Global EMC in Turkey

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Ege Test Center helps manufacturers to export their products.

Please contact us for the product tests and certifications required to export your electrical products to Australia: Contact Ege Test Center 

What is EMC Testing?

What is EMC Testing?

EMC (ElectroMagnetic Compatibility) is an issue that everybody who is interested in designing, manufacturing, importing, exporting electrical or electronic products should be aware.

You can visit our EMC testing page to see details: EMC Testing

You can send us your questions related to EMC testing through our online application page. Your questions will be answered for free: Ege Test Center Online Application

Incorrect CE Marking and manufacturer responsibility

CE Marking is mandatory for a wide variety of products including all electrical / electronic devices, allowing manufacturers to import and export their products freely within the European Union, with common product design and manufacturing requirements defined within EU Directives. 

By placing the mandatory conformity mark on a product, manufacturers (or if outside of the EU, the importer or authorised representative) are providing a clear indication that it meets all the relevant requirements and should therefore enjoy free movement between all 28 Member states.

Problems with the CE Mark

In recent years, however, Europe has seen an increasing number of goods incorrectly marked with the CE Mark flooding the market from foreign countries. The reasons for this have been three-fold:

  • Firstly, there has been much confusion around the CE Mark itself with similar marks from China often confusing consumers and being mistaken for the genuine CE Mark.
  • Secondly, the CE Mark has been illegitimately placed on products which do not require the Mark, giving consumers the false impression that the product is one of quality.
  • Thirdly, the CE Mark does not represent a product having undergone safety testing but rather a self-declaration mark from the manufacturer to allow the product’s free movement across Europe. The CE Mark’s aim is to provide a clear indication that a product meets the requirements of relevant CE marking directives and therefore should not be stopped at Member State borders.
Who is responsible?

Under CE Marking, manufacturers are responsible for undertaking a full risk analysis, complying with essential requirements and ensuring that they can provide evidence of having done so. If a harmonized standard applies to the product, the manufacturers have a duty to apply it. An additional duty the manufacturer will also now have is to determine if the standard is fully adequate for the product and its environment, or if the product requires further safety testing before being placed on the open market.

Whilst the vast majority of EU manufacturers are very thorough in ensuring they invest in meeting these standards, there has been criticism that manufacturers from a small number of EU member states have not been so rigorous. This has allowed cheaper, potentially unsafe products to enter the market.

Achieving CE compliance

Reassuringly, market surveillance authorities across the EU are addressing this issue with more active policing of CE Marking. This will ensure a more level playing field for manufacturers across the whole of the EU and will make sure that the CE Mark retains its status as a mark in which trust can be placed.

Achieving CE compliance can be a complex process due to the requirements of individual directives, particularly when combinations of directives apply simultaneously. For the key EU product safety and communications directives, Ege Test Center is able to provide expert help and guidance to support products through the relevant testing process.

For advice on CE Marking a device, please contact us or call TR +90 232 502 2078.

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European CE Marking Strategy for Medical Devices

To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.

How to obtain CE marking for your medical device

CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type. We have a detailed chart explaining the current The basic process follows these steps:

  1. Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC)
  2. Determine the classification of your device.
  3. Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.
  4. Prepare a CE Marking Technical File or a Design Dossier
  5. Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.
  6. Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile and has no measuring function.
  7. Obtain CE Marking and ISO 13485 certificates from your Notified Body.
  8. Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.

Why CE Marking?

The European CE marking regulation has been mainly set up to:

1. Harmonize all varying national regulations for consumer and industrial products in European Member States, so that the Single Market is encouraged;
2. Bring about cost savings for producers;
3. Enhance the safety of products;
4. Supply public bodies with a uniform procedure that can be checked.In the past, product requirements and test procedures in Europe were set by the individual Member States of the European Union. This meant that, for example, companies that wanted to sell their products on the European market sometimes had to deal with more than ten different technical requirements or procedures for just one product. The existence of all the different national legislation was contrary to the aim of the European Union in realizing one Single Market, in which there would be a free circulation of goods (as well as a free circulation of persons, services and capital).

