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CATEGORY 2 - MATERIALS PROCESSING

2B Test, Inspection and Production Equipment

CATEGORY 2 - MATERIALS PROCESSING

2B Test, Inspection and Production Equipment

Technical notes:


1. Secondary parallel contouring axes, (e.g., the w-axis on horizontal boring mills or a secondary rotary axis the centre line of which is parallel to the primary rotary axis) are not counted in the total number of contouring axes. Rotary axes need not rotate over 360°. A rotary axis can be driven by a linear device (e.g., a screw or a rack-and-pinion).
2. For the purposes of 2B, the number of axes which can be co-ordinated simultaneously for "contouring control" is the number of axes along or around which, during processing of the workpiece, simultaneous and interrelated motions are performed between the workpiece and a tool. This does not include any additional axes along or around which other relative movement within the machine are performed such as:
a. Wheel-dressing systems in grinding machines;
b. Parallel rotary axes designed for mounting of separate workpieces;
c. Co-linear rotary axes designed for manipulating the same workpiece by holding it in a chuck from different ends.
3. Axis nomenclature shall be in accordance with International Standard ISO 841:2001, Industrial automation systems and integration - Numerical control of machines - Coordinate system and Motion nomenclature.
4. For the purposes of 2B001 to 2B009 a "tilting spindle" is counted as a rotary axis.
5.'Stated "unidirectional positioning repeatability"' may be used for each machine tool model as an alternative to individual machine tests and is determined as follows:
a. Select five machines of a model to be evaluated;
b. Measure the linear axis repeatability (R↑,R↓) according to ISO 230-2:2014 and evaluate "unidirectional positioning repeatability" for each axis of each of the five machines;
c. Determine the arithmetic mean value of the "unidirectional positioning repeatability"-values for each axis of all five machines together. These arithmetic mean values of "unidirectional positioning repeatability”( ) become the stated value of each axis for the model ( x, y, …);
d. Since the Category 2 list refers to each linear axis there will be as many 'stated "unidirectional positioning repeatability" values as there are linear axes;
e. If any axis of a machine model not controlled by 2B001.a. to 2B001.c. has a 'stated "unidirectional positioning repeatability" equal to or less than the specified "unidirectional positioning repeatability" of each machine tool model plus 0,7 µm, the builder should be required to reaffirm the accuracy level once every eighteen months.
6. For the purposes of 2B001.a. to 2B001.c., measurement uncertainty for the "unidirectional positioning repeatability" of machine tools, as defined in the International Standard ISO 230 2:2014 or national equivalents, shall not be considered.
7. For the purpose of 2B001.a. to 2B001.c.., the measurement of axes shall be made according to test procedures in 5.3.2. of ISO 230-2:2014. Tests for axes longer than 2 meters shall be made over 2 m segments. Axes longer than 4 m require multiple tests (e.g., two tests for axes longer than 4 m and up to 8 m, three tests for axes longer than 8 m and up to 12 m), each over 2 m segments and distributed in equal intervals over the axis length. Test segments are equally spaced along the full axis length, with any excess length equally divided at the beginning, in between, and at the end of the test segments. The smallest "unidirectional positioning repeatability"-value of all test segments is to be reported.

(¹) such as in 2B001.a.1.

2B001 Machine tools and any combination thereof, for removing (or cutting) metals, ceramics or "composites", which, according to the manufacturer’s technical specification, can be equipped with electronic devices for "numerical control", as follows:

a. Machine tools for turning having two or more axes which can be coordinated simultaneously for "contouring control" having any of the following:

1. "Unidirectional positioning repeatability" equal to or less (better) than 0,9 µm along one or more linear axis with a travel length less than 1,0 m; or

2. "Unidirectional positioning repeatability" equal to or less (better) than 1,1 µm along one or more linear axis with a travel length equal to or greater than 1,0 m;

b. Machine tools for milling having any of the following:

1. Three linear axes plus one rotary axis which can be coordinated simultaneously for "contouring control" having any of the following:

a. "Unidirectional positioning repeatability" equal to or less (better) than 0,9 µm along one or more linear axis with a travel length less than 1,0 m; or

b. "Unidirectional positioning repeatability" equal to or less (better) than 1,1 µm along one or more linear axis with a travel length equal to or greater than 1,0m;

