Corporate Design-Vorlagen

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CE marking your legal obligations This
presentation is intended to provide a practical
approach guide to what you need to know about the
CE marking requirements for electrical and
electronic equipment placed on the European
Market
CE marking your legal obligations Presented by
Richard Poate Compliance Services Manager, TÜV
Product Service
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Who Am I?
Name Richard Poate
Title Compliance Services Manager
Employer TÜV Product Service Ltd
Experience 16 years experience in product compliance
Telephone [phone]
E-mail rpoate_at_tuvps.co.uk
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Contents

• CE marking and your legal obligations
• What is CE marking?
• What are EU Directives?
• What is Due diligence?
• How is CE marking enforced?
• Declaration of Conformity
• What is a Technical file?
• Overview of the LV, EMC and RTTE Directives
• How to identify which Directives apply
• Harmonised standards
• Presumption of conformity
• Placing products on the market
• Technical documentation required to demonstrate
  compliance
• Technical file contents
• Technical file format

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• What is CE marking?

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What is CE marking?

• CE marking
• Confusion Everywhere ???
• Chinese Export ???
• CE marking is a declaration by the manufacturer
  or responsible body that the product(s) meets the
  requirements of the applicable European
  Directive(s).

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What is CE marking?
CE marking Guaranteed no hangover? Guaranteed
to get drunk? Guaranteed good quality beer
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What is CE marking?

• Enables free movement of goods around EU member
  States (some non EU countries have adopted CE
  marking procedures)
• Places responsibility with the manufacturer or
  importer of goods whoever places the equipment
  on the market
• Relates to EU Directives (European Law)
• Primarily self certification
• Not evidence of compliance in itself

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CE Conformity Marking

• The CE marking shall consist of the initials CE
  taking the following form
• If the CE marking is reduced or enlarged the
  proportions given in the above graduated drawing
  must be respected
• The various components of the CE marking must
  have substantially the same vertical dimension,
  which may not be less than 5mm

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CE marking Quality?

• Consumers and retailers may associate CE marking
  with quality. Actually it has nothing to do
  with quality!

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• What are EU Directives?

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What are EU Directives?

• "New Approach" Directives (Community Law) set out
  the essential requirements (on safety for
  example)
• Written in general terms and must be met before
  products may be sold in the UK or anywhere else
  in the European Community
• European harmonised (EN) standards provide
  detailed technical information enabling
  manufacturers to meet the essential requirements
• Directives explain how manufacturers are able to
  demonstrate conformity with the essential
  requirements
• Products which meet essential requirements are to
  display the CE marking which means they can be
  sold anywhere in the Community / European
  Economic Area (EEA)

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New Approach CE marking Directives

• There are 21 CE marking Directives

Directive Amended by Title of directive
2006/95/EC Low Voltage
87/404/EEC 90/488/EEC93/68/EEC Simple Pressure Vessels
88/378/EE 93/68/EEC Safety of toys
89/106/EEC 93/68/EEC Construction products
2004/108/EC Electromagnetic compatibility (EMC)
2006/42/EC Machinery
89/686/EEC 93/68/EEC 93/95/EEC 96/58/EC Personal protective equipment (PPE)
90/384/EEC 93/68/EEC Non-automatic weighing instruments
90/385/EEC 93/42/EEC 93/68/EEC 2007/47/EC Active implantable medical devices
90/396/EEC 93/68/EEC Appliances burning gaseous fuels
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CE marking Directives
Directive Amended by Title of directive
92/42/EEC 93/68/EEC 2004/8/EC 2005/32/EC Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels
93/15/EEC Explosives for civil uses
93/42/EEC 98/79/EC 2000/70/EC 2001/104/EC2007/47/EC Medical devices
94/9/EC Equipment explosive atmospheres (ATEX)
94/25/EC 2003/44/EC Recreational craft
95/16/EC Lifts
97/23/EC Pressure equipment
98/79/EC In vitro diagnostic medical devices
1999/5/EC Radio Equipment and Telecommunications Terminal Equipment
2000/9/EC Cableway installations designed to carry persons
2004/22/EC Measuring instruments
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Summary of applicable Directives
The CE marking Directives listed below are the
ones that would most typically be applicable to
your products.
Directive Title of Directive
2006/95/EC Low Voltage Directive (LVD)
2004/108/EC Electromagnetic compatibility (EMC)
1999/5/EC Radio Equipment and Telecommunications Terminal Equipment
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Other applicable Directives

• Just because a Directive does not call for CE
  marking does not mean the Directive is not
  applicable.
• Other typically applicable directives-

Directive Title of Directive
2001/95/EC General Product Safety Directive (GPSD)
2002/96/EC Waste from Electrical and Electronic Equipment (WEEE)
2002/95/EC Restriction of Hazardous Substances (RoHS)
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• What is Due Diligence?

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What is Due Diligence?

• Knowing what is required
• Declaring that you have met the relevant
  requirements
• Demonstrating compliance with applicable
  Directives
• Being properly prepared
• ready to defend yourself in court
• being able to produce a technical file
• being confident in your safety case

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• How is CE marking enforced?

