GB 19489: Evolution and historical versions
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Laboratories -- General requirements for biosafety
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Basic data | Standard ID | GB 19489-2008 (GB19489-2008) | | Description (Translated English) | Laboratories -- General requirements for biosafety | | Sector / Industry | National Standard | | Classification of Chinese Standard | C52 | | Classification of International Standard | 13.100 | | Word Count Estimation | 38,320 | | Date of Issue | 2008-12-26 | | Date of Implementation | 2009-07-01 | | Older Standard (superseded by this standard) | GB 19489-2004 | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 21 of 2008 (No. 134 overall) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard specifies requirements for different levels of bio- security laboratory facilities, equipment, and security management of the basic requirements. Chapter 5 and 6. 1 and 6. 2 is based on laboratory biosafety requirements necessary for a higher level of protection and animal bio- safety laboratory biosafety laboratory. Infected animals for breeding and related laboratory activities, this standard specifies requirements for laboratory animal breeding facilities and environment of the basic requirements. When necessary, 6. 3 and 6. 4 apply to the appropriate level of protection of animal biosafety laboratory. This standard applies to biological factors involved in the operation of the laboratory. | GB 19489-2008: Laboratories -- General requirements for biosafety---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.
Laboratories.General requirements for biosafety
ICS 13.100
C52
National Standards of People's Republic of China
Replacing GB 19489-2004
Laboratory Biosafety General Requirements
Posted 2008-12-26
2009-07-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Terms and definitions 1
Risk assessment and risk control 3 2
4 laboratory biosafety level 4 rating
5 laboratory design principles and basic requirements of 4
6 laboratory facilities and equipment requirements 5
6.1 BSL-1 Lab 5
6.2 BSL-2 laboratory 6
6.3 BSL-3 laboratories 6
6.4 BSL-4 laboratory 9
6.5 Animal laboratory biosafety 10
7 12 management requirements
7.1 Organization and Management 12
7.2 Management responsibility 12
7.3 Personal liability 13
7.4 safety management system documents 13
7.5 Document Control 15
15 7.6 Safety Plan
7.7 security check 16
7.8 does not comply with the identification and control of 16 items
7.9 Corrective Action 16
7.10 Preventive Measures 16
7.11 Continuous Improvement 17
7.12 Internal Audit 17
7.13 Management Review 17
Laboratory personnel management 18 7.14
7.15 Laboratory Materials Management 18
7.16 Management laboratory activities 19
7.17 19 laboratory housekeeping
7.18 laboratory facilities and equipment management 19
7.19 Waste Disposal 20
Transport of hazardous materials 21 7.20
Emergency measures 21 7.21
7.22 Fire Safety 21
7.23 Accident report 21
Appendix A (informative) laboratory testing tight building envelope and the exhaust HEPA filter leak detection method Guide 23
Annex B (informative) laboratory biosafety guidelines of good work practices 26
Annex C (informative) laboratory bio hazardous materials spills Processing Guide 29
References 32
Foreword
This standard is the first 3.1.10,6.3.1.5,6.3.10.4,6.3.10.5,6.5.1.4 and 6.5.1.9 Article recommendatory, others are strong
Compulsory provisions.
This standard replaces GB 19489-2004 "General requirements for laboratory biosafety."
This standard compared with GB 19489-2004, the main changes are as follows.
--- Criteria for the classification of the elements have been adjusted, a clear distinction between technical elements and management elements (2004 edition, Chapter 6 to Chapter 20,
Excerpts of Chapter 5 to Chapter 7);
--- Remove the 2004 edition of some of the terminology and definitions (2004 version 2.2,2.3,2.8 and 2.11);
--- Revised 2004 edition of some of the terminology and definitions (2004 edition 2.1,2.4,2.6,2.7,2.9,2.10,2.12,2.13,
2.14 and 2.15);
--- Adding new terms and definitions (Excerpts 2.2,2.8,2.9,2.11,2.12,2.14,2.17,2.18 and 2.19) ;
--- Delete harm degree classification (Chapter 3 of the 2004 edition);
--- Revised and increased the risk assessment and risk control requirements (2004 edition, Chapter 4, Section 3 of this edition);
--- Revised the design principles of laboratory facilities and equipment, part of the requirements (2004 edition, Chapter 6, Section 7 and Section 9.3, this
The first version of Chapter 5 and Chapter 6);
--- Added laboratory facilities automation system requirements (this version 6.3.8);
--- Increased its laboratory facilities in invertebrates operating requirements (this version 6.5.5);
--- Added management requirements (Excerpts 7.4,7.5,7.8,7.9,7.10,7.11,7.12 and 7.13);
--- Removed some and GB 19781-2005 "Medical Laboratory Safety requirements" duplicate content (2004 edition Chapter 3,
, Chapter 13, Chapter 14, Chapter 15 and Chapter 17, Chapter 12);
--- Added Appendix A, Appendix B and Appendix C.
