HOME Cart(0) Quotation About-Us Policies PDFs Standard-List
www.ChineseStandard.net Database: 221887 (14 Apr 2026)
Path: Home > MISC > Page344 > WS 315-2025 || Home > Standard_List > MISC > Page344 > WS 315-2025

WS 315-2025 PDF English

Price & Delivery

US$219.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
WS 315-2025: Technical standard for preservation organization of human pathogenic microorganism
Status: Valid

WS 315: Evolution and historical versions

Std IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)Status
WS 315-2025English219 Add to Cart 3 days [Need to translate] Technical standard for preservation organization of human pathogenic microorganism Valid
WS 315-2010English289 Add to Cart 3 days [Need to translate] Technical requirement for preservation organization of human pathogenic microorganism Valid

Standard similar to WS 315-2025

WS/T 655 | WS 310.1 | GB 18469 | WS/T 868 | WS/T 852 |

Basic data

Standard ID WS 315-2025 (WS315-2025)
Description (Translated English) Technical standard for preservation organization of human pathogenic microorganism
Sector / Industry Health Industry Standard
Classification of Chinese Standard C06
Classification of International Standard 11.021
Word Count Estimation 10,142
Date of Issue 2025-04-18
Date of Implementation 2026-05-01
Older Standard (superseded by this standard) WS 315-2010
Issuing agency(ies) National Health Commission
Summary This standard specifies the requirements for facilities and equipment and management requirements for the preservation of pathogenic microorganisms (viruses) transmitted between humans. This standard applies to the construction and management of preservation institutions for pathogenic microorganisms (viruses) transmitted between humans.

WS 315-2010: Technical requirement for preservation organization of human pathogenic microorganism


---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.
Technical requirement for preservation organization of human pathogenic microorganism ICs 11.020 C59 Record number. 28388-2010 People's Republic of China Health Industry Standard Human-to-human pathogenic microorganisms (virus) species Technical specifications for depository establishment Issued by the Ministry of Health of the People's Republic of China Foreword... ¨ I 1 Scope... 1 2 Normative quotation documents...1 3 Terminology and definitions 1 4 Basic Principles of Setting Up...2...2 5 Categories and Responsibilities... 3 6 Facility and equipment requirements...3 7 Management requirements...5 References...7 Cream According to the "Law of the People's Republic of China on the Prevention and Control of Infectious Diseases", the "Regulations on Biosafety Management of Pathogenic Microorganism Laboratories", and "The Pathogens of Human Infectious Diseases" This standard is formulated by "Management Measures for the Collection Institutions of Microorganism (Virus) Species". This standard was proposed by the Professional Committee of Infectious Disease Standards of the Ministry of Health. This standard was approved by the Ministry of Health of the People's Republic of China. The organization responsible for drafting this standard. Chinese Center for Disease Control and Prevention. Participated in the drafting of this standard. China National Institute for the Control of Pharmaceutical and Biological Products, Guangdong Provincial Center for Disease Control and Prevention, Gansu Province Disease Control and Prevention Center, Qingdao Center for Disease Control and Prevention. The main drafters of this standard. Wu Guizhen, Ye Qiang, Wei Qiang, Han Jun, Li Zhenjun, Liang Mifang, Hairong, Duan Shumin, Jiang Yan, Zhao Chihong, Yang Xingfen, Yucao, Ji Water Conservancy. Human-to-human pathogenic microorganisms (virus) species Technical specifications for depository establishment

1 Scope

This standard specifies the basic principles, categories and responsibilities, requirements of facilities and equipment for the establishment of a collection of pathogenic microorganisms (viruses) that are transmitted from person to person. Basic requirements such as requirements and management requirements. This standard applies to disease prevention and control institutions, medical and health care, scientific research and teaching, pharmaceutical and biological product production units, etc. Agency for the preservation of infectious pathogenic microorganisms (virus) species.

2 Normative references

The clauses in the following documents become clauses of this standard after being quoted in this standard. For dated reference documents, all subsequent The amendments (not including errata content) or revisions do not apply to this standard. However, all parties who have reached an agreement based on this standard are encouraged to study Is the latest version of these files available? For undated reference documents, the latest version applies to this standard. GB 19489 Laboratory Biosafety General Requirements GB 50068 Unified Standard for Reliability Design of Building Structures GB 50223 Classification standard for seismic protection of construction engineering GB 50346 Technical Code for Biological Safety Laboratory Building List of pathogenic microorganisms of human infection, Ministry of Health.2006 Measures for the Administration of Collection Institutions for Human-to-human Pathogenic Microorganisms (Virus), Ministry of Health.2009

