EC type examination
The EC type examination is part of a conformity assessment procedure prescribed by the European Union , with which certain products are to be checked for compliance with EU standards before they are placed on the market . The legal basis for this are various directives within the framework of the so-called New Concept of 1985, on the basis of which uniform minimum requirements are to be guaranteed across Europe. Type tests are carried out by so-called notified bodies .
Areas of application
A type examination is possible within the scope of the following EU directives:
- Pressure equipment (PED): Directive 2014/68 / EU on pressure equipment
- Explosion protection ( ATEX ): Directive 2014/34 / EU
- Machinery (MRL): Directive 2006/42 / EC (Machinery Directive)
- Medical devices (MDD): Directive 93/42 / EEC on medical devices
- Measuring devices (MID): Directive 2004/22 / EC on measuring devices
- Non-automatic weighing instruments (NSW): Directive 2009/23 / EC
Type examination for explosion protection
ATEX directive 94/9 / EG (exemplary example)
The ATEX directive 94/9 / EC requires the EC type test for:
- electrical equipment and systems of categories 1 and 2
- mechanical devices and systems of category 1
- Devices and systems for use in mining
Steps of implementation
1. Manufacturer creates the technical documentation and prototypes
- The area of application, the intended use and compliance with the objectives of the guideline are described.
2. The EC type examination is requested from a notified body .
- Notified bodies are defined by the European Commission and are members of the European ATEX Notified Bodies Group (ExNBG)
3. Compliance with the protection goals of the directive (Essential Safety and Health Regulations (ESHR)) is checked by the notified body and its fulfillment is confirmed by the EC type-examination certificate.
4. The manufacturer issues an EU declaration of conformity based on the EC type-examination certificate . This is part of the scope of delivery of the product. The product is marked with the CE mark and the number of the notified body .
Proof of compliance with the protection objectives of the directive
Placing the products on the market
- The products may only be unchanged as the present in the EC-type examination test sample placed on the market are.
- All changes made after the product has been placed on the market must be assessed and, if necessary, subjected to a new test in coordination with the responsible notified body.
- In addition to the product, operating instructions (the intended use is described here) and the EU declaration of conformity are supplied to the operator.
- Thomas Klindt, Hans-J. Ostermann: The new EC Machinery Directive 2006/42 / EC. 2nd revised edition, Beuth Verlag, Berlin 2007, ISBN 978-3-410-16518-7 .
- New Legislative Framework (NLF) on orgalime.org, accessed June 30, 2014.
- European Commission: ATEX guidelines for Directive 2014/34 / EU (PDF), 1st edition from April 2016.