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;
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 specified 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 2B., 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 2.B., 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.
8. 'Stated positioning accuracy' derived from measurements made according to ISO 230/2:2014 or national equivalents may be used for each machine tool model as an alternative to individual machine tests. 'Stated positioning accuracy' means the accuracy value provided to national licensing authorities as representative of the accuracy of a specific machine model.
Determination of 'Stated Positioning Accuracy'
a. Select five machines of a model to be evaluated;
b. Measure the linear axis accuracies according to ISO 230/2:2014;
c. Determine the A‑values for each axis of each machine. The method of calculating the A‑value is described in the ISO standard;
d. Determine the mean value of the A‑value of each axis. This mean value Ā becomes the stated value of each axis for the model (Āx Āy...);
e. Since the Category 2 list refers to each linear axis there will be as many stated values as there are linear axes;
f. If any axis of a machine model not specified by 2B201.a. to c. has a stated positioning accuracy of 6 μm or better (less) for grinding machines, and 8 μm or better (less) for milling and turning machines, both according to ISO 230/2:2014, then the builder should be required to reaffirm the accuracy level once every eighteen months.
9. For the purposes of 2B201., measurement uncertainty for the positioning accuracy of machine tools, as defined in the International Standard ISO 230/2:2014 or national equivalents, shall not be considered.
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:
N.B.: SEE ALSO 2B201.
Note 1: 2B001 does not apply to special purpose machine tools limited to the manufacture of gears. For such machines see 2B003.
Note 2: 2B001 does not apply to special purpose machine tools limited to the manufacture of any of the following:
a. Crankshafts or camshafts;
b. Tools or cutters;
c. Extruder worms; or
d. Engraved or facetted jewellery parts.
e. Dental prostheses.
Note 3: A machine tool having at least two of the three turning, milling or grinding capabilities (e.g., a turning machine with milling capability), must be evaluated against each applicable entry 2B001.a., b. or c.
N.B.: For optical finishing machines, see 2B002.
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;
Note 1: 2B001.a. does not apply to turning machines specially designed for producing contact lenses, having all of the following:
a. Machine controller limited to using ophthalmic based software for part programming data input; and
b. No vacuum chucking.
Note 2: 2B001.a. does not apply to bar machines (Swissturn), limited to machining only bar feed thru, if maximum bar diameter is equal to or less than 42 mm and there is no capability of mounting chucks. Machines may have drilling or milling capabilities for machining parts with diameters less than 42 mm.
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 1.0 m;
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 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
3. A "unidirectional positioning repeatability" for jig boring machines, equal to or less (better) than 1.1 µm along one or more linear axis; or
4. Fly cutting machines having all of the following:
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:
a. "Unidirectional positioning repeatability" equal to or less (better) than 1.1 µm along one or more linear axis; and
b. Three or four axes which can be coordinated simultaneously for “contouring control”; or
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 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.
Note: 2B001.c. does not apply to grinding machine as follows:
a. Cylindrical external, internal, and external‑internal grinding machines, having all of the following:
1. Limited to cylindrical grinding; and
2. Limited to a maximum workpiece capacity of 150 mm outside diameter or length.
b. Machines designed specifically as jig grinders that do not have a z‑axis or a w‑axis, with a "unidirectional positioning repeatability" less (better) than 1.1 µm.
c. Surface grinders.
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. Having two or more rotary axes and 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 5 m and specially designed components therefor.
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’.
For the purposes of 2B002:
1. ‘MRF’ is a material removal process using an abrasive magnetic fluid whose viscosity is controlled by a magnetic field.
2. ‘ERF’ is a removal process using an abrasive fluid whose viscosity is controlled by an electric field.
3. ‘Energetic particle beam finishing’ uses Reactive Atom Plasmas (RAP) or ion‑beams to selectively remove material.
4. ‘Inflatable membrane tool finishing’ is a process that uses a pressurised membrane that deforms to contact the workpiece over a small area.
5. ‘Fluid jet finishing’ makes use of a fluid stream for material removal.