2. Five or more axes which can be coordinated simultaneously for "contouring control" having any of the following;

a. "Unidirectional positioning repeatability" equal to or less (better) than 0,9 µm along one or more linear axis with a travel length less than 1,0 m;

b. "Unidirectional positioning repeatability" equal to or less (better) than 1,4 µm along one or more linear axis with a travel length equal to or greater than 1 m and less than 4 m;

c. "Unidirectional positioning repeatability" equal to or less (better) than 6,0 µm (along one or more linear axis with a travel length equal to or greater than 4 m; or

d. Being a 'parallel mechanism machine tool';

3. A positioning accuracy for jig boring machines, with "all compensations available", equal to or less (better) than 3,0 μm according to ISO 230/2 (2006)¹ or national equivalents along one or more linear axis; or

4. Fly cutting machines, having all of the following characteristics:

a. Spindle "run-out" and "camming" less (better) than 0,0004 mm TIR; and

b. Angular deviation of slide movement (yaw, pitch and roll) less (better) than 2 seconds of arc, TIR over 300 mm of travel;

c. Machine tools for grinding having any of the following:

1. Having all of the following:

b. Three or more axes which can be coordinated simultaneously for "contouring control"; (¹) Manufacturers calculating positioning accuracy in accordance with ISO 230/2 (1988) or (1997) should consult the competent authorities of the Member State in which they are established.

2. Five or more axes which can be coordinated simultaneously for "contouring control";

a. "Unidirectional positioning repeatability" equal to or less (better) than 1,1 µm along one or more linear axis with a travel length less than 1 m;

b. "Unidirectional positioning repeatability" equal to or less (better) than 1,4 µm along one or more linear axis with a travel length equal to or greater than 1 m and less than 4 m; or

c. "Unidirectional positioning repeatability" equal to or less (better) than 6,0 µm along one or more linear axis with a travel length equal to or greater than 4 m.

d. Electrical discharge machines (EDM) of the non-wire type which have two or more rotary axes which can be coordinated simultaneously for "contouring control";

e. Machine tools for removing metals, ceramics or "composites", having all of the following:

1. Removing material by means of any of the following:

a. Water or other liquid jets, including those employing abrasive additives;

b. Electron beam; or

c. "Laser" beam; and

2. At least two rotary axes having all of the following:

a. Can be coordinated simultaneously for “contouring control”; and

b. A positioning accuracy of less (better) than 0,003°;

f. Deep-hole-drilling machines and turning machines modified for deep-hole-drilling, having a maximum depth-of-bore capability exceeding 5m.

2B002 Numerically controlled optical finishing machine tools equipped for selective material removal to produce non-spherical optical surfaces having all of the following characteristics:

a. Finishing the form to less (better) than 1,0 µm;

b. Finishing to a roughness less (better) than 100 nm rms.

c. Four or more axes which can be coordinated simultaneously for "contouring control"; and

d. Using any of the following processes:

1. Magnetorheological finishing ('MRF');

2. Electrorheological finishing ('ERF');

3. Energetic particle beam finishing';

4. Inflatable membrane tool finishing'; or

5. Fluid jet finishing'.

2B003 "Numerically controlled" or manual machine tools, and specially designed components, controls and accessories therefor, specially designed for the shaving, finishing, grinding or honing of hardened (Rc = 40 or more) spur, helical and double-helical gears with a pitch diameter exceeding 1 250 mm and a face width of 15% of pitch diameter or larger finished to a quality of AGMA 14 or better (equivalent to ISO 1328 class 3).

