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CE Certificate for product

Harmonization of your Export Products to CE Standards

CE standardization, which is one of the basic obligations to be met in exports to the European Union; From elevator to toy, from construction materials to low-voltage appliances, from medical supplies to pressurized containers. The inclusion of commercial products, all of which have a wide range of different uses, and which have a wide range of qualifications, depends on the fact that the product meets CE standards, which is the minimum acceptable safety and compliance level.

How to get CE certificate?

The CE marking protocols may appear complex to inexperienced business owners, so the European Standards Committee on Standardization is defined briefly by CEN. Our firm, which eliminates such confusion in the process of applying CE certificate , provides consultancy and guidance on the execution of the application process in a way that will be completed in favor of the manufacturer in accordance with the legal regulations. Experienced and strict implementation of regulations, CE certificate applicationThanks to our team of experts who will ensure that the process is completed in minimum time and without any problems, getting a CE certificate for commercial enterprises becomes a simple job. Our engineering team informs you after completing the preliminary work on all necessary documents and works in a coordinated manner and advises you on how to eliminate deficiencies if needed. The technical file, which includes the studies related to all scientific research and legislation, has been approved by CEN, in other words, your application is made in such a way that you can obtain CE certificate by our organization which has completed its international accreditation.

Application Process for CE Certificate

In addition to the official documents containing the information on the legal status of the commercial enterprise that applies, as well as the signature file of the authorized or representative persons, the application file also contains the text of the agreement between the manufacturer and the firms that make the application. We help you in all matters such as creating records related to documents, preparing system documents, conducting required tests and investigations about products (LVD test, EMC test, etc.) in laboratory environment and conducting certification tests and we enable you to get CE approval without any problem. For all your inquiries about CE marking protocols and applications, just contact us.

Why the CE mark inside?

Thanks to the knowledge and experience of the Egetest Center expert teams for CE Marking, you will be able to sell your product to the European market without any problem. For detailed information and communication, you can mail to marketing@egetestcenter.com or by entering the https://en.egetestcenter.com/applyonline/ and You can fill form.

Faulty CE Certificate and Liability of the Manufacturer

What is CE Mark and what is it taken for

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

The producers (or the importer or authorized representative), if they are outside the EU, undertake to fulfill the relevant requirements and therefore serve as a clear indication that they will enjoy free movement among all 28 member states.

Problems with CE marking

However, in recent years, Europe has been faced with an increase in the number of products that have been flagged with the CE marking by entering foreign markets. This causes three main problems:

First of all, the use of some markings similar to the CE marking in some products from China causes consumers to confuse frequently and to think of a genuine CE Mark.
Second, the CE marking was illegitimate for products that did not need it, and left the consumers with a false impression that the unsigned products were of poor quality.
Third, the CE Marking is not a mark on the quality of the product, it is a sign of the manufacturer’s own declaration to ensure free circulation of the product throughout Europe. The purpose of the CE Mark is a clear indication that a product meets the requirements of the relevant CE marking directives and should therefore not be stopped at the borders of the Member State.

Who is responsible for the problems?

In accordance with the CE Marking, manufacturers are responsible for conducting a full risk analysis to ensure that they meet the essential requirements and provide evidence that they have done so. If the product has a compatible standard, the manufacturer is obliged to implement it. An additional task of the manufacturer is now to determine whether the standard is entirely sufficient for the product and the environment, or if the product requires more safety testing before being placed on the market.

While the vast majority of EU producers are careful to invest in meeting these standards, there are criticisms that producers in a small number of EU member states have not been so strictly supervised. This led to cheaper, potentially unsafe products entering the market.

Achieving CE compliance

No doubt, EU-wide surveillance agencies address this issue with more effective policing of the CE Mark. This will provide a smoother playground for manufacturers in the EU and will ensure that the CE Mark remains as a mark to which trust can be placed.

Achieving CE compliance can be a complex process, especially when the combination of directives is applied simultaneously, due to the requirements of individual directives. For EU product security processes and directives, the Aegean Test Center can provide assistance and guidance with expert staff to support the products during the relevant testing process.

For CE-related recommendations Before contacting a device, we can contact us and provide the most accurate guidance by our expert teams.

For contact and detailed information

When you work with Ege Test Center expert teams, we eliminate the margin of error in CE Certification. For detailed information and communication, you can send an e-mail to marketing@egetestcenter.com or fill in the form at https://en.egetestcenter.com/applyonline/ and contact us.

Lightning Testing and Surge Immunity Testing

Ege Test Center offers engineering services for lightning immunity test requirements and overvoltage immunity testing requirements. The lightning test can be completed in single-stroke, multi-stroke and multiple burst tests. Direct lightning testing is typically required for external aircraft systems. An indirect lightning test is required to prevent problems with both internal and external aircraft electronics. It simulates secondary currents and voltages passing through indirect lightning, circuits and cables. The test is also called overvoltage immunity test.

