Non-Automatic Weighing Instruments

EuropeAid /114385/D/SV/CY Project
Assessment and administration capacity building
for the harmonisation with the New Approach directives
SEMINAR on New Approach Directives
March 4+5, 2004 in Nicosia
Non-Automatic Weighing
Instruments
90/384/EEC
The views expressed in this publication do not necessarily reflect the views of the European Commission.

The Directive
• Council Directive of 20 June 1990 on the
harmonization of the laws of the Member
States relating to non-automatic weighing
instruments (90/384/EEC)
• Published in the Official Journal of the
European Communities L 189, 20.07.1990.
• Amended by Council Directive 93/68/EEC of
22 July 1993 (The CE marking Directive)
February 2004 Practical Implementation of European New Approach Directives 2

Structure of the Seminar
• Overview of the Directive
• Essential requirements
• Conformity Assessment Procedures
• Harmonized Standard EN 45501
• Interpretation by Notified Bodies: WELMEC
Guidelines
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Overview of the Directive
• The Directive is a New Approach Directive
– Articles on
• Scope
• Free Movement, Market Surveillance
• Conformity Assessment
• Harmonized Standards
• Notified Bodies
• CE marking
• Final provisions
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Overview of the Directive
– Annexes:
• I:
• II:
• III:
• IV:
• V:
• VI:
Essential requirements
- EC type-examination (module B),
- EC declaration of type conformity (module D),
- EC verification (module F),
- EC unit verification (module G)
Design documentation
Markings and inscriptions
Minimum criteria for Notified Bodies
CE conformity marking
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Scope
• The applies to all non-automatic weighing
instruments (nawi) (art. 1 (1))
• Compliance with the essential requirements is
only required for nawi used in specific
applications (art. 3)
• The Directive requires control of instruments in
use (art. 13)
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Definition (art. 1(1))
• A weighing instrument is a measuring
instrument to determine the mass of a body by
using the action of gravity on that body.
• A weighing instrument is non-automatic when
the intervention of an operator is required
during weighing.
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Category of Use: Art. 1.2.a
• Instruments used to determine mass for:
– commercial transactions,
– calculation of a toll, tariff, tax, bonus, penalty,
remuneration, indemnity, or similar payment,
– application of laws and regulations, expert opinions
in court proceedings,
– weighing patients in the medical practice,
– medicin recipes in pharmacies and analysis in
pharmaceutical laboratories
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Category of Use: Art. 1.2.b
• Instruments used for other purposes than listed
in art. 1.2.a.
• These instruments
– must not comply with the essential requirements;
– must not bear the CE marking (under this
Directive)
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• art. 4:
Free Movement
– member States shall not impede placing on the
market (all nawi) or putting into service (nawi used
for art. 1.2.a applications) of instruments that meet
the requirements
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• Art. 2:
Market Surveillance
– Member States shall ensure that instruments are not
placed on the market (all nawi) or put into service
(nawi for art. 1.2.a applications) unless they meet
the requirements
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• Art. 5:
Presumption of Conformity
– member States shall presume conformity with the
essential requirements when instruments comply
with relevant harmonized European standards
– references of harmonized European standards are
published in the Official Journal of the European
Communities
– references are also available on:
www.newapproach.org
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• Art. 7:
Safeguard Clause
– Where a Member State considers that instruments
with CE marking do not meet the requirements
• when properly installed, and
• used for their intended purpose
it shall take all necessary steps to:
• withdraw the instruments from the market, or
• prohibit or restrict placing on the market or putting into
service of such instruments
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• Art. 8:
Conformity Assessment
– EC type examination (annex II.1)
followed by:
• EC declaration of type conformity (annex II.2),
or
• EC verification (annex II.3),
or:
– EC unit verification (annex II.4)
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• Art. 9:
– Member States:
Notified Bodies
• may designate bodies to do conformity assessment,
• apply minimum criteria (annex V),
• notify designated bodies to the European Commission,
– The Commission:
• allocates an identification number to the NoBo,
• published the rferences of the NoBo on the Offical
Journal of the EC
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CE marking, Inscriptions
• Art 10 and annex IV and annex VI:
– CE marking
– Supplementary data: - NoBo number
- “green M”
– Inscriptions (annex IV.2)
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Control of Instruments in Use
• Art. 13:
– Member States shall ensure that instruments
bearing the CE marking continue to conform to the
requirements.
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• Annex I
Essential requirements
• Metrological requirements:
– units of mass
– accuracy classes
– classification
– accuracy
– influence quantities and time
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• Annex I
Essential requirements
• Design and construction requirements:
– General
– Indication of weighing results
– printing of weighing results
– levelling
– zeroing, tare and preset tare devices
– instruments for direct sales to the public
– price labelling instruments
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Conformity Assessment
• EC type examination (annex II.1)
• EC declaration of type conformity (annex II.2)
• EC verfication (annex II.3)
• EC unit verification (annex II.4)
• Common provisions (annex II.5)
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• Annex II.1
EC Type examination
– Manufacturer or authorized representative:
• prepares a “type”and design documentation
• applies for approval
– Notified Body:
• examines design documentation (annex III),
• performs tests (EN 45501, WELMEC Guides),
• issues EC type-approval certificate,
• validity of certificate: 10 years.
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• Art. 8.1.a:
EC Type examination
• EC type examination not required for
instruments without:
– electronic components, and
– a spring to balance the load.
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EC Declaration of Type Conformity
• Annex II.2
– Manufacturer:
• operates quality system for production
• issues declaration of conformity
• affixes the CE marking
– Notified Body:
• evaluates and approves quality system
• performs EC surveillance (includes audits)
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• Annex II.3
EC Verification
– Manufacturer or authorized representative:
• issues declaration of conformity
• affixes the CE marking
– Notified Body:
• evaluates and tests each instrument
• issues certificate of conformity
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• Annex II.4
EC Unit Verification
– Instrument designed for specific application
– Manufacturer:
• issues declaration of conformity
• affixes the CE marking
– Notified Body:
• evaluates and tests the instrument,
• issues certificate of conformity
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• Annex II.5
Common Provisions
– Verification may take place anywhere, unless
transport to place of use requires dismantling, etc.
likely to affect metrological performance,
– If performance is sensitive to gravity, verification
may take place in two stages
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Harmonized Standards
• For the essential requirements:
– EN 45501: Metrological aspects of non-automatic
weighing instruments;
• for the manufacturer’s quality system:
– EN ISO 9001:2000;
• for the notified bodies:
– EN 45000-series
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EN 45501
• EN 45501: Metrological aspects of nonautomatic
weighing instruments
• Part 1:
– Terminology
– Metrological and technical specifications
– Test procedures
• Part 2:
– Pattern evaluation report format
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WELMEC
• WELMEC = European Cooperation in Legal
metrology,
• Founded by 18 European national metrology
services in 1990 (MoU) in anticipation of the
NAWI-Directive,
• Aim is to harmonise practices (tests,
evaluations) in legal metrology between
notified bodies,
• www.welmec.org
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WELMEC
• Issues guides, such as:
– 1: An Introduction to WELMEC
– 2: Directive 90/384/EEC: Common Application
– 2.1: Guide for Testing Indicators
– 2.2: Guide for Testing Point of Sale Devices
– 2.3: Guide for Examining Software
– 2.4: Guide for Load Cells
– 2.5: Guide for Modular Approach and Testing of PCc and
other Digital Peripheral Devices
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