Certain aspects of this standard may involve patent issues, the issuing authority of this standard does not assume the responsibility to identify these patents.
The Standard Appendix A, Appendix B and Appendix C are informative appendices.
This standard certification and accreditation by the National Standardization Technical Committee (SAC/TC261) and focal points.
This standard drafting units. China National Accreditation Center, the State Administration of Quality Supervision, Inspection and Quarantine Science and Technology Division, the China Disease Prevention
Control Center, China Animal Disease Control Center, the PLA Military Academy of Medical Sciences, Chinese Academy of Agricultural Sciences, Harbin Veterinary
Research Institute, Tianjin National Bio Protective Equipment Engineering Technology Research Center, Institute of Pathogen Biology, Chinese Academy of Medical Sciences, People's Republic of China
State Zhuhai Entry-Exit Inspection and Quarantine Tianjin People's Republic of China, People's Republic of China Ministry of Public Security Fire Department.
The main drafters of this standard. Song Guilan, Lu Jing, Wu Guizhen, Wu East, Jiwei, Wang Hongwei, Qian Jun, Qi built the city, Hezhao Wei, Lu Jian-chun,
Clear as thin, Wang Jianwei, Lu Bing, Wei Qiang, Hou Yanmei, off Yuntao, Shen pattern.
This standard replaces the standards previously issued as follows.
--- GB 19489-2004.
Introduction
Laboratory Biosafety involved must not only personal health laboratory staff event of an accident, is likely to give the crowd,
Animals or plants bring unpredictable hazards.
Occurrence laboratory biosafety incidents or accidents is difficult to completely avoid, it is important that the laboratory staff should understand that from
Risk activities and things should have been in control of the risk at an acceptable state engaged in related activities. Laboratory workers should be recognized but should not be too
Reliance on the security role of laboratory facilities and equipment, most fundamental reason is the lack of biological accidents and bio-safety awareness
Poor management.
Because of the importance of laboratory bio-safety, the World Health Organization published the third edition of "Laboratory Biosafety Manual" in 2004, the World
Industry standards organization launched on ISO 15190-2003 "Medical laboratory safety requirements," the revised program in 2006, a number of important
International professional organizations have developed a new document.
China in November 12, 2004 issued a "pathogenic microbiology laboratory bio-safety regulations" clearly defined biological laboratory
Security levels should its proposed experimental activities undertaken to adapt.
After nearly five years of practice, the domestic demand for bio-safety laboratory construction, operation and management of the appropriate requirements and a deeper understanding of
And a new consensus. To meet the needs of bio-safety laboratory construction and management, and promote development, it is necessary to revise GB 19489-2004.
Laboratory Biosafety General Requirements
1 Scope
This standard specifies the basic requirements for different levels of biosafety laboratory facilities, equipment and safety management.
Chapter 5, 6.1 and 6.2 as well as biological safety requirement is based biosafety laboratories, if necessary, apply a higher level of protection
Laboratory and animal biosafety laboratory.
Infected animals for breeding and related laboratory activities, this standard provides for laboratory animal breeding facilities and environment of the basic
begging. If desired, 6.3 and 6.4 for the appropriate level of protection of animal biosafety laboratory.
This standard applies to biological factors involved in laboratory operations.
2 Terms and definitions
The following terms and definitions apply to this standard.
2.1
Suspended in a gaseous medium particle size is generally 0.001μm ~ 100μm tiny solid or liquid particles form relatively stable points
Bulk system.
2.2
Resulting in death, unexpected illness, injury, damage and other losses.
2.3
With mechanical ventilation system, the overall sterilization conditions, chemical spray (when applicable) and the pressure can be monitored airlock, its doors have mutual
Lock function can not be turned on.
2.4
Microorganisms and bioactive substances.
2.5
With air control and efficient air filtering device operation panel, which can effectively reduce harmful aerosols produced during the experiment operator
And harm the environment.
