The new European software guide for legal metrology: Basic principles

The European guideline WELMEC 7.2 “Software Guide (Measuring Instruments Directive 2004/22/EC)” has recently been adopted. It contains requirements and validation recommendations for software in measuring instruments subject to regulations in the Measuring Instruments Directive (MID). The definition...

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Published inComputer standards and interfaces Vol. 28; no. 3; pp. 270 - 276
Main Authors Richter, Dieter, Grottker, Ulrich, Talebi, Daryoush, Schwartz, Roman
Format Journal Article
LanguageEnglish
Published Elsevier B.V 2006
Subjects
Online AccessGet full text
ISSN0920-5489
1872-7018
DOI10.1016/j.csi.2005.07.005

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Abstract The European guideline WELMEC 7.2 “Software Guide (Measuring Instruments Directive 2004/22/EC)” has recently been adopted. It contains requirements and validation recommendations for software in measuring instruments subject to regulations in the Measuring Instruments Directive (MID). The definition of software requirements is derived from essential MID requirements and is based on type-independent configurations of instruments and on risk classes. The definition is completed by instrument-specific requirements. Configurations of measuring instruments are divided into basic configurations of measuring instruments and extended IT configurations. Furthermore, the requirements are differentiated according to risk classes introduced in the guide. The methodology developed is applicable not only to the originally intended category of instruments, namely measuring instruments regulated by the MID, but also to far more classes of measuring instruments.
AbstractList The European guideline WELMEC 7.2 “Software Guide (Measuring Instruments Directive 2004/22/EC)” has recently been adopted. It contains requirements and validation recommendations for software in measuring instruments subject to regulations in the Measuring Instruments Directive (MID). The definition of software requirements is derived from essential MID requirements and is based on type-independent configurations of instruments and on risk classes. The definition is completed by instrument-specific requirements. Configurations of measuring instruments are divided into basic configurations of measuring instruments and extended IT configurations. Furthermore, the requirements are differentiated according to risk classes introduced in the guide. The methodology developed is applicable not only to the originally intended category of instruments, namely measuring instruments regulated by the MID, but also to far more classes of measuring instruments.
The European guideline WELMEC 7.2 'Software Guide (Measuring Instruments Directive 2004/22/EC)' has recently been adopted. It contains requirements and validation recommendations for software in measuring instruments subject to regulations in the Measuring Instruments Directive (MID). The definition of software requirements is derived from essential MID requirements and is based on type-independent configurations of instruments and on risk classes. The definition is completed by instrument-specific requirements. Configurations of measuring instruments are divided into basic configurations of measuring instruments and extended IT configurations. Furthermore, the requirements are differentiated according to risk classes introduced in the guide. The methodology developed is applicable not only to the originally intended category of instruments, namely measuring instruments regulated by the MID, but also to far more classes of measuring instruments.
Author Talebi, Daryoush
Grottker, Ulrich
Schwartz, Roman
Richter, Dieter
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Issue 3
Keywords Software guide
Software validation
Software requirements
Legal metrology
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References Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on Measuring Instruments (”The Measuring Instruments Directive”), Download from
Guide for Examining Software (Weighing Instruments). WELMEC 2.3 (Issue 2), 2002
MID-Software: Software Requirements and Validation Guide, Version 1.0, 29 October 2004, available for download at
WELMEC Guide 7.2: Software Guide (Measuring Instruments Directive 2004/22/EC), available for download at
Guide for modular approach and testing of PCs and other digital peripheral devices (Non-automatic Weighing Instruments). WELMEC 2.5 (Issue 2), 2000.
Software Requirements on the Basis of the Measuring Instruments Directive. WELMEC Guide 7.1 (Issue 1), 1999.
J. Jacobsen “Validation of software in measuring instruments”, in this journal.
Grottker, Schwartz (bib7) 2003; 44
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Grottker (10.1016/j.csi.2005.07.005_bib7) 2003; 44
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– reference: Guide for modular approach and testing of PCs and other digital peripheral devices (Non-automatic Weighing Instruments). WELMEC 2.5 (Issue 2), 2000.
– reference: WELMEC Guide 7.2: Software Guide (Measuring Instruments Directive 2004/22/EC), available for download at
– reference: Software Requirements on the Basis of the Measuring Instruments Directive. WELMEC Guide 7.1 (Issue 1), 1999.
– reference: J. Jacobsen “Validation of software in measuring instruments”, in this journal.
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– reference: MID-Software: Software Requirements and Validation Guide, Version 1.0, 29 October 2004, available for download at
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SubjectTerms Legal metrology
Software guide
Software requirements
Software validation
Title The new European software guide for legal metrology: Basic principles
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