2B004 Hot "isostatic presses" having all of the following, and specially designed components and accessories therefor:

a. A controlled thermal environment within the closed cavity and a chamber cavity with an inside diameter of 406 mm or more; and

b. Having any of the following:

1. A maximum working pressure exceeding 207 MPa;

2. A controlled thermal environment exceeding 1773 K (1500°C); or

3. A facility for hydrocarbon impregnation and removal of resultant gaseous degradation products.

2B005 Equipment specially designed for the deposition, processing and in-process control of inorganic overlays, coatings and surface modifications, as follows, for non-electronic substrates, by processes shown in the Table and associated Notes following 2E003.f., and specially designed automated handling, positioning, manipulation and control components therefor:

a. Chemical vapour deposition (CVD) production equipment having all of the following:

1. A process modified for one of the following:

a. Pulsating CVD;

b. Controlled nucleation thermal deposition (CNTD); or

c. Plasma enhanced or plasma assisted CVD; and

2. Having any of the following:

a. Incorporating high vacuum (equal to or less than 0,01 Pa) rotating seals; or

b. Incorporating in situ coating thickness control;

b. Ion implantation production equipment having beam currents of 5 mA or more;

c. Electron beam physical vapour deposition (EB-PVD) production equipment incorporating power systems rated for over 80 kW and having any of the following:

1. A liquid pool level "laser" control system which regulates precisely the ingots feed rate; or

2. A computer controlled rate monitor operating on the principle of photo-luminescence of the ionised atoms in the evaporant stream to control the deposition rate of a coating containing two or more elements;

d. Plasma spraying production equipment having any of the following:

1. Operating at reduced pressure controlled atmosphere (equal to or less than 10 kPa measured above and within 300 mm of the gun nozzle exit) in a vacuum chamber capable of evacuation down to 0,01 Pa prior to the spraying process; or

2. Incorporating in situ coating thickness control;

e. Sputter deposition production equipment capable of current densities of 0,1 mA/mm² or higher at a deposition rate of 15 µm/h or more;

f. Cathodic arc deposition production equipment incorporating a grid of electromagnets for steering control of the arc spot on the cathode;

g. Ion plating production equipment capable of the in situ measurement of either of the following:

1. Coating thickness on the substrate and rate control; or

2. Optical characteristics.

2B006 Dimensional inspection or measuring systems, equipment and "electronic assemblies", as follows:

a. Computer controlled or “numerically controlled” Coordinate Measuring Machines (CMM), having a three dimensional (volumetric) maximum permissible error of length measurement (E 0 , MPE) at any point within the operating range of the machine (i.e. within the length of axes) equal to or less (better) than (1,7 + L/1000) μm (L is the measured length in mm), according to ISO 10360-2 (2009);

b. Linear and angular displacement measuring instruments, as follows:

1. Linear displacement' measuring instruments having any of the following:

a. Non-contact type measuring systems with a "resolution" equal to or less (better) than 0,2 μm within a measuring range up to 0,2 mm;

b. Linear Variable Differential Transformer (LVDT) systems having all of the following:

1. Having any of the following:

a. "Linearity" equal to or less (better) than 0,1% measured from 0 to the 'full operating range', for LVDTs with a 'full operating range' up to and including ± 5 mm; or

b. "Linearity" equal to or less (better) than 0,1% measured from 0 to 5 mm for LVDTs with a 'full operating range' greater than ± 5 mm; and

2. Drift equal to or less (better) than 0,1% per day at a standard ambient test room temperature ±1 K;

c. Measuring systems having all of the following:

1. Containing a "laser";

2. A "resolution" over their full scale of 0,200 nm or less (better); and

3. Capable of achieving a "measurement uncertainty" equal to or less (better) than (1,6 + L/2 000) nm (L is the measured length in mm) at any point within a measuring range, when compensated for the refractive index of air and measured over a period of 30 seconds at a temperature of 20±0,01°C; or

d. "Electronic assemblies" specially designed to provide feedback capability in systems specified in 2B006.b.1.c.;

2. Angular displacement measuring instruments having an angular position "accuracy" equal to or less (better) than 0,00025°;

c. Equipment for measuring surface irregularities, by measuring optical scatter as a function of angle, with a sensitivity of 0,5 nm or less (better).

2B007 "Robots" having any of the following characteristics and specially designed controllers and "end-effectors" therefor:

a. Capable in real time of full three-dimensional image processing or full three-dimensional "scene analysis" to generate or modify "programmes" or to generate or modify numerical programme data;

b. Specially designed to comply with national safety standards applicable to explosive munitions environments;

c. Specially designed or rated as radiation-hardened to withstand a total radiation dose greater than 5 × 10E3 Gy (silicon) without operational degradation; or

d. Specially designed to operate at altitudes exceeding 30000 m.

