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GB/T 21415-2025: In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
Status: Valid

GB/T 21415: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 21415-2025	1074	Add to Cart	8 days	In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples	Valid
GB/T 21415-2008	130	Add to Cart	Auto, < 3 mins	In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials	Valid

Basic data

Standard ID: GB/T 21415-2025 (GB/T21415-2025)
Description (Translated English): In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100.10
Word Count Estimation: 54,563
Date of Issue: 2025-08-29
Date of Implementation: 2026-03-01
Older Standard (superseded by this standard): GB/T 21415-2008
Issuing agency(ies): State Administration for Market Regulation, National Standardization Administration

GB/T 21415-2025: In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT21415-2025
ICS 11.100.10 CCSC44 National Standard of the People's Republic of China Replaces GB/T 21415-2008 Establish calibration products for in vitro diagnostic medical devices, Trueness control of material and human sample assignment Metrological traceability requirements (ISO 17511.2020, IDT) Released on August 29, 2025, implemented on March 1, 2026 State Administration for Market Regulation The National Standardization Administration issued

Preface V Introduction VI 1 Scope 1 2 Normative references 1 3 Terms and definitions, symbols and abbreviations 2 4 General requirements that manufacturers should meet to establish, confirm and document the metrological traceability of values measured on human samples by a specific IVDMD14 4.1 Requirements for recording metrological traceability of measured values 14 4.2 Definition of measurand 15 4.3 Specification of the maximum permissible expanded measurement uncertainty Umax(y) 15 4.3.1 General requirements 15 4.3.2 Scope of regulations 15 4.4 Defining the calibration hierarchy 15 4.4.1 General requirements 15 4.4.2 Measured Quantity 16 4.4.3 Highest level of metrological traceability16 4.4.4 IVDMD traceable to SI units 16 4.4.5 IVDMD not traceable to SI units 16 4.4.6 Number of levels in a specific hierarchy 16 4.5 Selection and Requirements of RMs and Calibrators 16 4.5.1 General requirements 16 4.5.2 Characteristics to be recorded 16 4.5.3 Higher Grade RM 17 in accordance with ISO 15194 4.5.4 RM 17 not compliant with ISO 15194 4.5.5 Interchangeability of RMs 17 4.5.6 Other interchangeability assessment requirements 17 4.5.7 Application of non-interchangeable CRM 17 4.5.8 Replacement of RM 18 4.5.9 Addition of alternative RM 18 4.5.10 Non-Interchangeable End-User IVDMD Calibrators 18 4.6 MP Selection and Requirements 18 4.6.1 Reasons for selecting MP and documentation responsibilities 18 4.6.2 MP measurement status 18 4.6.3 Reference measurement laboratories 19 4.6.4 Effect of influence quantity 19 4.6.5 Variation of measured quantities within the calibration hierarchy 19 4.7 Estimating the uncertainty of end-user IVDMD calibrator values 19 4.7.1 General requirements 19 4.7.2 Documentation for evaluating the UCAL method 20 4.7.3 Statistical considerations and scope of the UCAL assessment 20 4.7.4 Representation of ucal 20 4.7.5 Product Changes 21 4.7.6 Information provided to end users 21 4.8 Confirmation of metrological traceability of IVDMD calibrator values 21 4.8.1 General confirmation requirements 21 4.8.2 Confirmation Strategy 21 4.8.3 Study Design Considerations and Acceptance Criteria 22 4.8.4 Calibration hierarchy with available RMPs 22 4.8.5 Calibration hierarchy without available RMP 22 4.8.6 Calibration Hierarchy without RMP and CRM 22 4.8.7 Confirmation of End-User IVDMD Calibrator Design Changes 23 4.9 Other Calibration Hierarchy Document Responsibilities 23 4.9.1 Obligations to End Users23 4.9.2 File Saving 23 4.9.3 Third-party manufacturers of IVDMD calibrators 23 4.9.4 Changes made by independent entities 23 4.9.5 Calibration hierarchy to support IVDMD developed by a single entity for its own use23 4.9.6 RM 23 other than end-user IVDMD calibrators 4.9.7 EQA and PT substances with quantifiable traceable target values 24 5 Calibration hierarchy model for metrological traceability 24 5.1 Elements describing the calibration hierarchy 24 5.2 Case with RMP and Level 1 RM 24 5.2.1 General Notes 24 5.2.2 Definition of measurand 25 5.2.3 Select RMP 26 5.2.4 Level 1 RM 26 5.2.5 Primary Calibrators 26 5.2.6 Interchangeability of Secondary RMs 27 5.2.7 Assigning Values to Secondary RMs or Calibrators 27 5.2.8 Manufacturer selection MP 27 5.2.9 Manufacturer's working calibrators 27 5.2.10 Manufacturer's permanent MP 27 5.2.11 Manufacturer's end-user calibrators27 5.2.12 End-user calibrator assignment (UCAL 27) 5.2.13 End-user IVDMD 27 5.3 Cases where there is a primary RMP and the measurand is defined by it 28 5.3.1 General Notes 28 5.3.2 Definition of measurand 29 5.3.3 Definition of the higher level RMP to be measured 30 5.3.4 Definition