Contrasting experiences from a legal metrology authority and

Contrasting experiences from a legal metrology authority and a manufacturer of measuring instruments Market Surveillance Conference Malta, October 23 rd and 24 th, 2008 Tanasko Tasić, METREL Testing Laboratory WELMEC European cooperation in legal metrology

Contents: Requirments (why) Checking (how) Documents (where) WELMEC European cooperation in legal metrology

About the author: 1984 ÷ 1997 (Rudi Čajavec, Fotona) Military industry, SW development (measuring target parameters) 1997 ÷ 2006 MIRS: • gaming, • SW testing (ISO/IEC 17025 accredited lab) • OIML TC 5 (D-SW), • WELMEC WG 7 (WELMEC 7. 2), • metrological databases, • Eurolab Technical Report No. 2/2006, • MID-SOFTWARE, Soft. Tools-Metro. Net 2006 …METREL Head of the Testing Laboratory Slovenian Accreditation WELMEC European cooperation in legal metrology

Messages: Both: (responsible) manufacturers and surveilance inspectors are on the same side, they both want safe, reliable and accurate measuring instruments. Each of them applies it's own tools. Manufacturer’s invest huge amount of efforts to ensure "complete" quality of instruments - not only metrological aspects (e. g. MID) but in addition testing to fulfill requirements of LVD and EMC directives, functionality and other customer requirements, . . . WELMEC European cooperation in legal metrology

Legislation requirements (EU directives) DIRECTIVE 2006/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (LVD) DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (EMC) DIRECTIVE 2004/22/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on measuring instruments (MID) DIRECTIVE 1999/34/EC OF THE EUROPEAN PARLIAMENT Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the AND OF THE COUNCIL of 10 May 1999 restriction of the use of certain hazardous substances in electrical and electronic equipment amending. Council Directive 85/374/EEC on the approximation of the laws, regulations and administrative …other markets… (Ro. HS) provisions of the Member States concerningliability for …UL/CSA… defective products (amendment 2003 -02 -04) WELMEC European cooperation in legal metrology

Implementation of directives in national legislation P R A V I L N I K o električni opremi, ki je namenjena za uporabo znotraj določenih napetostnih mej* Uradni list RS, št. 27/2004 z dne 23. 03. 2004 PRAVILNIK o elektromagnetni združljivosti (EMC) Uradni list Republike Slovenije Št. 132 / 15. 12. 2006 P R A V I L N I K o merilnih instrumentih (MID) Uradni list RS, št. 42/2006 z dne 19. 04. 2006 WELMEC European cooperation in legal metrology

Directions – how to check conformity requirements from the regulations (Internal Production Control) S E Z N A M S T A N D A R D O V, katerih uporaba ustvari domnevo o skladnosti proizvoda z zahtevami Pravilnika o električni opremi, ki je namenjena za uporabo znotraj določenih napetostnih mej (Uradni list RS, št. 27/04 ) S E Z N A M S T A N D A R D O V, katerih uporaba ustvari domnevo o skladnosti proizvoda s predpisi o elektromagnetni združljivosti (Uradni list RS, št. 77/2003 z dne 06. 08. 2003). . . WELMEC European cooperation in legal metrology

Nadzor/Surveillance LVD: -Tržni inšpektorat Republike Slovenije za aparate na trgu, (Market Inspectorate of the Republic of Slovenia) EMC: – Tržni inšpektorat Republike Slovenije za aparate na trgu, – Inšpektorat Republike Slovenije za elektronske komunikacije, elektronsko podpisovanje in pošto za nadzor nepremičnih naprav v obratovanju (Inspectorate for Electronic Communications) – Inšpektorat Republike Slovenije za energetiko in rudarstvo za nadzor nepremičnih naprav v obratovanju. (Inspectorate for Energetics and Mining) MID (& national metrological regulations): - Meroslovni nadzor Urad RS za meroslovje MIRS (Metrology Institute of the Republic of Slovenia – metrological surveillance department) WELMEC European cooperation in legal metrology

EC declaration of conformity The EC declaration of conformity must contain the following elements: • name and address of the manufacturer or his authorised representative established within the Community, • a description of the electrical equipment, • reference to the harmonised standards, • where appropriate, references to the specifications with which conformity is declared, • identification of the signatory who has been empowered to enter into commitments on behalf of the • manufacturer or his authorised representative established within the Community, • the last two digits of the year in which the CE marking was affixed. An example WELMEC European cooperation in legal metrology

