For silent bearings, see the list of war materials.
2A001 - The following anti-friction bearings and bearing systems and their components:
NB:
SEE ALSO PARAGRAPH 2A101.
Note:
Paragraph 2A001 does not control balls with manufacturer-specified tolerances classified as ISO3290 Class 5 or lower.
a.
ball bearings or solid roller bearings, having all tolerances specified by the manufacturer classified at least in tolerance class 4 of ISO492 (or national equivalents), and having rings as well as rotating elements (ISO5593) made of metal monel or beryllium;
Note:
2A001.a. does not control tapered roller bearings.
b.
Not used;
c.
active magnetic bearing systems using any of the following:
1.
materials with flux densities of 2.0T or more and yield strengths greater than 414MPa;
2.
fully electromagnetic three-dimensional homopolar polarizers for actuators; Or
3.
high temperature position sensors [450K (177°C) or more].
2A101 - Radial ball bearings, other than those specified in paragraph 2A001, having all tolerances specified by the manufacturer at least classified according to ISO492 in tolerance class 2 (or tolerance class ABEC-9 of ANSI/ ABMA Std 20, or other national equivalents) and having all of the following characteristics:
a.
inner ring with a bore diameter between 12 and 50mm;
b.
outer ring with an external diameter between 25 and 100mm; And
c.
width between 10 and 20mm.
2A225 - Crucibles made of materials resistant to liquid actinide metals, as follows:
a.
crucibles having the following two characteristics:
1.
a volume between 150cm 3 and 8000cm 3 ; And
2.
Made of or coated with any of the following materials, or a combination of these materials, having an overall impurity level equal to or greater than 2% by weight:
crucibles having the following two characteristics:
1.
a volume between 50cm 3 and 2000cm 3 ; And
2.
made of or internally coated with tantalum of 99.9% purity or greater by weight;
c.
crucibles having all of the following characteristics:
1.
a volume between 50cm 3 and 2000cm 3 ;
2.
made of or internally coated with tantalum of 98% purity or greater by weight; And
3.
covered with a layer of tantalum carbide, nitride or boride, or any combination of these three substances.
2A226 - Valves and valves having the following characteristics:
a.
a 'nominal size' equal to or greater than 5mm;
b.
fitted with a bellows shutter; And
c.
made entirely of or internally coated with a layer of aluminum, aluminum alloy, nickel or nickel alloy containing more than 60% nickel by weight.
Technical note:
For valves of different inlet and outlet diameters, 'nominal size' in paragraph 2A226 means the smallest diameter.
2 B - Testing, inspection and production equipment
Technical notes:
1.
Parallel secondary contouring axes, for example a w axis on horizontal boring machines or a secondary rotation axis whose reference axis is parallel to that of the main rotation axis, are not counted in the total number of axes contouring. The axes of rotation do not necessarily have to rotate 360°. An axis of rotation can be driven by a linear device (for example a screw or a rack).
2.
For the purposes of subcategory 2B, the number of axes that can be coordinated simultaneously for "contouring control" is the number of axes along or around which, during the processing of the workpiece, movements take place simultaneous and correlated between the machined part and a tool. It does not include other axes along or around which other relative movements within the machine are made. These axes are in particular:
a.
dressing systems in grinding machines;
b.
parallel rotary axes designed for mounting multiple workpieces;
c.
collinear rotary axes designed to manipulate the same workpiece by holding it in a chuck at different ends.
3.
Axis nomenclature complies with ISO841:2001 (Industrial automation systems and integration — Numerical machine control — Coordinate system and motion nomenclature).
4.
For the purposes of paragraphs 2B001 to 2B009, a “tilting spindle” is considered to be an axis of rotation.
5.
The 'guaranteed one-way positioning repeatability' can be used for each machine tool model in place of individual test protocols. It is determined as follows:
a.
select five machines of a model to evaluate;
b.
measure the repeatability of a linear axis (R↑, R↓) according to ISO230-2:2014 and evaluate the “unidirectional positioning repeatability” of each axis of each of the five machines;
c.
determine the arithmetic average of the “unidirectional positioning repeatability” values of each axis of the five machines. These arithmetic averages of “unidirectional positioning repeatability” (
)
become the guaranteed value of each axis of the model (
, , …);
d.
as the category 2 list refers to each linear axis, there will be as many values of 'guaranteed unidirectional positioning repeatability' as there are linear axes;
e.
if any axis of a machine model not covered by 2B001.a. at 2B001.c. has a 'guaranteed one-way positioning repeatability' equal to or less than that of each machine tool model plus 0.7μm, the manufacturer should be required to reaffirm the accuracy level every eighteen months.
6.
For the purposes of 2B001.a. in 2B001.c., the measurement uncertainty for the “unidirectional positioning repeatability” of machine tools, as defined by international standard ISO230-2:2014 or equivalent national standards, shall not be taken into account .
7.
For the purposes of 2B001.a. to 2B001.c., the measurement of the axes is carried out in accordance with the test procedure provided for in paragraph 5.3.2 of standard ISO230-2:2014. Tests involving axes with a length greater than 2 meters are carried out on segments of 2 meters. Axes longer than 4 meters require several tests (two tests for axes whose length is greater than 4 meters and does not exceed 8 meters, three tests for axes whose length is greater than 8 meters and does not exceed 12 meters, etc.), each covering segments of 2 meters, distributed at regular intervals over the entire length of the axis. The segments tested are evenly spaced over the total length of the axle, with any excess length distributed equally at the beginning, middle and end of the segments tested. The lowest value of “one-way positioning repeatability” obtained for all segments tested is the value to be reported.
2B001 - Machine tools and any combination thereof, for the removal (or cutting) of metals, ceramics or "composite" materials which may, in accordance with the manufacturer's technical specifications, be equipped with electronic devices for "numerical control ", as following:
NB:
SEE ALSO 2B201.
Note 1: Paragraph 2B001 does not control special machine tools limited to the manufacture of gears. For these machines, see paragraph 2B003.
Note 2: Paragraph 2B001 does not control special machine tools limited to the manufacture of any of the following components:
a.
crankshafts or camshafts;
b.
cutting tools or tools;
c.
extruder worms;
d.
engraved or faceted pieces of jewelry; Or
e.
dental prosthesis.
Note 3: A machine tool having at least two of the following three properties: turning, milling or grinding (for example: a turning machine capable of milling), must be assessed against each relevant subparagraph 2B001 .a., b. or c.
NB:
For optical finishing machines, see paragraph 2B002.
a.
Turning machine tools having two or more axes which can be coordinated simultaneously for “contouring control”, having any of the following characteristics:
1.
“unidirectional positioning repeatability” equal to or less (better) than 0.9μm along one or more linear axes with a travel length less than 1.0m; Or
2.
“unidirectional positioning repeatability” equal to or less (better) than 1.1μm along one or more linear axes with a travel length equal to or greater than 1.0m;
Note 1:
Paragraph 2B001.a. does not control turning machines specially designed for the production of contact lenses having all of the following characteristics:
a.
machine controller limited to the use of ophthalmic software for partial programming of data entry; And
b.
no suction device.
