(2014/30/EU) ELECTROMAGNETIC COMPATIBILITY REGULATION AND TESTS UNDER IT
Aim
ARTICLE 1 – (1) The purpose of this Regulation is to regulate the electromagnetic compatibility of the equipment and to ensure the operation of the market in a way that the equipment complies with a sufficient level of electromagnetic compatibility.
Scope
ARTICLE 2 – (1) This Regulation covers the equipment defined in Article 5.
(2) This Regulation;
a) Equipment within the scope of the Radio and Telecommunication Terminal Equipment Regulation published in the Official Gazette dated 24/3/2007 and numbered 26472,
b) All kinds of instruments, indicators, equipment, mechanisms, parts, equipment, hardware or software used or intended to be used to operate or control an aircraft in flight, including the aircraft, engine, propeller and communication devices, and equipment that is a part of the fuselage, engine or propeller or used to maneuver the aircraft on the ground,
c) Radio equipment used by amateur radio operators, provided that it is not available on the market (All components to be installed by amateur radio operators, commercial equipment modified by amateur radio operators and modified for use by these amateurs are not considered as commercially available equipment.)
ç) Equipment that is not capable of producing or contributing to electromagnetic emissions exceeding levels that enable radio and telecommunications equipment and other equipment to operate as designed,
d) Equipment that operates without unacceptable loss of performance as a result of electromagnetic disturbance resulting from normal use,
e) It does not include evaluation kits for professionals, produced exclusively for these purposes in research and development facilities.
(3) If the basic requirements specified in Annex I regarding the equipment specified in the first paragraph are regulated partially or completely in more detail in another European Union legislation, this Regulation will not be implemented or the implementation of this Regulation will be suspended regarding these requirements as of the date of entry into force of the said legislation.
Rest
ARTICLE 3 – (1) This Regulation has been prepared based on the Law on the Preparation and Implementation of Technical Legislation on Products dated 29/6/2001 and numbered 4703.
Compliance with European Union legislation
ARTICLE 4 – (1) This Regulation has been prepared within the framework of compliance with the European Union legislation, taking into account the European Parliament and Council Directive on Electromagnetic Compatibility No. 2014/30/EU dated 26/2/2014.
Definitions
ARTICLE 5 – (1) In this Regulation;
a) EU: European Union,
b) Accreditation: Official acceptance by a national accreditation body that a conformity assessment body meets the requirements set by the relevant national or international standards and the additional requirements stipulated in the relevant sectoral regulations in order to carry out a specific conformity assessment activity.
c) Immunity: The ability of the equipment to operate as designed without loss of performance during the presence of electromagnetic disturbance,
d) Ministry: Ministry of Science, Industry and Technology,
d) CE mark: The mark issued by the manufacturer indicating that the device complies with all relevant rules of the technical legislation requiring the affixation of the CE mark,
e) Device: Any ready-to-use device or combination of devices designed for the end user and offered for sale as a single functional unit that is likely to produce electromagnetic disturbances or whose performance is likely to be affected by such disturbances (defined as a combination of parts or sub-components and devices that are intended to be fitted to the device by the end user and that are likely to produce electromagnetic disturbances or whose performance is likely to be affected by such disturbances, including, as the case may be, movable installations and devices intended to move and operate in specific locations). is evaluated.)
