- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol). This item of legislation is currently only available in its original format.
8. Every capacity measure submitted for testing shall be in a clean condition.
9. Subject to regulation 12, 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, either—
(i)volumetrically, by comparison with one or more Northern Ireland local standards or Northern Ireland working standards, or by means of appropriate testing equipment; or
(ii)gravimetrically, by determining the weight of water of known density using a suitable weighing machine.
10.—(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.
11.—(1) The 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 by comparison with one or more Northern Ireland local standards (other than a brim measure made of metal); or
(c)by means of a peristaltic pump dispenser.
(2) In this regulation “peristaltic pump dispenser” means a device, operating on the peristaltic principle, designed to deliver a known quantity of water for the testing of dispensing measures for pharmaceutical purposes.
12.—(1) Where—
(a)a group of capacity measures of the same nominal capacity and the same manufacture is submitted for testing; and
(b)the conditions specified in paragraph (2) 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).
(2) The conditions referred to in paragraph (1)(b) 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) 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) or, if the submitter so requests, with paragraph (5).
(4) The sample of measures shall be selected in accordance with BS 6001: Part 1: 1991, and 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) and in accordance with BS 6002: 1993.
(5) 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) which the inspector considers to be representative, shall be tested gravimetrically as described in regulation 9(c) and in accordance with BS 6002: 1993.
(6) Under each of paragraphs (4) and (5), the test shall provide an acceptable quality level equal to 1 per cent.
(7) If the sample selected as specified in paragraph (3) satisfies the test specified in paragraph (4) or both the tests specified in paragraph (5), the other measures in the group shall be treated as having satisfied the test or tests as the case may be.
13.—(1) In relation to capacity measures imported into Northern Ireland from another member State or from an EEA State, subject to paragraph (4), an inspector shall not carry out any test in accordance with the provisions of regulations 8 to 12 if, together with the capacity measures being so imported, he is presented with the requisite documentation.
(2) In this regulation and in regulation 16 “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 and stating which tests have been applied to them; and
(b)the test results relating to those tests.
(3) A body is an “approved body” for the purpose of this regulation if it is a body in a member State or in an EEA State which has the responsibility in that State for metrological control of capacity measures or is a laboratory which has been accredited in a member State or an EEA State as being a body which conforms with the criteria set out in EN 45001(1).
(4) Nothing in these Regulations shall prevent an inspector testing in accordance with regulations 8 to 12 where he is not satisfied—
(a)as to the authenticity of the test report or the results presented to him; or
(b)that the test results presented to him are results which in fact relate to the capacity measures being imported.
14. For the purposes of the performance by an inspector of his functions under the Order 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, make available for the inspector’s use such material as the inspector may reasonably require, and any material so made available shall be returned to the person in question.
EN 45001 is a European Standard which has the status of a British Standard; it is identical with BS 7501 (ISBN 0 580 17939 7), “General criteria for the operation of testing laboratories”
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
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