Note 2:
Paragraph 2B001.a. does not apply to bar lathes (Swissturn) which only machine bars in a row if the maximum diameter of the bars is equal to or less than 42 mm and if it is not possible to mount chucks. The machines can be capable of drilling and milling parts with a diameter of less than 42 mm.
b.
milling machine tools, having any of the following characteristics:
1.
having three linear axes and one rotation axis which can be coordinated simultaneously for "contouring control", having any of the following characteristics:
a.
“unidirectional positioning repeatability” equal to or less (better) than 0.9μm along one or more linear axes with a travel length less than 1.0m; Or
b.
“unidirectional positioning repeatability” equal to or less (better) than 1.1μm along one or more linear axes with a travel length equal to or greater than 1.0m;
2.
having five or more axes capable of being coordinated simultaneously for “contouring control” having any of the following characteristics;
NB:
“Parallel mechanism machine tools” are defined in 2B001b.2.d.
a.
“unidirectional positioning repeatability” equal to or less (better) than 0.9μm along one or more linear axes with a travel length less than 1.0m;
b.
“unidirectional positioning repeatability” equal to or less (better) than 1.4μm along one or more linear axes with a travel length equal to or greater than 1m and less than 4m;
c.
“unidirectional positioning repeatability” equal to or less (better) than 6.0μm along one or more linear axes with a travel length equal to or greater than 4m; Or
d.
being a “parallel mechanism machine tool”;
Technical note:
A parallel mechanism machine tool is a machine tool with multiple bars connected to a platform and actuators; each actuator operates the corresponding bar simultaneously and independently.
3.
“unidirectional positioning repeatability” for pointing machines equal to or less (better) than 1.1μm along one or more linear axes; Or
4.
handwheel trimming machines, having all of the following characteristics:
a.
Spindle “runout” and “runout” less than (better) than 0.0004mm, full needle reading (TIR); And
b.
angular deviation of carriage movement (yaw, roll and pitch) less than (better) than 2 arc seconds, full needle reading (TIR), over 300mm of travel;
c.
grinding machine tools, having any of the following characteristics:
1.
having all of the following characteristics:
a.
“unidirectional positioning repeatability” equal to or less (better) than 1.1μm along one or more linear axes; And
b.
three or more axes can be coordinated simultaneously for “contouring control”; Or
2.
having five or more axes capable of being coordinated simultaneously for “contouring control” having any of the following characteristics;
a.
“unidirectional positioning repeatability” equal to or less (better) than 1.1μm along one or more linear axes with a travel length less than 1m;
b.
“unidirectional positioning repeatability” equal to or less (better) than 1.4μm along one or more linear axes with a travel length equal to or greater than 1m and less than 4m; Or
c.
“unidirectional positioning repeatability” equal to or less (better) than 6.0μm along one or more linear axes with a travel length equal to or greater than 4m.
Note:
Paragraph 2B001.c. does not control the following grinding machines:
a.
machines for external, internal, or external and internal grinding of cylinders, having all of the following characteristics:
1.
limited to cylindrical grinding; And
2.
limited to a maximum dimension or external diameter of machinable parts of 150mm;
b.
machines specially designed as pointing machines having no z-axis or w-axis, having a “unidirectional positioning repeatability” equal to or less (better) than 1.1μm.
c.
flat surface grinding machines.
d.
non-wire electric discharge machines having two or more axes of rotation capable of being coordinated simultaneously for “contouring control”;
e.
machine tools for the removal of metals, ceramics or “composite” materials, having all of the following characteristics:
1.
removal of material by any of the following processes:
a.
jets of water or other liquids, including those using abrasive additives;
b.
electrons; Or
c.
“laser” beams; And
2.
at least two axes of rotation having all of the following characteristics:
a.
be able to be coordinated simultaneously for “contouring control”; And
b.
positioning accuracy less than (better) than 0.003°;
f.
deep hole drilling machines and turning machines modified for deep hole drilling, having a maximum bore depth capacity greater than 5m.
2B002 – CNC optical finishing machine tools, equipped for selective abrasion to produce non-spherical optical surfaces and having all of the following characteristics:
a.
shape finish less than (better) than 1.0 μm;
b.
finish roughness less than (better than) 100 nm RMS;
c.
four or more axes that can be coordinated simultaneously for “contouring control”; And
d.
using one of the following techniques:
1.
'magnetorheological finish';
2.
'electrorheological finish';
3.
'energetic particle beam finishing';
4.
'expanding membrane finish'; Or
5.
'fluid jet finishing'.
Technical notes:
For the purposes of paragraph 2B002:
1.
The 'magnetorheological finishing' technique is an abrasion technique using a magnetic abrasive fluid whose viscosity is controlled by a magnetic field.
2.
The 'electrorheological finishing' technique is an abrasion technique using an abrasive fluid whose viscosity is controlled by an electric field.
3.
The 'energetic particle beam finishing' technique involves using reactive atomic plasmas or ion beams to perform selective abrasion.
4.
The 'expanding membrane finishing' technique is a technique using a pressurized membrane which deforms to contact the workpiece over a small area.
5.
The 'fluid jet finishing' technique uses a fluid stream for abrasion.
2B003 - “Numerically controlled” or hand-operated machine tools and specially designed components, controls and accessories therefor, specially designed for shaving, finishing, grinding or lapping hardened spur, helical and double helical gears (R c = 40 or greater), having a pitch circle diameter greater than 1250mm and a tooth width of 15% or more of the pitch circle diameter, finished to a grade of AGMA 14 or better (equivalent to ISO1328 class 3).
2B004 - Hot “isostatic presses”, having all of the following characteristics, and specially designed components and accessories therefor:
NB:
SEE ALSO 2B104 and 2B204.
a.
comprising a controlled thermal environment in the enclosed cavity and having a working cavity of an internal diameter equal to or greater than 406mm; And
b.
having one of the following characteristics:
1.
a maximum working pressure above 207MPa;
2.
a controlled thermal environment greater than 1773K (1500°C); Or
3.
a capacity for impregnation with hydrocarbons and elimination of the resulting gaseous decomposition products.
Technical note:
Working cavity dimension means the inner diameter of the working cavity of the press in which the working temperature and pressure are realized and does not include mounting devices. This dimension will designate, depending on which of the two chambers contains the other, either the internal diameter of the high pressure chamber, or the internal diameter of the chamber isolated from the oven, the value taken into consideration being the smallest.
NB:
For specially designed dies, molds and tools, see 1B003, 9B009 and the War Material Lists.
2B005 - Equipment specially designed for the deposition, processing and in-process control of coatings, coatings and modifications of inorganic surfaces, as follows, for non-electronic substrates, by processes mentioned in the table following paragraph 2E003 .f. and in associated notes, their specially designed automated handling, placement, manipulation and control components:
a.
production equipment for chemical vapor deposition (CVD), having all of the following characteristics:
NB:
SEE ALSO 2B105.
