This document specifies the classification, requirements, test methods, labels, markings, inspection rules, accompanying documents, packaging, transportation, and storage of biological safety cabinets.
This document is applicable to biological safety cabinets.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
GB/T 16273.1 Graphical symbols for use on equipment - Part 1: Common symbols
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
biological safety cabinet; BSC
negative pressure filter exhaust cabinet intended to prevent the operator and the environment from being exposed to the biological aerosol generated during the test
3.2
biological agents
biologically active substances such as animals, plants, microorganisms, and biotoxins
3.3
biohazard
direct or potential hazard caused by biological agents
3.4
cross contamination
unexpected entry of substances outside the target object into the target object
3.5
product protection
process of preventing airborne contaminants from entering the biological safety cabinet through the front access opening
3.6
working area
area from one side to the other, from the rear side to the inside of the front access glass, from the high efficiency particulate air filter or the disperse cover to the work surface in the biological safety cabinet
3.7
operating area
area for users to operate in the working area of the biological safety cabinet, which is defined by the manufacturer of the biological safety cabinet according to the requirements for personnel, products, and cross contamination protection
3.8
high efficiency particulate air filter; HEPA
disposable dry-type filter with extended/creased media with the following characteristics:
——The rigid shell wraps all the creased filter materials;
——For particles with a diameter of 0.3 μm [such as monodisperse dioctyl phthalate (DOP) smoke particles or equivalent particles generated by the heating method], the filtration efficiency is not less than 99.99%;
——When the clean filter operates at the rated flow rate, the maximum pressure drop is not more than 250 Pa;
——When a polydisperse aerosol with a median size of 0.7 μm and a geometric standard deviation of 2.4 is used for the scanning test, the penetration shall not exceed 0.01%.
3.9
downflow air
airflow from the upper part of the biological safety cabinet, filtered by the high efficiency air filter and flowing vertically downward to the working area
3.10
inflow air
airflow entering into the biological safety cabinet from the front access opening of the biological safety cabinet
3.11
nominal set point velocities
downflow air and inflow air velocity of the biological safety cabinet set by the manufacturer under normal working conditions
3.12
front access opening height
opening distance for air inflow after the front access opening is opened
4 Classification
4.1 General
Biological safety cabinets are divided into three classes: Class I, Class II, and Class III according to the airflow and the design structure of the isolation barrier.
4.2 Class I BSC
Class I BSC refers to a biological safety cabinet with the front access opening. The operator can operate in the operating area through the front access opening to protect people and the environment. The negative pressure airflow sucked inward from the front access opening is used to protect the safety of personnel; the exhaust air is filtered by the HEPA to protect the environment from contamination.
4.3 Class II BSC
Class II BSC refers to a biological safety cabinet with the front access opening. The operator can operate in the operating area through the front access opening to protect personnel, products, and the environment during operation. The negative pressure airflow sucked inward from the front access opening is used to protect the safety of personnel; the vertical airflow filtered by the HEPA is used to protect the test sample; the airflow is filtered by the HEPA and discharged to protect the environment from contamination. Class II BSC can be classified into four types: A1, A2, B1, and B2, based on the proportion of exhaust airflow to the total system flow rate and internal design structure.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Classification 5 Requirements 6 Test methods 7 Labeling and marking 8 Inspection rules 9 Accompanying documents 10 Packaging, transportation and storage Annex A (Normative) Preparation of Bacillus subtilis spore suspension Annex B (Normative) Selection and calibration of sprayers Annex C (Normative) Potassium iodide method Annex D (Normative) Measurement of air volume in circular and rectangular ducts Bibliography
