GB/T 41844-2022 English PDF

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GB/T 41844-2022: Specifications for prevention and control of human DNA contamination in DNA testing products
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Basic data

Standard ID: GB/T 41844-2022 (GB/T41844-2022)
Description (Translated English): Specifications for prevention and control of human DNA contamination in DNA testing products
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A92
Classification of International Standard: 13.310
Word Count Estimation: 20,219
Date of Issue: 2022-10-12
Date of Implementation: 2023-05-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 41844-2022: Specifications for prevention and control of human DNA contamination in DNA testing products

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Specifications for prevention and control of human DNA contamination in DNA testing products ICS 13.310 CCSA92 National Standards of People's Republic of China Specifications for the prevention and control of human-originated contamination of DNA testing products Requirements, MOD) Released on 2022-10-12 2023-05-01 Implementation State Administration for Market Regulation Released by the National Standardization Management Committee

table of contents

Preface I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Abbreviations 3 5 General provisions 4 6 Product Type 4 6.1 General requirements 4 6.2 Products in direct contact with biospots or that may contain human DNA4 6.3 Chemicals, reagents, solvents and other disposable consumables involved in the analysis of human DNA5 6.4 Protective products used during collection and analysis of biological material5 7 Quality Management System 5 7.1 General requirements 5 7.2 Documentation and records 5 7.3 Authorization 6 7.4 Subcontracting and raw material procurement 6 7.5 Control of non-conforming products 6 7.6 Corrective and preventive measures 6 7.7 Staff pollution detection regulations 6 8 Risk management of human DNA contamination 7 8.1 General requirements 7 8.2 Risk assessment 7 8.3 Risk Reduction Measures 8 8.4 Risk control measures 8 9 Monitoring of Human DNA Contamination in the Environment 8 10 Requirements for products subject to post-production processing 9 11 Requirements for products that do not require post-production treatment 9 11.1 Product testing 9 11.2 Batch records 9 12 Product Packaging, Labeling and Documentation 9 Appendix A (informative) Related markers of DNA typing 11 Appendix B (Normative) Compliance Test 12 Appendix C (Informative) Current Effectiveness Guidelines for Post-production Processing in Product Manufacturing 14 Reference 15

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 modified to adopt ISO 18385.2016 "Minimizing the use of forensic science applications to collect, store and analyze biological materials Necessary Guidelines for the Risk of Human-Origin DNA Contamination on Products”. Compared with ISO 18385.2016, this document has made the following structural adjustments. --- Chapter 1 and Chapter 5 correspond to Chapter 1 of ISO 18385.2016; --- Chapter 3 corresponds to Chapter 2 of ISO 18385.2016; --- Chapter 4 corresponds to Chapter 3 of ISO 18385.2016; --- Chapter 6 corresponds to Chapter 4 of ISO 18385.2016; --- Chapter 7 corresponds to Chapter 5 of ISO 18385.2016; --- Chapter 8 corresponds to Chapter 6 of ISO 18385.2016; --- Chapter 9 corresponds to Chapter 7 of ISO 18385.2016; --- Chapter 10 corresponds to Chapter 8 of ISO 18385.2016; --- Chapter 11 corresponds to Chapter 9 of ISO 18385.2016; --- Chapter 12 corresponds to Chapter 10 of ISO 18385.2016; ---Appendix A corresponds to Appendix C of ISO 18385.2016; ---Appendix B corresponds to Appendix A of ISO 18385.2016; ---Appendix C corresponds to Appendix B of ISO 18385.2016. The technical differences between this document and ISO 18385.2016 and their reasons are as follows. --- Changed the term "forensic science DNA level" (see 3.13), which increases operability and is more in line with my country's national conditions; ---Changed the "Staff Contamination Detection Regulations" and added "Manufacturers should consult with customers about potential staff DNA contamination Quality control query and comparison method" (see 7.7), to meet the needs of my country's use of DNA pollution prevention; ---Increase the content of "aerosol pollution" in the risk assessment [see 8.2g)], and consider the risks of all production links as comprehensively as possible factor; --- Change "14 or more markers" to "21 or more markers" [see B.4.3a)], which is more applicable to the Chinese population. The following editorial changes have been made to this document. --- In order to coordinate with the existing standards, the name of the standard was changed to "Code for the Prevention and Control of Human-derived Pollution of DNA Testing Products"; --- Added the chapter "Normative References"; --- Added Chapter 5 "General Provisions", covering the content of the mandatory clauses in Chapter 1 of ISO 18385.2016. 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 by the Ministry of Public Security of the People's Republic of China. This document is under the jurisdiction of the National Criminal Technology Standardization Technical Committee (SAC/TC179). This document was drafted by. Physical Evidence Appraisal Center of the Ministry of Public Security, Hubei Provincial Public Security Department, China National Accreditation Center for Conformity Assessment, Suzhou Yuewei Gene Technology Co., Ltd., Kaijie Enterprise Management (Shanghai) Co., Ltd., Southern Medical University. The main drafters of this document. Zhao Lei, Lu Liang, Liu Kaihui, Chang Jingjing, Xie Qun, Tian Xuemei, Wang Haisheng, Gao Junwei, Zhang Rui, Niu Huiyuan, Jie Tong.

Introduction

As the sensitivity of DNA testing techniques increases, unintentional contamination from manufacturers of DNA testing reagents and consumables poses a threat to forensic science. DNA analysis caused more disruption. The purpose of this document is to establish standards for the manufacture of forensic science human DNA testing products. Consumables used in forensic DNA testing may introduce human-derived DNA contamination during the production process. In the production process of reagents and consumables The quality control and pollution traceability in the industry are very important. Specifications for the prevention and control of human-originated contamination of DNA testing products WARNING. If adequate precautions are not taken, performance of this document may result in damage to health or personal injury.

1 Scope

This document specifies the general provisions for the prevention and control of human-originated contamination of products used in DNA testing, product types, quality management systems, human-originated DNA pollution risk management, monitoring of human-derived DNA contamination in the environment, product requirements that require post-production treatment, no need for post-production Handled product requirements, product packaging, labeling and supporting documents. This document applies to the production of consumables and reagents that can be used without cleaning. This document does not cover product specifications (such as product product design).

2 Normative references

This document has no normative references.

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 allele alele DNA fragments with primary structural differences at the same locus. 3.2 Amplification The process of exponentially replicating segments of a DNA sequence. NOTE. Also known as polymerase chain reaction (PCR). 3.3 Blank samples without DNA components are used to verify that there is no contamination (3.7) during the amplification (3.2) process. 3.4 Samples containing known DNA components are used to verify that the amplification (3.2) process is normal. 3.5 Analytical threshold analyticalthreshold The minimum peak height requirement that can be reliably identified as an amplification product peak from background noise. 3.6 Batch release test batchreleasetest The test conducted by the manufacturer (3.15) or entrusted by the manufacturer before the release of the same batch of products and the test is qualified. [Source. ISO /T S21003-7.2008, 3.1.9] 3.7 pollution contamination The presence of DNA of human origin that could be detected during manufacturing or packaging could affect forensic science DNA analysis. ......

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