1.
a process modified by one of the following techniques:
a.
vapor deposition by pulsating chemical process
b.
controlled nucleation thermal deposition (CNTD); Or
c.
plasma-assisted or plasma-enhanced chemical vapor deposition; And
2.
having one of the following characteristics:
a.
rotating seals under high vacuum (less than or equal to 0.01Pa); Or
b.
device for controlling the thickness of the coating in situ;
b.
production equipment for ion implantation, having beam currents of 5mA or more;
c.
production equipment for electron beam physical vapor deposition (EB-PVD), comprising power systems of more than 80kW and having any of the following characteristics:
1.
a “laser” liquid bath level control system, which precisely adjusts the ingot feed rate; Or
2.
a computer-controlled rate monitoring device, operating on the principle of photoluminescence of ionized atoms in the evaporating flow, for controlling the rate of deposition of a coating containing two or more elements;
d.
production equipment for plasma spraying, having any of the following characteristics:
1.
operation under controlled atmosphere at reduced pressure (less than or equal to 10kPa, measured 300mm above the spray gun outlet) in a vacuum chamber capable of evacuating air down to 0.01Pa before the spraying process spray; Or
2.
device for controlling the thickness of the coating in situ;
e.
production equipment for sputter deposition capable of having current densities equal to or greater than 0.1mA/mm 2 at a deposition rate equal to or greater than 15 μm/hour;
f.
production equipment for cathodic arc deposition, comprising a grid of electromagnets for controlling the direction of the arc spot at the cathode;
g.
production equipment for ion plating allowing in situ measurement of any of the following characteristics:
1.
coating thickness on substrate and flow control; Or
2.
optical characteristics.
Note:
Paragraph 2B005 does not control equipment for chemical vapor deposition, for cathodic arc deposition, for sputter deposition, for ion plating or for ion implantation, specially designed for cutting or machining
.
2B006 - Dimensional control or measuring systems, equipment and “electronic assemblies” as follows:
a.
computer-controlled or “numerically controlled” coordinate measuring machines (CMM), having, at any point within the operating range of the machine (i.e. within the length of the axes ), a maximum allowable error of length measurement (E 0,MPE ) in three dimensions (volumetric) equal to or less than (better) (1.7 + L/1000) μm (L representing the measured length, expressed in mm), in accordance with ISO10360-2:2009;
Technical note:
The E 0,MPE of the most accurate configuration of the CMM specified by the manufacturer (e.g., best of the following: probe, stylus length, motion parameters, environment), “with all available corrections” , must be compared to the threshold of 1.7+L/1000μm.
NB:
SEE ALSO 2B206.
b.
linear and angular displacement measuring instruments, as follows:
1.
'linear displacement' measuring instruments having any of the following characteristics:
Note:
Interferometers and optical encoder displacement measurement systems containing a “laser” are only controlled in 2B006.b.1.c and 2B206.c.
Technical note:
For purposes of paragraph 2B006.b.1. 'Linear displacement' means the change in distance between the measuring probe and the measured object.
a.
non-contact type measuring systems, having a “resolution” equal to or less (better) than 0.2μm in a measuring range equal to or less than 0.2mm;
b.
sLinear displacement measuring systems or instruments, linear position feedback units and "electronic assemblies" as follows:
Note:
Interferometers and optical encoder measuring systems containing a "laser" are only specified in 2B006.b.3 and 2B206.c.
1.
'non-contact type measuring systems', having a "resolution" equal to or less (better) than 0.2 μm in a measuring range equal to or less than 0.2 mm;
Technical note:
For the purposes of 2B006.b.1, 'non-contact type measuring systems' are designed to measure the distance between the probe and the measured object along a single vector, when the probe or the The measured object is moving.
2.
Linear position feedback units specially designed for machine tools and having an overall "accuracy" less (better) than [800 + (600 × L/1000)] nm (L being the actual length expressed in mm);
3.
measuring systems having all of the following characteristics:
a.
containing a "laser";
b.
having a full-scale "resolution" of 0.200 nm or less (best); And
c.
capable of achieving a "measurement uncertainty" equal to or less (better) than (1.6 + L/2000) nm (L representing the measured length, expressed in mm) at any point within the measurement range, when compensated for the refractive index of air, the measurement being carried out over a period of 30 seconds, at a temperature of 20±0.01 °C; Or
4.
"electronic assemblies" specially designed to provide feedback capability in systems specified in 2B006.b.3.;
c.
rotary position feedback units specially designed for machine tools or angular displacement measuring instruments, having an angular positioning "accuracy" equal to or less (better) than 0.9 arc seconds;
Note:
Paragraph 2B006.c. does not control optical instruments such as autocollimators using collimated light (for example, "laser" light) to detect the angular displacement of a mirror.
d.
equipment intended to measure surface roughness (including surface defects), by measuring optical dispersion, with a sensitivity equal to or less (better) than 0.5 nm.
Note:
Paragraph 2B006 includes machine tools, other than those listed in paragraph 2B001, that may serve as measuring machines if they meet or exceed the criteria established for the function of measuring machines
2B007 - “Robots” having any of the following characteristics and their specially designed control units and “end effectors”:
NB:
SEE ALSO 2B207.
a. Not used
b.
specially designed to meet national safety standards for potentially explosive weapons environments;
Note:
Paragraph 2B007.b does not control "robots" specially designed for spray painting booths.
c.
specially designed or radiation-hardened to withstand a total radiation dose of more than 5×10 3 Gy(silicon) without their operation being impaired; Or
Technical note:
The term Gy (silicon) refers to the energy in Joules per kilogram absorbed by an unshielded silicon sample when exposed to ionizing radiation.
d.
specially designed to operate at altitudes above 30,000m.
2B008 - 'Tilting rotary tables' and "tilting spindles" specially designed for machine tools, as follows :
a.
Not used
b.
Not used
c.
'tilting rotary tables' having all of the following characteristics:
1.
designed for turning, milling or grinding machine tools; And
2.
having two axes of rotation designed to be coordinated simultaneously for "contouring control";
Technical note:
A 'tilting rotary table' is a table that allows the workpiece to rotate and pivot around two non-parallel axes
d.
tilting pins" having all of the following characteristics:
1.
designed for turning, milling or grinding machine tools; And
2.
designed to be coordinated simultaneously for “contouring control”;
2B009 - Centrifugal turning machines and flow forming machines which, in accordance with the manufacturer's technical specifications, may be equipped with "numerical control" units or computer control and having all of the following characteristics:
NB:
SEE ALSO 2B109 AND 2B209.
a.
three or more axes can be coordinated simultaneously for “contouring control”; And
b.
a rolling force of more than 60kN.
Technical note:
For the purposes of paragraph 2B009, machines combining the functions of centrifugal turning and flow forming are considered to be flow forming machines.
2B104 - “Isostatic presses”, other than those specified in paragraph 2B004, having all of the following characteristics:
NB:
SEE ALSO 2B204.
a.
maximum working pressure equal to or greater than 69 MPa;
b.
designed to achieve and maintain a controlled thermal environment of 873K (600°C) or higher; And
c.
a chamber with a diameter equal to or greater than 254mm.
2B105 - Chemical vapor deposition (CVD) ovens, other than those specified in 2B005.a, designed or modified for the densification of carbon-carbon composite materials.
2B109 - Flow forming machines, other than those specified in 2B009, and specially designed components therefor, as follows:
NB:
SEE ALSO 2B209.
a.
flow forming machines having all of the following characteristics:
1.
capable, in accordance with the manufacturer's technical specifications, of being fitted with "digital control" units or computer control, even if not originally fitted; And
2.
having more than two axes that can be coordinated simultaneously for “contouring control”;
b.
components specially designed for flow forming machines specified in 2B009 or 2B109.a.
