manfred kochsiek wilfried schulz physikalisch-technische bundesanstalt braunschweig und berlin...
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Manfred KochsiekWilfried Schulz
Physikalisch-Technische BundesanstaltBraunschweig und Berlin
Modernisation of Legal Metrology in Germany
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Content
• Legal Metrology in Germany
• Political, economic and technical developments
• Principles of the Measuring Instruments Directive (MID)
• Conformity assessment
• Requirements for notified bodies
• National changes• Consequences for PTB and verification
authorities
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Legal Metrology in Germany
Basis
• European Directives
• National Law on Metrology and Verification
Fields of application
• Commercial transactions
• Official transactions
• Environment
• Labour
• Health
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Legislation for Metrology
Responsible Body
Parliament
Federal Ministry
Regulation
National Law• Metrology and Verification
Act• Units of Measurement Act
Ordinance• Metrology and Verification• Pre-packages• Fees
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Type approvalCalibration of standardsConsultancy for the authorities
PTB
Responsible Body Main tasks
Enforcement of legal metrology today
Verification offices
Approved testinglaboratories
Initial verification and subsequent verification(electricity, gas, water, heat)
Initial verificationPeriodic re-verificationMarket surveillanceApproval of testing laboratories
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Political, economic and technical developments
• Measuring Instruments Directive 2004/22/EEC (MID)
• Liberalization of the markets (energy)
• Private bodies for testing and assessment of instruments
• Software-controlled instruments
• Measuring data transfer in in open systems
• Remote displays without access to the consumer
• Measuring systems with exchangeable components
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Principles of the Measuring Instruments Directive 2004/22/EC (MID)
• Free movement of measuring instruments
• Requirements up to placing on the market
• Essential requirements for measuring instruments
• Presumption of conformity for compliance with harmonised EN or OIML-IR
• Conformity assessment procedures
• Notified bodies
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• Water meters• Gas meters and volume conversion devices• Active electrical energy meters• Heat meters• Measuring systems for liquids other than
water• Automatic weighing instruments• Taximeters• Material measures• Dimensional measuring instruments• Exhaust gas analysers
Instruments covered by MID
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The MID does not prescribe:
• Legal metrological control
• Legal status of the notified bodies
• Requirements for instruments after putting into use
• Maximum permissible error in service
• Subsequent verification
• Period of validity for conformity assessment
• Fees
Subject to national legal control
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European Law
• All instruments covered by MID• Non-automatic weighing instruments (NAWI)
German Law (Examples):
• Electricity meters for U <= 123 kV
• Instruments for speed control
• Breath analysers
• Sound level meters
• Radiation protection measuring instruments
Instruments subject to legal control
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MID-Conformity assessment
Product verification (F)
QM-systemProduction (D)
CompleteQM-system
Final product
Conformity assessment + markings
Conformity assessment procedureManufacturing process
Module B+F Module B+D Module H1
Design Prototype
Type Type evaluation (B)
Type evaluation (B)
Serial production
Design examination
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MID Annexes MI-001...MI-010
Instrument specific
requirements
Annexes MI-001...MI-010
Instrument specific
requirements
Article1 to 27Article1 to 27
Annexes of the OrdinanceAnnexes of the Ordinance
Metrology ActMetrology Act
National transposition
Annex IAnnexes A -H1
Horizontal
requirements
Annex IAnnexes A -H1
Horizontal
requirements
Metrology OrdinanceMetrology Ordinance
Transposition of the MID into national law
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1) “Old Approach” - Directives (1971 – 1986)2) Directive on Non-automatic weighing
instruments (1990)3) MID Instruments (2006)
Legal frame in Germany
4) German Law on Metrology and Verification (2006)
4 Categories of regulations as from 30 October 2006
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German legislation takes account of
• Complex measuring systems in open networks
• Software requirements and testing of software
• Distinction of measuring instrument, measuring system, sub-assembly and peripheral equipment
• Measuring instruments and measuring systems with separate displays
• Correct measurements not only measuring instruments
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• MID-conformity assessment procedures also applicable to devices subject to national legal control
• MID-conformity assessment by Notified Bodies (NB)
• National conformity assessment by Conformity assessment Body (CAB)
• Requirements for CAB and NB equivalent
National and EC requirements harmonized
≡
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Privatisation of conformity assessment
• Private Notified Bodies (NAWI and MID) possible
• Private CABs (national) possible
• Stronger involvement of private bodies for subsequent verification, e.g. weighing instruments
• Private bodies shall be independent from development, production and repair of the instruments
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• Periodical subsequent verification to ensure durability
• Subsequent verification for all instruments
• MPE in service = 2 x MPE for initial verification
• Sampling procedures for re-verification possible
• Metrological surveillance
Measures after putting into use
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Metrological surveillance
• Obligation for users to notify their instruments
• Metrological surveillance under the responsibility of the verification authorities
a) Market surveillance of measuring instruments after placing on the market
b) Surveillance of the users of measuring instruments
c) Surveillance of private bodies
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Metrological surveillance
Target group
Requirements for the use of instrument
Surveillance of the user
Requirements for placing on the
market
User of the instrument
Market surveillance
Manufacturer
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Effects on the verification authorities
• Decreasing number of initial verifications as a consequence of the MID
• Decreasing number of re-verifications as a national political consequence
• Considerable loss of fees and staff cuts
• Strengthening of market surveillance
• Surveillance of private bodies
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Effects on PTB
• Role as Notified Body for the MID-modules B, D and H1
• Type examinations and design examinations (B, H1)
• Approval and surveillance of QM-systems (D, H1)
• Competition with NB in other European countries
• Competition with national bodies (if there are candidates)
• PTB designated as co-ordinator of national bodies
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Transitional period
• Previous national approvals valid until 30.10.2016
• National initial verifications valid until 30.10.2016
• EEC-approvals are valid according to validity of approval
• EEC-initial verifications valid until expiring date
• Amendments of approvals (national) until 30.10.2016
• Re-verifications possible for an unlimited period
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Co-operation with the EU Commission:
• Determination of the normative documents (OIML IR)
• Harmonization of notified bodies
• Information exchange concerning market surveillance
• Elaboration of WELMEC-guidelines endorsed by the EU Commission
WELMEC
European cooperation in legal metrology
Harmonization of MID-application
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