Tehnična mapa (Technical Construction File) • a general description of the electrical equipment, • conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. , • descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment, Datasheets for critical sub-assemblies • a list of the standards applied in full or in part, and descriptions of the solutions adopted to satisfy the safetyaspects of this Directive where standards have not been applied, • results of design calculations made, examinations carried out, etc. , • Copies of any markings and labels • Copy of instructions (user, maintenance, installation) • test reports. • Declaration of Conformity • for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive; WELMEC European cooperation in legal metrology

CE marking WELMEC European cooperation in legal metrology

Our customers? • Research and Development § Type testing § Confirmation of the concept • Sales § Non - standard specifications § Old sins • Service and quality dept. § Complaints • History WELMEC European cooperation in legal metrology

Conformity assessment, testing Conformity assessment is any activity to determine, directly or indirectly, that a process, product, or service meets relevant standards and fulfills relevant requirements. Conformity assessment activities may include: Testing Surveillance Inspection Auditing Certification Registration Accreditation Preskušanje (testing) ISO/IEC 17025 Determination of the characteristics of a product, a process or a service according to certain procedure, methodology or requirements WELMEC European cooperation in legal metrology

What do we test? Safety of the instruments Electromagnetic compatibility Functionality (Firm. Ware/Soft. Ware) Accuracy User documentation WELMEC European cooperation in legal metrology

What do we test? Safety… 61010 -1 -1, -32, -31…IEC 61557 -1~-12 Electromagnetic compatibility: Specification for emission and immunity: stated in in IEC 61326: 2002 Functionality (FW) Clearance and creepage distances (PCAD, vernier caliper ) Enclosure: Device temperatures Manipulation with the instrument ESD: IEC 61000 -4 -2 Accuracy 61000 -4 -3 “single fault”: checking dangers for an user …EM field: IEC Magnetic field: IEC (SW) • Repeatability 61000 -4 -8 Power circuitry Functionality AC • power Measurement systems circuitry (high (humidity, temperature, …), Environmental influences energy) Operating 61000 -4 -11 User manual Voltage dip: IEC • … Aging Installability Short interruptions: IEC 61000 -4 -11 …. . … Functionality Burst: IECOther functionality 61000 -4 -5 Dielectric strength test Surge: IEC 61000 -4 -5 …. . Usability Conducted RF: IEC 61000 -4 -6 Mechanical tests, shock and impact… Stress testing DC power Burst: IEC Security 61000 -4 -4 Surge: IEC 61000 -4 -4 Resuorce utilisation Conducted RF: IEC 61000 -4 -6 … I/O signal/control (including functional earth lines) Conducted RF: IEC 61000 -4 -6 I/O signal/control connected directly to power supply network Burst: IEC 61000 -4 -4 WELMEC European cooperation in legal metrology Surge: IEC 61000 -4 -5

When do we test (some lifecycle phases) Safety EMC Functionality Accuracy User documentation Functional prototype Development series Prototype series Serial production WELMEC European cooperation in legal metrology

Electrical safety protection means – why? WELMEC European cooperation in legal metrology

Electrical safety protection means – why? 50 V / 500 V 300 V / 2500 V 50 V / 800 V 300 V / 4000 V 50 V / 1500 V 300 V / 6000 V 600 V / 8000 V WELMEC European cooperation in legal metrology

History of METREL Testing Laboratory • Founded in 2002 • Before: testing of new products performed by R&D engineers • Purpose: to perform complete type approval testing of Metrel products regarding (inter)national legislation, standards and Metrel quality aims • Status: comprehensive test equipment, 4 employees with extensive knowledge and experience WELMEC European cooperation in legal metrology

Electrical and mechanical safety • Complete safety inspection according to EN 61010 and EN 61557 • Skilled engineer with 10 years of experience in testing electrical and mechanical safety • Test results recognized by accredited laboratories • Tests of dielectric strength, protective bonding impedance, heating, creapage and clearance distances WELMEC European cooperation in legal metrology

Examples: what do we do to our instruments WELMEC European cooperation in legal metrology

Examples: what do we do to our instruments WELMEC European cooperation in legal metrology

Examples: what do we do to our instruments WELMEC European cooperation in legal metrology

Examples: what do we do to our instruments WELMEC European cooperation in legal metrology

WELMEC European cooperation in legal metrology

Examples: what do we do to our instruments WELMEC European cooperation in legal metrology