Technical note:
For the purposes of paragraph 2B109, machines combining the functions of centrifugal turning and flow forming are considered to be flow forming machines.
2B116 – Vibration testing systems, equipment and components, as follows:
a.
Vibration testing systems using closed-loop feedback or servo control techniques and including digital control, capable of vibrating a system at 10gRMS or greater between 20Hz and 2kHz while transmitting forces equal to or greater than 50kN, measured 'bare table';
b.
digital controls, associated with specially designed vibration testing software, with a 'real-time control bandwidth' greater than 5 kHz designed for use with vibration testing systems specified in 2B116.a;
Technical note:
In 2B116.b, 'real-time control bandwidth' is the maximum rate at which a control can perform complete cycles of sampling, data processing, and transmission of control signals.
c.
vibrating pots, with or without associated amplifiers, capable of transmitting a force equal to or greater than 50kN, measured "bare table", and usable in the vibration test systems specified in paragraph 2B116.a;
d.
support structures for the parts to be tested and electronic equipment designed to combine several vibrating pots into a complete vibrating system capable of providing an effective combined force equal to or greater than 50kN, measured 'bare table', usable in the vibration test systems referred to in paragraph 2B116.a.
Technical note:
In paragraph 2B116, the term 'bare table' means a flat table or surface without fixtures or equipment.
2B117 - Controls for equipment and processes, other than those specified in 2B004, 2B005.a, 2B104 or 2B105, designed or modified for the densification and pyrolysis of composite parts of rocket nozzles and noses return vehicles e.
2B119 - Balancing machines and related equipment, as follows:
NB:
SEE ALSO 2B219.
a.
balancing machines having all of the following characteristics:
1.
not being able to balance rotors/assemblies with a mass greater than 3kg;
2.
capable of balancing rotors/assemblies at speeds above 12500 rpm;
3.
capable of making balancing corrections in two or more planes; And
4.
capable of balancing up to a residual unbalance of 0.2g×mm per kg of rotor mass;
Note:
Paragraph 2B119.a. does not control balancing machines designed or modified for dental or other medical equipment.
b.
indicator heads designed or modified for use with machines specified in 2B119.a.
Technical note:
Indicator heads are sometimes known as balancing instruments.
2B120 - Motion simulators or rotary tables having all of the following characteristics:
a.
two or more axes;
b.
designed or modified to incorporate slip rings or non-contact integrated devices capable of transmitting electrical power, information signals, or both; And
c.
having one of the following characteristics:
1.
for each axis having all of the following characteristics:
a.
capable of reaching rates of 400 degrees/s or more, or 30 degrees/s or less; And
b.
a rate resolution equal to or less than 6 degrees/s and an accuracy equal to or less than 0.6 degrees/s;
2.
having, in the worst case, a rate stability equal to or better than (less than) plus or minus 0.05%, averaged over 10 degrees or more; Or
3.
a positioning “accuracy” equal to or less (better than) 5 arcseconds.
Note 1:
Paragraph 2B120 does not control rotary tables designed or modified for machine tools or medical equipment. For controls of machine tool rotary tables, see paragraph 2B008.
Note 2:
Motion simulators or rotary tables listed in 2B120 remain covered whether or not they are equipped with slip rings or integrated non-contact devices at the time of export.
2B121 - Positioning tables (equipment capable of performing precise rotary positioning in any axis), other than those specified in 2B120, having all of the following characteristics:
a.
two or more axes; And
b.
a positioning “accuracy” equal to or less (better than) 5 arcseconds.
Note:
Paragraph 2B121 does not control rotary tables designed or modified for machine tools or medical equipment. For controls of machine tool rotary tables, see paragraph 2B008.
2B122 - Centrifuges capable of delivering accelerations greater than 100g and designed or modified to incorporate slip rings or non-contact integrated devices capable of transmitting electrical power, information signals, or both.
Note:
Centrifuges listed in paragraph 2B122 remain covered whether or not they are equipped with slip rings or integrated non-contact devices at the time of export.
2B201 - Machine tools and any combinations thereof, other than those specified in paragraph 2B001, as follows, for the removal or cutting of metals, ceramics or "composite" materials which may, in accordance with the manufacturer's technical specifications, be equipped with electronic devices for simultaneous “contouring control” on two or more axes:
Technical note:
Guaranteed positioning accuracy levels derived, in accordance with the procedures below, from measurements made according to ISO230-2:1988 ( 1 ) or equivalent national standards may be used for each machine tool model if provided to national authorities — and accepted by them — in place of individual test protocols. Determination of guaranteed positioning accuracy:
a.
select five machines of a model to evaluate;
b.
measure linear axis accuracies according to ISO230-2:1988 ( 1 ) ;
c.
determine the precision value (A) for each axis of each machine. The method for calculating the precision value is described in standard ISO230-2:1988 ( 1 ) ;
d.
determine the average of the precision value for each axis. The average becomes the guaranteed positioning accuracy of each axis for the model (Âx, Ây…);
e.
paragraph 2B201 referring to each linear axis, there will be as many guaranteed positioning accuracy values as there are linear axes;
f.
if any axis of a machine tool not covered by paragraphs 2B201.a., 2B201.b. or 2B201.c. has a guaranteed positioning accuracy equal to or less (better) than 6μm in the case of grinding machines and equal to or less than (better) than 8μm in the case of milling and turning machines, determined in both cases in accordance with ISO230-2:1988 ( 1 ) , the manufacturer should be required to reaffirm the level of accuracy every eighteen months.
a.
milling machine tools, having any of the following characteristics:
1.
positioning accuracies, “with all available corrections”, equal to or less (better) than 6μm along any linear axis according to ISO230-2:1988 ( 1 ) or equivalent national standards;
2.
two or more contouring rotation axes; Or
3.
having five or more axes that can be coordinated simultaneously for “contouring control”;
Note:
Paragraph 2B201.a. does not control milling machines having the following characteristics:
a.
a displacement of the X axis of more than 2m; And
b.
an overall positioning accuracy on the X axis greater than (worse) 30μm.
b.
Grinding machine tools, having any of the following characteristics:
1.
positioning accuracies, “with all available corrections”, equal to or less (better) than 4μm along any linear axis according to ISO 230-2:1988 ( 1 ) or equivalent national standards;
2.
two or more contouring rotation axes; Or
3.
having five or more axes that can be coordinated simultaneously for “contouring control”;
Note:
Paragraph 2B001.b. does not control the following grinding machines:
a.
machines for external, internal, or external and internal grinding of cylinders, having all of the following characteristics:
1.
limited to a maximum capacity of machinable parts of 150mm in dimension or external diameter; And
2.
axes limited to x, z and c;
b.
pointing machines without a z or w axis whose overall positioning accuracy is less (better) than 4 μm according to ISO230-2:1988 ( 2 ) or equivalent national standards.
c.
