08.03.2007
With the coming into force of the new Measuring Instruments Directive 2004/22/EC (MID) on 31 March 2004, Working Group 1.13 of PTB set out to prepare itself for the new development - thus already long before the planned Europe-wide implementation of this directive by 30 October 2006. At the beginning of 2005, information letters were sent out to approx. 100 manufacturers of weighing instruments in which the date 30-10-2006 was pointed out to them and in which they were asked for timely submissal of their applications. All in all, 63 applications were submitted before 30 October 2006. Although some of them were withdrawn later on and others had to be rejected, more than twenty Type Examination Certificates could be issued punctually by 30 October 2006 or in the course of the following month.
Before any Type Examination Certificates could be issued according to MID, several difficulties had to be overcome. Basically, these consisted in: a lack of clarity concerning the testing severance in EMC tests; the treatment of software; the question as to how to ensure consistent production (MID, Annex B, No. 4.6); and the question as to how the Type Examination Certificate itself should be drawn up. Furthermore, with regard to the carrying out of technical audits in accordance with Annex H1 of the MID, the PTB staff entered completely unknown territory.
In the meetings within the framework of the WELMEC Working Group 2 (WELMEC = European Legal Metrology Cooperation) it was decided to require for all automatic weighing instruments the severity level according to OIML R51/2006 (OIML = Organisation Internationale de Métrologie Légale) during the EMC tests. Although for software testing, WELMEC-Guide 7.2 (which is intended specially for this purpose) served as a basis, it was carried out much more in accordance with the essential requirements of No. 8 of Annex I of the MID. To determine the capability of the manufacturer to ensure a consistent production, Working Group 1.13 drew up a list of 10 core questions for the manufacturer which has meanwhile proved its worth. The question as to how the Type Examination Certificate itself should be drawn up led in some points to discussions with the Certification Body for Measuring Instruments (ZS-M) within PTB because - due to their frequently modular design - weighing instruments are not “manufactured” until they have reached the installation site. This has to be taken into consideration in the chapter “Requirements for production” which is envisaged for this purpose. In the case of other measuring instruments, however, conditions relating to the installation site would usually fall under the chapter “Requirements for using the instrument”.
The audits which served to assess the entire quality management system of the manufacturer under MID aspects according to Annex H1 - involving representatives of the verification authorities as sub-contractors of PTB - resulted in the issuing of two certificates on the recognition of the quality management system.
Despite all initial difficulties and the fears on the part of not a few persons involved - i.e. that it would not be possible to issue Type Examination Certificates in time (by the deadline of 30 October 2006) - the implementation of the MID was achieved most satisfactorily. Meanwhile, applications for first revisions of Type Examination Certificates have arrived, a fact which demonstrates the dynamic developments that are taking place in the field of automatic weighing instruments.
Contact person:
Karsten Schulz, FB 1.1, AG 1.13, e-mail: karsten.schulz@ptb.de