WS/T 4812-2022 in English

VALID

Technical requirements for evaluation of national standard strains of pathogenic microorganisms

Issued on:2022-11-05
Implemented on:2023-05-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $240.00
$233.00

Standard No:	WS/T 4812-2022
Document status:	VALID
Title in English:	Technical requirements for evaluation of national standard strains of pathogenic microorganisms
Title in Chinese:	病原微生物菌（毒）种国家标准株评价技术标准
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2022-11-05
Implemented on:	2023-05-01
ICS Classification:	11.020-Medical Sciences and health care facilities in general
Chinese Classification:	C04-Basic standards and general methods
Professional Classification:	WS-Hygiene
Related Keywords:	national standard strain evaluation system national standard strain evaluation application form national standard strains standard strains standard strains type core characteristics
Related Topics:	pathogen Pathogenic microorganisms en standard microdisk standard strain mic Primary strain Standard strain mic National Standard Unit Pathogenic microorganisms Virus seed plate National Material Technology Microbial Toxicity Evaluation Microbial Toxicity Evaluation standard virus strain Virus standard strain Pathogenic microorganisms domestic biotechnology Microbial inoculation instrument Bacteria Pathogen The strain Stable species country evaluation pathogen strain pathogen strain Microorganisms and pathogenic microorganisms microbial pathogenic microorganism Pathogenic microorganisms transmitted among humans national seed Microbiological Technology Evaluation standard biotechnology Plant logo Pathogenic flora poisonous species Microorganisms virus strain several microbial methods Standard strain, MIC Sequencing of pathogenic microorganisms Microorganisms \| Pathogenic microorganisms \| Environmental microorganisms \| Pathogenic microorganism inspection \| Peg8000 virus principle GJB3206B standard original text Microbial standard strain number Microbial strain sampling, isolation and purification Luciferase virus principle Crude oil national standard gb36170 The latest national standard for reservoir classification and evaluation Virus Standard Strain Report Evaluation of nursing quality for single disease Clostridium botulinum standard strain The latest national standards for graphite raw materials Acceptance records of standard strains List of microbial standard strains United Nations National Standard for Biomass Molded Fuel Bacterial and virus seed generation industry Microbial standard strain management National standard endotoxin National standard classification of biological samples for biotechnology National standards for technical indicators of high-purity liquid helium Standard strain acceptance record National standard intelligent manhole cover original text Biosafety standard strain management National military standard types and requirements What are the national standards for sterility? Standard strain acceptance record National standard method for microextraction Standard strain verification cycle Air microbiology assessment Commonly used standard strains of microorganisms Summary of biological toxicity standards Standard strain number Heterotrophic bacteria standard strains Total number of colonies of standard strains National Microbiological Identification Microbiology laboratory national industry Source of standard strains Are somatic cells considered microorganisms in national standards? Pharmacopoeia standard strains National standard recombinant raw materials Botulinum toxin standard strain Six new technology evaluation criteria Microbial inoculation method for urine specimens Packaging standard requirements for microbial inoculants Microbiological national standard environment National standard technical document for industrial and mining lamps Take the logarithm of the standard strain stock solution Clinical isolates and standard strains belong to the same genus

本标准规定了人间传染的病原微生物菌(毒)种国家标准株评价技术基本原则、技术要求、申请与评价程序。
本标准适用于全国各级各类病原微生物菌(毒)种保藏机构，以及涉及病原微生物菌(毒)种研究、教学、检测、诊断、研发等相关活动的机构。

Introduction

Core value and scope of application of the standard

This standard systematically constructs the national standard strain evaluation system for pathogenic microorganisms (viruses) for the first time, and explicitly requires that the standard strains must have the five characteristics of representativeness, effectiveness, standardization, controllability, and safety. It is applicable to preservation institutions at all levels across the country and related units such as scientific research, teaching, and testing.

Classification system of standard strains

Type	Core characteristics	Typical applications
Model strain	Original naming basis strain	Taxonomic benchmark
Reference strain	Clear characteristic indicators	Quality control control
Vaccine strain	Stable immunogenicity	Vaccine research and development

Key technical evaluation indicators

Biological evaluation

Requires complete genome sequence information, clear hazard classification (according to the national pathogenic microorganism hazard classification regulations), and must reflect the characteristics of subspecies diversity.

Activity evaluation

Taking the influenza virus H1N1 standard strain as an example, it must meet the following requirements:
1. Virus titer ≥6.5 lg EID₅₀/mL
2. Hemagglutination titer ≥1:160
3. No mycoplasma contamination

Stability evaluation

The passage should not exceed 5 generations, and generation records, culture condition parameters and molecular characteristic stability certificates must be provided.

Application and evaluation process

Submit the "National Standard Strain Evaluation Application Form" (including the actual bacterial and viral strains)
Preliminary review by the preservation subcenter (30 working days)
Expert committee review (centralized review twice a year)
Issuance of the National Standard Strain Certificate

Implementation suggestions

1. Establish a standard strain traceability system to record the transmission history and characteristic changes
2. Use lyophilized storage (below -70℃) to ensure stable activity
3. Regularly review key biological characteristics (at least once every 5 years)

More samples: YD/T 3934-2021 DL/T 368-2010 GB 18306-2015

Sample only — not a preview of WS/T 4812-2022