1 Scope
This standard specifies terms and definitions, classification and marking, materials, requirements, test methods, inspection rules as well as sign, packaging, transport and storage of exhaust high efficiency filtration units.
This standard is applicable to exhaust high efficiency filtration units used to remove harmful bio-aerosol from Biosafety Level 3 or higher facilities. Reference may be made to this standard for the exhaust high efficiency filtration units for similar purposes.
This standard is not applicable to exhaust high efficiency filtration units for removing radioactive aerosol.
2 Normative references
The following referenced documents are indispensable for the application 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/T 6165 Test method of the performance of high efficiency particulate air filter - Efficiency and resistance
GB/T 13554 High efficiency particulate air filter
GB 18457 Stainless steel needle tubing for manufacture of medical devices
GB 19489 Laboratories - General requirements for biosafety
GB 50346 Architectural and technical code for biosafety laboratories
GB 50591 Code for construction and acceptance of cleanroom
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
exhaust high efficiency filtration units
filtration unit used in specific biorisk environment to remove harmful bio-aerosol in exhaust, which has the functions of in-situ disinfection and leak detection
3.2
aerosol
relatively stable dispersion system formed by solid or liquid fine particles which, with a particle size of 0.001 μm to 100 μm, suspend in gaseous medium
[GB 19489-2008, Definition 2.1]
3.3
bio-aerosol
aerosol containing biological factor
3.4
high efficiency particulate air filter
air filter used for air filtration and conforming to GB 13554
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and marking
5 Materials
6 Requirements
7 Test methods
8 Inspection rules
9 Sign, packaging, transport and storage
Annex A (Normative) Tightness detection method
Annex B (Informative) Alternating pressure tightness detection method
Annex C (Normative) Method for aerosol concentration uniformity test
