Administrative Schritte zu Konformitätsuntersuchungen. in Zeiten der Globalisierung Beispiel China

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1 PTB Seeon 9. Internationale EMATEM Sommerschule Administrative Schritte zu Konformitätsuntersuchungen in Zeiten der Globalisierung Beispiel China Dr. Jürgen Rose Fachbereich Wärme und Vakuum, Leiter AG Messung thermischer Energie juergen.rose@ptb.de

2 PTB Conformity assessments of heat meters, sub-assemblies and combinations thereof according to European Directive on Measuring Instruments (MID) Dr. Jürgen Rose, Department Heat and Vacuum of PTB, Head of Working Group Thermal Energy Measurement Head of CEN TC 176 WG2, Member TC 11 OIML, WELMEC WG 11 Head of German WG Heat Metering

3 Topics PTB Presentation I What is National Metrology Institute of Germany Consumption heat meters in Europe Presentation II Trends in heat metering processes Presentation III Basic for selling of consumption meters in Europe: Conformity Assessments according to European Directive on Measuring Instruments (MID) Presentation IV Testing Procedures and Harmonized Standards Estimation of measurement uncertainties Presentation V Notified Bodies in Europe Administrative steps to get EC-Type Examination Certificate for MID - Module B (e.g. at PTB)

4 Look at PTB internet homepage - Certification body -

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6 Main steps - conformity assessments at Notified Body PTB 1. Fill application for Conformity Assessement according to MID - Module B, formless, with your official signature, signet and with declaration, that only PTB will be charged as Notified Body, briefly introduce the meter All this send through the post to official address: Dr. Harry Stolz Physikalisch-Technische Bundesanstalt, Bundesallee Braunschweig - Germany NOTE: Modul B certificates are not enough to come into EC-market! + Modul D or + Modul F or + Modul H1 needed 2. Wait for hints and instructions, accept PTB s General Terms and Conditions of Certification (AZB) of Physikalisch-Technische Bundesanstalt for product certifications and QA approvals and General Terms and Conditions of Business (AGB) for conformity assessments, testing, measuring and calibration services 3. You will be informed about responsible persons - charged with assessments 4. If they are able to handle, wait for instructions about prepayment with invoice information Please Note Prepayment acc.to PTB s invoice to 100 % is necessary. Consequently it s only allowed, to start conformity assessments, when PTB received prepayment. Calculations: acc.to preliminary estimation of worktime, about 117 /hour (for testing, assessments and inluding MID Type Examination Certificate, if positively examinated) Summarized for Heat meters, max , needed time interval about 3 monthes This is only for orientation, no fixed price and without any warranty! PTB will payback money in case of reduced efforts with detailed accountings

7 Harmonized Standards and Normative Documents

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9 Related aspects of acceptance of test results done by manufacturer opportunities (1)

10 Related aspects of acceptance of test results, opportunities (2) If sub-assemblies of heat meters have already separated MID Type Examination Certificates - Module B (issued by an European Notified Body, added by MID Conformity based on Production Control - Module D ): -> Then these assemblies will not be subject of conformity assessments. e.g.: temperature sensor pairs Test results done by manufacturer are helpful in principle : There is no must for acceptance by Notified Bodies! Test results, supervised by e.g. ILAC International Laboratory Accreditation Cooperation, added by disclosed measurement uncertainty estimations acc.to ISO/BIPM Guide to Expression of Uncertainty in Measurement (GUM), with conformity assessments acc.to ISO 17025, 9001 series create faithful relation to manufacturer s test results. Please Note: Send all of test results you have, supervised documents, uncertainty estimations as original documentated and signated to your Notified Body. It could be helpful to reduce efforts, money and assessment time.

11 At first step, manufacturer will get a draft of certificate with possibility to comment this

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15 PTB Conformity assessments of heat meters, sub-assemblies and combinations thereof according to European Directive on Measuring Instruments (MID) Thank you good bye good day Dr. Jürgen Rose, Department Heat and Vacuum of PTB