All the different product requirements brought many costs for the producers. With the help of the CE marking Directives or ‘New Approach’ Directives, the measures have been optimized by setting up European (European-wide) requirements, the harmonization of national legislation and directives, standards and mutual recognition of the technical standards, tests methods (compliance tests) and test laboratories, so that producers no longer need to adapt their products to the different markets.

During the process of harmonization the safety level of all products was attuned and raised. In most European countries, safety and health had already been the subject of directives for many years but the safety level was not always satisfactory.

With the help of the conformity assessment procedures, the authorities can ascertain that the products that are placed on the market comply with the requirements as stated in the regulations of the directives. The CE marking is consequently largely for the benefit of the authorities. However, safe products are also necessary for the end user in the work or consumer environment.

What is Radiated Emission test?

Radiated Emission is only one of the Electromagnetic Compatibility (EMC) tests. It is a test that must be performed in an anechoic chamber  or Open Area Test Site (OATS) after the EMC standard has been determined. This standard has to be determined according to the product. Radiated Emission testing is to determine whether the intended product is below a certain level of unwanted electromagnetic frequencies. If the measurement results of a product is under the limit value stated on the standard, this test is counted as PASS. If measurements exceed the limit, it is necessary to make improvements on the product in terms of design change or EMC. The work done on this kind of product is R & D work and it is very essential for manufacturers.

The measurement frequency range of Radiated Emission tests usually starts from 30 MHz and can be up to 1 GHz, 2 GHz or 6 GHz depending on the product specification and the standard applied. Measurements are made via antennas designed for specified frequencies and measuring devices called EMI Receivers. The measurement distance between the product and the antenna is typically 3 meters or 10 meters. It is also possible to change the limits according to the measurement distance. For instance, a limit value of 40 dBuV/m at 3 meters can be reduced to 30 dBuV/m at 10 meters.

Radiated Emission test is one of the most basic tests of EMC tests and is a test that the product designers need to be aware of. Precautions related to the EMC testing of a product must be initiated at the design stage of the product and should continue during the serial production phase. Even when the product is at the end user, precautions should be followed.

New Radio Equipment Directive 2014/53/EU

The Radio and Telecommunications Terminal Equipment Directive (1999/5 / EC), which had been used for the CE marking of wireless devices, has left its place to the new Radio Equipment Directive (2014/53 / EU) since 13 June 2017.

Manufacturers, importers, exporters and distributors who will carry out CE marking rules on their wireless devices are required to take the necessary precautions. You can access the English version published in the Official Journal of the EU here: RED: Radio Equipment Directive (2014/53/EU)

 

Ce Belgeleri

Ce Belgesi Uygunluk

CE belgesi Avrupa’ ya uygunluk anlamına gelmektedir.  Avrupa Birliğinde şuan da yirmi sekiz ülke bulunmaktadır. Ce belgesi bu ülkeler içinde satılan ürünlerin asgari güvenlik, sağlık ve çevre koruma gereklerine göre denetlendiğini/ değerlendirildiğini gösterir. Ce belgesine sahip ürünler bu ülkelerin hepsinde satılabilme özelliğine sahiptir. Bu ürünler mutfak robotlarına, dolaplara, yer parkelerine kadar geniş bir yelpazededir. Her ürünün uygunluğu için bakılan belirli kriterler vardır. Ürünler uzmanlar tarafından incelenip Avrupa Birliğinde bulunan ülkelere uygun kalitede yapıldığını onaylanır. CE belgesi ürünleri en çok teknolojik alanlı ürünlerle hayatımızdadır. Örneğin kullandığınız telefon ve bilgisayarlar yurt dışı tabanlı markalar olup ürünlerin Avrupa Birliği ülkelerinde satılmaları CE belgesine sahiplik durumudur. CE belgesi ürün kalitesini belirten bir belgedir.