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:
N.B.: SEE ALSO 2B104 and 2B204.
a. A controlled thermal environment within the closed cavity and a chamber cavity with an inside diameter of 406 mm or more; and
1. A maximum working pressure exceeding 207 MPa;
2. A controlled thermal environment exceeding 1,773 K (1,500°C); or
3. A facility for hydrocarbon impregnation and removal of resultant gaseous degradation products.
The inside chamber dimension is that of the chamber in which both the working temperature and the working pressure are achieved and does not include fixtures. That dimension will be the smaller of either the inside diameter of the pressure chamber or the inside diameter of the insulated furnace chamber, depending on which of the two chambers is located inside the other.
N.B.: For specially designed dies, moulds and tooling see 1B003, 9B009 and the Munitions List.
2B005 Equipment specially designed for the deposition, processing and in‑process control of inorganic overlays, coatings and surface modifications, as follows, for 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:
N.B.: SEE ALSO 2B105.
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
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 allowing for the in situ measurement of any of the following:
1. Coating thickness on the substrate and rate control; or
2. Optical characteristics.
Note: 2B005.a., 2B005.b., 2B005.e., 2B005.f. and 2B005.g. do not apply to chemical vapour deposition, cathodic arc, sputter deposition, ion plating or ion implantation equipment, specially designed for cutting or machining tools.
2B006 Dimensional inspection or measuring systems, equipment, position feedback units and “electronic assemblies”, as follows:
a. Computer controlled or “numerical controlled” Coordinate Measuring Machines (CMM), having a three dimensional (volumetric) maximum permissible error of length measurement (E0,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/1,000 µm (L is the measured length in mm), according to ISO 10360‑2 (2009);
The E0,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) and with “all compensations available” shall be compared to the 1.7 + L/1,000 µm threshold.
b. Linear displacement measuring instruments or systems, linear position feedback units, and "electronic assemblies", as follows:
Note: Interferometer and optical‑encoder measuring systems containing a "laser" are only specified in 2B006.b.3.
1. ‘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;
For the purposes of 2B006.b.1., ‘non‑contact type measuring systems’ are designed to measure the distance between the probe and measured object along a single vector, where the probe or measured object is in motion.
2. Linear position feedback units specially designed for machine tools and having an overall “accuracy” less (better) than (800 + (600 x L/1,000)) nm (L equals effective length in mm);
3. Measuring systems having all of the following:
a. Containing a “laser”;
b. A ‘resolution’ over their full scale of 0.200 nm or less (better); and
c. 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
For the purposes of 2B006.b., 'resolution' is the least increment of a measuring device; on digital instruments, the least significant bit.
4. “Electronic assemblies” specially designed to provide feedback capability in systems specified by 2B006.b.3.;
c. Rotary position feedback units specially designed for machine tools or angular displacement measuring instruments, having an angular position “accuracy” equal to or less (better) than 0.9 second of arc;
Note: 2B006.c. does not apply to optical instruments, such as autocollimators, using collimated light (e.g., laser light) to detect angular displacement of a mirror.
d. Equipment for measuring surface roughness (including surface defects), by measuring optical scatter with a sensitivity of 0.5 nm or less (better).
Note: 2B006. includes machine tools, other than those specified by 2B001., that can be used as measuring machines if they meet or exceed the criteria specified for the measuring machine function.
2B007 “Robots” having any of the following characteristics and specially designed controllers and “end‑effectors” therefor:
N.B.: SEE ALSO 2B207.
b. Specially designed to comply with national safety standards applicable to potentially explosive munitions environments;
Note: 2B007.b. does not apply to “robots” specially designed for paint‑spraying booths.
c. Specially designed or rated as radiation‑hardened to withstand a total radiation dose greater than 5 x 103 Gy (Si) without operational degradation; or
d. Specially designed to operate at altitudes exceeding 30,000 m.
2B008 ‘Compound rotary tables’ and “tilting spindles”, specially designed for machine tools, as follows:
b. Not used since 2017;
c. ‘Compound rotary tables’ having all of the following:
1. Designed for machine tools for turning, milling or grinding; and
2. Two rotary axes designed to be coordinated simultaneously for “contouring control”;
A ‘compound rotary table’ is a table allowing the workpiece to rotate and tilt about two non‑parallel axes.
d. “Tilting spindles” having all of the following:
1. Designed for machine tools for turning, milling or grinding; and
2. Designed to be coordinated simultaneously for “contouring control”.
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 all of the following:
N.B.: SEE ALSO 2B109 AND 2B209.
a. Two or more controlled axes of which at least two can be coordinated simultaneously for “contouring control”; and
b. A roller force more than 60 kN.