2B008 Assemblies or units, specially designed for machine tools, or dimensional inspection or measuring systems and equipment, as follows:

a. Linear position feedback units having an overall "accuracy" less (better) than (800 + (600 x L/1 000)) nm (L equals the effective length in mm);

b. Rotary position feedback units having an "accuracy" less (better) than 0,00025°;

c. "Compound rotary tables" and "tilting spindles", capable of upgrading, according to the manufacturer's specifications, machine tools to or above the levels specified in 2B.

2B009 Spin-forming machines and flow-forming machines, which, according to the manufacturer’s technical specification, can be equipped with “numerical control” units or a computer control and having both of the following:

a. Three or more axes which can be coordinated simultaneously for "contouring control"; and

b. A roller force more than 60 kN.

2B104 "Isostatic presses", other than those specified in 2B004, having all of the following:

a. Maximum working pressure of 69 MPa or greater;

b. Designed to achieve and maintain a controlled thermal environment of 873 K (600 °C) or greater; and

c. Possessing a chamber cavity with an inside diameter of 254 mm or greater.

2B105 Chemical vapour deposition (CVD) furnaces, other than those specified in 2B005.a., designed or modified for the densification of carbon-carbon composites.

2B109 Flow-forming machines, other than those specified in 2B009, and specially designed components as follows:

a. Flow-forming machines having all of the following:

1. According to the manufacturer's technical specification, can be equipped with "numerical control" units or a computer control, even when not equipped with such units; and

2. With more than two axes which can be coordinated simultaneously for "contouring control".

b. Specially designed components for flow-forming machines specified in 2B009 or 2B109.a.

2B116 Vibration test systems, equipment and components therefor, as follows:

a. Vibration test systems employing feedback or closed loop techniques and incorporating a digital controller, capable of vibrating a system at an acceleration equal to or greater than 10 g rms between 20 Hz and 2 kHz while imparting forces equal to or greater than 50 kN, measured 'bare table';

b. Digital controllers, combined with specially designed vibration test software, with a 'real-time control bandwidth' greater than 5 kHz designed for use with vibration test systems specified in 2B116.a.;

c. Vibration thrusters (shaker units), with or without associated amplifiers, capable of imparting a force equal to or greater than 50 kN, measured 'bare table', and usable in vibration test systems specified in 2B116.a.;

d. Test piece support structures and electronic units designed to combine multiple shaker units in a system capable of providing an effective combined force equal to or greater than 50 kN, measured 'bare table', and usable in vibration systems specified in 2B116.a.

2B117 Equipment and process controls, other than those specified in 2B004, 2B005.a., 2B104 or 2B105, designed or modified for densification and pyrolysis of structural composite rocket nozzles and reentry vehicle nose tips.

2B119 Balancing machines and related equipment, as follows:

a. Balancing machines having all the following characteristics:

1. Not capable of balancing rotors/assemblies having a mass greater than 3 kg;

2. Capable of balancing rotors/assemblies at speeds greater than 12500 rpm;

3. Capable of correcting unbalance in two planes or more; and

4. Capable of balancing to a residual specific unbalance of 0,2 g mm per kg of rotor mass;

b. Indicator heads designed or modified for use with machines specified in 2B119.a

2B120 Motion simulators or rate tables having all of the following characteristics:

a. Two axes or more;

b. Designed or modified to incorporate slip rings or integrated non-contact devices capable of transferring electrical power, signal information, or both; and

c. Having any of the following characteristics:

1. For any single axis having all of the following:

a. Capable of 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 a worst-case rate stability equal to or better (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 arc second.

2B121 Positioning tables (equipment capable of precise rotary positioning in any axes), other than those specified in 2B120, having all the following characteristics:

a. Two axes or more; and

b. A positioning "accuracy" equal to or less (better) than 5 arc second.

2B122 Centrifuges capable of imparting accelerations above 100 g and designed or modified to incorporate slip rings or integrated non-contact devices capable of transferring electrical power, signal information, or both.

