Contrasting experiences from

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Contrasting experiences from a legal metrology
authority and a manufacturer of measuring
instruments Market Surveillance
Conference Malta, October 23rd and 24th,
2008 Tanasko Tasic, METREL Testing Laboratory
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Contents
Requirments (why) Checking (how) Documents
(where)
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About the author

• 1984 1997 (Rudi Cajavec, Fotona)
• Military industry, SW development (measuring
  target parameters)
• 1997 2006 MIRS
• gaming,
• SW testing (ISO/IEC 17025 accredited lab)
• OIML TC5 (D-SW),
• WELMEC WG7 (WELMEC 7.2),
• metrological databases,
• Eurolab Technical Report No. 2/2006,
• MID-SOFTWARE, SoftTools-MetroNet
• 2006 METREL
• Head of the Testing Laboratory
• Slovenian Accreditation

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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. 
Manufacturers 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, ...
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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 2002/95/EC of the
European Parliament and of the Council of 27
January 2003 on the restriction of the use of
certain hazardous substances in electrical and
electronic equipment (RoHS)
DIRECTIVE 1999/34/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 10 May 1999 amendingCouncil
Directive 85/374/EEC on the approximation of the
laws, regulations and administrative provisions
of the Member States concerningliability for
defective products (amendment 2003-02-04)
other markets UL/CSA
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Implementation of directives in national
legislation
P R A V I L N I K o elektricni opremi, ki je
namenjena za uporabo znotraj dolocenih
napetostnih mej Uradni list RS, t. 27/2004 z
dne 23.03.2004 PRAVILNIK o elektromagnetni
zdruljivosti (EMC) Uradni list Republike
Slovenije t. 132 / 15. 12. 2006 P R A V I L N
I K o merilnih instrumentih (MID) Uradni list RS,
t. 42/2006 z dne 19.04.2006
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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 elektricni opremi, ki je
namenjena za uporabo znotraj dolocenih
napetostnih mej (Uradni list RS, t. 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 zdruljivosti (Uradni list RS,
t. 77/2003 z dne 06.08.2003) ......
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Nadzor/Surveillance

• LVD
• Trni inpektorat Republike Slovenije za aparate
  na trgu,
• (Market Inspectorate of the Republic of
  Slovenia)
• EMC
• Trni inpektorat Republike Slovenije za
  aparate na trgu,
• Inpektorat Republike Slovenije za elektronske
  komunikacije, elektronsko podpisovanje in poto
  za nadzor nepremicnih naprav v obratovanju
• (Inspectorate for Electronic Communications)
• Inpektorat Republike Slovenije za energetiko
  in rudarstvo za nadzor nepremicnih 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)

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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
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Tehnicna 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

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CE marking
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Our customers?

• Research and Development
• Type testing
• Confirmation of the concept
• Sales
• Non - standard specifications
• Old sins
• Service and quality dept.
• Complaints
• History

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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
Preskuanje (testing) ISO/IEC 17025 Determination
of the characteristics of a product, a process
or a service according to certain procedure,
methodology or requirements
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What do we test?
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What do we test?

• Safety61010-1-1, -32, -31IEC 61557-1-12
• Clearance and creepage distances (PCAD, vernier
  caliper )
• Device temperatures
• single fault checking dangers for an user
• Power circuitry
• Measurement circuitry (high energy)
• Dielectric strength test
• Mechanical tests, shock and impact

Electromagnetic compatibility Specification for
emission and immunity stated in in IEC
613262002 Enclosure ESD IEC 61000-4-2 EM
field IEC 61000-4-3 Magnetic field IEC
61000-4-8 AC power Voltage dip IEC
61000-4-11 Short interruptions IEC
61000-4-11 Burst IEC 61000-4-5 Surge IEC
61000-4-5 Conducted RF IEC 61000-4-6 DC
power Burst IEC 61000-4-4 Surge IEC
61000-4-4 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 Surge IEC
61000-4-5 Conducted RF IEC 61000-4-6
Functionality (FW) Manipulation with the
instrument
Accuracy Repeatability Environmental influences
(humidity, temperature, ), Aging
Functionality (SW) Operating systems Installabilit
y Functionality Usability Stress
testing Security Resuorce utilisation
User manual ..
Other functionality ..
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When do we test (some lifecycle phases)
Functional prototype
Development series
Prototype series
Serial production
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Electrical safety protection means why?
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Electrical safety protection means why?
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History of METREL Testing Laboratory

