Center for Testing and European Certification

www.ctec-sz.comwww.ctec-sz.com

Center for Testing andEuropean Certification

CTEC – general overviewCTEC – general overview

CE marking of technical products – CE marking of technical products – bridge to the European marketbridge to the European market

www.ctec-sz.com


Principles of the New Approach and the related regulations of the European Union facilitate the free movement of goods within the European market and ensure protection of life and health of people, domestic animals, consumer protection and protection of the environment and property.

Any product that is covered by one or more New Approach Directives, must conform to their applicable requirements.

Proof of this is the affixation of the CE marking to the product and/ or its packaging.

MARKING


The CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market.

By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA) and in Turkey. This also applies to products made in other countries which are sold in the EEA and Turkey.

However, not all products must bear the CE marking, only product categories mentioned in specific EU directives on the CE marking.

There are more than 20 New Approach Directives.

WHAT IS MARKING?


NEW APPROACH DIRECTIVES89/686/EEC Personal protective equipment

90/385/EEC Active implantable medical devices

92/42/EEC Hot-water boilers

93/15/EEC Explosives for civil uses

93/42/EEC Medical devices

94/25/EC Recreational craft

94/9/EC Equipment and protective systems intended for use in potentially explosive atmospheres

95/16/EC Lifts

97/23/EC Pressure equipment

98/79/EC In vitro diagnostic medical devices

99/5/EC Radio and telecommunications terminal equipment

2000/9/EC Cableway installations designed to carry persons

2004/108/EC Electromagnetic compatibility

2004/22/EC Measuring Instruments Directive

2006/42/EC Machinery

2006/95/EC Low voltage directive

2009/105/EC (ex-87/404/EEC) Simple pressure vessels

2009/48/EC Safety of toys

2009/23/EC (ex-90/384/EEC) Non-automatic weighing instruments

2009/142/EC (ex-90/396/EEC) Appliances burning gaseous fuels

Regulation (EU) No 305/2011 Construction products


СE marking is the only marking which attests conformity of the product with the applicable requirements of the relevant legislation of the European Community.

Member States shall ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

MAIN PRINCIPLES OF THE MARKING IN ACCORDANCE WITH

REGULATION No 765/2008


AFFIXATION OF THE MARKING TO YOUR PRODUCT

The CE marking must be affixed by the manufacturer after completion of the requirements of the relevant directive/s.

CE marking must be affixed according to its legal format visibly, legibly and indelibly. If a Notified Body was involved in the

production control phase, its identification number must also be displayed.


DIRECTIVE 93/68/EEC

MARKING -


It is the manufacturer’s responsibility to draw up and sign an “EC declaration of conformity” proving that the product meets the requirements.

After that your CE-marked product is ready for the market.

EC DECLARATION OF CONFORMITY

Declaration of performance underRegulation (EU) 305/2011 onConstriction products


RESPONSIBILITIES OF THE ECONOMIC

OPERATORS

MANUFACTURER:

DISTRIBUTOR:

IMPORTER:

It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the EC declaration of conformity and to affix CE marking on a product.

Distributors must verify the presence of both the CE marking and the necessary supporting documentation.

If the product is being imported from a third country, the importer has to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request.


NOTIFIED BODIES

Notified bodies are nominated by governments and approved by the European Commission.

The manufacturer may apply to any notified body approved for the relevant Directive within the European Economic Area.

The notified body must be selected according to its impartiality, competence and authority.

Each notified body obtains an identification number by the European Commission.

NANDO (Information System) – official journal or the European commission where the notified bodies are listed.

New Approach Notified and Designated Organizations


CTEC IN BRIEF Private organization founded in 2002 in the town of Stara Zagora as a body for conformity assessment of technical products

Recognized company on the Bulgarian market in the field of laboratory testing and certification of construction products, machinery and electrical equipment

Increasing market share of the foreign market (Serbia, Turkey, Greece, UK, Russia, China, South Korea, etc.)

Notified body under 4 European Directives with identification number NB 1871

Two on-site testing laboratories accredited according to EN ISO/IEC 17025

Notified laboratory for reaction to fire testing of construction products

50 people permanent staff more than half of them engineers and 15 external auditors


CTEC LOCATION

Great location in the central part

of Bulgaria,at an equal distance

to all Balkan neighbors.

Great location in the central part

of Bulgaria,at an equal distance

to all Balkan neighbors.


MEMBERSHIP

Manager of the CTEC is: Board member of the Bulgarian Institute for Standardization Chairwoman of the Forum of Notified Bodies in Bulgaria Member of the National Council of Metrology

CTEC is a member of: Association of Notified Bodies for Construction Products; Forum of Notified Bodies; 25 technical committees for standardization as an active member; Bulgarian Industrial Capital Association; Bulgarian Association of Electrical Engineering and Electronics (BASSEL). Bulgarian Branch Chamber of Machines Building Bulgarian Chamber of Commerce and Industry


NOTIFIED BODY NB 1871


As a Notified Body with accredited laboratories CTEC performs:

1. Conformity assessment / certification of:1. Conformity assessment / certification of:

2. Voluntary certification2. Voluntary certification

3. Testing of construction products3. Testing of construction products

4. Testing of machinery, electrical equipment and devices4. Testing of machinery, electrical equipment and devices

Construction products – Regulation (EU) 305/2011 Construction products – Regulation (EU) 305/2011

Machinery – Directive 2006/42/EC Machinery – Directive 2006/42/EC

Low voltage equipment - Directive 2006/95/EC Low voltage equipment - Directive 2006/95/EC

OUR SERVICES

Noise emission in the environment by equipment for use outdoors - Directive 2000/14/EC

Noise emission in the environment by equipment for use outdoors - Directive 2000/14/EC


5. Management systems certification 5. Management systems certification

ISO 9001:2008 - quality management system ISO 9001:2008 - quality management system

CTEC is accredited by Bulgarian Accreditation Service according to EN ISO/IEC 17021 to perform:

Certificates issued by CTEC are valid in all countries members of the EU.

OUR SERVICES

BS OHSAS 18001:2007 - occupational health and safety management system

BS OHSAS 18001:2007 - occupational health and safety management system

ISO 14001:2004 – environmental management ISO 14001:2004 – environmental management

6. Professional education, specialized seminars and trainings in European technical legislation, Product certification, CE marking, Quality management, etc.

6. Professional education, specialized seminars and trainings in European technical legislation, Product certification, CE marking, Quality management, etc.


The CTEC office and laboratory equipment


THANK YOU FOR YOUR ATTENTION!

eng. Blagovesta Shineva – Мanaging Director

Center for Testing and European Certification Ltd.

Stara Zagora 6006, 2, Industrialna Str.

tel..: +359 42 620 368, mob. +359 887 598 697

e-mail: [email protected] , website: www.ctec-sz.com

Center for Testing and European Certification

Documents

Transcript of Center for Testing and European Certification