 CE belgesi uygunluk değerlendirmelerinde dikkat edilen bazı koşullar vardır. Bu koşullar ürün modülleri tasarım ve üretim aşamalarını kapsar. Bazı modüller sadece bir   bazıları da iki aşamayı birden kapsar.  CE belgesi uygunluk değerlendirme modülleri 8 ana kategoriden oluşmaktadır. Bu belgeye aday tüm ürünler İç üretim kontrolünden geçmektedir. Bunlar;

-AT tip incelemesi

– Üretimin dahili kontrolüne dayalı tipe uygunluk

– Üretim sürecinin kalite güvencesine dayalı tipe uygunluk

– Ürün kalite güvencesine dayalı tipe uygunluk

– Ürün doğrulamasına dayalı tipe uygunluk

– Birim doğrulamasına dayalı uygunluk

– Tam kalite güvencesine uygunluk

Bu unsurlar göz önünde bulunarak, markanın ürünleri tek tek test ve muayene aşamasından geçerek uzmanlar tarafından belirlenen modüller uygun olup olmadığı detaylı bir inceleme sürecinden geçer. Marka CE belgesi almış bir marka ise yeni ürünler piyasaya çıkmadan ürünler bu modüllere uygun hale getirilip, prosedür aşaması tamamlanmış olmalıdır. Markalar bu hizmete dışarıdan kolaylıkla erişebilirler. Sizin için ürünlerinizin CE belgesine uygun olup olmadığını dikkatlice inceleyen firmalar vardır. Bu belgeye başvurmadan önce emin olmak için bu firmalara başvurarak ürünlerinizden emin olabilirsiniz.

silikon

Üçüncü Ülkelerden İthalat Edilen Ürünler İçin CE Belgesi

Avrupa Birliği Direktifleri kapsamında 3. dünya ülkelerindeki üreticilerin Avrupa Birliği pazarında satışa sunmak istedikleri ürünler için CE Belgesi alma prosedürü AB ülkelerindeki üreticilerden farklı şekilde gerçekleşir.

Üreticinin Yeni Yaklaşım Direktifleri doğrultusunda ürünü tasarlamaları, üretmeleri ve gerekli uygunluk değerlendirme prosedürlerini buna göre gerçekleştirmeleri gerekir. Üçüncü dünya ülkelerinden AB’ye yapılacak ithalatlarda, sorumluluk ithalatçı firmaya aittir. Dolayısıyla CE işareti için ithalatçı firmanın başvuruda bulunması gerekir. Avrupa Birliği ülkeleri için ise sorumluluk üretici firmaya aittir. Bir AB ülkesinden başka bir AB ülkesine yapılacak ithalatta, CE belgesi için başvuruda bulunması gereken üçüncü dünya ülkelerinde olduğu gibi ithalatçı firma değil, üretici firmadır.

Avrupa Birliği ortak pazarında satışa sunulmak için CE Belgesi taşıması gereken ürünler için yapılacak ithalat işlemlerinde firmanın ilgili ürünün Avrupa Birliği standartlarına uygun olduğunu kanıtlaması şarttır.

AB’den Diğer Ülkelere Yapılacak İhracatlar

Avrupa Birliği ülkelerine yapılacak ihracat için CE Belgesi alınması zorunlu olduğu gibi, üçüncü dünya ülkelerine yapılacak ihracatlar için CE sertifikası gerekli değildir. Yalnızca Avrupa Birliği ülkelerini ve direktifi kabul eden Türkiye gibi ülkeleri kapsayan CE Belgesi, Avrupa sınırları içerisinde satılacak ürünler için geçerlidir. Dolayısıyla Avrupa Birliği ülkelerinden diğer ülkelere yapılacak ihracatlar için üreticilerin CE Belgesi alması ya da LVD, EMI, EMC gibi testler yaptırmasına gerek yoktur.