2B201 Machine tools and any combination thereof, other than those specified in 2B001, as follows, for removing or cutting metals, ceramics or "composites", which, according to the manufacturer's technical specification, can be equipped with electronic devices for simultaneous "contouring control" in two or more axes:

a. Machine tools for milling, having any of the following characteristics:

1. Positioning accuracies with "all compensations available" equal to or less (better) than 6 µm according to ISO 230 2:1988(¹) or national equivalents along any linear axis;

2. Two or more contouring rotary axes; or

3. Five or more axes which can be coordinated simultaneously for "contouring control";

b. Machine tools for grinding, having any of the following characteristics:

1. Positioning accuracies with "all compensations available" equal to or less (better) than 4 µm according to ISO 230 2:1988(¹) or national equivalents along any linear axis;

2. Two or more contouring rotary axes; or

3. Five or more axes which can be coordinated simultaneously for "contouring control";

c. Machine tools for turning, that have positioning accuracies with "all compensations available" better (less) than 6 μm according to ISO 230 2:1988(¹) along any linear axis (overall positioning) for machines capable of machining diameters greater than 35 mm;

2B204 "Isostatic presses", other than those specified in 2B004 or 2B104, and related equipment, as follows:

a. "Isostatic presses" having both of the following characteristics:

1. Capable of achieving a maximum working pressure of 69 MPa or greater; and

2. A chamber cavity with an inside diameter in excess of 152 mm;

b. Dies, moulds and controls, specially designed for "isostatic presses" specified in 2B204.a.

2B206 Dimensional inspection machines, instruments or systems, other than those specified in 2B006, as follows:

a. Computer controlled or numerically controlled coordinate measuring machines (CMM) having either of the following characteristics:

1. Having only two axes and having a maximum permissible error of length measurement along any axis (one dimensional), identified as any combination of E0x,MPE, E0y,MPE, or E0z,MPE, equal to or less (better) than (1,25 + L/1000) μm (where L is the measured length in mm) at any point within the operating range of the machine (i.e., within the length of the axis), according to ISO 10360-2(2009); or

2. Three or more axes and having a three dimensional (volumetric) maximum permissible error of length measurement (E0,MPE) equal to or less (better) than (1,7 + L/800) μm (where L is the measured length in mm) at any point within the operating range of the machine (i.e., within the length of the axis), according to ISO 10360-2(2009);

b. Systems for simultaneous linear-angular inspection of hemishells, having both of the following characteristics:

1. "Measurement uncertainty" along any linear axis equal to or less (better) than 3,5 µm per 5 mm; and "Angular position deviation" equal to or less than 0,02°;

c. Linear displacement' measuring systems having all of the following characteristics:

1. Containing a "laser"; and

2. Maintaining, for at least 12 hours, at a temperature of ± 1 K around a standard temperature and standard pressure, all of the following:

a. A "resolution" over their full scale of 0,1 µm or better; and

b. With a "measurement uncertainty" equal to or better (less) than (0,2 + L/2 000) µm (L is the measured length in millimeters).

2B207 "Robots", "end-effectors" and control units, other than those specified in 2B007, as follows:

a. "Robots" or "end-effectors" specially designed to comply with national safety standards applicable to handling high explosives (for example, meeting electrical code ratings for high explosives);

b. Control units specially designed for any of the "robots" or "end-effectors" specified in 2B207.a.

2B209 Flow forming machines, spin forming machines capable of flow forming functions, other than those specified in 2B009 or 2B109, and mandrels, as follows:

a. Machines having both of the following characteristics:

1. Three or more rollers (active or guiding); and

2. Which, according to the manufacturer's technical specification, can be equipped with "numerical control" units or a computer control;

b. Rotor-forming mandrels designed to form cylindrical rotors of inside diameter between 75 mm and 400 mm.