2.6
Set in a closed chamber is the probability of contamination between different laboratory areas, if necessary, install a mechanical ventilation system, which has a door interlock function,
It can not be turned on.
2.7
Especially the flow of pollution from small regional pollution probability of the probability of large areas controlled airflow.
2.8
It may result in death, injury or illness, property damage, environmental damage working conditions or a combination of these root causes or state.
2.9
Identify hazards exist and to determine the characteristics of the process.
2.10
Usually 0.3μm particle test substance under the conditions specified above 99.97% removal efficiency air filter.
2.11
Causes or could cause an accident.
2.12
Biological factors involved in the operation of the laboratory.
2.13
Laboratory biosafety conditions and the state of not less than the allowable level, to avoid laboratory staff, visitors, communities and the environment is not
Acceptable damage, in line with relevant regulations, standards and other laboratory biosafety liability requirements.
2.14
Laboratory physical partitions, within the region of biological risk is relatively large, the need for laboratory graphic design, airtight envelope of gas
Stream, and entry into, personal protection and other regional control.
2.15
Provide a detailed technical briefing material risks and precautions to use the information.
2.16
Individual risk factors prevent people being biological, chemical or physical harm and other equipment and supplies.
2.17
Probability and severity of the consequences of the risk of synthesis.
2.18
Assess risk and to determine whether the acceptable size of the whole process.
2.19
To reduce the risk taken comprehensive measures.
3 risk assessment and risk control
3.1 The laboratory shall establish and maintain a risk assessment and risk control procedures to ongoing hazard identification, risk assessment and implement the necessary control
Control measures. Content Lab to consider include.
3.1.1 When laboratory activities involving pathogenic biological agents, biological laboratories should be a risk assessment. Risk assessment should consider (but not limited to,
To) the following.
a) biological agents known or unknown characteristics of biological factors such as species, source, infectious, transmission, susceptibility to latency agent
Amount - effect (response) relationship, pathogenicity (including acute and long-term effects), variability, stability in the environment, and other creatures
And interactions, the relevant experimental data, epidemiology, prevention and treatment programs and other environments;
b) Where applicable, the laboratory itself or accidents have occurred related laboratory analysis;
c) routine laboratory activities and unconventional activities in the process of risk (limited to biological factors), including all the people into the workplace
Members and staff may be involved (eg. contractor personnel) activities;
Risks associated with d) facilities, equipment and so on;
e) if applicable, the risks associated with experimental animals;
f) people related risks, such as physical condition, ability, may affect the working pressure;
g) accident, accident risks;
h) has been misused and the risk of malicious use;
i) the scope of the risk, nature and timing;
Probability j) risk assessment;
k) hazards and possible consequences of the analysis;
l) to determine the acceptable level of risk;
m) where applicable, to eliminate, reduce or control risk management and technical measures, and measures taken after the residual risks or new risks
Assessment;
n) where applicable, the degree of adaptation operating experience and risk control measures taken by the assessment;
o) where applicable, emergency measures and the expected impact assessment;
p) where applicable, to determine the facilities and equipment requirements, identification of training needs, carry out the operation control input information provided;
q) where applicable, information, resources (including external resources) assessment of risk reduction and control of hazards required;
r) Comprehensive assessment of risks, needs, resources, feasibility, applicability and the like.
3.1.2 in advance of all proposed risk assessment carried out their activities, including chemistry, physics, radiation, electrical, flood, fire, natural disasters
Risks assessed.
3.1.3 Risk assessment should have experienced professionals (not limited to this in-house personnel) carried out.
3.1.4 The risk assessment process should be documented, risk assessment report should indicate the time of the assessment, and the editorial staff is based on regulations, standards, research reported
Advertising, authoritative information, data and so on.
3.1.5 should periodically conduct a risk assessment or review of risk assessment reports, assessment period should be based on risk characteristics and laboratory activities and
determine.
3.1.6 develop new laboratory activities or want to change the assessed through laboratory activities (including related facilities, equipment, personnel, scope of activities,
Management, etc.), in advance or re-risk assessment.
3.1.7 Operation extraordinary amount or while engaged in special activities, the laboratory should conduct a risk assessment to determine the bio-security requirements applicable
, Should be approved by the relevant authorities.
3.1.8 When the event occurs, should be re-accident risk assessment.
3.1.9 When should the relevant policies, regulations, standards and other changes to re-risk assessment.
3.1.10 take risk control measures should first consider the elimination of hazards (if applicable), and then consider to reduce the risk (to reduce the potential damage
The likelihood or severity of occurrence), and finally to consider personal protective equipment.