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Legal status of Directives

• Directives are agreed, adopted accepted by the
  governments of the member states into their own
  national law
• The Directives are transposed into UK Law as
  Statutory Instruments
• Gives the Directives the same status as other
  laws in this country

Directive UK Law
2006/95/EC Low Voltage Directive The Electrical Equipment (Safety) Regulations 1994 (SI 1994/3260)
2004/108/EC EMC Directive EMC Regulations 2006 (SI 2006/3418)
1999/5/EC RTTE Directive The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 (SI 2000 No.730)
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Who enforces the Law?

• In Great Britain by-
• Local Trading Standards (Great Britain)
• District Councils (Northern Ireland)
• The Office of Communications (Ofcom) where
  responsibility where enforcement relates to the
  protection and management of the radio spectrum

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Market surveillance

• The enforcement authority can
• Challenge any product on the market
• Pull samples from the market for examination
• Request a manufacturer, importer or retailer to
  provide their Technical File(s)
• Contract 3rd party test laboratories to test or
  check products
• Respond to public complaints
• Notify other member states (e.g. RAPEX)
• Instigate criminal proceedings resulting in
  potential
• Banning of products from sale
• Ordering product recalls
• Payment of fines
• Imprisonment of responsible persons

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Enforcement examples

• Both the examples shown below were notified to
  ALL Member States using Safeguard Clauses of the
  relevant Directives.

Electric police car (toy) "Biltema Electric
police car" (battery operated) Type/model
26-941. Country of origin China/Hong Kong.
Risk of injury. When released on a tilted
surface (10 degrees tilt, 50N applied to the
brake pedal)), the toy should not move more than
5cm, however, when tested the toy did not stop at
all. The toy does not comply with the Toys
Directive and the European Standards. Voluntary
withdrawal of the product from the market and
consumers by importer.
AC-DC electrical adapter "CELLY"Type/model
CBR8310. Country of origin China. Risk of
electric shock. Risk of electric shock because of
insufficient insulation in transformer T1 between
the primary and the secondary circuit. This
product does not comply with the LVD Directive
and the European Standards. Recall from
consumers ordered by authority.
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• Declaration of Conformity (DoC)

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What is a DoC?

• A formal statement that products comply with
• applicable Directives
• applicable standards
• Signed by responsible person within the
  organisation (e.g. company director)
• It is not evidence of compliance in itself
• Minimum legal requirement

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What is the Relevance of a DoC

• Legal claim that products comply with all
  applicable Directives
• Manufacturer (or responsible body) attests
  conformity with all relevant Directives and takes
  sole legal responsibility
• Signatory accepts liability for compliance with
  the Directives
• Signatory may be subject to prosecution or even
  imprisonment
• In some instances Directives may require a
  Notified Body to issue a Certificate of
  Conformity in order to verify product
  compliance, e.g.
• High risk medical devices
• High risk machinery

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The DoC must include

• Name address of manufacturer (or their
  authorised representative)
• Description of the electrical equipment including
  type, model and any other information that
  clearly relates the equipment to the Declaration
• A reference to harmonised standards applied and
  when harmonised standards have not been applied,
  references to International or National
  standard(s) with which conformity is declared.
  If standards have not been applied, reference
  should be made to other specifications adopted or
  to the safety objectives that have been applied
  and satisfied
• Identification of the signatory empowered to
  enter into commitments on behalf of the
  manufacturer (or their authorised
  representative)
• The last two digits of the year in which CE
  marking was affixed

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Example Declaration of Conformity (DoC)
EU DECLARATION OF CONFORMITY EU DECLARATION OF CONFORMITY
Date of Issue Date of DoC
Reference Number Serial Number for this DoC
Directive Relevant Directive's
Conforming Apparatus Equipment Title, Part Number (and Serial Numbers as applicable)
Manufacturer
Authorised Representative
Harmonised StandardsReferenced or Applied Relevant standards, amendments and dates of issues
Specifications with which Conformity is Declared If Harmonised Standards are not used then insert standards used and reference number of Notified Body Certificate.
xxxxLtd hereby declare that the equipment named has been designed (alternative) tested and found to comply with the relevant sections of the above referenced specifications. The unit complies with all essential requirements of the Directives. xxxxLtd hereby declare that the equipment named has been designed (alternative) tested and found to comply with the relevant sections of the above referenced specifications. The unit complies with all essential requirements of the Directives.
Signed
Name
Position
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• Technical Files

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Technical Files

• Technical files are your documented evidence to
  show that products properly comply with the
  requirements of the directives which apply to
  it.

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Technical Files

• Technical documentation must be such as to enable
  enforcement authorities to assess the conformity
  of the electrical equipment to the requirements
  of the Regulations
• It must cover the design, manufacture and
  operation of electrical equipment
• It can be the same document as your design file
  for the equipment
• Most importantly, it forms the basis of your
  safety case!