2B219 Centrifugal multiplane balancing machines, fixed or portable, horizontal or vertical, as follows:

a. Centrifugal balancing machines designed for balancing flexible rotors having a length of 600 mm or more and having all of the following characteristics:

1. Swing or journal diameter greater than 75 mm;

2. Mass capability of from 0,9 to 23 kg; and

3. Capable of balancing speed of revolution greater than 5000 r.p.m.;

b. Centrifugal balancing machines designed for balancing hollow cylindrical rotor components and having all of the following characteristics:

1. Journal diameter greater than 75 mm;

2. Mass capability of from 0,9 to 23 kg;

3. Capable of balancing to a residual imbalance equal to or less than 0,01 kg × mm/kg per plane; and

4. Belt drive type.

2B225 Remote manipulators that can be used to provide remote actions in radiochemical separation operations or hot cells, having either of the following characteristics:

a. A capability of penetrating 0,6 m or more of hot cell wall (through-the-wall operation); or

b. A capability of bridging over the top of a hot cell wall with a thickness of 0,6 m or more (over-the-wall operation).

2B226 Controlled atmosphere (vacuum or inert gas) induction furnaces, and power supplies therefor, as follows:

a. Furnaces having all of the following characteristics:

1. Capable of operation above 1 123 K (850 °C);

2. Induction coils 600 mm or less in diameter; and

3. Designed for power inputs of 5 kW or more;

b. Power supplies, with a specified power output of 5 kW or more, specially designed for furnaces specified in 2B226.a.

2B227 Vacuum or other controlled atmosphere metallurgical melting and casting furnaces and related equipment as follows:

a. Arc remelt and casting furnaces having both of the following characteristics:

1. Consumable electrode capacities between 1000 cm³ and 20000 cm³, and

2. Capable of operating with melting temperatures above 1973 K (1700°C);

b. Electron beam melting furnaces and plasma atomization and melting furnaces, having both of the following characteristics:

1. A power of 50 kW or greater; and

2. Capable of operating with melting temperatures above 1 473 K (1 200°C).

c. Computer control and monitoring systems specially configured for any of the furnaces specified in 2B227.a. or b.

2B228 Rotor fabrication or assembly equipment, rotor straightening equipment, bellows-forming mandrels and dies, as follows:

a. Rotor assembly equipment for assembly of gas centrifuge rotor tube sections, baffles, and end caps;

b. Rotor straightening equipment for alignment of gas centrifuge rotor tube sections to a common axis;

c. Bellows-forming mandrels and dies for producing single-convolution bellows.

2B230 All types of 'pressure transducers' capable of measuring absolute pressures and having all of the following:

a. Pressure sensing elements made of or protected by aluminium, aluminium alloy, aluminum oxide (alumina or sapphire), nickel, nickel alloy with more than 60% nickel by weight, or fully fluorinated hydrocarbon polymers;

b. Seals, if any, essential for sealing the pressure sensing element, and in direct contact with the process medium, made of or protected by aluminium, aluminium alloy, aluminum oxide (alumina or sapphire), nickel, nickel alloy with more than 60% nickel by weight, or fully fluorinated hydrocarbon polymers; and

c. Having either of the following characteristics:

1. A full scale of less than 13 kPa and an 'accuracy' of better than + 1% of full-scale; or

2. A full scale of 13 kPa or greater and an 'accuracy' of better than + 130 Pa when measured at 13 kPa.

2B231 Vacuum pumps having all of the following characteristics:

a. Input throat size equal to or greater than 380 mm;

b. Pumping speed equal to or greater than 15 m³/s; and

c. Capable of producing an ultimate vacuum better than 13 mPa.

2B232 High-velocity gun systems (propellant, gas, coil, electromagnetic, and electrothermal types, and other advanced systems) capable of accelerating projectiles to 1,5 km/s or greater.

2B233 Bellows-sealed scroll-type compressors and bellows-sealed scroll-type vacuum pumps having all of the following:

a. Capable of an inlet volume flow rate of 50 m3/h or greater;

b. Capable of a pressure ratio of 2:1 or greater; and

c. Having all surfaces that come in contact with the process gas made from any of the following materials:

1. Aluminium or aluminium alloy;

2. Aluminium oxide;

3. Stainless steel;

4. Nickel or nickel alloy;

5. Phosphor bronze; or

6. Fluoropolymers.

2B350 Chemical manufacturing facilities, equipment and components, as follows:

a. Reaction vessels or reactors, with or without agitators, with total internal (geometric) volume greater than 0,1 m³ (100 litres) and less than 20 m³ (20000 litres), where all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials:

