PART IIITESTING
Capacity measures for testing to be cleanI48
Every capacity measure submitted for testing shall be in a clean condition.
Method of testing of capacity measuresI59
Subject to regulation 12 below, the inspector shall test every capacity measure—
a
by trial for use in the manner in which it is to be used as a measure, either for holding or for delivering its contents;
b
by using—
i
where practicable, water or an intended liquid of use, or
ii
in the case of a dry capacity measure where the use of a liquid is impracticable, seeds, glass beads or polystyrene beads of an appropriate and regular size, proper precautions being taken to achieve reliable and consistent results; and
c
subject in the case of dispensing measures for pharmaceutical purposes to regulation 11 below, either—
i
volumetrically, by comparison with one or more local or working standards or by means of appropriate testing equipment which complies with the requirements of the Weights and Measures (Local and Working Standard Capacity Measures and Testing Equipment) Regulations 199011; or
ii
gravimetrically, by determining the weight of water of known density using a suitable weighing machine.
Testing of nominal capacity and scale marks of capacity measuresI610
1
The inspector shall test the nominal capacity and all the scale marks or, in the case of a graduated measure, such of them as he considers necessary.
2
The capacity of a measure shall be the volume at 20 °C when the measure is on a horizontal surface and—
a
in the case of a line measure, the bottom part of the meniscus coincides with the top of the line, or
b
in the case of a brim measure, the surface of the liquid is in the same plane as the brim.
Testing of dispensing measures for pharmaceutical purposesI111
F1The inspector shall test every dispensing measure for pharmaceutical purposes either—
a
in accordance with the requirements of BS 6696: 1986, using a suitable weighing machine; or
b
volumetrically—
i
by comparison with one or more local standards (other than a brim measure made of metal), or
ii
by means of a peristaltic pump dispenser which complies with the requirements of the Weights and Measures (Local and Working Standard Capacity Measures and Testing Equipment) Regulations 1990.
Testing of groups of capacity measuresI212
1
Where—
a
a group of capacity measures F2of the same nominal capacity and the same manufacture is submitted for testing; and
b
the conditions specified in paragraph (2) below are satisfied with respect to the group,
the inspector may, at the request of the person submitting them (“the submitter”), confine the testing to a number of measures determined and selected as specified in paragraph (3) below.
2
The conditions referred to in paragraph (1)(b) above are that—
a
the group shall be clearly identifiable and shall comprise more than 500 but not more than 150,000 measures;
b
the measures in the group shall all have been produced by the same production process; and
c
the group shall be accompanied by records of the production process and of any subsequent action taken by the manufacturer which are adequate to show that the measures in the group are likely to fall within the prescribed limits of error.
3
The number of measures referred to in paragraph (1) above shall be determined, and the measures shall be selected, by sampling plans and procedures using samples which the inspector considers to be representative; and the sample of measures shall be tested, in accordance either with paragraph (4) below or, if the submitter so requests, with paragraph (5) below.
4
Under this paragraph the sample of measures—
a
shall be selected F3... in accordance with BS 6001: Part 1: 1991; and
b
shall be tested for all the appropriate requirements of these Regulations, including limits of error on capacity conducted either volumetrically or gravimetrically as described in regulation 9(c) above and in accordance with BS 6002: 1993.
5
Under this paragraph the sample of measures shall be selected in accordance with BS 6001: Part 1: 1991 and—
a
the sample shall be tested for all the appropriate requirements of these Regulations except limits of error on capacity; and
b
a sub-sample of the measures selected under paragraph (3) above which the inspector considers to be representative, shall be tested gravimetrically as described in regulation 9(c) above and in accordance with BS 6002: 1993.
6
Under each of paragraphs (4) and (5) above, the test shall provide an acceptable quality level equal to 1 per cent.
7
If the sample selected as specified in paragraph (3) above satisfies the test specified in paragraph (4) above or both the tests specified in paragraph (5) above, the other measures in the group shall be treated as having satisfied the test or tests as the case may be.
Capacity measures imported from F5a member State or EEA StateI313
1
In relation to capacity measures imported into Great Britain from F6a member State or an EEA State, subject to paragraph (4) below, an inspector shall not carry out any test in accordance with the provisions of regulations 8 to 12 above if, together with the measures being imported, he is presented with the requisite documentation.
2
In this regulation and in regulation 16 below “requisite documentation” means—
a
the test report of an approved body that the capacity measures which are the subject of that report have been tested on the same basis as those set out in regulations 8 to 12 above and stating which tests have been applied to them; and
b
the test results relating to those tests.
F43
A body is an “approved body” for the purposes of this regulation if it is a body in a member State or in an EEA State which has responsibility in that State for metrological control of capacity measures or is a laboratory which has been accredited for the purposes of testing capacity measures in a member State or in an EEA State as being a body which conforms with the criteria set out in BS EN ISO/IEC 17025:2000.
4
Nothing in these Regulations shall prevent an inspector testing in accordance with regulations 8 to 12 above where he is not satisfied—
a
that the test report or the results presented to him are authentic; or
b
that the test results presented to him are results which in fact relate to the capacity measures being imported.
Provision of material for inspector’s useI714
For the purposes of the performance by an inspector of his functions under the Act or these Regulations relating to inspection, testing, passing as fit for use for trade and stamping of any capacity measure, a person submitting such a measure to an inspector or who an inspector has reasonable cause to believe has possession of such a measure for use for trade shall, if requested, provide for the inspector’s use such material as the inspector may reasonably require, and any material so provided shall be returned to the person in question.