RISE offers evaluation of software in measuring instruments with regard to risks for incorrect measurements and measured values. The EU Directive for Measuring Instruments (MID) and guidelines from the WELMEC co-operation are the basis for the evaluation work.
Measuring instruments used in sales to private individuals in Europe must meet EU requirements. It is important that the measuring instruments are quality assured and provide reliable measurement results. The requirements are described in the Measuring Instruments Directive, 2014/32 / EU (MID). The MID includes various types of measuring instruments such as water meters, gas meters, electricity meters, heat meters, measurement systems for liquids other than water (such as petroleum pumps), automatic weighing instruments and taximeters. For non-automatic weighing instruments, there is a separate directive, 2014/31/EU (NAWI).
An approved test of a measuring instrument and the preparation of a certificate according to MID, opens up a market across the EU to the manufacturer. The approval procedure includes an evaluation of the software according to WELMEC Guide 7.2, or WELMEC Guide 2.3 (for non-automatic weighing instruments).
An approved test of a measuring instrument and the preparation of a certificate according to MID, opens up a market across the EU to the manufacturer. A RISE certificate is sufficient for marketing in all EU countries.
An accredited software test report can also be used by many national authorities outside Europé.
The software evaluation at RISE follows the guidelines in WELMEC Guide 7.2, OIML D31 and OIML R117. We work with design reviews, document reviews and functional tests. Long-term storage of measurement data, transfer of data, separation of the various parts of the software and download of legally relevant software are specially examined.
For non-automatic scales, the RISE follows the guidelines in WELMEC Guide 7.5. The protection of the software, the interfaces of the software and the identification of the software are specially examined. We work with design reviews, document reviews and functional tests.
RISE reviews, according to Welmec Guide 7.6, that the risk analysis for the measuring instrument deals with protective assets, consequences of a fault, threats, attack vectors and techniques for reducing the risks. We work with design reviews and document Reviews.
The result of the RISE evaluation of software in measuring instruments or risk analysis assessment, is reported in a written report. The reports are part of the documentation needed to be able to issue a MID certificate for the measuring instrument.
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Evaluation of software in measuring instruments according to WELMEC Guide 7.2, 7.5 and 7.6
WELMEC Guide 7.2, Software Guide (Measuring Instruments Directive 2014/32/EU1) See WELMEC Guide 7.2 v2020
WELMEC Guide 7.5, Guide for Examining Software (Non-automatic Weighing Instruments) See WELMEC Guide 7.5 v2020
WELMEC Guide 7.6, Guide for Software Risk Assessment for Measuring Instruments. See WELMEC GUIDE 7.6 v2021
Software Risk Assessment, Annex A. See WELMEC Guide 7.6 v2021, Annex_A
Price on tender
The delivery time depends on whether the software for the measuring instrument is written before the evaluation is started, or if the evaluation is done in parallel with parts of the development work.
The manufacturer needs to compile documentation showing how the requirements of the WELMEC guide are met. For WELMEC Guide 7.2, it is especially important that documentation according to requirement U1 or P1 is available.
The basis for the risk analysis shall be according to Welmec Guide 7.6 and at least contain Annex A including an assessment whether instrument specific attack vectors need to be defined, a description of the measuring instrument, method of use and environment. The risk analysis itself must describe, among other things, what should be protected, the consequences of identified, probability of failure and what techniques have been taken to reduce the risks.