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GB/T 16126-2025: Specification for quality assurance of human biomonitoring
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
GB/T 16126-2025	English	359	Add to Cart	4 days [Need to translate]	Specification for quality assurance of human biomonitoring
GB/T 16126-1995	English	599	Add to Cart	3 days [Need to translate]	Guidelines for quality assurance of biological monitoring

GB/T 16126-2025: Specification for quality assurance of human biomonitoring

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ICS 13.040.30 CCSC51 National Standards of the People's Republic of China Replaces GB/T 16126-1995 Human biomonitoring quality assurance standards Published on 2025-08-29 Implemented on 2026-03-01 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Table of Contents

Preface III 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4.Ethics and the Review of Human Genetic Resources 3. 5.On-site investigation 3 5.1 Selection of Monitoring Targets 3 5.2 Questionnaire Survey 3 5.3 Physical Examination 4 5.4 Sample Collection, Dispensing, and Preservation 6.Laboratory testing 8. 6.1 Basic Testing Requirements 8 6.2 Laboratory Testing Methods 9 6.3 Quality Control of Testing 9 6.4 Laboratory Safety 10 6.5 Data Processing and Result Presentation 10 7 Data Management and Application 11 7.1 Data Acquisition 11 7.2 Data Verification and Processing 11 7.3 Results Report 11 Reference 13

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. This document replaces GB/T 16126-1995 "Quality Assurance Specification for Biological Monitoring". Compared with GB/T 16126-1995, except for structural adjustments... Aside from integration and editorial changes, the main technical changes are as follows. ---Added 14 terms and definitions. human biosurveillance, field investigation, bias, biobank, biosafety, limit of detection, quantification Limits, precision, accuracy, calibration curves, standard samples/reference materials, certified reference materials, quality control samples Products and sample blanks (see Chapter 3); ---Two terms and definitions have been deleted. biomonitoring and living environment (see Chapter 3 of the.1995 edition); ---One term and definition has been changed. Quality Assurance (see Chapter 3, Chapter 3 of the.1995 edition); ---Added content on ethics and human genetic resource review (see Chapter 4); ---Added on-site investigation content such as questionnaires and physical examinations (see 5.2 and 5.3); ---The criteria for determining the monitoring targets have been changed (see 5.1, 4.1 of the.1995 edition); ---The sample size and sampling method for the monitored population have been removed (see sections 4.2 and 4.3 of the.1995 edition); ---Added content on sampling biosafety, sample blank, sample receiving, sample aliquoting, and sample storage (see 5.4.4, 5.4.8, etc.) 5.4.12, 5.4.13 and 5.4.15); ---Changes have been made to the procedures for collecting blood, urine, breast milk, and hair samples (see 5.4.9.1, 5.4.9.2, 5.4.9.3, and 5.4.9.4,.1995 edition). 4.7.3.1, 4.7.3.2, 4.7.3.3 and 4.7.3.4); ---The content regarding the collection of exhaled air, fat, placenta, and other tissues has been removed (see sections 4.7.3.5, 4.7.3.6, and 4.7.3.7 of the.1995 edition). 4.7.3.8 and 4.7.3.9); ---The management of test records has been removed (see section 5.2.6 of the.1995 edition); ---A blank test has been added (see 6.3.1); ---The principles for determining the method limit of detection and the method limit of quantitation have been changed (see 6.3.2, 5.2.5.3 and 5.2.5.4 of the.1995 edition); ---The content and requirements related to precision have been removed (see section 5.2.5.2 of the.1995 edition); ---The relevant content and requirements for plotting the calibration curve have been changed (see 6.3.3, 5.3.1 of the.1995 version); ---The relevant content and requirements for accuracy evaluation have been revised (see 6.3.4, 5.2.5.1 of the.1995 version); ---The relevant content and requirements for parallel sample analysis have been revised (see 6.3.5, 5.3.2 of the.1995 version); ---The relevant content and requirements for data processing and result presentation have been revised (see 6.5, 6.1 and 6.2 of the.1995 edition); ---Added requirements for data collection, data verification and processing, as well as data security (see 7.1, 7.2 and 7.3.5); ---The results report content has been changed (see 7.3, 6.4 of the.1995 edition). Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed and is under the jurisdiction of the National Center for Disease Control and Prevention. This document was drafted by. the Institute of Environmental and Health Related Product Safety, Chinese Center for Disease Control and Prevention; Qingdao University; Fudan University; and Beijing University. University. The main drafters of this document are. Shi Xiaoming, Zheng Yuxin, Qu Weidong, Lü Yuebin, Cao Zhaojin, Zhu Ying, Jia Guang, Dai Yufei, Zhao Feng, and Qu Yingli. The release history of this document and the document it replaces is as follows. ---First published in.1995 as GB/T 16126-1995; ---This is the first revision. Human Biomonitoring Quality Assurance Standard 1.Scope This document specifies the quality assurance and quality control procedures for field investigations, laboratory testing, data management, and application in human biomonitoring. Technical requirements and operating procedures. This document serves as guidance for monitoring human exposure levels to environmental chemicals in production and living environments.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB/T 6682 Specifications and test methods for water used in analytical laboratories GB/T 8170 Rules for rounding off numerical values and the representation and determination of limiting values GB 19489 General Requirements for Laboratory Biosafety GB/T 27417 Guidelines for Conformity Assessment of Chemical Analysis Methods GB/T 27476.5 Laboratory Safety – Part 5.Chemical Factors GB/T 32465 Requirements for Validation and Internal Quality Control of Chemical Analysis Methods GB/T 37864 General requirements for the 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 Rules for Biomonitoring Methods for Occupational Populations 3.Terms and Definitions The following terms and definitions apply to this document. 3.1 Human biomonitoring Regularly (scheduledly) monitor the levels of chemical substances and their metabolites in human biological samples, or the harmless biological effects they cause. Levels are used to assess the extent to which humans are exposed to chemicals and their potential health effects. 3.2 field survey The process by which trained investigators systematically collect information from a target population using on-site or remote survey methods. Note. Survey methods include centralized surveys, door-to-door surveys, intercept surveys, observation methods, telephone surveys, mailed questionnaires, email surveys, and online surveys. 3.3 bias Systematic errors arising from each stage of the research, from design and implementation to data processing and analysis, as well as biases in the interpretation and inference of results. Sexual factors can lead to biased discrepancies between research findings and reality. ...