For the purpose of 2B009, machines combining the function of spin‑forming and flow‑forming are regarded as flow‑forming machines.
2B104 “Isostatic presses”, other than those specified by 2B004, having all of the following:
N.B.: SEE ALSO 2B204.
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 by 2B005.a., designed or modified for the densification of carbon‑carbon composites.
2B109 Flow‑forming machines, other than those specified by 2B009, and specially designed components as follows:
N.B.: SEE ALSO 2B209.
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 by 2B009 or 2B109.a.
Note: 2B109 does not apply to machines that are not usable in the production of propulsion components and equipment (e.g. motor cases and interstages) for systems specified by 9A005, 9A007.a. or 9A105.a.
Machines combining the function of spin‑forming and flow‑forming are for the purpose of 2B109 regarded as flow‑forming machines.
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 by 2B116.a.;
In 2B116.b., ‘real‑time control bandwidth’ means the maximum rate at which a controller can execute complete cycles of sampling, processing data and transmitting control signals.
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 by 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 by 2B116.a.
In 2B116, ‘bare table’ means a flat table, or surface, with no fixture or fittings.
2B117 Equipment and process controls, other than those specified by 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:
N.B.: SEE ALSO 2B219.
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 12,500 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;
Note: 2B119.a. does not apply to balancing machines designed or modified for dental or other medical equipment.
b. Indicator heads designed or modified for use with machines specified by 2B119.a.
Indicator heads are sometimes known as balancing instrumentation.
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.
Note 1: 2B120 does not apply to rotary tables designed or modified for machine tools or for medical equipment. For controls on machine tool rotary tables see 2B008.
Note 2: Motion simulators or rate tables specified by 2B120 remain controlled whether or not slip rings or integrated non‑contact devices are fitted at time of export.
2B121 Positioning tables (equipment capable of precise rotary positioning in any axes), other than those specified by 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.
Note: 2B121 does not apply to rotary tables designed or modified for machine tools or for medical equipment. For controls on machine tool rotary tables see 2B008.
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.
Note: Centrifuges specified by 2B122 remain controlled whether or not slip rings or integrated non‑contact devices are fitted at time of export.
2B201 Machine tools and any combination thereof, other than those specified by 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 turning, that have positioning accuracies with all compensations available better (less) than 6 μm according to ISO 230/2:2014 along any linear axis (overall positioning) for machines capable of machining diameters greater than 35 mm;
Note: 2B201.a. does not apply to bar machines (Swissturn), limited to machining only bar feed thru, if maximum bar diameter is equal to or less than 42 mm and there is no capability of mounting chucks. Machines may have drilling or milling capabilities for machining parts with diameters less than 42 mm.
b. 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 230/2:2014 or national equivalents along any linear axis; or
2. Two or more contouring rotary axes;
Note: 2B201.b. does not apply to milling machines having the following characteristics:
a. X‑axis travel greater than 2 m; and
b. Overall positioning accuracy on the x‑axis more (worse) than 30 µm.
c. 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 230/2:2014 or national equivalents along any linear axis; or
2. Two or more contouring rotary axes.
Note: 2B201.c. does not apply to the following grinding machines:
a. Cylindrical external, internal, and external‑internal grinding machines having all of the following characteristics:
1. Limited to a maximum workpiece capacity of 150 mm outside diameter or length; and
2. Axes limited to x, z and c;
b. Jig grinders that do not have a z‑axis or a w‑axis with an overall “positioning accuracy” less (better) than 4 µm according to ISO 230/2:2014 or national equivalents.
Note 1: 2B201 does not apply to special purpose machine tools limited to the manufacture of any of the following parts:
a. Gears;
b. Crankshafts or camshafts;
c. Tools or cutters;
d. Extruder worms.