of primary RMP and measurand 30 5.3.5 Level 1 RMP Documentation 30 5.3.6 Assigning a value of 30 to the secondary RM 5.3.7 Manufacturer Selection MP 31 5.3.8 Manufacturer's working calibrators 31 5.3.9 Manufacturer's permanent MP 31 5.3.10 Manufacturer's end-user calibrators 31 5.3.11 End-user IVDMD 31 5.4 The case where the RMP defines the measurand as calibrated by a specific primary calibrator 31 5.4.1 General Notes 31 5.4.2 Definition of measurand 32 5.4.3 Assignment of primary reference materials 32 5.4.4 Assignment of values for primary calibrators 33 5.4.5 Selection and intended use of RMPs within the calibration hierarchy 33 5.4.6 Manufacturer Selection MP 33 5.4.7 Manufacturer's working calibrators 33 5.4.8 Manufacturer's permanent MP 33 5.4.9 End-User IVDMD Calibrators 33 5.4.10 End-User IVDMD 34 5.5 Where internationally agreed calibrators are available and used to define the measurand 34 5.5.1 General Notes 34 5.5.2 Internationally agreed calibrators --- Material description 35 5.5.3 Assignment of values for internationally agreed calibrators 36 5.5.4 Interchangeability of internationally agreed calibrators 36 5.5.5 Calibration and selection of manufacturer-selected MP 36 5.5.6 Characteristics and assignment of values to manufacturer's working calibrators 36 5.5.7 Manufacturer's Standing MP 36 5.5.8 End-User IVDMD Calibrators 37 5.5.9 End-User IVDMD 37 5.6 Where metrological traceability is supported by internationally harmonised schemes 37 5.6.1 General Notes 37 5.6.2 International harmonization scheme 38 5.6.3 Assigning values to the consistent RM 39 5.6.4 Application of Consistent RM 39 5.6.5 End-User IVDMD 39 5.7 The measurand is only traceable to the manufacturer's internal custom RM(s)39 5.7.1 General Notes 39 5.7.2 RM Selection 40 5.7.3 Manufacturer selection MP 41 5.7.4 Manufacturer's permanent MP 41 5.7.5 End-User IVDMD Calibrators 41 5.7.6 End-User IVDMD 41 5.7.7 Documentation of the calibration hierarchy 41 6 Labeling information provided by manufacturers to end users42 Reference 43 Preface 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 replaces GB/T 21415-2008 "Measurement of Calibrators and Control Materials for Quantities in Biological Samples of In Vitro Diagnostic Medical Devices" Compared with GB/T 21415-2008, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Changed the scope to include metrological traceability of values assigned to human samples to clarify that the final reported values of human samples are metrologically traceable to Highest available reference system component (see Chapter 1, Chapter 1 of the.2008 edition); --- Added the case where there is a first-level RMP and the measured value is defined by it (see 5.3); --- Changed Chapter 4 to clarify the requirements for in vitro diagnostic medical device manufacturers to establish and record (calibrators, accuracy control materials) and human samples) assignment of metrological traceability requirements, no longer citing ISO Guide 35.1989, and adding the revised The requirements set out in Chapters 6, 7 and 8 of the.2008 edition (see Chapter 4, Chapter 4 of the.2008 edition); --- Changed Chapter 5 to include other metrological traceability calibration hierarchy models, including the measurement of enzyme catalytic concentration (where the measurand is primary reference measurement procedure definitions) and the assignment of values of measurands that are metrologically traceable to internationally harmonized schemes (detailed in ISO 21151). (See Chapter 5 of the.2008 edition for detailed explanation). This document is equivalent to ISO 17511.2020 "Establishment of calibrators, trueness control materials and human samples for in vitro diagnostic medical devices" Metrological traceability requirements for assigned values. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. Beijing Institute of Medical Device Inspection (Beijing Medical Bioprotection Equipment Inspection and Research Center), National Health Health Commission Clinical Laboratory Center, China Institute of Metrology, Shanghai Clinical Laboratory Center, China Food and Drug Control Institute, China Qualified National Accreditation Center for Assessment, Beijing Hospital, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., and Combio Diagnostics (Shanghai) Co., Ltd. Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Beijing Jiuqiang Biotechnology Co., Ltd., Mike Biotech Co., Ltd., Beijing KingMed Medical Testing Laboratory Co., Ltd., Sysmex Biotechnology (Wuxi) Co., Ltd., and Abbott Trading (Shanghai) Co., Ltd. The main drafters of this document are. Chen Wenxiang, Kang Juan, Zhou Weiyan, Wu Liqing, Ju Yi, Yu Ting, Chen Baorong, Li Muyang, Shi Xiaoyong, Lin Xiyang, Wang Rongfei, Wang Xiaojian, Sun Keqi, Yang Xiaolong, Yang Yun, Zou Yingshu, and Wu Xiaojun. The previous versions of this document and the documents it replaces are as follows. ---First published in.2008 as GB/T 21415-2008; ---This is the first revision.