3.1.11 hazard identification, risk assessment and risk control process is not only suitable for laboratory, routine operation of facilities and equipment, but also for
Laboratory facilities and equipment for cleaning, maintenance or shut down period.
3.1.12 In addition to the laboratory's own activities, risk considerations, it must also consider external staff activity, brought about the use of goods or services provided by external
risks of.
3.1.13 The laboratory shall have mechanisms to monitor the activities of their requirements to ensure that the requirements be implemented in a timely and effective manner.
3.2 Risk Assessment Laboratory complexity and risk control activities of hazard characteristics that exist in the laboratory, where applicable, the laboratory is not
Some require complex risk assessment and risk control activities.
3.3 Risk Assessment Report should be taken to the laboratory risk control measures, to establish safety management systems and to develop a basis for safe operation.
3.4 Risk assessment is based on data and risk control measures to be taken, safety procedures, etc. should be national authorities and the World Health
Organization, the World Organization for Animal Health, the International Standards Organization and other agencies or industry authority issued guidelines and standards as the basis; any new technology
Surgery before use well-proven and, where applicable, shall be approved by the relevant authorities.
3.5 Risk Assessment Report shall be approved institution laboratory bio-safety administrations; not listed in the national competent authorities publish
List of pathogenic microorganisms risk assessment of biological agents and, where applicable, shall be approved by the relevant authorities.
Laboratory biosafety level 4 rating
4.1 based on protective measures against biological agents operated to take the laboratory bio-safety level is divided into one, two, three and four
Level, a minimum level of protection, up to four levels of protection. In accordance with relevant state regulations.
a) a biosafety level suitable for the operation of the laboratory does not cause disease in animals or humans normally micro
biological;
b) biosafety level two laboratory suitable for operation can cause human or animal disease but under normal circumstances to
People, animals or the environment does not pose a serious hazard, the risk of transmission is limited and rarely cause severe disease after laboratory infection, and with
Preparation of effective treatment and prevention of microorganism;
c) biosafety level three laboratory suitable for operation can cause severe human or animal disease, relatively easy straight
Or indirect contact between people, animals and human, animal and zoonotic microorganisms;
d) biosafety level four laboratory suitable for operation can cause very serious human or animal disease microorganisms
Thereof, and China has not yet found or already announced the elimination of microorganisms.
4.2 to BSL-1, BSL-2, BSL-3, BSL-4 (bio-safetylevel, BSL) indicates that only in laboratory in vitro biological corresponding operation
Security level.
4.3 In ABSL-1, ABSL-2, ABSL-3, ABSL-4 (animalbio-safetylevel, ABSL) is meant to include animals live in gymnastics
Appropriate biosafety level for laboratory.
4.4 based on differences in the experimental activities, the use of personal protective equipment and isolation facilities basis of different laboratories divided into the following situations.
4.4.1 Operation generally considered non-pathogenic airborne biological agents lab.
4.4.2 can be effectively utilized safety isolation device (such as. biological safety cabinets) operate in conventional amounts airborne pathogenic biological agents lab.
4.4.3 can not effectively use safe operation of the conventional isolation means the amount of airborne pathogenic biological agents lab.
4.4.4 The use of the laboratory airborne pathogenic biological agents have life-support systems are operating to convince conventional amounts.
4.5 should be based on relevant state department issued pathogenic microorganisms classification list, based on a risk assessment, to determine the biological laboratory
Security level.
5 laboratory design principles and basic requirements
5.1 Laboratory siting, design and construction should be consistent with national and local environmental protection and construction authorities and other regulations and requirements.
5.2 Laboratory fire and safety channel should meet the fire safety requirements and the requirements of the country, taking into account the special requirements of biosafety;
When necessary, should be consulted in advance is recommended fire authorities.
5.3 laboratory safety and security should comply with the safety regulations and requirements of the relevant departments of the State class facilities.
5.4 Laboratory and other building materials and equipment shall comply with relevant state regulations and requirements of the products production, sale and use.
5.5 The laboratory shall ensure that the design of biology, chemistry, physics and radiation hazard control in the level of protection assessed acceptable Cheng
Degrees, provide a safe work area for the association and the adjacent public space work environment and to prevent harm to the environment.
5.6 laboratory corridors and passage of people and goods should be without prejudice to the adoption.