Note 2: A machine tool having at least two of the three turning, milling or grinding capabilities (e.g., a turning machine with milling capability), must be evaluated against each applicable entry 2B001.a. or 2B201.a., b or c.
2B204 “Isostatic presses”, other than those specified by 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 by 2B204.a.
In 2B204 the inside chamber dimension is that of the chamber in which both the working temperature and the working pressure are achieved and does not include fixtures. That dimension will be the smaller of either the inside diameter of the pressure chamber or the inside diameter of the insulated furnace chamber, depending on which of the two chambers is located inside the other.
2B206 Dimensional inspection machines, instruments or systems, other than those specified by 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);
The E0,MPE of the most accurate configuration of the CMM specified according to ISO 10360‑2(2009) by the manufacturer (e.g., best of the following: probe, stylus length, motion parameters, environment) and with all compensations available shall be compared to the 1.7 + L/ 800 μm threshold.
b. Linear displacement measuring instruments, as follows:
1. Non‑contact type measuring systems with a “resolution” equal to or better (less) than 0.2 μm within a measuring range up to 0.2 mm;
2. Linear variable differential transformer (LVDT) systems having both of the following characteristics:
a. Having any of the following:
1. “Linearity” equal to or less (better) than 0.1% measured from 0 to the full operating range, for LVDTs with an operating range up to 5 mm; or
2. “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
b. Drift equal to or better (less) than 0.1% per day at a standard ambient test room temperature ± 1 K (± 1ºC);
3. Measuring systems having both of the following characteristics:
a. Containing a laser; and
b. Capable of maintaining for at least 12 hours, over a temperature range of ± 1 K (± 1ºC) around a standard temperature and a standard pressure:
1. A “resolution” over their full scale of 0.1 μm or better; and
2. With a “measurement uncertainty” equal to or better (less) than (0.2 + L/2000) μm (L is the measured length in millimeters);
Note: Item 2B206.b.3. does not apply to measuring interferometer systems, without closed or open loop feedback, containing a laser to measure slide movement errors of machine tools, dimensional inspection machines, or similar equipment.
In Item 2B206.b. ‘linear displacement’ means the change of distance between the measuring probe and the measured object.
c. Angular displacement measuring instruments having an “angular position deviation” equal to or better (less) than 0.00025°;
Note: Item 2B206.c. does not apply to optical instruments, such as autocollimators, using collimated light (e.g., laser light) to detect angular displacement of a mirror.
d. 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
2. “Angular position deviation” equal to or less than 0.02°.
Note 1: 2B206 includes machine tools, other than those specified by 2B201, that can be used as measuring machines if they meet or exceed the criteria specified for the measuring machine function.
Note 2: A machine specified by 2B206 is controlled if it exceeds the control threshold anywhere within its operating range.
All parameters of measurement values in 2B206 represent plus/minus i.e. not total band.
2B207 “Robots”, “end‑effectors” and control units, other than those specified by 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 by 2B207.a.
2B209 Flow forming machines, spin forming machines capable of flow forming functions, other than those specified by 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.
Note: 2B209.a. includes machines which have only a single roller designed to deform metal plus two auxiliary rollers which support the mandrel, but do not participate directly in the deformation process.
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 5,000 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. A minimum achievable residual specific unbalance equal to or less than 10 g 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).
Remote manipulators provide translation of human operator actions to a remote operating arm and terminal fixture. They may be of ‘master/slave’ type or operated by joystick or keypad.
2B226 Controlled atmosphere (vacuum or inert gas) induction furnaces, and power supplies therefor, as follows:
N.B.: SEE ALSO 3B.
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 by 2B226.a.
Note: 2B226.a. does not apply to furnaces designed for the processing of semiconductor wafers.
2B227 Vacuum or other controlled atmosphere metallurgical melting and casting furnaces and related equipment as follows:
a. Arc remelt furnaces, arc melt furnaces and arc melt and casting furnaces, having both of the following characteristics:
1. Consumable electrode capacities between 1,000 cm3 and 20,000 cm3; and
2. Capable of operating with melting temperatures above 1,973 K (1,700°C);
b. Electron beam melting furnaces, plasma atomisation furnaces and plasma 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 by 2B227.a. or b.
d. Plasma torches specially designed for the furnaces specified by 2B227.b. having both of the following characteristics:
1. Operating at a power greater than 50kW; and
2. Capable of operating above 1473 K (1200°C);
e. Electron beam guns specially designed for the furnaces specified by 2B227.b. operating at a power greater than 50kW.
