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GB/T 15000.3-2023: Directives for the work of reference materials - Part 3: Reference materials - Characterization and assessment of homogeneity and stability
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Directives for the work of reference materials - Part 3: Reference materials - Characterization and assessment of homogeneity and stability
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GB/T 15000.3-2023
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| GB/T 15000.3-2008 | English | RFQ |
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Directives for the work of reference materials -- Reference materials -- General and statistical principles for certification
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GB/T 15000.3-2008
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| GB/T 15000.3-1994 | English | 359 |
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Directives for the work of reference materiapls (3). General principles and statistic methods for certification of reference materials
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GB/T 15000.3-1994
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Basic data | Standard ID | GB/T 15000.3-2023 (GB/T15000.3-2023) | | Description (Translated English) | Directives for the work of reference materials - Part 3: Reference materials - Characterization and assessment of homogeneity and stability | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A00 | | Classification of International Standard | 01.120 | | Word Count Estimation | 86,862 | | Date of Issue | 2023-05-23 | | Date of Implementation | 2023-09-01 | | Older Standard (superseded by this standard) | GB/T 15000.3-2008 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 15000.3-2023: Directives for the work of reference materials - Part 3: Reference materials - Characterization and assessment of homogeneity and stability
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ICS 01:120
CCSA00
National Standards of People's Republic of China
Replace GB/T 15000:3-2008
Guidelines for working with standard samples
Part 3: Standard samples
Value determination and homogeneity and stability assessment
Part 3: Reference materials-Characterization and
(ISO Guide35:2017, Referencematerials-
2023-05-23 release 2023-09-01 implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
Introduction V
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 symbols 3
5 agreement 4
6 Overview of standard sample production 4
6:1 Overview 4
6:2 Project Design Summary 4
6:3 Procurement of raw materials5
6:4 Feasibility study 6
6:5 Standard sample processing 6
6:6 Evaluation of uniformity 6
6:7 Stability assessment 6
6:8 Selection of measurement procedures 6
6:9 Metrological traceability 6
6:10 Evaluation of fixed value and uncertainty 6
6:11 Interchangeability assessment 7
6:12 Shipping Matters 7
6:13 Assignment 7
6:14 Stability Monitoring 7
6:15 Standard samples for repeated batch production 7
7 Homogeneity Evaluation 7
7:1 Overview 7
7:2 Requirements for uniformity test studies 8
7:3 Properties to be studied9
7:4 Statistically valid sampling plan9
7:5 Selection and implementation of measurement procedures for homogeneity studies 11
7:6 Homogeneity study design 12
7:7 Rating Uniformity Studies 15
7:8 Cases of poor repeatability of measurement procedures17
7:9 Intra-element uniformity 18
7:10 Confirmation of homogeneity 20
7:11 Uncertainty assessment for homogeneity studies 20
8 Stability assessment and monitoring 21
8:1 Overview 21
8:2 Stability assessment 22
8:3 Classification of stability studies 24
8:4 General Requirements for Effective Stability Studies 25
8:5 Assessing the results of stability studies 26
8:6 What to do after a significant trend is found in a stability study 32
8:7 Uncertainty assessment for stability studies 32
8:8 Estimation of shelf life ("shelf life") from stability studies 34
8:9 Instructions for use on stability management 34
8:10 Stability Monitoring 34
9 Material ratings 37
9:1 Overview 37
9:2 Establish Metrological Traceability 37
9:3 Use a single reference measurement procedure (see ISO /IEC Guide 99 definition) in a single laboratory for valuation 39
9:4 Use two or more methods with demonstrable accuracy in one or more competent laboratories for non-operationally defined
The measured value is determined 41
9:5 Valuation of operationally defined measurands using a competent laboratory network 43
9:6 Purity 44
9:7 Identity 45
9:8 Presence/absence 47
9:9 Sequencing scales 47
9:10 Qualitative properties 47
9:11 Determination of non-standard values 47
10 Evaluation of measurement uncertainty 48
10:1 Basis for Assessing the Uncertainty of CRM Characteristic Values 48
10:2 Basic model for batch values 48
10:3 Sources of uncertainty 48
10:4 Inclusion intervals and factors 49
Appendix A (Informative) Design and Evaluation of Valuation Research 50
Appendix B (Informative) Statistical Methods 58
Appendix C (Informative) Example 66
Appendix D (Informative) Evaluation of Measurement Uncertainty 74
Reference 75
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents"
drafting:
This document is part 3 of GB/T 15000 "Guidelines for Standard Sample Work": GB/T 15000 has published the following parts:
--- Part 1: State the general provisions of standard samples in technical standards;
--- Part 2: Common terms and definitions;
--- Part 3: Determination of standard samples and evaluation of uniformity and stability;
--- Part 4: Contents of certificates, labels and accompanying documents;
--- Part 5: Internal development of quality control samples;
--- Part 6: General rules for standard sample packaging;
--- Part 7: General requirements for the ability of standard sample producers;
--- Part 8: Use of standard samples:
