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Part 3AMENDMENTS TO COUNCIL REGULATION (EC) NO 428/2009

Amendments to Category 2 - Materials Processing

regulation 10 10.—(1) The section headed Category 2 - Materials Processing is amended as follows.

(2) In the section headed 2B Test, Inspection and Production Equipment—

regulation 10 2 a (a)in entry 2B001.b.4.a.—

regulation 10 2 a i (i)for ““run-out”” substitute “‘run-out’”;

regulation 10 2 a ii (ii)for ““camming”” substitute “‘camming’”;

regulation 10 2 b (b)after entry 2B001.b.4.b., insert—

“Technical Notes:
For the purposes of 2B001.b.4.a.:
1.‘Run-out’ (out-of-true running) is the radial displacement in one revolution of the main spindle measured in a plane perpendicular to the spindle axis at a point on the external or internal revolving surface to be tested (ISO 230-1:2012).
2.‘Camming’ (axial displacement) is axial displacement of one revolution of the main spindle measured in a plane perpendicular to the spindle faceplate, at a point next to the circumference of the spindle faceplate (ISO 230-1:2012).”;

regulation 10 2 c (c)in entry 2B001.c.2.c., for “4 m.” substitute “4 m;”;

regulation 10 2 d (d)in the Note to entry 2B001.c.2.c., for “length.” substitute “length;” and for “1,1 μm.” substitute “1,1 μm;”;

regulation 10 2 e (e)in entry 2B001.d., for “Electrical discharge machines” substitute “Electrical Discharge Machines”;

regulation 10 2 f (f)in entry 2B002.d.—

regulation 10 2 f i (i)for “Magnetorheological finishing” substitute “‘Magnetorheological finishing’”;

regulation 10 2 f ii (ii)for “Electrorheological finishing” substitute “‘Electrorheological finishing’”;

regulation 10 2 g (g)in the N.B. at the end of entry 2B004, after “tooling” insert “,”;

regulation 10 2 h (h)in entry 2B006.b.3.c—

regulation 10 2 h i (i)for ““measurement uncertainty”” substitute “‘measurement uncertainty’”;

regulation 10 2 h ii (ii)after “0,01°C;” omit “or”;

regulation 10 2 i (i)in the Note at the end of entry 2B006.d., for “2B006” substitute “2B006.a.”;

regulation 10 2 j (j)for entry 2B352.c., including the Technical Note, substitute—

“c.Centrifugal separators as follows:
1.Centrifugal separators, capable of continuous separation without the propagation of aerosols, having all the following:
a.Flow rate exceeding 100 litres per hour;
b.Components of polished stainless steel or titanium;
c.One or more sealing joints within the steam containment area; and
d.Capable of in-situ steam sterilisation in a closed state;
2.Single-use centrifugal separators, in which all components that come in direct contact with the substances being processed are disposable or single-use.
Technical Note:
Centrifugal separators and single-use centrifugal separators include decanters.”;

regulation 10 2 k (k)after entry 2B352.i., insert—

“j.Peptide synthesizers that are partly or entirely automated and capable of generating peptides at a ‘system synthesis scale’ of 1 mmol or greater.
Technical note:
‘System synthesis scale’ denotes the maximum amount of peptide (mmol) that can be produced by the instrument using the largest compatible reaction vessels. For multiple peptides produced in parallel, this is the sum of the largest compatible reaction vessels.
N.B.: For other chemical reaction vessels or reactors, see 2B350.”.

(3) In the section headed 2D Software, in Note 2 to entry 2D002—

regulation 10 3 a (a)for “See 2D001 and 2D003 for” substitute “ For”;

regulation 10 3 b (b)after “in 2B002” insert “, see 2D001 and 2D003”.

(4) In the section headed 2E Technology—

regulation 10 4 a (a)in the Note to entry 2E001 for “coordinate measurement machines” substitute “Coordinate Measuring Machines (CMM)”;

regulation 10 4 b (b)in the Technical Note to the table (Deposition techniques) that appears after entry 2E301—

regulation 10 4 b i (i)in paragraph a—

regulation 10 4 b i aa (aa)for “ N.B.1 ” substitute “ N.B.1. ”;

regulation 10 4 b i bb (bb)for “ N.B.2 ” substitute “ N.B.2. ”;

regulation 10 4 b i cc (cc)for “ N.B.3 ” substitute “N.B.3.”;

regulation 10 4 b ii (ii)in paragraphs d and f—

regulation 10 4 b ii aa (aa)for “ N.B.1 ” substitute “N.B.1.”;

regulation 10 4 b ii bb (bb)for “ N.B.2 ” substitute “N.B.2.”.