1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight;

2. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight);

3. Glass (including vitrified or enamelled coating or glass lining);

4. Nickel or ‘alloys’ with more than 40 % nickel by weight;

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 reaction vessels or reactors specified in 2B350.a.; and impellers, blades or shafts designed for such agitators, where all surfaces of the agitator that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials:

1. ‘Alloys’ with more than 25% nickel and 20% chromium by weight;

2. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight);

3. Glass (including vitrified or enamelled coatings or glass lining);

4. Nickel or ‘alloys’ with more than 40% nickel by weight;

5. Tantalum or tantalum ‘alloys’;

6. Titanium or titanium ‘alloys’;

7. Zirconium or zirconium 'alloys'; or

8. Niobium (columbium) or niobium ‘alloys’;

c. Storage tanks, containers or receivers with a total internal (geometric) volume greater than 0,1 m³ (100 litres) where all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials:

1. ‘Alloys’ with more than 25% nickel and 20% chromium by weight;

2. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight);

3. Glass (including vitrified or enamelled coatings or glass lining);

4. Nickel or ‘alloys’ with more than 40% nickel by weight;

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 0,15 m², and less than 20 m²; and tubes, plates, coils or blocks (cores) designed for such heat exchangers or condensers, where all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials:

1. ‘Alloys’ with more than 25% nickel and 20% chromium by weight;

2. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight);

3. Glass (including vitrified or enamelled coatings or glass lining);

4. Graphite or 'carbon graphite';

5. Nickel or ‘alloys’ with more than 40% nickel by weight;

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 of internal diameter greater than 0,1 m; and liquid distributors, vapour distributors or liquid collectors designed for such distillation or absorption columns, where all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials:

1. ‘Alloys’ with more than 25% nickel and 20% chromium by weight;

2. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight);

3. Glass (including vitrified or enamelled coatings or glass lining);

4. Graphite or 'carbon graphite';

5. Nickel or ‘alloys’ with more than 40% nickel by weight;

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 that come in direct contact with the chemical(s) being processed are made from any of the following materials:

1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; or or

2. Nickel or ‘alloys’ with more than 40 % nickel by weight;

g. Valves and components, as follows:

1. Valves, having both of the following:

a. A 'nominal size' greater than 10 mm (3/8"); and

b. All surfaces that come in direct contact with the chemical(s) being produced, processed, or contained are made from 'corrosion resistant materials';

2. Valves, other than those specified in 2B350.g.1., having all of the following;

a. A 'nominal size' equal to or greater than 25,4 mm (1") and equal to or less than 101,6 mm (4");

b. Casings (valve bodies) or preformed casing liners;

c. A closure element designed to be interchangeable; and

d. All surfaces of the casing (valve body) or preformed case liner that come in direct contact with the chemical(s) being produced, processed, or contained are made from 'corrosion resistant materials';

3. Components, designed for valves specified in 2B350.g.1 or 2B350.g.2., in which all surfaces that come in direct contact with the chemical(s) being produced, processed, or contained are made from 'corrosion resistant materials', as follows:

a. Casings (valve bodies);

b. Preformed casing liners;

h. Multi-walled piping incorporating a leak detection port, in which all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials:

1. ‘Alloys’ with more than 25% nickel and 20% chromium by weight;

2. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight);

3. Glass (including vitrified or enamelled coatings or glass lining);

4. Graphite or 'carbon graphite';

5. Nickel or ‘alloys’ with more than 40 % nickel by weight;

6. Tantalum or tantalum ‘alloys’;

7. Titanium or titanium ‘alloys’;

8. Zirconium or zirconium ‘alloys’; or

9. Niobium (columbium) or niobium ‘alloys’;

i. Multiple-seal and seal-less pumps, with manufacturer's specified maximum flow-rate greater than 0,6 m³/hour, or vacuum pumps with manufacturer's specified maximum flow-rate greater than 5 m³/hour (under standard temperature (273 K (0oC)) and pressure (101,3 kPa) conditions), other than those specified in 2B233; and casings (pump bodies), preformed casing liners, impellers, rotors or jet pump nozzles designed for such pumps, in which all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials:

