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JJF 1507-2015The Selection and Use of Reference Materials (English PDF)

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Issued by

Ministry of Health, Beijing Hospital, Zhang Chuan Bao (Beijing Hospital, Ministry of Health)

Level / Type

National · Mandatory

Issue date

January 30, 2015

Implementation date

April 30, 2015

Scope

JJF 1507-2015 (The Selection and Use of Reference Materials) is available as an English-translated PDF.

JJF 1507-2015 — This Standard specifies the standard material, especially those with the main purpose of certified reference materials and general principles in the selection and use of, the guidelines apply to substances used in legal metrology, measurement and related fields.

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Document preview — JJF 1507-2015

National Standard of the People's Republic of China

ICS
17.020
Classification
A 67

Issued by: Ministry of Health, Beijing Hospital, Zhang Chuan Bao (Beijing Hospital, Ministry of Health)

Contents

  • Introduction (III)
  • 1 Scope (1)
  • 2. References (1)
  • 3 Terms and definitions (1)
  • 3.1 Control (1)

1 Scope (1)

2 References (1)

3 Terms and definitions (1)

3.1 Control (1)

Experimental standard deviation of 3.2 (2)

3.3 Matrix effects (2)

3.4 Outliers (2)

3.5 Statistical outliers (2)

3.6 Straggling value (2)

3.7 Detectable levels (2)

3.8 Culling level (2)

4 Standard substance and its effects (3)

Type 4.1 Standard substances and their property values (3)

4.2 Standard substance value type (3)

Uncertainty 4.3 standard material characteristic values (4) Metrological traceability 4.4 standard material characteristic values (5)

4.5 The main purpose of the standard substance (5)

4.6 Agreed reference scales setup and hold in the role of the standard substance (6)

5 Standard substance calibration application (7)

5.1 Overview (7)

5.2 Calibration Model (8)

6 Standard material used in the assignment of material (8)

6.1 Overview (8)

6.2 Pure substances (9)

6.3 Preparation of the weighing method and volumetric methods (9)

6.4 Titration analysis (10)

7 Standard material used in measurement/confirmation procedure (11)

7.1 Overview (11)

7.2 Measurement data requirements (11)

7.3 Measurement Evaluation precision (11)

7.4 Measuring accuracy of the assessment (13)

7.5 Metrological traceability setup and hold (14)

8 Standard material used in measurement quality control (15)

8.1 Overview (15)

8.2 Measurement precision verification (15)

8.3 Quality Control Chart (17)

8.4 Interlaboratory comparison (18)

9 Select, standard substance (19)

9.1 Measurements required limits (19)

9.2 with correlation measurement systems (20)

9.3 Select Program (20)

10 Standards of maintenance and use (22)

Save 10.1 (22)

10.2 (22)

10.3 Verification (23)

Appendix A using standard econometric material traceability system (25)

In keeping with the conventions established reference scale Examples of applications (28) Appendix B Standards Appendix C Common linear regression calibration model (30) Examples Appendix D use reference materials to carry out multi-point method validation (offset Assessment) (35) Appendix E decision errors (38) Appendix F Quality Control Charts - General Control Chart (39)

Introduction

As reference material traceability and transfer vectors have been a reasonable choice widely used standard material and should with respect to ensure the effectiveness of these activities is important. The main purpose of this specification is to. Promote from the application point the basic concept of standard material, properties, understanding of the role, depending on the purpose to guide the user to choose the right way and use of reference materials, and to establish effective measurement results metrological traceability, achieve comparable measurement results, reliable.

This specification mainly with reference to ISO Guide 33 "certified reference material using the" formulation, also refer to the OIMLD18 "Certified reference material measurement national legal metrology services in the field of control applications covering the basic principles of" GB/T 6379 "measurement methods and results of Accuracy (trueness and precision)", EURACHEM/CITAC means Southern "analysis to quantify the measurement uncertainty" and other domestic and foreign documents, and in accordance with China's national conditions, the standard substance is mainly used Way, effective material selection criteria and a variety of applications, general principles to be followed, etc. and provisions set forth in the attached it gives the relevant data recorded in the determination of basic assumptions, presentation and application examples and other aspects of the Evaluation of Uncertainty.

This specification uses statistical methods based on the following assumptions.

1) the certified values of certified reference material is a characteristic value of the best estimate of the true value;

2) Whether the material (uniformity) was related to the measurement process, they are all random variability, standard substance Laid Valuation results and the use of reference material to carry out measurements of the amount are in line with normal distribution.

Based on the above assumptions, JJF 1059.1 "Evaluation and Expression of Uncertainty in Measurement" Uncertainty spread specified in the Evaluation method applicable to this specification.

This specification is the first release.

Selection and Application of Standards

1 Scope

This specification defines the standard material, especially those with the main purpose of the certified reference material and through the selection and use of the Principles, guidelines applicable to materials used in legal metrology, measurement and related fields.

This specification also for the preparation of reference materials (production) organization to provide a reference, according to user objects, develop suitable Reference material, improve the ability to provide users with a standard material and technical services.

Note. This specification refers to CRMs National Standard, two standard materials.

2. References

This specification references the following documents.

JJF 1001 common measurement terms and definitions JJF 1005 Standards common terms and definitions JJF 1059.1 Evaluation and Expression of Uncertainty in Measurement JJF 1117.1 chemical measurement comparison GB/T 3358 statistical Vocabulary and symbols (ISO 3534, IDT) GB/T 4091 conventional control charts (ISO 8258, IDT) Analyzing and processing GB/statistical processing and interpretation of normal sample outliers T 4883 data GB/T 6379 Methods of measurement and accuracy (trueness and precision) (ISO 5725, IDT) results GB/T 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assignment Metrological traceability (ISO 17511, IDT) GB/T 28043 using statistical methods (ISO 13528, IDT) than on the ability to inter-laboratory validation OIMLD18 certified reference materials in the field of measurement control covering national legal metrology service application group this principle (OIMLD18. TheuseofCertifiedReferenceMaterialsinFieldsCoveredbyMe-trologicalControlExercisedbyNationalServicesofLegalMetrology-BasicPrinciples) ISO/IEC Guide 99 international vocabulary of metrology - Basic and general concepts and associated terms (ISO/IEC Guide 99. InternationalVocabularyofMetrology-BasicandGeneralConceptsandAssociated Terms (VIM)) ISO Guide 33 certified reference materials for use (ISO Guide33. UseofCertifiedReferenceMa-terials) for dated references, only the dated edition applies to this specification; undated reference documents Member, the latest edition (including any amendments) applies to this specification

3 Terms and definitions

3.1 Control Chart to monitor the process control and reduce process variability, sample statistical measure sequence described in a particular order points drawn

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