This document replaces GB/T 15000:3-2008 "Guidelines for Standard Sample Work (3) General Principles and Statistical Methods for Valuation of Standard Samples"
Compared with GB/T 15000:3-2008, except for structural adjustment and editorial changes, the main technical changes are as follows:
---Changed the scope of the standard (see Chapter 1, Chapter 1 of the:2008 edition);
--- Added "Measurement Model", "Standard Value", "Information Value", "Calibration Sample", "Quality Control Sample", "Synchronous Stability Study" and "< Standard
7 terms such as “Sample > Production” (see 3:3, 3:5, 3:6, 3:7, 3:8, 3:9, 3:10);
--- Deleted "determination", "inter-bottle uniformity", "in-bottle uniformity", "mixing", "matrix material", "feeding", "short-term stability" and "long-term stability
10 terms such as "severance", "service life" and "validity period" (see 3:4, 3:5, 3:6, 3:7, 3:8, 3:9, 3:10, 3:11,
3:12, 3:13);
---Changed the two definitions of "standard sample" and "certified standard sample" (see 3:1, 3:2, 3:1, 3:2 of the:2008 edition);
--- Increased the relevant provisions of "agreement", "design and evaluation of valuation research", "evaluation of measurement uncertainty" and other content (see Chapter 5, appendix
Record A, Appendix D);
---Change "project design" to "overview of standard sample production", refine and change "measurement traceability", "fixed value and uncertainty evaluation"
"Determining", "Interchangeability Evaluation", "Assignment", "Stability Monitoring", "Standard Samples for Repeated Batch Production" and other corresponding technical contents; (see Section
Chapter 6, Chapter 5 of the:2008 edition);
---Change "homogeneity study" to "homogeneity evaluation", refine and change "statistically valid sampling plan" and "homogeneity study measurement":
The selection and implementation of measurement procedures, "confirmation of homogeneity", "uncertainty evaluation of homogeneity research" and other corresponding technical contents (see Section
Chapter 7, Chapter 7 of the:2008 edition);
---Change "stability study" to "stability assessment and monitoring", refine and change the classification of "stability assessment" and "stability study"
Classes "General Requirements for an Effective Stability Study" "Measures to Take After Significant Trends Are Found in a Stability Study" "Uncertainty in a Stability Study"
Quantitative assessment" and other corresponding technical content (see Chapter 8, Chapter 8 of the:2008 edition);
---Change "determination of characteristic value" to "determination of material value", change "establish and prove traceability" to "establish metrological traceability", and refine
Technical content such as practical methods, measurement scheme design and some issues related to characteristics (see Chapter 9, Chapter 9 of the:2008 edition);
---Change "measurement uncertainty assessment" to "measurement uncertainty assessment", refine and change the "assessment of CRM characteristic value uncertainty
The basis of degree", "inclusion interval and inclusion factor" and other corresponding technical content (see Chapter 10, Chapter 6 of the:2008 edition);
---Deleted the relevant provisions of "data and uncertainty assessment", "certificate" and other contents (Chapter 10 and Chapter 11 of the:2008 edition):
This document is equivalent to ISO Guide35:2017 "Guidelines for the Valuation of Standard Samples and Evaluation of Uniformity and Stability": file type by
The ISO guidance document is adjusted to the national standard of our country:
The following minimal editorial changes have been made to this document:
--- In order to coordinate with existing standards, change the name of the standard to "Guidelines for Standard Sample Work Part 3: Standard Sample Value and Uniformity
Safety and Stability Assessment:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed and managed by the National Standard Sample Technical Committee (SAC/TC118):
This document is drafted by: China Association for Standardization, Metallurgical Industry Information Standard Research Institute, Building Materials Industry Technical Supervision Research Center, National
Home geological experiment test center:
The main drafters of this document: Xu Dajun, Wu Zhongxiang, Lu Xingan, He Ping, Wang Xianghong, Tian Wen, Tang Benling, Zhao Yaxian, Zhang Fan, Shi Yuting,
Hu Xiaoyan, Liu Ying, Xu Jianping:
The release status of previous versions of this document and the documents it replaces are as follows:
---It was first released as GB/T 15000:3-1994 in:1994;
--- When it was revised for the first time in:2008, it was incorporated into GB/T 15000:5-1994 "Guidelines for Standard Sample Work (5) Chemical Composition Standard Samples
Contents of "General Rules for Product Technology" (the previous versions of GB/T 15000:5-1994 are: GB/T 15000:5-1994);
--- This is the second revision:
Introduction
The production of reference samples (RMs) is a key activity in improving and maintaining a global system of measurement consistency: As stated in ISO Guide 33 [1]
As mentioned above, RMs with different properties are used for measurements such as calibration, quality control, proficiency testing and method validation, and also for assigning other materials:
value: Certified Reference Samples (CRMs) are also used to confirm or establish metrological traceability of agreed scales such as octane, hardness and pH: for
To be comparable in space and time, measurements need to be traceable to appropriate and prescribed reference standards: in chemistry, biology, and physics, and in matters involving
In other disciplines of materials and materials, CRM plays an important role in establishing the traceability of measurement results: Laboratory application CRM as an easy-to-acquire