introduction

In laboratory medicine, the purpose of testing human samples is to obtain experimental results that enable clinicians to assess the risk of disease. To be clinically valuable, regardless of the measurement procedure used, it is important that different laboratories or a single laboratory The results obtained from a given human sample tested by different in vitro diagnostic medical devices (IVDMDs) within a laboratory should be equivalent. The uniform application of medical decision limits and reference intervals can reduce the risk of harm caused by medical decisions based on nonequivalent test results. The equivalence of results for the same measurand between different IVDMDs is crucial for analyzing results in medical records to support clinical decision making and conduct flow analysis. Epidemiological investigations are also important. Metrological traceability is established by assigning values to calibrators in a measurement procedure (MP) to the highest available reference system for the measurand. Metrological traceability describes the calibration hierarchy and the order of assignment, showing the An unbroken link between the measurement results of a sample and the highest available reference system part in the calibration hierarchy. The highest level of metrological traceability in the calibration hierarchy) depends on the higher level reference measurement procedure (RMP), reference material, The availability of a standardized quality (RM) or consensus solution. When different IVDMDs intended to measure the same measurand do not measure the same or closely related measurables, Limitations arise when traceability is required. Some measurands of medical interest may be well-defined elements or molecules. Medical decisions rely on measurands composed of complex and varied chemical structures, molecular species, and molecular complexes in different proportions, such as There are multiple subtypes of glycoproteins, variant amino acid sequences, nucleic acid sequences and other complex molecular forms. When expected, sample-specific effects in human samples due to factors such as disease, drugs or other pathological conditions may lead to the expected measured For a given IVDMD, even with metrological traceability to a higher-level reference system, the calibration hierarchy The selectivity of MPs at each level may also affect their ability to obtain equivalent human sample results with other IVD MDs measuring the same measurand. ability. This document establishes requirements for IVDMD manufacturers to describe the calibration hierarchy for measured quantities that are measured using a specified IVDMD. This document includes various calibration hierarchy models that provide potential technical solutions for different types of measurands. Use this document as a reference for the preparation of IVDMDs. Complying with ISO 14971 requirements as part of the manufacturer's extensive risk management program is expected to help reduce variability in outcomes across different IVDMDs. risk of harm to patients. Establish calibration products for in vitro diagnostic medical devices, Trueness control of material and human sample assignment Metrological traceability requirements

