GB/T 43429-2023General requirements for preservation of human pathogenic microorganisms and samples (English PDF)
人感染病原微生物与样本保藏通用要求
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
November 27, 2023
Implementation date
November 27, 2023
Scope
GB/T 43429-2023 is the English-translated version of 人感染病原微生物与样本保藏通用要求.
GB/T 43429-2023 sets out what a collection that holds human-infectious pathogens has to record and how it has to store them.
It fixes the basic requirements for preservation, the general requirements for the deposit information kept on pathogenic microorganisms and viruses and on samples, and the general requirements for storage conditions, and its five informative appendices give worked descriptions of bacterial, viral and fungal preservation records and of clinical specimen and environmental sample records.
It defines strain, sample and preservation, and among the standards it quotes are GB 19489, GB/T 37864 and WS 315. Clause 1 applies it to preservation centres at every level, to specialised preservation laboratories and to regulators assessing an institution. Issued on 27 November 2023, it has applied since that same date.
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Document preview — GB/T 43429-2023
National Standard of the People's Republic of China
- ICS
- 07.080
- Classification
- C 04
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Basic requirements
- 5 General requirements for deposited information
- 5.1 Preservation information of pathogenic microorganisms (viruses)
- 5.2 Sample preservation information
- 6 General requirements for storage conditions
- Appendix A (informative) Example of description of bacterial preservation information
- Appendix B (informative) Example 11 of virus preservation information description
- Appendix C (informative) Example 13 of description of fungal preservation information
- Appendix D (informative) Example 15 of description of clinical specimen preservation information
- Appendix E (informative) Example 16 of description of environmental sample preservation information
- Reference
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.
1 Scope
This document stipulates the basic requirements for the preservation of pathogenic microorganisms and samples of human infections, general requirements for preservation information and preservation conditions.
This document is applicable to all levels of preservation centers, professional preservation laboratories and other preservation institutions for pathogenic microorganisms (viruses) transmitted to humans.
Preservation, storage and use of biological bacteria (virus) species and samples, etc. Institutions regulate the preservation/preservation of internal pathogenic microorganisms and samples, and also apply to related Relevant regulatory authorities evaluate the institution's ability to preserve/preserve pathogenic microorganisms and samples.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.
GB 19489 General requirements for laboratory biosafety
GB/T 37864 General requirements for quality and capability of biobanks
WS315 Technical specifications for the establishment of institutions for the preservation of pathogenic microorganisms (viruses) transmitted to humans
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 pathogenic microorganism
Microorganisms that can invade humans and animals and cause infection or even infectious diseases.
Note: Including viruses, bacteria, fungi, rickettsiae, parasites, etc.
3.2 Bacteria (virus) microorganismstrain
Human-infected pathogenic microorganisms with infectious activity that have preservation value and have been identified, classified and given a fixed number. [Source: WS315-2010, 3.1, with modifications]
3.3 Samples
Contains human-to-human pathogenic microorganisms with infectious activity, body fluids, tissues, excreta and other biological materials of humans and animals that have preservation value.
Materials of physical origin, as well as materials such as food and environmental samples.
3.4 Preservation
The preservation institution collects, identifies, catalogs, and stores bacterial (virus) species or samples in an appropriate manner in accordance with the law, maintains their activity and biological characteristics, and The activity of providing bacterial (virus) strains or samples to units that are legally engaged in experimental activities related to pathogenic microorganisms. [Source: WS315-2010, 3.2, with modifications]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB 19489-2008 — Laboratories - General requirements for biosafety
GB/T 37864-2019 — General requirements of quality and competence for biobank
WS 315-2025 — Technical standard for preservation organization of human pathogenic microorganism
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GB/T 43429-2023
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