3 Terms and definitions

The following terms and definitions apply to this standard. 3.1 Bacteria (virus) species Cultivated, human-to-human fungi, actinomycetes, bacteria, rickettsiae, spirochetes, mycoplasma, chlamydia, viruses, etc. have preservation value , And have been identified, classified and given a fixed number by the bacteria (virus) species preservation agency. 3.2 preservation The preservation institution collects, verifies, catalogs, and stores bacteria (virus) species or samples in an appropriate manner in accordance with the law, maintains its activity and biological characteristics, and The activity of providing bacteria (virus) species or samples to units that legally engage in experimental activities related to pathogenic microorganisms. 3.3 Depository Species or samples of bacteria (virus) designated by the competent health administrative department of the State Council to receive, store and manage bacteria (virus) An institution that supplies bacteria (virus) species or samples to laboratories engaged in pathogenic microorganism experiments. 3.4 Collection Center Species or samples of bacteria (virus) designated by the competent health administrative department to receive, centrally store and manage bacteria (virus) A comprehensive preservation institution of bacteria (virus) species or samples supplied by the laboratory for the original microbiological experiment activities. Preservation professional laboratory A specific species or sample of bacteria (virus) designated by the health administrative department to receive, store and manage in accordance with regulations, and to Institutions that provide bacteria (virus) species or samples from depository centers and laboratories that legally engage in pathogenic microorganism experiments. 3.6 Identification 3.15 Providing area Provide the transfer area of bacteria (virus) species or samples. 3.16 Omce area Outside the experimental work area, it is effectively isolated from the laboratory area and is an area for storing relevant materials and files.

4 Basic principles of setting

The health administrative department of the State Council shall meet the needs of infectious disease prevention and control, medical treatment, inspection and quarantine, scientific research, teaching, production, etc., and the flow of infectious diseases. 3.11 The preservation area should be in the building

5 Categories and responsibilities

The preservation institutions are divided into national preservation centers, provincial preservation centers, and preservation professional laboratories. For their categories and responsibilities, refer to Administrative Measures for the Preservation Institutions of Pathogenic Microorganisms (Virus)."

6 Facilities and equipment requirements

The standards and requirements for the facilities, equipment and related materials used by the preservation institution.