Aviation and Military

  • RTCA / DO-160D / E / F
  • MIL-STD-461D / E / F (CS116 and RS105)
  • Airbus US0100.1.2
  • Airbus A380 4421 M1F 0000 00
  • Boeing D6-16050-4 / 5
  • Boeing D6-36440
  • Def Stan 59-411 DCS08
  • EUROCAE ED-105
  • EUROCAE ED-84
  • EuroFighter SPE-J-000-E-1000
  • NASA SL-E-0002
  • SAE ARP5412

Automotive

  • EN 50498
  • ISO 7637-1 / 2
  • General Motors GMW3097
  • Directive 2004/104 / EC (on Temporary Immunity)
  • Automotive Type Approval / e-Mark
  • DaimlerChrysler DC 10614
  • SAE J1113
  • Ford ES-XW7T-1A278-AB and -AC
  • LA DOT 92-088-04 (LED Temporary Special)

Telecom / Information Technology

  • GR-1089-CORE
  • ITU-T K.20 and K.21
  • CE Mark
  • IEEE Std C62.41.2
  • EN 300386
  • IEC 61000-4-4
  • IEC 61000-4-5
  • IEC 61000-4-12

Communication for Lightning Testing and Surge Immunity Testing

For detailed information and communication, you can send an email to marketing@egetestcenter.com or you can fill in the form by clicking the Online Application link and you can reach us

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.

For Communication and Apply

For detailed information and communication, you can send an email to marketing@egetestcenter.com or you can fill in the form by clicking the Online Application link and you can reach us

RoHS Certificate and New Directives

What is RoHS Certificate

RoHS is  a directive that requires the presence of certain substances on electronic cards or materials. It consists of the initials of the Restriction of Hazardous Substances Directive as an English word. Directive 2002-95-EC of 27 January 2003 adopted by the Council of Europe on the harmful substances in electronic products that restrict the activity of certain harmful elements.

Electrical household appliances, which are used in the environments where people live and where we live in the same environment with direct live contact or indirect air contact , need to obtain RoHS  certificate. Take the television in your living room, for example.

All components that make up this television, as well as all parts such as plastic outer casing cables, must have a RoHS  certificate. What happens if these parts do not have a RoHS  certificate? The chemical contents of the components continue to continuously release the carcinogenic toxic particles into the air while the materials continue to dry continuously and interact with the air. Therefore, all individuals (children and babies) who breathe the air and share the same air live in the same environment by continuously breathing the toxic chemical air and have incorporated these unhealthy toxic chemicals into their body in a long period of time. Especially RoHS It is highly probable that the chemicals used in these products, which are strictly prohibited in terms of their directives, are quite harmful poisonous diseases. As EGE TEST CENTER , we  provide quality service with our expert team in obtaining RoHS  certificate.

RoHS Directive has been updated!

2011/65/EU, the RoHS directive, one of the most important directives for CE marking, has been updated. This directive is for the restriction of certain hazardous substances in electrical and electronic equipments (EEE). Annex II of this directive is now annex 2015/863. You can check new Annex 2015/863 of RoHS directive  from here (official web site of EU): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2015.137.01.0010.01.ENG

 

RoHS directive

Would you like us to test your product according to the new directives?

As of 22 July 2019, the products which are in compliance with the RoHS directive annex of 2015/863, will be allowed to market. By contacting Ege Test Center, you can test whether your products are RoHS compliant. You can contact us via our online application page at: https://en.egetestcenter.com/applyonline/

Ce Certification

How to get CE certificate?

Ege Test Center and CE Certificate

With the expert engineers trained in the defense industry and international test organizations, the CE certification works of your Ege Test Center products are completed quickly and quickly.

CE Certificate is taken following the following ways:

1. Stage Research and Detection

  • First of all, product specifications are determined by determining the technical characteristics and intended use of the product.
  • The directives entered by the product within the scope of CE are determined.
  • After determining the product directives specific standards within the scope of the directive are determined.
  • Determined if the notified body is required. Some risky product groups have a mandatory certification.
  • Roadmap is examined under the directive or directives and the most appropriate road map is selected.
  • Examining the requirements of the Quality Management System; Some directives provide for a quality system in the process of CE marking

2. Stage Test and Control process

  • Testing, analysis and technical controls of the product according to the standards determined within the scope of the directives / directives and taking the necessary reports.
  • Where necessary, obtaining certificates and test reports from the Notified Body establishment in risk product groups;
  • Doing Risk Analysis;
  • Preparation of appropriate user manual;
  • Technical Documentation / Preparation of Technical File;
  • Declaration of Conformity;

3. Stage Placing CE Marking and Storing Technical File

  • CE marking is placed on the product according to the relevant directive.
  • Store the Technical File of the Product for the period specified in the product directive and, where necessary, be archived to the competent authorities / market surveillance authorities.