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;
Note: 2B228.a. includes precision mandrels, clamps, and shrink fit machines.
b. Rotor straightening equipment for alignment of gas centrifuge rotor tube sections to a common axis;
In 2B228.b. such equipment normally consists of precision measuring probes linked to a computer that subsequently controls the action of, for example, pneumatic rams used for aligning the rotor tube sections.
c. Bellows‑forming mandrels and dies for producing single‑convolution bellows.
In 2B228.c. the bellows have all of the following characteristics:
1. Inside diameter between 75 mm and 400 mm;
2. Length equal to or greater than 12.7 mm;
3. Single convolution depth greater than 2 mm; and
4. Made of high‑strength aluminium alloys, maraging steel or high strength “fibrous or filamentary materials”.
2B230 All types of “pressure transducers” capable of measuring absolute pressures and having all of the following characteristics:
a. Pressure sensing elements made of or protected by aluminium, aluminium alloy, aluminium 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, aluminium 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 measuring at 13 kPa.
For the purposes of 2B230, ‘accuracy’ includes non‑linearity, hysteresis and repeatability at ambient temperature.
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.
1. The pumping speed is determined at the measurement point with nitrogen gas or air.
2. The ultimate vacuum is determined at the input of the pump with the input of the pump blocked off.
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.
Note: This item does not apply to guns specially designed for high velocity weapon systems.
2B233 Bellows‑sealed scroll‑type compressors and bellows‑sealed scroll‑type vacuum pumps having all of the following characteristics:
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.
1. In a scroll compressor or vacuum pump, crescent‑shaped pockets of gas are trapped between one or more pairs of intermeshed spiral vanes, or scrolls, one of which moves while the other remains stationary. The moving scroll orbits the stationary scroll; it does not rotate. As the moving scroll orbits the stationary scroll, the gas pockets diminish in size (i.e., they are compressed) as they move toward the outlet port of the machine.
2. In a bellows‑sealed scroll compressor or vacuum pump, the process gas is totally isolated from the lubricated parts of the pump and from the external atmosphere by a metal bellows. One end of the bellows is attached to the moving scroll and the other end is attached to the stationary housing of the pump.
3. Fluoropolymers include, but are not limited to, the following materials:
a. Polytetrafluoroethylene (PTFE),
b. Fluorinated Ethylene Propylene (FEP),
c. Perfluoroalkoxy (PFA),
d. Polychlorotrifluoroethylene (PCTFE); and
e. Vinylidene fluoride‑hexafluoropropylene copolymer.
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 (20,000 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:
3. Glass (including vitrified or enamelled coating or glass lining);
b. Agitators designed for use in reaction vessels or reactors specified by 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:
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:
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:
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:
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
2. Nickel or alloys with more than 40% nickel by weight;
g. Valves with a ‘nominal size’ greater than 10mm (3/8”) and casings (valve bodies) or preformed casing liners designed for such valves, 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:
9. Ceramic materials as follows:
a. Silicon carbide with purity of 80% or more by weight;
b. Aluminium oxide (alumina) with purity of 99.9% or more by weight;
c. Zirconium oxide (zirconia);
For the purposes of 2B350.g, the ‘nominal size’ is defined as the smaller of the inlet and outlet port diameters.
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:
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); 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:
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;
For the purposes of 2B350.i., the term seal refers to only those seals that come into direct contact with the chemical(s) being processed (or are designed to), and provide a sealing function where a rotary or reciprocating drive shaft passes through a pump body.
j. Incinerators designed to destroy chemicals specified in ML7 or 1C350, or chemical munitions, having specially designed waste supply systems, special handling facilities and an average combustion chamber temperature greater than 1,273 K (1,000oC), 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.
k. Prefabricated repair assemblies designed for items specified by 2B350.a.3. or 2B350.c.3., having all of the following, and specially designed components therefor:
1. Designed for mechanical attachment to the glass‑lining; and
2. Metallic surfaces that come in direct contact with the chemical(s) being processed which are made from tantalum or tantalum alloys.