1 Scope

This document specifies the establishment of metrological traceability for in vitro diagnostic medical device (IVDMD) calibrators, trueness control materials and human sample assignments. The technical requirements and documentation requirements necessary for human origin. Human samples are samples for intended measurement as specified by each IVDMD. The metrological traceability of the assigned values extends to the highest available reference system component, ideally a reference measurement procedure (RMP) and a certified reference Reference Material (CRM). All parties involved in any step described in the IVDMD Calibration Hierarchy are required to comply with the requirements, including but not limited to (IVDMD) manufacturers, RMP developers (see ISO 15193), reference material (RM) producers (see ISO 15194), and those supporting IVD Reference/calibration laboratory within the MD calibration hierarchy (see ISO 15195). Note 1.RM producers intended for use in IVDMD standardization or calibration include those producing RMs that can be used by multiple IVDMD end users and/or calibration laboratories. The commercial value of an RM that is intended for use by a single end-user medical laboratory (e.g., where the measurement standard (calibrator) is used only for calibration of the laboratory's own MP) business and non-commercial organizations. This document applies to. a) All IVDMDs that provide measurement results in numerical form [i.e. ratio scale and/or difference (interval) scale, and count scale]; b) IVDMDs that report measurement results as a qualitative value that is a combination of two measurements (i.e., the signal from the specimen being measured and the specific concentration or activity at the critical value) or by a counting scale with a corresponding decision threshold. Includes IVDMDs classified into ordinal categories based on predetermined quantitative intervals; c) RMs of trueness control materials intended for use in IVDMD calibration verification or assessment, i.e., some interchangeable CRMs and a some external quality assessment (EQA) substances (if stated in the intended use statement of the RM); d) Intended for use with a designated IVDMD, with assigned values for dedicated calibrators and accuracy control materials; e) IVDMDs described in a) and b) that do not require end-user calibration (i.e., when the IVDMD is factory calibrated by the manufacturer). This document does not apply to. a) IVDMD calibrators and accuracy control materials whose measured value is zero according to the formula; b) Control substances used only for internal quality control in medical laboratories to assess the imprecision (repeatability or reproducibility) of IVDMD ity), and/or for evaluating changes in IVDMD results compared to a previously determined calibration status; c) Control substances used only for internal quality control in medical laboratories, with recommended acceptance intervals that are not metrologically traceable. Source to a higher level reference system; d) Properties reported on nominal and ordinal scales, without reference to the magnitude of the values. Note 2 to entry. Nominal scales are commonly used to report, for example, blood cell types, microbial types, identification of nucleic acid sequences, and identification of urine particles. Note 3.Ordinal scales are often used to distinguish between dichotomous outcomes (e.g., “sick” vs. “healthy”) and occasionally to distinguish between non-dichotomous outcomes, where the outcome Categories are ranked, but ranked categories cannot distinguish relative degrees of difference, such as visually grading the presence of hemoglobin in a urine sample. Negative, 1, 2, 3.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. ......

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Question 5: Should I purchase the latest version GB/T 21415-2025?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 21415-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.