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• Low Voltage, EMC, RTTE Directives

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Identification of applicable Directives

• Review the scope of the Directives
• Seek the assistance of Notified Bodies (if
  applicable)
• Refer to official guidance on-line
• European Union
• Europa the official website of the European
  Union http//europa.eu/
• The official source of information relating to
  all European Directives
• UK
• BIS Department for Business Innovation Skills
  website
• http//www.bis.gov.uk/policies/business-sectors/en
  vironmental-and-technical-regulations/technical-re
  gulations
• Provides a range of on line and downloadable
  guidance to the directives written in plain
  English

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• Harmonised Standards

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What are Harmonised Standards?

• A "Harmonised Standard" is a standard that
• supports one or more Directives
• has been produced by CEN or CENELEC
• has been published in the Official Journal of the
  EC (OJ)
• has been published by at least one national
  standards body
• provides a presumption of conformity with the
  EHSRs
• These standards, produced under a mandate from
  Member States through the Commission, provide the
  technical measures to meet the EHSRs

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What are Harmonised Standards?

• In other words the
• Directives state the legal objectives (EHSRs)
  to be met (1)
• and
• Harmonised Standards identify the technical
  means (requirements) to meet these legal
  objectives.
• Harmonised Standards are one way of meeting the
  EHSRs and are never intended to be mandatory,
  however compliance with them does give a
  presumption of conformity
• 1 The EHSRs of the Machinery Directive do
  contain technical requirements.

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Presumption of conformity

• Products are presumed to conform to the
  objectives of the Directives where the equipment
  has been manufactured and tested in accordance
  with a harmonized standard
• Alternatively, the manufacturer may construct the
  product in conformity with the essential
  requirements of the Directives, without applying
  harmonised, international or national standards
• In such a case the product will not benefit from
  presumption of conformity
• The manufacturer must include in the technical
  documentation a description of the solutions
  adopted to satisfy the requirements of the
  Directives

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• Placing products on the market

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Placing products on the market

• Before a product is placed on the market 
• manufacturer must compile technical documentation
  which makes it possible to assess product
  compliance with relevant Directives
• manufacturer or authorised representative must
  draw up the DoC
• manufacturer or authorised representative must
  affix the CE marking  

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CE marking or not...?

• If one or more CE marking Directives apply then
  you must apply CE marking!

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CE marking or not...?

• Low Voltage Directive applies to all electrical
  equipment having input OR output voltages between
  50-1000Vac and between 75-1500Vdc
• EMC Directive applies to all electrical and
  electronic apparatus which are liable to cause
  electromagnetic disturbance or the performance of
  which is liable to be affected by such
  disturbance
• RTTE Directive applies to all radio and
  telecommunication terminal equipment (with
  certain exclusions) as defined in the Directive
• Machinery Directive applies to an assembly of
  linked parts or components at least one of which
  moves, with appropriate actuators, control and
  power circuits joined together for a specific
  application. In particular for processing,
  treatment , moving or packaging of material.

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• Technical file contents

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Technical file contents

• A general description of the electrical equipment
  
• This requirement can normally be met by the
  description (including model number etc.) found
  in the equipment manual
• Conceptual design
• This can be met by a general assembly drawing
  and / or photographs plus a block diagram. The
  drawings should relate to a particular model
  number and year of manufacture. Circuit diagrams
  are also required.

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Technical file contents

• Descriptions and explanations necessary for the
  understanding of the drawings and schemes
  referred to previously and the operation of the
  electrical equipment
• To some extent the equipment manual may meet
  this requirement but it may be necessary to
  include a schematic operation description
• A list of standards applied in full (or in part),
  and descriptions of the solutions adopted to
  satisfy the safety requirements of the
  Regulations / Directive where standards have not
  been applied.
• If no standards have been applied references
  should be made as to how the safety requirements
  have been satisfied
• List of components
• complete listing of all components, materials and
  parts used in the product (i.e. complete Bill of
  Materials)
• Safety approval information on critical
  components and materials

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Technical file contents

• Results of design calculations made, examinations
  carried out, etc
• In many cases test reports will meet this
  requirement if they can demonstrate that the
  design calculations have been made correctly
• Test reports. This could include test reports
  drawn up by the manufacturer, a Notified Body or
  any other person the manufacturer considers to be
  competent
• These reports will demonstrate how the product
  complies with the relevant directives
• Typically this will be by the application of
  harmonised standards
• A copy of the EC Declaration of Conformity

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Technical file format

• Must be controlled
• Must contain all the required information
• Can be a traditional paper file
• Information may be stored electronically
• Hyperlinks can be used to link documents
• Needs to be backed-up
• Must be easy to produce all documentation at
  short notice
• Must be easy to maintain and must be kept up to
  date
• You cant just do it then forget about it!

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• Thanks for Listening
• Any Questions?

Richard Poate Compliance Services Manager, TÜV
Product Service Tel [phone]
558215rpoate_at_tuvps.co.uk www.tuvps.co.uk