Turning machine tools having positioning accuracies, “with all available corrections”, less (better) than 6 μm along any of the linear axes (global positioning) according to ISO230-2:1988 ( 2 ) or equivalent national standards, for machines capable of machining diameters greater than 35mm;
Note:
Paragraph 2B201.c. does not apply to bar lathes (Swissturn) which only machine the bars in a row if the maximum diameter of the bars is equal to or less than 42mm and if it is not possible to mount chucks. The machines can be capable of drilling and milling parts with a diameter of less than 42mm.
Note 1:
Paragraph 2B201 does not control special machine tools limited to the manufacture of any of the following components:
a.
gears;
b.
crankshafts or camshafts;
c.
cutting tools or tools;
d.
extruder worms;
Note 2:
A machine tool having at least two of the following three properties: turning, milling or grinding (for example: a turning machine capable of milling), must be evaluated against each relevant paragraph 2B201.a. , b. or c.
Note 3:
Paragraphs 2B201a.3. and 2B201b.3. include machines based on a parallel linear kinematic design (e.g. hexapods) having five or more axes, none of which are rotary.
2B204 - “Isostatic presses”, other than those specified in paragraphs 2B004 or 2B104, and corresponding equipment, as follows:
a.
“isostatic presses” having the following two characteristics:
1.
capable of reaching a maximum working pressure equal to or greater than 69 MPa; And
2.
having a chamber with an internal diameter greater than 152mm;
b.
Mandrels, molds and controls specially designed for "isostatic presses" specified in 2B204.a.
Technical note:
In paragraph 2B204, the interior dimension of the chamber is that of the chamber in which the working pressure and temperature are obtained and does not include fasteners. This dimension will designate, depending on which of the two chambers contains the other, either the internal diameter of the high pressure chamber, or the internal diameter of the chamber isolated from the oven, the value taken into consideration being the smallest.
2B206 - Dimensional control machines, instruments or systems, other than those specified in paragraph 2B006, as follows:
a.
computer-controlled or numerically controlled coordinate measuring machines (CMM) having any of the following characteristics:
1.
having only two axes and a maximum allowable error of measuring length along any axis (one-dimensional) — any combination of E 0x,MPE , E 0y,MPE , or E 0z,MPE — equal to or less than (better than) (1.25+L/1000)μm (L representing the measured length, expressed in mm), at any point located within the operating range of the machine (i.e. within the length of the axes) , in accordance with ISO10360-2:2009; Or
2.
three or more axes and having a maximum allowable length measurement error (E 0,MPE ) equal to or less than (better) (1.7+L/800)μm (L representing the measured length, expressed in mm), in any point within the operating range of the machine (i.e. within the length of the axes), in accordance with ISO10360-2:2009;
Technical note:
The E 0,MPE of the most accurate configuration of the CMM specified in accordance with ISO10360-2:2009 by the manufacturer (for example, the best of the following: probe, stylus length, motion parameters, environment ), with all available corrections, must be compared to the threshold of 1.7 + L/800μm.
b.
systems for the simultaneous linear-angular verification of half-shells having the following two characteristics:
1.
“measurement uncertainty” on any linear axis equal to or less (better) than 3.5 μm per 5mm; And
2.
“angular positioning deviation” equal to or less (better) than 0.02°;
c.
'linear displacement' measuring instruments having all of the following characteristics:
Technical note:
For the purposes of 2B206.c., 'linear displacement' means the change in distance between the measuring probe and the measured object.
1.
containing a “laser”; And
2.
capable of maintaining, for at least 12 hours, at a temperature of ± 1°K compared to a normal temperature and at normal pressure, all of the following elements:
a.
a “resolution” for full scale of 0.1μm or better; And
b.
with a “measurement uncertainty” equal to or better than (less than) (0.2 + L/2000)μm (L representing the measured length expressed in mm).
Note:
Paragraph 2B206.c. does not apply to interferometric measuring systems, without open or closed loop feedback, including a laser to measure movement errors of machine tool carriages, dimensional control machines or similar equipment.
d.
linear variable differential transformer (LVDT) systems having the following two characteristics:
Technical note :
For the purposes of 2B206.c, 'linear displacement' means the change in distance between the measuring probe and the object being measured.
1.
having one of the following characteristics:
a.
"Linearity" equal to or less (better) than 0.1% measured from 0 to full operating range for LVDTs whose full operating range is equal to or less than 5 mm; Or
b.
"Linearity" equal to or less (better) than 0.1% measured from 0 to 5 mm for LVDTs with an operating range greater than 5 mm; And
2.
drift equal to or better than (less than) 0.1% per day at a reference ambient temperature of the test chamber ± 1 K (± 1 °C).
Note 1:
Machine tools that can be used as measuring machines are covered if they correspond to the criteria established for the function of machine tools or the function of measuring machines, or if they exceed these criteria.
Note 2:
A machine described in paragraph 2B206 is affected if it exceeds the control limit at any point within its operating range.
Technical notes:
All measurement values in paragraph 2B206 represent permitted positive or negative deviations from the prescribed value, i.e. not the entire range.
2B207 - “Robots”, “end effectors” and their control units, other than those specified in 2B007, as follows:
a.
“robots” or “end effectors” specially designed to meet national safety standards applicable to the handling of high explosives (e.g. meeting the specifications of the electricity coding for high explosives);
b.
control units specially designed for one of the “robots” or “end effectors” specified in 2B207.a.
2B209 - Flow-forming or centrifugal-turning machines capable of performing flow-forming functions, other than those specified in 2B009 or 2B109, and chucks, as follows :
a.
machines having the following two characteristics:
1.
having three or more rollers (active or guide); And
2.
capable, in accordance with the manufacturer's specifications, of being equipped with “digital control” or computer control units;
b.
turning chucks designed to turn cylindrical rotors with an internal diameter varying between 75 and 400mm.
Note:
Paragraph 2B209.a covers machines that have only one roller designed to deform the metal and two auxiliary rollers to retain the mandrel, but not directly involved in the deformation process.
2B219 - Multi-plane centrifugal balancing machines, fixed or movable, horizontal or vertical, as follows:
a.
centrifugal balancing machines designed to balance flexible rotors of length equal to or greater than 600mm and having all of the following characteristics:
1.
useful diameter or trunnion diameter greater than 75mm;
2.
mass capacity from 0.9 to 23kg; And
3.
capable of carrying out balancing at a rotation speed greater than 5000 rpm;
b.
centrifugal balancing machines designed to balance cylindrical, hollow rotor components having all of the following characteristics:
1.
trunnion diameter greater than 75mm;
2.
mass capacity from 0.9 to 23kg;
3.
capable of limiting residual imbalance to 0.01kg × mm/kg per plane or less; And
4.
be of the belt-operated type.
2B225 - Remote manipulators which can be used to act remotely in radiochemical separation operations or hot cells, having any of the following characteristics:
a.
the ability to penetrate a hot cell wall equal to or greater than 0.6m (wall penetration); Or
b.
the ability to cross the top of a hot cell wall with a thickness equal to or greater than 0.6m (wall crossing).
Technical note:
Remote joysticks transmit commands from the human driver to a remote operating arm and terminal device. They can be of the 'master/slave' type or controlled by a joystick or keyboard.
