1. Scope
This standard outlines the definition of biological safety cabinets, their classification and naming conventions, technical specifications, testing procedures, inspection criteria, labeling requirements, as well as packaging, transportation, and storage guidelines. It is designed to ensure the safe and effective use of these cabinets in various scientific and medical applications.
The standard applies to the design, manufacturing, and testing of biological safety cabinets used in microbiology, biomedicine, animal experimentation, genetic engineering, and the production of biological products. It provides a comprehensive framework for ensuring that these cabinets meet essential safety and performance standards.
2. Normative References
The following documents are referenced within this standard and form an integral part of its requirements. For documents with a specific date, only the edition cited applies. Subsequent amendments or revisions to these documents do not apply unless explicitly stated. However, it is recommended that users review the latest versions of these documents to ensure compliance with current practices. For documents without a specified date, the most recent edition applies.
GB 191 - Packaging, Storage, and Transportation Symbols
GB/T 1184 - Shape and Position Tolerances (Without Specified Tolerance Values)
GB/T 13554 - High-Efficiency Air Filters
GBJ 71 - Specifications for Construction and Acceptance of Clean Rooms
3. Terms and Definitions
The following terms and definitions are applicable to this standard:
3.1 Biological Safety Cabinet
A type of cabinet designed to protect the operator, the environment, and the product by controlling the airflow and filtering out harmful airborne particles. It prevents the release of potentially hazardous bioaerosols during operation.
3.2 Biohazard
A risk or danger posed by biological agents such as microorganisms, viruses, or other biological materials that can cause harm to humans, animals, plants, or the environment.
3.3 Biohazard Levels
3.3.1 Hazard Class I / Biohazard Level I
These agents pose a low risk to healthy individuals and are not known to cause serious illness. They are typically non-pathogenic or have low virulence and are unlikely to spread between people or animals.
3.3.2 Hazard Class II / Biohazard Level II
These agents present a moderate risk to individuals but limited risk to the general population. They may cause disease in healthy individuals, but there are usually effective methods of prevention and treatment available.
3.3.3 Hazard Class III / Biohazard Level III
These agents are highly dangerous and can cause severe or fatal diseases through direct contact or aerosol transmission. They pose a high risk to individuals but a lower risk to groups. Effective preventive and therapeutic measures are generally available, though strict control measures are required.
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