GB/T 16126-2025 Specification for quality assurance of human biomonitoring English, Anglais, Englisch, Inglés, えいご
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
ICS 81.080
CCS H 57
National Standard of the People's Republic of China
GB/T 16126-2025
Replaces GB/T 16126-1995
Specification for quality assurance of human biomonitoring
Issue date: 2025-08-29 Implementation date: 2026-03-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
the Standardization Administration of the People's Republic of China
Contents
Foreword
1 Scope
2 Normative References
3 Terms and Definitions
4 Ethical and Human Genetic Resource Review
5 Field Survey
5.1 Monitoring Subject Selection
5.2 Questionnaire
5.3 Physical Examination
5.4 Sample Collection, Subdivision, and Storage
6 Laboratory Testing
6.1 General Testing Requirements
6.2 Laboratory Testing Methods
6.3 Quality Control of Testing
6.4 Laboratory Safety
6.5 Data Processing and Result Expression
7 Data Management and Application
7.1 Data Collection
7.2 Data Verification and Processing
7.3 Result Reporting
References
Specification for quality assurance of human biomonitoring
1 Scope
This document specifies the technical requirements and operational procedures for quality assurance and quality control in field surveys, laboratory testing, and data management and application in human biomonitoring.
It provides guidance for monitoring exposure levels of environmental chemicals in human populations within production and living environments.
2 Normative References
The following documents contain provisions that, through reference in this text, constitute essential requirements for this document. For dated references, only the edition cited applies. For undated references, the latest version (including all amendments) applies.
GB/T 6682: Specifications and Test Methods for Water for Analytical Laboratories
GB/T 8170: Rules for Rounding Off Numbers and Expression and Judgment of Limiting Values
GB 19489: General Requirements for Laboratory Biosafety
GB/T 27417: Guidelines for Conformity Assessment—Validation and Verification of Chemical Analytical Methods
GB/T 27476.5: Safety Requirements for Testing Laboratories—Part 5: Chemical Factors
GB/T 32465: Requirements for Verification & Validation of Detection Methods and Internal Quality Control on Chemical Analysis
GB/T 37864: General Requirements for Quality and Competence of Biobanks
GB/T 38576: Collection and Processing of Human Blood Samples
GB/T 38735: Collection and Processing of Human Urine Samples
GBZ/T 295: General Guidelines for Biomonitoring Methods in Occupational Populations
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Human Biomonitoring
The systematic detection of chemical substances and their metabolites in human biological samples, or the assessment of their harmless biological effects, to evaluate exposure levels and potential health impacts.
3.2 Field Survey
A systematic information collection process conducted by trained personnel through on-site or remote methods (e.g., centralized surveys, household visits, intercept interviews, observation, telephone surveys, mailed questionnaires, email, or online surveys).
3.3 Bias
Systematic errors introduced during study design, implementation, data processing, and analysis, or partiality in result interpretation, leading to deviations between findings and reality.
3.4 Quality Assurance (QA)
Measures taken to ensure the accuracy and comparability of monitoring data, encompassing study design, sample collection, measurement protocols, personnel training, laboratory management, and data processing.
3.5 Biobank
A comprehensive system for storing human biological samples (e.g., blood, tissues, cells, DNA) along with related clinical, diagnostic, and follow-up data, including quality control and information management.
3.6 Biosafety
Procedures and protective measures to prevent acquired infections or environmental release of harmful microorganisms during sample collection and laboratory operations.
3.7 Limit of Detection (LOD)
The lowest detectable concentration of a substance, with a false-negative probability (β) and false-positive probability (α) (default values: α = β = 0.05 per IUPAC).
3.8 Limit of Quantification (LOQ)
The lowest concentration or quantity of a analyte that can be quantitatively determined with acceptable accuracy and precision.
3.9 Precision
The consistency of repeated measurements under specified conditions.
3.10 Accuracy
The agreement between measured values and true values.
3.11 Calibration Curve
A mathematical or graphical representation of the relationship between analyte concentration and signal response.
3.12 Reference Material (RM)
A homogeneous and stable material with one or more specified properties, certified for intended use in measurement processes.
3.13 Certified Reference Material (CRM)
A reference material with certified property values, uncertainties, and metrological traceability.
3.14 Quality Control Sample
A stable and homogeneous material resembling routine samples, used to monitor system precision and stability.
3.15 Sample Blank
A sample collected using pure water or other media instead of biological samples to assess contamination.
4 Ethical and Human Genetic Resource Review
Establish review systems and measures to ensure compliance with national regulations on ethics and human genetic resource management.
5 Field Survey
5.1 Monitoring Subject Selection
Select representative populations based on monitoring objectives and metabolic characteristics of environmental chemicals.
Design sampling methods scientifically to enhance response rates and minimize non-response bias.
Develop replacement principles to avoid selection bias.
5.2 Questionnaire
5.2.1 Questionnaire Design
Standard
GB/T 16126-2025 Specification for quality assurance of human biomonitoring (English Version)
Standard No.
