation of shelf life or shelf life (35) 6.9 Instructions for use related to stability management (36) 6.10 Stability monitoring (36) 7 fixed value(39) 7.1 Basic requirements (39) 7.2 Establishment of Metrological Traceability (39) 7.3 A laboratory uses a primary or authoritative organization to determine the reference measurement procedure (41) 7.4 A laboratory adopts a measurement procedure in which property values are transferred from one reference material to another Matching Candidate Standards (42) 7.5 Preparation method (43) 7.6 One or more competent laboratories use two or more methods with demonstrable accuracy, right? Measurand settings defined by operations (44) 7.7 A network of competent laboratories for the assessment of measurands defined by operations (52) 7.8 Purity rating (53) 7.9 Applications of Robust Statistics (54) 7.10 Application of multi-purpose collaborative research (57) 7.11 Fixed values other than authorized values (58) 7.12 Selection of standard substance units for value determination (58) 8 Evaluation of measurement uncertainty (59) 8.1 Basic principles (59) 8.2 The basic model of batch valuation (59) 8.3 Sources of uncertainty (60) 8.4 Inclusion intervals and inclusion factors (60) 8.5 Representation of setting results (61) Appendix A Random Number Table(62) Appendix B Suspicious Value Test(65) Appendix C Normal Distribution Test (67) Appendix D Homogeneity of Variance Test (76) Appendix E Data consistency test between groups (86) Appendix F Evaluation of Measurement Uncertainty (88) Appendix G Development of Qualitative Characteristic Standard Materials (90) Appendix H Examples(94)IntroductionReference material development (production) activities are critical to maintaining and improving globally consistent measurement systems. in accordance with JJF 1507 "Selection and Application of Standard Materials", standard materials with different characteristics can be used for measurement calibration, quality control, Proficiency testing, method validation and assigning values to other materials. Certified reference materials can also be used for confirmation and establishment of agreed standards The traceability of the ruler. In order to ensure comparability in different regions and at different times, measurement results need to be traced to appropriate and specified reference objects. elephant. For the measurement of materials and substances in the fields of chemistry, biology, and physics, the traceability of measurement results of certified reference materials plays a key role in the implementation of the concept. The laboratory uses the available certified reference materials as measurement standards to establish Traceability of measurement results to international standards. The characteristic values of certified reference materials can be traced to the International System of Units (SI) or other internationally recognized reference objects. In my country, the certified reference materials used for unifying the quantity value are further divided into primary reference materials and secondary reference materials. It is necessary to have a unified technical specification to guide its standardized development (production) and accurate value determination to support the management of reference materials And the effective establishment of the measurement value traceability system. This specification expounds the reliability of obtaining traceability to appropriate reference objects in the development (production) of primary and secondary reference materials. Approaches to property values, including homogeneity assessment, stability assessment and risk management for stability, property value determination and Assignment, uncertainty assessment of certified value, establishment of metrological traceability of certified value, etc. General Requirements for R&D (Production) Institutions", JJF 1854 "Establishment, Evaluation and Expression of Measurement and Traceability of Standard Substances" and so on in combination. The technical requirements of this specification are consistent with ISO Guide 35.2017 "Reference Substances - Determination and Uniformity, Stability In order to enhance the operability and provide more targeted guidance, based on the international guidelines Editorial revisions and content chapter adjustments have been made on the basis of this article, and detailed introductions and statistical methods such as analysis of variance have been added. example. The usage of the specification is based on the following conventions. 1) The specified measurand has a unique true value; 2) Unless otherwise stated, all probability estimates are based on a normal distribution; 3) The Uncertainty Propagation Law applies throughout the text to the synthesis of uncertainty contributions, other measurement uncertainty assessment methods It is also applicable in some cases and must be used. For further guidance, see ISO /IEC Guide 98-3 "Measuring Uncertainty Part 3.Guidelines for the Expression of Uncertainty in Measurement (GUM) and its annexes. This specification replaces JJF 1343-2012 "General Principles and Statistical Principles for Valuation of Standard Substances". Relevant technical requirements The requirements have been adjusted and supplemented according to ISO Guide 35.2017.Compared with JJF 1343-2012, the main changes are. 1) Add guidance content for other types of reference materials and non-certified values; 2) Add more guidance on replicating batch homogeneity studies, homogeneity study design and related statistical evaluation methods instructive content with examples; 3) Add more information on replicated batch stability studies, accelerated stability studies, different storage and handling conditions, and Instructive content for stability studies, storage life and validity period estimation under repeated use; 4) The fixed value mode has been rearranged. Increase the value of the preparation method, comparison method, multi-laboratory cooperation and Technical guidance for purity determination and application of robust statistical methods. The relevant contents of qualitative characteristic reference materials newly added in ISO Guide 35.2017, this specification is given in the form of appendix, It is used to provide reference for the development of new reference materials. For multivariate characteristic quantities, such as spectral data, this specification does not apply. The release status of previous versions of this specification. JJF 1343-2012. Valuation, homogeneity and stability evaluation of reference materials1 ScopeThis specification is applicable to guide the development (production) of various primary and secondary reference materials, especially their fixed value and homogeneity. performance and stability assessment. Other standard substances can be implemented by reference.2 Normative referencesThis specification references the following documents. JJF 1001 General Metrology Terms and Definitions General terms and definitions of JJF 1005 reference materials JJF 1059.1 Evaluation and Expression of Measurement Uncertainty JJF 1059.2 Evaluation of Uncertainty of Measurement by Monte Carlo Method JJF 1186 Standard substance certificate and label requirements JJF 1218 Standard material development report preparation rules JJF 1342 General requirements for reference material development (production) institutions JJF 1854 Establishment, Evaluation and Expression of Metrological Traceability of Standard Substances GB/T 3358.2 Statistics Vocabulary and Symbols Part 2.Applied Statistics (ISO 3534-2, IDT) GB/T 3358.3 Statistical Vocabulary and Symbols Part 3.Experimental Design (ISO 3534-3, IDT) ISO Guide 35 Guidelines for Valuation and Homogeneity and Stability Evaluation of Standard Substances (Referencematerials- ISO /IEC Guide 99 Basic concepts of international metrology vocabulary and related terms (Internationalvo- For dated references, only the dated version applies to this specification; for undated references document, its latest version (including all amendments) applies to this specification.3 Terms and DefinitionsStandards specified in JJF 1001, JJF 1005, GB/T 3358.2, GB/T 3358.3, ISO /IEC Guide 99 quasi-substances, certified reference materials, measurement models, measurement procedures, characteristic values, certified values, indicated values, calibration materials, quality Quantity control substances and other terms and the following terms are applicable to this specification. When there are different definitions of the same term, the Terminology in JJF 1005, JJF 1001 and ISO /IEC Guide 99. A method of experimental research on the stability of standard substances, which will be exposed under different storage conditions and time The unit performs measurements in a short period of time. [ISO Guide 35.2017,3.9] ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of JJF 1343-2022_English be delivered?Answer: Upon your order, we will start to translate JJF 1343-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 6 ~ 10 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of JJF 1343-2022_English with my colleagues?Answer: Yes. 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