Note: For the purposes of 2B350, the materials used for gaskets, packing, seals, screws, washers or other materials performing a sealing function do not determine the status of control, provided that such components are designed to be interchangeable.
1. For the purposes of 2B350.d., 2B350.e., 2B350.h., and 2B350.i., ‘carbon graphite’ is a composition consisting of amorphous carbon and graphite, in which the graphite content is eight percent or more by weight.
2. For the listed materials in the above entries, the term ‘alloy’ when not accompanied by a specific elemental concentration is understood as identifying those alloys where the identified metal is present in a higher percentage by weight than any other element.
2B351 Toxic gas monitoring systems and their dedicated detecting components, other than those specified by 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 by 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:
N.B.: SEE ALSO 9A350 FOR SPRAYING AND FOGGING SYSTEMS.
a. Containment facilities and related equipment, as follows:
1. Complete containment facilities that meet the criteria for P3 or P4 (BL3, BL4, L3, L4) containment as specified in the WHO Laboratory Biosafety Manual (3rd edition, Geneva, 2004);
2. Equipment designed for fixed installation in containment facilities specified by 2B352.a.1., as follows:
a. Double‑door pass‑through decontamination autoclaves;
b. Breathing air suit decontamination showers;
c. Mechanical‑seal or inflatable‑seal walkthrough doors.
b. Fermenters and components thereof, as follows:
1. Fermenters capable of cultivation of “microorganisms” or of live cells for the production of viruses or toxins, without the propagation of aerosols, having a total capacity of 20 litres or more;
2. Components designed for fermenters specified by 2B352.b.1., as follows:
a. Cultivation chambers designed to be sterilised or disinfected in situ;
b. Cultivation chamber holding devices; or
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).
Fermenters include bioreactors (including single‑use (disposable) bioreactors), chemostats and continuous‑flow systems.
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;
Centrifugal separators include decanters.
d. Cross (tangential) flow filtration equipment and related components, as follows:
1. Cross (tangential) flow filtration equipment capable of separation of micro‑organisms, viruses, toxins or cell cultures having all the following characteristics:
a. A total filtration area equal to or greater than 1 square metre; 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.
In 2B352.d.1.b. ‘sterilised’ denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g. steam) or chemical agents. Disinfected denotes the destruction of potential microbial infectivity in the equipment through the use of chemical agents with a germicidal effect. Disinfection and sterilisation are distinct from sanitisation, the latter referring to cleaning procedures designed to lower the microbial content of equipment without necessarily achieving elimination of all microbial infectivity or viability.
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 square metres for each component and designed for use in cross (tangential) flow filtration equipment specified by 2B352.d.;
Note: 2B352.d. does not apply to reverse osmosis equipment or hemodialysis equipment, as specified by the manufacturer.
e. Steam, gas or vapour sterilisable freeze‑drying equipment with a condenser capacity exceeding 10 kg of ice 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;
Note: 2B352.f.1. does not apply to suits designed to be worn with self‑contained breathing apparatus.
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;
Note 1: 2B352.f.2. includes class III biosafety cabinets, as described in the latest edition of the WHO Laboratory Biosafety Manual or constructed in accordance with national standards, regulations or guidance.
Note 2: 2B352.f.2. does not include isolators specially designed for barrier nursing or transportation of infected patients.
g. Aerosol inhalation equipment designed for aerosol challenge testing with “microorganisms”, “viruses” or “toxins” as follows:
1. Whole‑body exposure chambers having a capacity of 1 cubic metre or greater;
2. Nose‑only exposure apparatus or closed animal restraint tubes designed for use with such apparatus, utilising directed aerosol flow and having capacity for exposure of 12 or more rodents, or 2 or more animals other than rodents;
h. Spray drying equipment capable of drying toxins or pathogenic microorganisms having all of the following characteristics:
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 micrometers 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;
i. Nucleic acid assemblers and synthesizers, which are partly or entirely automated, and designed to generate continuous nucleic acids greater than 1.5 kilobases in length with error rates less than 5% in a single run.