To establish the traceability of its measurement results with international standards: CRM has characteristic values that can be traced back to international
System of digits (SI) or other internationally recognized reference standards in the production process: In this regard, my country has established a supporting standard sample production and application
The basic national standard system used to ensure that the quality of the standard samples it produces meets the requirements of end users: In this standard system
Among them, GB/T 15000 "Guidelines for Standard Sample Work" is the basic and general standard to guide the work of standard samples in my country: GB/T 15000
It aims to establish the guidelines generally applicable to standard sample producers' preparation, valuation, packaging storage, distribution and application, and consists of 8 parts:
--- Part 1: State the general provisions of standard samples in technical standards: The purpose is to specify the stated standards in the formulation of technical standards
General requirements for samples, relationship between standard samples and technical standards, technical criteria for selecting standard samples, etc:
--- Part 2: Common terms and definitions: The purpose is to specify terms and definitions related to standard samples, especially for standard samples
terminology in product brochures, certificates and corresponding research and development reports:
--- Part 3: Determination of standard samples and evaluation of uniformity and stability: The purpose is to provide more specific guidance on technical issues
It provides a basic model for standard sample homogeneity, stability assessment and value determination process:
--- Part 4: Contents of certificates, labels and accompanying documents: The purpose is to establish the applicable standards for the preparation of standard sample certificates, labels and attachments
Relevant requirements that need to be complied with when including file content:
--- Part 5: Internal development of quality control samples: The purpose is to standardize and guide the development and use of quality control samples:
--- Part 6: General rules for standard sample packaging: The purpose is to establish the basic rules applicable to standard sample packaging, storage and transportation:
--- Part 7: General requirements for the ability of standard sample producers: The purpose is to specify the relevant organizational management and operational requirements to ensure
Producers of standard samples can produce standard samples that meet the requirements:
--- Part 8: Use of standard samples: The purpose is to provide guidance for the correct use of standard samples:
This document explains how to develop various methods to obtain reliable property values of standard samples, so that the property values can be traced to the appropriate specific
standard:
With the development of RM production methods, the types of RM have also increased with the advancement of technology, which has increased the need for a wider range of RM production:
The need for applicable technical guidance: At the same time, laboratories are increasingly using ISO /IEC 17025 and ISO 15189, requiring certification
The metrological traceability of quasi-samples is more clearly stated:
This document adds footnotes based on GB/T 15000:3-2008 (ISO Guide 35:2006, IDT) in combination with national conditions, providing a wider
It provides general uniformity and stability research strategies and guidance, and makes specific provisions on the establishment of metrological traceability in RM production:
Guidelines for working with standard samples
Part 3: Standard samples
Value determination and homogeneity and stability assessment
1 Scope
This document explains and provides methods for the following concepts related to standard sample production:
---Evaluation of uniformity;
--- Stability assessment and risk management related to the stability of characteristics;
---Determination and assignment of standard sample characteristics;
--- Uncertainty evaluation of standard value;
--- Establishment of measurement traceability of standard value:
This document provides support for the implementation of ISO 17034: Other methods may also be used as long as the requirements of ISO 17034 are met:
This document provides brief guidance (6:11) on the need for interchangeability assessments, but does not provide technical details;
method (9:6 to 9:10) and provides brief guidance on the sampling of such standards for homogeneity testing (Chapter 7), but does not cover qualitative standards:
Statistical methods for homogeneity and stability assessment of quasi-samples: This document also does not apply to multivariate, such as spectral data:
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
2: Applied statistics)
Note: GB/T 3358:2-2009 Statistics Vocabulary and Symbols Part 2: Applied Statistics (ISO 3534-2:2006, IDT)
3: Design of experiments)
Note: GB/T 3358:3-2009 Statistical vocabulary and symbols Part 3: Experimental design (ISO 3534-3:1999, IDT)
Note: GB/T 15000:2-2019 Standard Sample Work Guidelines Part 2: Common Terms and Definitions (ISO Guide30:2015, IDT)
ISO /IEC Guide99 International vocabulary of metrology basic and common concepts and related terms (VIM) [Internationalvocabu-
Note: This document uses "VIM" to represent "International Metrology Vocabulary":
3 Terms and Definitions
The terms and definitions defined in ISO Guide30, ISO /IEC Guide99, ISO 3534-2, ISO 3534-3 and the following apply to
this document: When there are multiple definitions for the same term, the definition in ISO Guide 30 is preferred:
The addresses of terminology databases maintained by ISO and IEC for standardization are as follows:
---ISO online browsing platform: http://www:iso:org/obp
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