GB/T 16126-2025
Status
to be valid
Language
English
File Format
PDF
Word Count
10500 words
Price(USD)
315.0
Implemented on
2026-3-1
Delivery
via email in 1~5 business day
Detail of GB/T 16126-2025
Standard No.
GB/T 16126-2025
English Name
Specification for quality assurance of human biomonitoring
GB/T 16126-2025 Specification for quality assurance of human biomonitoring English, Anglais, Englisch, Inglés, えいご
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
ICS 81.080
CCS H 57
National Standard of the People's Republic of China
GB/T 16126-2025
Replaces GB/T 16126-1995
Specification for quality assurance of human biomonitoring
Issue date: 2025-08-29 Implementation date: 2026-03-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
the Standardization Administration of the People's Republic of China
Contents
Foreword
1 Scope
2 Normative References
3 Terms and Definitions
4 Ethical and Human Genetic Resource Review
5 Field Survey
5.1 Monitoring Subject Selection
5.2 Questionnaire
5.3 Physical Examination
5.4 Sample Collection, Subdivision, and Storage
6 Laboratory Testing
6.1 General Testing Requirements
6.2 Laboratory Testing Methods
6.3 Quality Control of Testing
6.4 Laboratory Safety
6.5 Data Processing and Result Expression
7 Data Management and Application
7.1 Data Collection
7.2 Data Verification and Processing
7.3 Result Reporting
References
Specification for quality assurance of human biomonitoring
1 Scope
This document specifies the technical requirements and operational procedures for quality assurance and quality control in field surveys, laboratory testing, and data management and application in human biomonitoring.
It provides guidance for monitoring exposure levels of environmental chemicals in human populations within production and living environments.
2 Normative References
The following documents contain provisions that, through reference in this text, constitute essential requirements for this document. For dated references, only the edition cited applies. For undated references, the latest version (including all amendments) applies.
GB/T 6682: Specifications and Test Methods for Water for Analytical Laboratories
GB/T 8170: Rules for Rounding Off Numbers and Expression and Judgment of Limiting Values
GB 19489: General Requirements for Laboratory Biosafety
GB/T 27417: Guidelines for Conformity Assessment—Validation and Verification of Chemical Analytical Methods
GB/T 27476.5: Safety Requirements for Testing Laboratories—Part 5: Chemical Factors
GB/T 32465: Requirements for Verification & Validation of Detection Methods and Internal Quality Control on Chemical Analysis
GB/T 37864: General Requirements for Quality and Competence of Biobanks
GB/T 38576: Collection and Processing of Human Blood Samples
GB/T 38735: Collection and Processing of Human Urine Samples
GBZ/T 295: General Guidelines for Biomonitoring Methods in Occupational Populations
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Human Biomonitoring
The systematic detection of chemical substances and their metabolites in human biological samples, or the assessment of their harmless biological effects, to evaluate exposure levels and potential health impacts.
3.2 Field Survey
A systematic information collection process conducted by trained personnel through on-site or remote methods (e.g., centralized surveys, household visits, intercept interviews, observation, telephone surveys, mailed questionnaires, email, or online surveys).
3.3 Bias
Systematic errors introduced during study design, implementation, data processing, and analysis, or partiality in result interpretation, leading to deviations between findings and reality.
3.4 Quality Assurance (QA)
Measures taken to ensure the accuracy and comparability of monitoring data, encompassing study design, sample collection, measurement protocols, personnel training, laboratory management, and data processing.
3.5 Biobank
A comprehensive system for storing human biological samples (e.g., blood, tissues, cells, DNA) along with related clinical, diagnostic, and follow-up data, including quality control and information management.
3.6 Biosafety
Procedures and protective measures to prevent acquired infections or environmental release of harmful microorganisms during sample collection and laboratory operations.
3.7 Limit of Detection (LOD)
The lowest detectable concentration of a substance, with a false-negative probability (β) and false-positive probability (α) (default values: α = β = 0.05 per IUPAC).
3.8 Limit of Quantification (LOQ)
The lowest concentration or quantity of a analyte that can be quantitatively determined with acceptable accuracy and precision.
3.9 Precision
The consistency of repeated measurements under specified conditions.
3.10 Accuracy
The agreement between measured values and true values.
3.11 Calibration Curve
A mathematical or graphical representation of the relationship between analyte concentration and signal response.
3.12 Reference Material (RM)
A homogeneous and stable material with one or more specified properties, certified for intended use in measurement processes.
3.13 Certified Reference Material (CRM)
A reference material with certified property values, uncertainties, and metrological traceability.
3.14 Quality Control Sample
A stable and homogeneous material resembling routine samples, used to monitor system precision and stability.
3.15 Sample Blank
A sample collected using pure water or other media instead of biological samples to assess contamination.
4 Ethical and Human Genetic Resource Review
Establish review systems and measures to ensure compliance with national regulations on ethics and human genetic resource management.
5 Field Survey
5.1 Monitoring Subject Selection
Select representative populations based on monitoring objectives and metabolic characteristics of environmental chemicals.
Design sampling methods scientifically to enhance response rates and minimize non-response bias.
Develop replacement principles to avoid selection bias.
5.2 Questionnaire
5.2.1 Questionnaire Design