2B226 - Induction furnaces (vacuum or inert gas) under controlled atmosphere and their electrical power systems, as follows:
NB:
SEE ALSO 3B.
a.
ovens having all of the following characteristics:
1.
capable of operating above 1123K (850°C);
2.
having induction coils with a diameter of less than or equal to 600mm; And
designed for powers of 5kW or more;
Note:
Section 2B226.a. does not control ovens designed for processing semiconductor wafers.
b.
electrical power systems with a power of 5 kW or more, specially designed for ovens specified in 2B226.a.
2B227 - Vacuum melting and casting furnaces or other controlled environment furnaces for metallurgy and their related equipment, as follows:
a.
arc remelting and casting furnaces having the following two characteristics:
1.
capacity of consumable electrodes between 1000cm 3 and 20000cm 3 ; And
2.
capable of operating at melting temperatures above 1973 K (1700°C);
b.
electron beam melting furnaces and atomizing plasma melting furnaces having both of the following characteristics:
1.
power equal to or greater than 50kW; And
2.
capable of operating at melting temperatures above 1473 K (1200°C);
c.
computer control and monitoring systems specially developed for any of the furnaces specified in 2B227.a or 2B227.b;
d.
plasma torches specially designed for furnaces specified in 2B227.b having both of the following characteristics:
1.
operating at a power greater than 50 kW; And
2.
capable of operating at temperatures above 1473 K (1200°C);
e.
electron guns specially designed for furnaces specified in 2B227.b operating at a power greater than 50 kW.
2B228 - Equipment for manufacturing or assembling rotors, dressing equipment for rotors, mandrels and dies for forming bellows, as follows:
a.
rotor assembly equipment for assembling gas centrifuge rotor tube sections, baffles and caps;
Note:
2B228.a includes precision chucks, fasteners, and shrink-fit machines.
b.
rotor dressing equipment for aligning sections of gas centrifuge rotor tubes with respect to a common axis;
Technical note:
In 2B228.b, such equipment will normally include precision measuring sensors linked to a computer which then controls the action of pneumatic clamping devices (for example, to align sections of rotor tubes).
c.
Bellows forming mandrels and dies for the production of single convolution bellows.
Technical note:
In 2B228.c, bellows have all of the following characteristics:
1.
inner diameter between 75 and 400mm;
2.
length equal to or greater than 12.7mm;
3.
single convolution having a depth greater than 2mm; And
4.
made of high strength aluminum alloys, maraging steel or “fibrous or filamentary materials” having high strength.
2B230 - 'Pressure sensors' of any type capable of measuring absolute pressures and having all of the following characteristics:
a.
sensitive elements made of or coated with aluminum, aluminum alloy, aluminum oxide (alumina or sapphire), nickel or nickel alloy containing more than 60% nickel by weight, or polymers fully fluorinated hydrocarbons;
b.
seals, where applicable, essential to seal sensitive elements in direct contact with the process medium, made of or coated with aluminum, aluminum alloy, aluminum oxide (alumina or sapphire), nickel or nickel alloy containing more than 60% nickel by weight, or fully fluorinated hydrocarbon polymers; And
c.
having one of the following characteristics:
1.
a full scale less than 13 kPa and a 'precision' better than ± 1% (full scale); Or
2.
a full scale equal to or greater than 13 kPa and an 'accuracy' better than ±130Pa when measured at 13 kPa.
Technical notes:
1.
In paragraph 2B230, 'pressure sensor' means a device that converts pressure measurements into an electrical signal.
2.
For the purposes of 2B230, 'precision' includes non-linearity, hysteresis and repeatability at room temperature.
2B231 - Vacuum pumps having all of the following characteristics:
a.
an inlet neck equal to or greater than 380mm;
b.
a pumping capacity equal to or greater than 15 m 3 /s; And
c.
the ability to produce a final vacuum better than 13 mPa.
Technical notes:
1.
The pumping capacity is determined at the measuring point with nitrogen or air.
2.
The final vacuum is determined at the pump inlet with the pump inlet closed.
2B232 - High-velocity cannon systems (propelled, gas, coil, electromagnetic or electrothermal, and other advanced systems) capable of accelerating projectiles up to 1.5 km/s or more.
NB:
SEE ALSO LIST OF WAR MATERIALS.
2B233 - Bellows-sealing screw compressors and bellows-sealing screw vacuum pumps.
NB:
SEE ALSO 2B350.i.
a.
capable of providing an inlet flow of a volume equal to or greater than 50m 3 /h;
b.
capable of achieving a compression ratio equal to or greater than 2:1; And
c.
of which all surfaces coming into contact with the process gas consist of one of the following materials:
1.
aluminum or aluminum alloy;
2.
aluminum oxide;
3.
stainless steel;
4.
nickel or nickel alloy;
5.
phosphor bronze; Or
6.
fluoropolymers.
2B350 - Facilities, equipment and components for the production of chemical substances, as follows:
a.
reactors or reaction vessels, with or without agitators, with a total internal (geometric) volume greater than 0.1m 3 (100 litres) and less than 20m 3 (20,000 litres), in which all surfaces coming into direct contact with the chemical substances contained or to be produced consist of one of the following materials:
NB
For prefabricated repair kits, see 2B350.k.
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
2.
fluoropolymers (polymeric or elastomeric materials containing more than 35% by weight of fluorine);
3.
glass (including vitrified, enameled or glass coating);
4.
nickel or 'alloys' containing more than 40% by weight of nickel;
5.
tantalum or tantalum 'alloys';
6.
titanium or titanium 'alloys';
7.
zirconium or zirconium 'alloys'; Or
8.
niobium (columbium) or niobium 'alloys';
b.
agitators designed for use in reactors or reaction vessels specified in 2B350.a. and propellers, blades or rods designed for such agitators, in which all surfaces of the agitators coming into direct contact with the chemical substances contained or to be produced are made of one of the following materials:
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
2.
fluoropolymers (polymeric or elastomeric materials containing more than 35% by weight of fluorine);
3.
glass (including vitrified, enameled or glass coating);
4.
nickel or 'alloys' containing more than 40% by weight of nickel;
5.
tantalum or tantalum 'alloys';
6.
titanium or titanium 'alloys';
7.
zirconium or zirconium 'alloys'; Or
8.
niobium (columbium) or niobium 'alloys';
c.
tanks, tanks or receivers with a total internal (geometric) volume greater than 0.1m 3 (100 litres) in which all surfaces coming into direct contact with the chemical substances contained or to be produced are made of one of the following materials:
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
2.
fluoropolymers (polymeric or elastomeric materials containing more than 35% by weight of fluorine);
3.
glass (including vitrified, enameled or glass coating);
4.
nickel or 'alloys' containing more than 40% by weight of nickel;
5.
tantalum or tantalum 'alloys';
6.
titanium or titanium 'alloys';
7.
zirconium or zirconium 'alloys'; Or
8.
niobium (columbium) or niobium 'alloys';
d.
heat exchangers or condensers with a heat transfer surface area greater than 0.15m 2 and less than 20m 2 and pipes, plates, coils or blocks (cores) designed for such heat exchangers or condensers, in which all surfaces coming in direct contact with the chemical substances to be produced are made of one of the following materials:
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
2.
fluoropolymers (polymeric or elastomeric materials containing more than 35% by weight of fluorine);
3.