Testing of electromagnetic compatibility (EMC) Complete EMC testing in our own laboratory according to IEC 61326: 2002 & IEC 61000 -4 -x • Automated EMC testing • Emission measurements • Immunity to r. f. fields, r. f. common mode fields, a. c. power fields, ESD, fast transients, surge, power fail WELMEC European cooperation in legal metrology

WELMEC European cooperation in legal metrology

Complete accuracy verification of standard Metrel instruments • Comprehensive accuracy verification of microclimatic instruments • Automated testing procedures • Custom made measuring adapters (high-current resistors, highvoltage high-resistance decades). • Influence of microclimatic parameters on accuracy (temperature, humidity) • Long term stability of the instruments WELMEC European cooperation in legal metrology

Avtomatizirani postopki WELMEC European cooperation in legal metrology

Remote monitoring workstation User monitoring aplication INTERNET Measuring results database server VPN tunnel Measuring instrument server Factory LAN RS 232, USB TCP/IP LAN Server MI 4100 LAN protection RS 485 Factory junction station Control of reference signal generator RS 485 RS 232 MI 4100 Reference signal generator System under test WELMEC(voltage, current) Reference sygnals European cooperation in legal metrology

Remote monitoring workstation User monitoring aplication INTERNET Measuring results database server VPN tunnel Measuring instrument server Factory LAN RS 232, USB TCP/IP LAN Server MI 4100 LAN protection RS 485 Factory junction station Control of reference signal generator RS 485 RS 232 MI 4100 Reference signal generator System under test WELMEC(voltage, current) Reference sygnals European cooperation in legal metrology

Support during early development phases • Electrical and mechanical safety • Selection of materials • Usability • Functional suitability WELMEC European cooperation in legal metrology

Checking of the functionality § Extensive experience in testing software functionalities § View from the customer perspective § Verification of instrument functions § Verification of PC software functions § Recommendations for improvements in usability § Comparative tests of METREL and other instruments WELMEC European cooperation in legal metrology

And then the customer asks: How does our instrument stand high electrical fields in 400 k. V switching stations? (e. g. 15 k. V/m, 50 Hz) WELMEC European cooperation in legal metrology

The answer to that question can be found only during field measurements WELMEC European cooperation in legal metrology

Workflow MPL R&D Error 1 Error 2 … Error 1 Error 2 Error 3 Error 4 … WELMEC European cooperation in legal metrology

Planning and tracking WELMEC European cooperation in legal metrology

Quality requirements for measuring instruments Conditio sine qua non - Legislation: ▪ LVD directive Functional requirements: ▪ EMC directive ▪ Measuring functionality – standards (e. g. IEC Proving the conformance to the reqs - standards: 61557 -x, VDE 404 -x) ▪ MID directive • Safety: IEC 61010 -1, -032; IEC 61557 -1, Legal metrology requirements: ▪ Generic state-of-the art technical standards ▪ Ro. HS directive -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, 12; (best practice) • Type approval (type examination) Competence of the conformity assessment laboratories/bodies: ▪ … Aditional customer functionality requirements • EMC: EN 61326, -1, -2; IEC 61000 -4 -1, -2, -3, ▪ • First verification Standards: 4, -5, -6, -8, -11; (e. g. yellow housing) • Regular (periodical) verifications • Functionality: IEC 61557 -1, -2, -3, -4, -5, -6, -7, • ISO/IEC 17025: General requirements for the competence of -8, -9, -10, -11, 12; VDE 404 -1, 2; VDE 0701, testing and calibration laboratories, 0702, … • IEC 17020: General criteria for the operation of various types • SW: IEC 9126, IEC 12119 of bodies performing inspection And this is not the end! Activities required by the factory quality system (according to the ISO 9001: 2000) are not mentioned • Testing: accreditation, CB-sheme: supervised testing (comparisons) • Calibration: accreditation • Control bodies: accreditation WELMEC European cooperation in legal metrology

verification testing, type testing calibration TCF MPE, Safety, EMC Direct manufacturer’s responsibility surveillance Measuring instruments in use type approval WELMEC European cooperation in legal metrology

Messages: Both (serious) manufacturers and surveilance inspectors are on the same side, they both want safe, reliable and accurate measuring instruments. Each of them applies it's own tools. Manufacturer’s invest huge amount of efforts to ensure "complete" quality of instruments - not only metrological aspects (e. g. MID) but in addition testing to fulfill requirements of LVD and EMC directives, functionality and other customer requirements, . . . WELMEC European cooperation in legal metrology

Thank you for your kind attention! Questions? WELMEC European cooperation in legal metrology