5.7 should design emergency evacuation routes, emergency exits should be clearly identified.
5.8 According door of the room you need to install locks, door locks should be easy to quickly open interior.
5.9 required (eg. While handling hazardous materials), the entrance to the room should be alert and access restrictions.
5.10 should assess the biological material, samples, pharmaceuticals, chemicals and the like are misused confidential information, and the risk of improper use is theft, and mining
Take appropriate physical precautions.
5.11 should be designed to ensure that the storage, transport, collection, treatment and disposal of hazardous materials safety.
5.12 laboratory temperature, humidity, illumination, noise and cleanliness and other indoor environmental parameters should meet the work requirements and health-related requirements.
5.13 laboratory design should also consider energy conservation, environmental protection and comfort requirements, shall comply with the requirements of occupational health and ergonomics requirements.
5.14 The laboratory shall arthropods and measures to prevent rodents from entering.
5.15 animal laboratory biosafety facilities should also be considered for animal respiration, excretion, hair, grasping bite, struggle, escape, animal experiments
Potential biological. (exposure, medical examinations, sampling, anatomy, such as inspection), animal husbandry, the disposal of animal carcasses and excreta produced by other processes
Risk protection.
5.16 should have the appropriate level of protection based on the type of animal, body size, habits, and other experimental purposes choice for animal feed
Support facilities, laboratory facilities, sterilization facilities and cleaning facilities.
5.17 laboratory animals can not be recycled exhaust air.
5.18 animal laboratory design, such as. space, access roads, the dissection room, cages, etc. should consider requiring animal experiments and animal welfare.
5.19 When applicable, it shall comply with the national animal laboratory animal breeding facility standards.
6 laboratory facilities and equipment requirements
6.1 BSL-1 laboratory
6.1.1 Laboratory doors should be locked and windows, door locks and door opening direction shall be without prejudice to the person in the room to escape.
6.1.2 should be located washbasins, should be provided in the near laboratory exit.
6.1.3 In the laboratory should be located at the entrance cloakroom or hanging devices, personal clothing and lab coats can be placed separately.
6.1.4 Laboratory walls, ceilings and floors should be easy to clean, impervious, corrosion and chemical sterilization agent. Floors should be smooth,
Non-slip, not carpeted.
6.1.5 Laboratory Taiwan cabinet and seats should be firm, corners should be smooth.
6.1.6 Laboratory Taiwan cabinet, etc., and its place should be easy to clean, test table should be waterproof, corrosion-resistant, heat-resistant and strong.
6.1.7 The laboratory shall have sufficient space station and placed in cabinets and other laboratory equipment and supplies.
6.1.8 should be based on the nature of work and processes arrange the laboratory equipment, the Taiwan cabinet, articles, etc., to avoid mutual interference, cross-contamination and should wish
Hinder escape and first aid.
6.1.9 The laboratory can use natural ventilation. If the use of mechanical ventilation, avoid cross-contamination.
6.1.10 If you have windows that can be opened, should be installed anti-mosquito screens.
6.1.11 The laboratory shall avoid unnecessary internal reflections and glare.
6.1.12 If the operation of irritation or corrosive substances should be 30m equipped with an eyewash, as necessary, provided emergency sprinklers.
6.1.13 If the operation of toxic, irritating, volatile radioactive substances should be based on risk assessment, with appropriate negative pressure ventilation cabinet.
6.1.14 The use of highly toxic, radioactive and other substances, should be equipped with appropriate safety facilities, equipment and personal protective equipment shall comply with national,
Party relevant regulations and requirements.
6.1.15 The use of high-pressure gas and combustible gases, there should be safety measures should be consistent with national, local regulations and requirements.
6.1.16 shall be provided for emergency lighting devices.
6.1.17 should have sufficient power supply.
6.1.18 fixed power outlet should be sufficient to avoid multiple devices using a common power outlet. Should be reliable grounding system should be shut
Key node installation leakage protection device or monitoring and alarm device.
6.1.19 Water Supply and Sewerage System should not leak, the water should have backflow prevention design.
6.1.20 shall apply with emergency equipment such as fire-fighting equipment, accident handling equipment, first aid equipment.
6.1.21 shall be equipped with suitable communications equipment.
6.1.22 when necessary, should be equipped with proper sterilization equipment.
6.2 BSL-2 laboratory
6.2.1 When applicable, shall comply with the requirements of 6.1.
6.2.2 The laborat...
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