glass (including vitrified, enameled or glass coating);
4.
graphite or 'carbon graphite';
5.
nickel or 'alloys' containing more than 40% by weight of nickel;
6.
tantalum or tantalum 'alloys';
7.
titanium or titanium 'alloys';
8.
zirconium or zirconium 'alloys';
9.
silicon carbide;
10.
titanium carbide; Or
11.
niobium (columbium) or niobium 'alloys';
e.
distillation or absorption columns with an internal diameter greater than 0.1 meter and liquid distributors, vapor distributors or liquid collectors designed for these distillation or absorption columns, in which all surfaces coming into direct contact with the chemical substances to be produced consist of one of the following materials:
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
2.
fluoropolymers (polymeric or elastomeric materials containing more than 35% by weight of fluorine);
3.
glass (including vitrified, enameled or glass coating);
4.
graphite or 'carbon graphite';
5.
nickel or 'alloys' containing more than 40% by weight of nickel;
6.
tantalum or tantalum 'alloys';
7.
titanium or titanium 'alloys';
8.
zirconium or zirconium 'alloys'; Or
9.
niobium (columbium) or niobium 'alloys';
f.
remotely operated filling equipment in which all surfaces coming into direct contact with the chemical substances to be produced are made of one of the following materials:
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium; Or
2.
nickel or 'alloys' containing more than 40% by weight of nickel;
g.
valves and valves, and their components:
1.
valves and valves having all of the following characteristics:
a.
a 'nominal size' greater than 10mm (3/8″); And
b.
all surfaces coming into direct contact with chemical substances produced, processed or contained are made of one of the following 'corrosion resistant materials':
2.
valves, other than those specified in 2B350.g.1., having all of the following characteristics:
a.
a 'nominal size' equal to or greater than 25.4mm (1″) and equal to or less than 101.6mm (4″);
b.
housings (valve bodies) or preformed liners;
c.
an interchangeable shutter element; And
d.
all surfaces of the housing (valve body) or preformed liner coming into direct contact with the chemical substances produced, processed or contained are made of one of the 'corrosion resistant materials';
3.
components designed for valves specified in 2B350.g.1. or 2B350.g.2., in which all surfaces coming into direct contact with the chemical substances produced, processed or contained are made of one of the 'corrosion resistant materials';
a.
housings (valve bodies);
b.
preformed folders;
Technical notes:
1.
For the purposes of 2B350.g., 'corrosion-resistant materials' means any of the following materials:
a.
nickel or alloys containing more than 40% by weight of nickel;
b.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
c.
fluoropolymers (polymeric or elastomeric materials containing more than 35% by weight of fluorine);
d.
glass (including vitrified or enameled coating);
e.
tantalum or tantalum 'alloys';
f.
titanium or titanium 'alloys';
g.
zirconium or zirconium 'alloys';
h.
niobium (columbium) or niobium 'alloys'; Or
i.
ceramic materials, as follows:
1.
silicon carbide with a purity of 80% or more by weight;
2.
aluminum oxide (alumina) with a purity of 99.9% or more by weight;
3.
zirconium oxide (zirconia).
2.
'Nominal size' means the smallest of the inlet and outlet diameters.
h.
multi-walled piping incorporating a leak detection port, in which the surfaces coming into direct contact with the chemical substances contained or to be produced are made of one of the following materials:
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
2.
fluoropolymers (polymeric or elastomeric materials containing more than 35% by weight of fluorine);
3.
glass (including vitrified, enameled or glass coating);
4.
graphite or 'carbon graphite';
5.
nickel or 'alloys' containing more than 40% by weight of nickel;
6.
tantalum or tantalum 'alloys';
7.
titanium or titanium 'alloys';
8.
zirconium or zirconium 'alloys'; Or
9.
niobium (columbium) or niobium 'alloys';
i.
pumps with multiple seals and pumps without seals, with a maximum flow rate specified by the manufacturer greater than 0.6m 3 per hour, or vacuum pumps with a maximum flow rate specified by the manufacturer greater than 5m 3 per hour [under standard temperature (273K, or 0°C) and pressure (101.3kPa) conditions], other than those specified in paragraph 2B233, and housings (pump bodies), preformed liners, impellers, rotors or nozzles designed for these pumps, in which the surfaces coming into direct contact with the chemical substances to be produced are made of one of the following materials:
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
2.
ceramics;
3.
ferrosilicon (iron alloys with high silicon content);
4.
fluoropolymers (polymeric or elastomeric materials containing more than 35% by weight of fluorine);
5.
glass (including vitrified, enameled or glass coating);
6.
graphite or 'carbon graphite';
7.
nickel or 'alloys' containing more than 40% by weight of nickel;
8.
tantalum or tantalum 'alloys';
9.
titanium or titanium 'alloys';
10.
zirconium or zirconium 'alloys'; Or
11.
niobium (columbium) or niobium 'alloys';
Technical note:
In paragraph 2B350.i., the term seal only concerns seals coming into direct contact with the chemical substances treated (or to be treated), and offering a sealing function at the passage point of a transmission shaft rotary or reciprocating through the body of a pump.
j.
incinerators designed to destroy chemical substances specified in paragraph 1C350, equipped with specially designed waste introduction devices, special handling devices and having an average combustion chamber temperature greater than 1273K (1000°C), in which all the surfaces of the waste introduction system coming into direct contact with the chemical waste are made of or manufactured from one of the following materials:
1.
'alloys' containing more than 25% by weight of nickel and 20% by weight of chromium;
2.
ceramics; Or
3.
nickel or 'alloys' containing more than 40% by weight of nickel.
k.
prefabricated repair kits having metallic surfaces, made of tantalum or tantalum alloys, in direct contact with the treated chemical substance(s), as follows, and their specially designed components:
1.
designed to be mechanically attached to glass-lined reactors or reaction vessels specified in 2B350.a.; Or
2.
designed to be mechanically attached to glass-lined tanks, tanks or receivers specified in 2B350.c.;
Note:
For the purposes of 2B350, the materials used for packings, glands, gaskets, screws, washers and any other material providing a sealing function do not determine the status, since these components are interchangeable.
Note:
For the purposes of 2B350, the materials used for packings, glands, gaskets, screws, washers and any other material providing a sealing function do not determine the status, since these components are interchangeable.
Technical notes:
1.
'Carbon-graphite' is a compound of amorphous carbon and graphite with a graphite content of 8% or more by weight.
2.
For the above materials, the term "alloy", when not accompanied by a specific concentration of an element, means alloys containing a higher percentage by weight of the indicated metal than of any other element.
2B351 - Toxic gas identification systems and their associated detection elements, other than those specified in 1A004, as follows, and replaceable detectors, sensors and sensor cartridges:
a.
designed to operate continuously and capable of detecting war toxins and chemical substances referred to in paragraph 1C350, at concentrations less than 0.3 mg/m 3 of air; Or
b.
designed to detect inhibition of cholinesterase activity.