• Founded in 2002
• Before testing of new products performed by RD
  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 knowledgeand experience

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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

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Examples what do we do to our instruments
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Examples what do we do to our instruments
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Examples what do we do to our instruments
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Examples what do we do to our instruments
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Examples what do we do to our instruments
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Testing of electromagnetic compatibility (EMC)

• Complete EMC testing in our own laboratory
  according to IEC 613262002 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

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

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Avtomatizirani postopki
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Remote monitoring workstation
User monitoring aplication
INTERNET
Measuring results database server
VPN tunnel
Measuring instrument server
Factory LAN
RS 232,
TCP/IP
USB
LAN Server
MI4100
LAN protection
RS 485
Factory junction station
Control of reference signal generator
RS 485
RS 232
MI4100
System under test
Reference signal generator
Reference sygnals (voltage, current)
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Remote monitoring workstation
User monitoring aplication
INTERNET
Measuring results database server
VPN tunnel
Measuring instrument server
Factory LAN
RS 232,
TCP/IP
USB
LAN Server
MI4100
LAN protection
RS 485
Factory junction station
Control of reference signal generator
RS 485
RS 232
MI4100
System under test
Reference signal generator
Reference sygnals (voltage, current)
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• Support during early development phases
• Electrical and mechanical safety
• Selection of materials
• Usability
• Functional suitability

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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 improvementsin usability
• Comparative tests of METREL and otherinstruments

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And then the customer asks How does our
instrument stand high electrical fields in 400 kV
switching stations? (e.g. 15 kV/m, 50 Hz)
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The answer to that question can be found only
during field measurements
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Workflow
MPL
RD
TEST REQUEST
SW xy beta 001
SW xy beta 002
Error 1 Error 2
SW xy beta fin
Error 1 Error 2
Error 1 Error 2 Error 3 Error 4
Error 1 Error 2 Error 3 Error 4
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Planning and tracking
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Quality requirements for measuring instruments

• Conditio sine qua non - Legislation
• LVD directive
• EMC directive
• MID directive
• RoHS directive

• Functional requirements
• Measuring functionality standards (e.g. IEC
  61557-x, VDE 404-x)
• Generic state-of-the art technical standards
  (best practice)
• Aditional customer functionality requirements
  (e.g. yellow housing)

• Proving the conformance to the reqs - standards
• Safety IEC 61010-1, -031, -032 IEC 61557-1,
  -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, 12
• EMC EN 61326, -1, -2 IEC 61000-4-1, -2, -3, -4,
  -5, -6, -8, -11
• Functionality IEC 61557-1, -2, -3, -4, -5, -6,
  -7, -8, -9, -10, -11, 12 VDE 404-1, 2 VDE 0701,
  0702,
• SW IEC 9126, IEC 12119

• Legal metrology requirements
• Type approval (type examination)
• First verification
• Regular (periodical) verifications

• Competence of the conformity assessment
  laboratories/bodies
• Standards
• ISO/IEC 17025 General requirements for the
  competence of testing and calibration
  laboratories,
• IEC 17020 General criteria for the operation of
  various types of bodies performing inspection
• Testing accreditation, CB-sheme supervised
  testing (comparisons)
• Calibration accreditation
• Control bodies accreditation

And this is not the end! Activities required by
the factory quality system (according to the ISO
90012000) are not mentioned  
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verification
testing, type testing
calibration
TCF
MPE, Safety, EMC
Direct manufacturers responsibility
Measuring instruments in use
type approval
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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. 
Manufacturers 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, ...
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Thank you for your kind attention! Questions?