6.1.2022
2B352
EN
Official Journal of the European Union
L 3/105
f.
2. (continued) c.
Means to safely manipulate items in the workspace; d.
Supply and exhaust air to and from the workspace is HEPA filtered; Note 1: 2B352.f.2. includes Class III biosafety cabinets, as described in the latest edition of the WHO Laboratory Biosafety Manual or constructed in accordance with national standards, regulations or guidance.
Note 2: 2B352.f.2. includes any isolator meeting all of the above mentioned characteristics, regardless of its intended use and its designation.
Note 3: 2B352.f.2. does not include isolators specially designed for barrier nursing or transportation of infected patients. g.
Aerosol inhalation equipment designed for aerosol challenge testing with "microorganisms", viruses or "toxins" as follows: 1.
Whole-body exposure chambers having a capacity of 1 m3 or more; 2.
Nose-only exposure apparatus utilising directed aerosol flow and having capacity for exposure of any of the following: a. 12 or more rodents; or b.
2 or more animals other than rodents; 3.
Closed animal restraint tubes designed for use with nose-only exposure apparatus utilising directed aerosol flow; h.
Spray drying equipment capable of drying toxins or pathogenic "microorganisms" having all of the following: 1.
A water evaporation capacity of ≥ 0,4 kg/h and ≤ 400 kg/h; 2.
The ability to generate a typical mean product particle size of ≤10 μm with existing fittings or by minimal modification of the spray-dryer with atomisation nozzles enabling generation of the required particle size; and 3.
Capable of being sterilised or disinfected in situ; i.
Nucleic acid assemblers and synthesisers, which are partly or entirely automated, and designed to generate continuous nucleic acids greater than 1,5 kilobases in length with error rates less than 5 % in a single run.
2C
Materials None.
2D
Software
2D001
"Software", other than that specified in 2D002, as follows: a.
"Software" specially designed or modified for the "development" or "production" of equipment specified in 2A001 or 2B001 to 2B009 b.
"Software" specially designed or modified for the "use" of equipment specified in 2A001.c., 2B001 or 2B003 to 2B009.
Note: 2D001 does not control part programming "software" that generates "numerical control" codes for machining various parts.