4. Stage Product Launch

  • At the end of the above processes, the product is entitled to carry CE marking and it is free to have free movement in our country and EU market.

In the CE certification process, our company will prepare your CE Certificate declaration by serving you in the fields of consulting, testing, reporting and technical file preparation with the laboratory facilities of EGE TEST CENTER.

For communication and detailed information

For communication and detailed information you can click This page or send mail marketing@egetestcenter.com

CE Certificate for product

Why CE Certificate is Necessary?

The CE Certificate is a sign that is essential for the products to be included in the European Union market. A product bearing the CE certificate; It provides a guarantee for human health and safety, energy saving, environmental protection, life and property safety. It is documented that a product carrying CE certificate does not harm human health and environment and can be used safely.

The CE Marking covers devices that can be used in different business areas such as machines, toys, low-voltage electrical appliances, simple pressure vessels, gas-burning appliances and equipment, building materials, radio telecommunication equipment. In order to be able to market and market these products in the EU market, CE Certificate must be carried. Devices that do not have CE marking cannot be sold in European Union countries.

CE Certificate Which Products Are Important?

For vehicles with electrical or electronic components, the fact that they carry the CE Certificate means that these products can be used safely. It will not only harm the health and safety of human beings, it will be documented with this sign that the product will not directly harm the other living things and the environment. In order for a device to receive CE marking, it is necessary to undergo a lot of tests in the laboratory.If the product fails in one or more of these tests, manufacturers must reconfigure the product. The CE Mark is not eligible to carry unless the product has passed all tests.

Important Of CE Certificate

CE Certificate is important for the marketing of devices with electronic products or electronics, which should be considered by consumers. Selling of products without the CE mark in the European Union and Turkey are prohibited. Conscious consumers tend to prefer not to use electrical devices that do not carry CE certificate in order to protect both human health and the environment.

Detailed information and communication

For detailed information and communication you can send e-mail to marketing@egetestcenter.com or click This link and you can fill form in page.

What is IP Protection Degree and Class?

What are IP Protection and Degrees?

Degree of IP Protection The degrees used to measure the resistance of mechanical or electrical devices to water, dust or external impacts. The main purpose of the code is to provide detailed information about the marketed product. Ege Test Center provides you with detailed information on these scopes and expert IPs . For information and support, you can send an email to marketing@egetestcenter.com or contact us by filling out the form at https://en.egetestcenter.com/applyonline/ .

Examples of IP Protection standards

The main standards of IP Protection are in many different scopes such as EN 60529 , EN 60335 , EN 60598 . To the EN 60529 Standard, the classification of the degree of protection provided by enclosures for electrical equipment not exceeding 72.5 kV .

IP The degree of protection is determined as in the example;

IP 5 8 = First Household – Solids Class

IP5 8 = Second Household – Liquid Grade

You can use the following table to determine the strength class for your product:

 

LEVELPROTECTION AGAINST OBJECT SIZEBODY PROTECTION
0There is no protection against contact and entry of objects.
ONE> 50 mm Protection against objectsSolid objects with diameters 50 mm or more cannot enter the device
2ND> 12.5 mm Protection against objects of sizeSolid objects with a diameter of 12.5 mm cannot enter the device
3>> 2.5 mm Protection against objectsSolid particles with diameters of 2.5 mm or more cannot enter the device
4> 1 mm Protection against objectsSolid particles with diameters of 1 mm or more cannot enter the device
5Product Dust ResistantDust particles cannot enter the device in a way that will interfere with normal operation of the device
6Product Protection against objects in Dustproof DimensionsFully protected against dust.

To determine the class of your product’s resistance to liquids:

LEVELPROTECTED AGAINSTTESTEDDETAIL
0Unprotected
ONEProtection against vertical water dropletsDrops of vertical water do not damage the deviceTest Time: 10 MinutesOil value, 1 mm / min
2NDProtection against vertical drops of water when the housing of the device is at an angle of 15 °Even when the body of the device is vertical with an angle of 15 ° in both directions, the water droplets that fall vertically do not damage the device.Test Time: 10 MinutesWater value, 3 mm / min
3Protection against spraying thin water dropletsFine water droplets with a vertical angle of 60 ° in both directions even if they come to the device does not damage the deviceTest Time: 5 MinutesWater Volume: 0.7 l / min
Pressure: 80,7100 kPa
4Protection against splashing waterWater splashes from any direction into the housing of the device do not damage the appliance.Test Time: 5 MinutesWater Volume: 10 l / min
Pressure: 80 lt100 kPa
5Protection against splash waterWater from any direction to the body of the device does not damage the deviceTest Time: At least 15 MinutesWater Volume: 12,5 lt / min
Pressure: 30 kPa at a distance of 3 m
6Protection against strong water jets (water jet)Strong splashes of water from any direction into the housing of the device do not damage the applianceTest Time: Min. 3 MinutesWater Volume: 100 l / min
Pressure: 100 kPa at a distance of 3 m
6KProtection against increased water jet pressureIt is resistant to high pressure powerful water jets. (12.5 mm hose)Test Time: Min. 3 MinutesWater Volume: 75 l / min
Pressure: 1000 kPa at a distance of 3 m
7Protection against the effects of temporary immersionIt is protected from pressure and resistant to harmful water ingress if immersed in water under defined conditions. (Immersion up to 1 m).Test Time: 30 MinutesAt least 1 meter from the bottom of the device and at least 15 cm from the device was measured
8Protection against the effects of continuous immersionThe device is resistant to continuous immersion in water under the conditions specified by the manufacturer.Test Period: Continuous in waterThe depth determined by the manufacturer is usually 3 meters.
9KProtection against high temperature water jetsIt is resistant to close range, high pressure and high temperature water jets.

In addition, there are some letters in the IP Protection classes for your product, which can be used as protection level to protect your product against access to dangerous parts, and some letters can be used to get additional information about your product’s protection. These letters are as follows;

 

LEVELPROTECTED AGAINST ACCESS TO HAZARDOUS PARTS
TOBack of hand
BFinger
CAppliance
DWire

 

LETTERMEANING
FOil resistant
HHigh-voltage device
MDevice in water test
SDurable device still during the water test
WWeather conditions

Sometimes there are different classes used to determine the product resistance of the product. These mechanical effects are indicated by Jul.

IP LEVEL DROPPULSE ENERGYEQUIVALENT FALL MASS AND HEIGHT
0
ONE0.225 J150 g drops to 15 cm
2ND0,375 J250 g drops to 15 cm
30.5 J250 g drops to 20 cm
52 J500 g falling to 40 cm
76 J1.5 kg falls to 40 cm
920 J5.0 kg falls to 40 cm

Imported CE certificate from Third Country

CE Certificate for Products Imported from Third Countries

Within the scope of the European Union Directives, the procedure for obtaining CE certificate for the products that the manufacturers in the third world want to sell in the European Union market takes place differently from the producers in the EU countries.

In accordance with the Manufacturer’s New Approach Directives, the product must be designed, manufactured and carried out according to the appropriate conformity assessment procedures.From the third world countries to the EU, the responsibility belongs to the importer company.Therefore the importer must apply for the CE marking.The responsibility for the European Union Countries belongs to the manufacturer. It is not the importer company, but the manufacturer, as it is in the third world countries that need to apply for the CE certificate in the importation from one EU country to another EU country. In the case of import operations for products that need to carry CE certificate to be put up for sale in the European Union common market, the company has to prove that the product is in compliance with European Union standards.

Exports from EU to Other Countries

CE certificate is mandatory for export to European Union countries but CE certificate is not required for exports to third world countries. Only countries such as covering the CE Certificate of European Union countries like Turkey accepted the directive is applicable to products to be sold within the European boundaries. Therefore, for export from European Union countries to other countries, manufacturers do not need to obtain CE Certificate or do tests such as LVD, EMI, EMC.

 

Ce Certification

EMC Test for Medical Devices

The Importance of Medical Devices in Our Lives

Nowadays, the medical devices used in medicine are very important. Ultrasound, magnetic resonance, dentist chair, radiological methods, such as the diseases formed in our body to be seen in the finest detail is possible to see. There are EMC tests that must be applied to medical devices used in medicine, the accuracy and construction of these tests is very important. In the case of improper application of parts, such as standard, test coverage, human health is at great risk when any problem occurs.

The Importance of CE Marking for Medical Devices

The CE marking is of great importance for the medical devices to easily move around Europe. The EMC tests of these types of medical products and the CE Marking carry important factors such as health, safety, environment and consumer protection.

To get CE Mark on Medical Devices

Ege Test Center team of experts is implementing in conjunction with the first of medical devices accredited scope of the EMC Tests and reporting stage in your side apply.medical your device accredited in scope to get the Ege Test Center marketing@egetestcenter.com could e-mail address or  https://www.egetestcenter.com/applyonline/ You can reach us by filling in the form.