2B352 - Equipment that may be used when handling biological materials, as follows:
a.
icontainment facilities and related equipment, as follows:
1.
complete containment facilities meeting P3 or P4 containment criteria (BL3, BL4, L3, L4) as specified by the WHO Laboratory Biological Safety Manual (3rd edition , Geneva, 2004);
2.
fixed equipment designed for installation in containment facilities specified in 2B352.a., as follows:
a.
decontamination autoclaves with two doors forming an airlock;
b.
showers for decontamination of pressure suits;
c.
access doors equipped with mechanical or inflatable seals;
b.
fermenters and their components:
1.
fermenters usable for the cultivation of pathogenic “micro-organisms”, or living cells for the production of pathogenic viruses or toxins, without the propagation of aerosols, and of a total capacity equal to or greater than 20 liters;
2.
components designed for fermenters specified in 2B352. b.1.:
a.
culture chambers designed to be sterilized or disinfected in situ;
b.
culture rooms equipped with devices;
c.
process control units capable of simultaneously monitoring and controlling two or more parameters of a fermentation system (e.g. temperature control, pH, nutrients, agitation, dissolved oxygen, air flow, foam);
Technical note:
For purposes of 2B352.b., fermenters include bioreactors, single-use (disposable) bioreactors, chemostats, and continuous flow systems.
c.
centrifugal separators capable of carrying out separation continuously and without the propagation of aerosols and having all of the following characteristics:
1.
flow rate greater than 100 liters per hour;
2.
polished stainless steel or titanium components;
3.
one or more seals in the vapor containment zone; And
4.
capable of performing in situ steam sterilization in a closed environment;
Technical note:
Centrifugal separators include decanters.
d.
cross (tangential) flow filtration devices usable for the separation of pathogenic microorganisms, viruses, toxins or cell cultures having all of the following characteristics:
1.
cross (tangential) flow filtration devices usable for the separation of pathogenic microorganisms, viruses, toxins or cell cultures having all of the following characteristics:
a.
a total filtering surface of at least 1m 2 ; And
b.
having one of the following characteristics:
1.
enabling in situ sterilization or disinfection; Or
2.
using disposable or single-use filtration components;
Technical note:
For purposes of 2B352.d.1.b., the term sterilized means the elimination of all viable microbes from the device by physical (e.g., steam) or chemical agents. The term disinfected means the destruction, in the device, of possible sources of microbial infection by means of chemical agents having a germicidal effect. Disinfection and sterilization are distinct forms of cleaning, the latter referring to procedures designed to decrease the microbial content of the device without necessarily allowing the elimination of any microbial infectivity or viability.
Note:
Section 2B352.d. does not apply to reverse osmosis devices, in accordance with the manufacturer's instructions.
2.
cross-flow (tangential) filtration components (for example: modules, elements, cassettes, cartridges, units or plates) having a filtering area of at least 0.2m 2 for each component and designed for use in filtration devices cross-flow (tangential) filtration specified in 2B352.d.;
e.
steam or gas sterilizable freeze-drying devices having a condenser with a capacity equal to or greater than 10kg and less than 1000kg of ice per 24 hours;
f.
protective and containment equipment, as follows:
1.
complete or partial protective suits, or hoods depending on a connected external air supply and operating under positive pressure;
Note:
Paragraph 2B352.f.1. does not control suits designed to be worn with a self-contained breathing apparatus.
2.
biocontainment chambers, isolators or biosafety cabinets having all of the following characteristics under normal operating conditions:
a.
fully enclosed workspace in which a physical barrier separates the operator from what they are working on;
b.
possibility of operating under negative pressure;
c.
means allowing safe handling in the work space;
d.
filtration of air entering and leaving the work space using a HEPA filter;
Note 1:
Section 2B352.f.2. includes Class III biological safety cabinets as described in the latest edition of the WHO Laboratory Biological Safety Manual or as constructed in accordance with national standards, regulations or guidance.
Note 2:
Section 2B352.f.2. does not include isolators specifically designed for the protection of nursing personnel or the transport of infected patients.
g.
Aerosol inhalation equipment designed for aerosol challenge testing of “micro-organisms”, “viruses” or “toxins”, as follows:
1.
whole body exposure chambers with a capacity of 1m 3 or more;
2.
Nose-only exposure devices using a directed aerosol flow and having sufficient capacity to:
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 devices using a directed aerosol flow;
h.
spray drying equipment capable of drying toxins or pathogenic microorganisms having all of the following characteristics:
1.
water evaporation capacity of ≥0.4kg/h and ≤400kg/h;
2.
capable of producing an average particle size of ≤ 10 μm with existing equipment or by slight modification of the spray dryer with atomizing nozzles allowing production of the required particle size; And
3.
can be sterilized or disinfected in situ.
i.
partially or fully automated nucleic acid assemblers and synthesizers designed to generate continuous nucleic acids of more than 1.5 kilobases in length at one time with an error rate of less than 5%
2C - Materials
Nothing.
2D - Software
2D001 - “Software”, other than that referred to in paragraph 2D002:
a.
“Software” specially designed or modified for the “development” or “production” of equipment specified in 2A001 or 2B001.
b.
“Software” specially designed or modified for the “use” of equipment specified in 2A001.c., 2B001 or 2B003 through 2B009.
Note:
Paragraph 2D001 does not control part programming “software” that generates “numerical control” codes for the machining of various parts.
2D002 - “Software” intended for electronic devices, even when residing in an electronic system or device, enabling such devices or systems to operate as a “digital control” unit, capable of carrying out the simultaneous coordination of more of four axes for “contouring control”.
Note 1:
Paragraph 2D002 does not control “software” specially designed or modified for the operation of articles not covered by Category 2.
Note 2:
Paragraph 2D002 does not control “software” intended for products specified in paragraph 2B002. See paragraphs 2D001 and 2D003 for “software” intended for products specified in paragraph 2B002.
Note 3:
Paragraph 2D002 does not cover “software” exported with items not covered by category 2 and constituting the minimum necessary for their operation.
2D003 - “Software” designed or modified for the operation of equipment specified in 2B002 and which converts optical design, machinable part measurement and abrasion functions into “numerical controls” to obtain the shape of desired machinable part.
2D101 - “Software” specially designed or modified for the “use” of equipment specified in 2B104, 2B105, 2B109, 2B116, 2B117 or 2B119 through 2B122.
NB:
SEE ALSO 9D004.
2D201 - “Software” specially designed for the “use” of equipment specified in 2B204, 2B206, 2B207, 2B209, 2B219 or 2B227.
2D202 - “Software” specially designed or modified for the “development”, “production” or “use” of equipment specified in 2B201.
Note:
Paragraph 2D202 does not control part programming "software" that generates "numerical control" codes but does not permit direct use of equipment intended to machine various parts.
2D351 - “Software”, other than that specified in paragraph 1D003, specially designed for the “use” of equipment specified in paragraph 2B351.
2E - Technology
2E001 - “Technology”, within the meaning of the general technology note, for the “development” of equipment or “software” referred to in subcategories 2A, 2B or 2D.
Note:
2E001 includes "technology" for integrating sensor systems into corded measuring machines specified in 2B006.a.
2E002 - “Technology”, within the meaning of the general technology note, for the “production” of equipment covered in subcategories 2A or 2B.
2E003 - Other “technologies”, as follows:
a.
“technology” for the “development” of interactive computer graphics as an integrated element in “numerical control” units for the preparation or modification of part programs;