1. ‘Alloys’ with more than 25% nickel and 20% chromium by weight;

2. Ceramics;

3. Ferrosilicon (high silicon iron alloys);

4. Fluoropolymers (polymeric or elastomeric materials with more than 35% fluorine by weight);

5. Glass (including vitrified or enamelled coatings or glass lining);

6. Graphite or 'carbon graphite';

7. Nickel or ‘alloys’ with more than 40% nickel by weight;

8. Tantalum or tantalum ‘alloys’;

9. Titanium or titanium ‘alloys’;

10. Zirconium or zirconium ‘alloys’; or

11. Niobium (columbium) or niobium ‘alloys’;

j. Incinerators designed to destroy chemicals specified in entry 1C350, having specially designed waste supply systems, special handling facilities and an average combustion chamber temperature greater than 1273 K (1000°C), in which all surfaces in the waste supply system that come into direct contact with the waste products are made from or lined with any of the following materials:

1. ‘Alloys’ with more than 25% nickel and 20% chromium by weight;

2. Ceramics; or

3. Nickel or ‘alloys’ with more than 40% nickel by weight.

2B351 Toxic gas monitoring systems and their dedicated detecting components, other than those specified in 1A004, as follows; and detectors; sensor devices; and replaceable sensor cartridges therefor:

a. Designed for continuous operation and usable for the detection of chemical warfare agents or chemicals specified in 1C350, at concentrations of less than 0,3 mg/m³; or

b. Designed for the detection of cholinesterase-inhibiting activity.

2B352 Equipment capable of use in handling biological materials, as follows:

a. Complete biological containment facilities at P3, P4 containment level;

b. Fermenters and components as follows:

1. Fermenters capable of cultivation of pathogenic "microorganisms" or of live cells for the production of pathogenic viruses or toxins, without the propagation of aerosols, having a total capacity of 20 litres or more;

2. Components designed for fermenters in 2B352.b.1. as follows:

a. Cultivation chambers designed to be sterilised or disinfected in situ;

b. Cultivation chamber holding devices;

c. Process control units capable of simultaneously monitoring and controlling two or more fermentation system parameters (e.g., temperature, pH, nutrients, agitation, dissolved oxygen, air flow, foam control);

c. Centrifugal separators, capable of continuous separation without the propagation of aerosols, having all the following characteristics:

1. Flow rate exceeding 100 litres per hour;

2. Components of polished stainless steel or titanium;

3. One or more sealing joints within the steam containment area; and

4. Capable of in-situ steam sterilisation in a closed state;

d. Cross (tangential) flow filtration equipment capable of separation of pathogenic micro-organisms, viruses, toxins or cell cultures having all the following characteristics:

1. Cross (tangential) flow filtration equipment capable of separation of pathogenic microorganisms, viruses, toxins or cell cultures having all of the following characteristics:

a. A total filtration area equal to or greater than 1 m²; and

b. Having any of the following characteristics:

1. Capable of being sterilised or disinfected in-situ; or

2. Using disposable or single-use filtration components;

2. Cross (tangential) flow filtration components (e.g. modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0,2 m² for each component and designed for use in cross (tangential) flow filtration equipment specified in 2B352.d.;

e. Steam, gas or vapour sterilisable freeze-drying equipment with a condenser capacity of 10 kg of ice or more in 24 hours and less than 1 000 kg of ice in 24 hours;

f. Protective and containment equipment, as follows:

1. Protective full or half suits, or hoods dependent upon a tethered external air supply and operating under positive pressure;

2. Biocontainment chambers, isolators, or biological safety cabinets having all of the following characteristics, for normal operation:

a. Fully enclosed workspace where the operator is separated from the work by a physical barrier;

b. Able to operate at negative pressure;

c. Means to safely manipulate items in the workspace;

d. Supply and exhaust air to and from the workspace is HEPA filtered;

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 atomization nozzles enabling generation of the required particle size; and

3. Capable of being sterilised or disinfected in situ.

General Notes

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Definition of Terms

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Images

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Reasons for Control

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CN Codes

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