7 Management requirements

7.1 Organization 7.1.1 The preservation institution shall establish a special bacteria (virus) species preservation and biosafety management committee to be responsible for the technical guidance, Biological safety supervision and inspection, formulation of internal rules and regulations. 7.1.2 The management of each laboratory of the depository shall be responsible for the design, implementation, maintenance and improvement of the safety management system. 7.1.3 The preservation institution shall establish a sound and clarify the responsibilities of leaders and personnel at all levels. 7.2 Management System 7.2.1 The preservation institution shall establish and improve relevant system documents, and pass management specifications, procedural documents, standard operating procedures (SoP) and records, etc. File management. 7.2.2 The preservation institution shall establish standard operating procedures and technical regulations for the collection, isolation, verification, storage, passage, and supply of bacteria (virus) species or samples. Fan, internal transfer workflow system. 7.2.3 The preservation institution shall establish various systems and ensure the quality of preservation to prevent bacteria (virus) from being caused by improper operation or unexpected circumstances. The resulting bacteria (virus) species are lost. The backup system for precious bacteria (virus) species with special preservation value should be included. 7.2.4 The preservation institution shall establish an emergency response system and emergency response plan. 7.2.5 The depository institution shall establish a system of access and approval. 7.2.6 The laboratory designates a person to be responsible for health monitoring. It is necessary to carry out pre-job and regular health checkups of staff and retain background serum. Carry out vaccination from time to time and establish personal health records. 7.2.7 The preservation institution shall establish a strict confidential management system for bacteria (virus) species. 7.2.8 The preservation institution shall establish a routine monitoring system for the preservation of bacteria (virus) species. regularly measure the temperature, the capacity of liquid nitrogen, and the temperature of the preservation equipment Abnormal alarm situation. 7.2.9 The preservation institution shall establish a regular maintenance system for the preservation facilities and equipment of bacteria (virus) species, and assign a special person to manage it. 7.2.10 The preservation institution shall establish a correct and safe label use system. 7.2.1l The preservation institution shall establish a responsibility system for the preservation and management of bacteria (virus) species. 7.2.12 The preservation institution shall establish an information file management system for bacteria (virus) species, and shall have paper information data files and digital information data files The files should be kept safe and protected against moisture, mildew, insects, fire, magnetism and theft. 7.2.13 The preservation institution shall establish the destruction system of bacteria (virus) species. 7.2.14 The preservation institution shall establish a disinfection system for the preservation institution. 7.3 Technical requirements 7.3.1 Bacteria (virus) species information management requirements 7.3.1.1 The preservation institution shall number the bacteria (virus) species that meet the preservation conditions after identification and review, establish a numbering rule, and have a database Inquire. The number includes the original number, registration number, and preservation number. 7.3.1.2 The preserved bacteria (virus) species or samples should have serial numbers, sources, isolation dates, regions, providers, preservation conditions, and degree of harm. Type, phenotypic profile, genotype profile, drug susceptibility profile, preliminary identification results, providing unit and other background information. Ws 315- 2ˉ010 7.3.1.3 The appraisal record should contain the appraisal personnel, method, reagent, date and other information. 7.3.1.4 Passage records should include information such as the number of bacteria (virus) species, passaging personnel, and growth status. 7.3.1.5 The preservation record shall include information such as location, quantity and person in charge. 7.3.1.6 The exit database records should include information such as date, quantity, manager, and whereabouts. 7.3.1.7 The destruction record shall include information such as the person who approved the destruction, the operator, and the method of destruction. 7.3.2 Requirements for the preservation of bacteria (virus) species 7.3.2.1 The original bank, main seed bank and working bank should be established for the preservation of bacteria (virus) species and stored separately. 7.3.2.2 The material and thickness of the preserved bacteria (poison) should meet the safety requirements to ensure that it is not easy to break or burst in a low temperature environment. 7.3.2.3 Use appropriate preservation methods for pathogenic microorganisms, including cryopreservation, freeze-drying, etc. 7.3.2.4 The same bacteria (virus) should be preserved in two or more ways. 7.3.2.5 If only one preservation method can be used, the bacteria (virus) species must be backed up and stored in two separate preservation areas. 7.3.2.6 Bacteria (virus) species are managed by a two-person double-lock system, and storage and delivery should be recorded and archived. 7.3.2.7 The destruction record shall include information such as the person who approved the destruction, the operator, and the method of destruction. 7.3.2.8 There should be a firm label on the storage container, indicating the bacteria (virus) species number, date and other information. 7.3.3 Requirements for the entry and exit of bacteria (virus) species The bacteria (virus) species entering and leaving the preservation area should be identified with a clear background. 7.4 Personnel requirements 7.4.1 The preservation unit should have a corresponding number of management, technical, security, and facility maintenance personnel to ensure the smooth progress of the preservation work. 7.4.2 All relevant personnel responsible for the preservation of bacteria (virus) species shall undergo relevant qualification review. 7.4.3 All relevant personnel responsible for the preservation of bacteria (virus) species have the necessary professional knowledge, receive regular skills training, and have biosafety training Qualifications such as certificate, post certificate Possess the technical ability to preserve experimental activities. 7.4.4 The management personnel responsible for the preservation of bacteria (virus) species should have management experience in the preservation of certain bacteria (virus) species, and be familiar with the preservation of the entire bacteria (virus) species It has good management and coordination capabilities and is responsible for the daily supervision and management of the preservation of bacteria (virus) species. 7.4.5 Security guards should have undergone professional training and hold a professional certificate. When necessary, there should be armed police to guard. 7.4.6 Practitioners should be in good health and receive necessary health monitoring and vaccination. 7.5 Security requirements 7.5.1 The monitoring system of the bacteria (virus) species preservation area should be operated 24h. 7.5.2 The preservation and management of bioterrorism-related bacteria (viruses) should meet relevant national requirements. 7.5.3 For the monitoring system set up by the preservation institution, the monitoring area should reach all areas of the preservation institution, equipped with various video display devices. 7.6 Management of experiments and deposited materials 7.6.1 The depository institution shall have policies for selecting, purchasing, collecting, receiving, inspecting, using, disposing and storing laboratory materials (including external services). Policies and procedures to ensure safety. 7.6.2 The pipes used for cryopreservation should have low-temperature resistance and anti-rupture properties, while thermal expansion and cold shrinking, and the nozzle should have a special design to prevent low-temperature conditions. In this state, the gaps in the nozzles cause infectious materials to spill and contaminate the outside. 7.7 Experimental waste management 7.7.1 The management of the treatment and disposal of experimental waste in the preservation institution shall meet the relevant national requirements. 7.7.2 Experimental waste should be disposed of in specially designed, dedicated and marked containers for the disposal of experimental waste. 7.7.3 Sharp objects should be directly discarded in a puncture-resistant container. 7.7.4 The preservation agency shall formulate procedures for handling contaminated items in accidents. 7.8 Personal protection requirements 7.8.1 The preservation institution shall, in accordance with the degree of harm of the bacteria (virus) species preserved and the content of the experimental activities, configure personal protection that meets the corresponding biological safety. Care supplies. 7.8.2 Personal protection in the biosafety laboratory shall comply with relevant national standards and requirements. 7.8.3 The experiment staff should strengthen personal protection, including face protection, during the process of removing bacteria (virus) species or samples from the cryogenic equipment.
WS 315-2025 English cover page

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of WS 315-2025_English be delivered?

Answer: Upon your order, we will start to translate WS 315-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of WS 315-2025_English with my colleagues?

Answer: Yes. The purchased PDF of WS 315-2025_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version WS 315-2025?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version WS 315-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.
Terms of Service | Contact Information | Privacy Policy | Refund Policy | Shipping Policy