f) Distributor: Any natural or legal person other than the manufacturer or importer who has a device in the supply chain and makes it available on the market,
g) Hardware: Any device or fixed installation,
g) Electromagnetic disturbance: Electromagnetic noise, an unwanted signal or a change in the propagation medium itself that can reduce the performance of the equipment,
h) Electromagnetic environment: All electromagnetic phenomena that can be observed in a certain place,
i) Electromagnetic compatibility: The ability of the equipment to operate satisfactorily in its own electromagnetic environment without causing intolerable electromagnetic disturbance in equipment in the same environment,
i) Recall: Any measure taken to return a device currently in the possession of the end user,
j) Security purposes: Purposes to ensure the safety of life and property,
k) Economic operator: Manufacturer, authorized representative, importer and distributor,
l) Manufacturer: Any natural or legal person who manufactures the device or has it designed or manufactured and markets it under his own name or trademark,
m) Importer: A real or legal person resident in Turkey who imports a product from abroad and puts it on the market,
n) Commission: European Commission,
o) Placing on the market: Providing devices to the market for distribution, consumption or use through a commercial activity, for a fee or free of charge,
ö) Withdrawal from the market: Any measure aimed at preventing the device in the supply chain from being placed on the market,
p) Placement on the market: The first time a device is available on the market,
r) Fixed installation: A certain combination of various types of devices and, where applicable, other devices, mounted, installed and intended for permanent use at a predetermined location,
s) Technical specification: A document stating the technical requirements that must be present in the hardware,
ş) TÜRKAK: Turkish Accreditation Agency,
t) Conformity assessment body: The organization that carries out conformity assessment activities, including calibration, testing, certification and inspection,
u) Conformity assessment: The process that shows whether the essential requirements of this Regulation are met regarding the device,
ü) Harmonized standard: A European standard adopted upon the request of the Commission in order to implement harmonized European Union legislation,
v) Member country: Country that is a member of the European Union,
y) Authorized representative: Any natural or legal person resident in Turkey who has received a written power of attorney from a manufacturer to act on its behalf regarding certain tasks,
expresses.
CHAPTER TWO
Essential Requirements, Making it available on the Market and/or Putting it into Service,
Free Movement of Hardware
Basic requirements
ARTICLE 6 – (1) The equipment must meet the basic requirements specified in Annex-I.
Making it available on the market and/or putting it into service
ARTICLE 7 – (1) The Ministry takes all necessary measures to ensure that the equipment is placed on the market and/or put into service only if it is properly installed, maintained, used for its intended purpose and in compliance with this Regulation.
Free movement of equipment
ARTICLE 8 – (1) The Ministry does not prevent equipment that complies with this Regulation from being placed on the market and/or put into service for reasons related to electromagnetic compatibility.
(2) The requirements of this Regulation do not prevent the application of the following special measures regarding the commissioning or use of equipment:
a) Measures to overcome the existing or anticipated electromagnetic compatibility problem in a particular region.
b) Measures taken for security reasons to protect national communications networks or receiving and transmitting stations where they are used for security purposes in well-defined spectrum situations.
(3) Without prejudice to the Regulation on the Notification of Technical Legislation and Standards Between Turkey and the European Union published in the Official Gazette dated 3/4/2002 and numbered 24715, these special measures are notified to the Commission and EU member states by the Ministry through the Ministry of Economy.
(4) It is allowed to introduce and/or exhibit equipment that does not comply with the conditions in this Regulation at trade fairs, exhibitions or similar events, provided that a clear sign is placed stating that the equipment cannot be placed on the market and/or put into service until it complies with the conditions specified in this Regulation. Introduction may only be made if appropriate precautions are taken to prevent electromagnetic disturbance.
CHAPTER THREE
Obligations of Economic Operators
Manufacturer's obligations
ARTICLE 9 – (1) When placing the device on the market, manufacturers ensure that the device is designed and manufactured in accordance with the basic requirements specified in Annex-I.
(2) Manufacturers shall prepare the technical file mentioned in Annex II or Annex III and apply or have it implemented the relevant conformity assessment procedure mentioned in Article 16. Where the compliance of the device with the safety requirements set out in Annex I is demonstrated by the conformity assessment procedure, manufacturers shall issue an EU declaration of conformity and affix the CE marking.
(3) Manufacturers shall keep the technical file and the EU declaration of conformity for 10 years from the date the device is placed on the market.
(4) Manufacturers shall ensure that the device's compliance with this Regulation is maintained throughout series production. It monitors and takes action regarding changes in the device design or features and changes in harmonized standards or other technical specifications that form the basis for declaring the conformity of the device.
(5) Manufacturers must ensure that the device they place on the market; It ensures that this information is included on the device when it carries a type, batch or serial number or other element that allows identification, and that this information is included on the packaging of the device or in a document supplied with the device in cases where the size or structure of the device does not allow this.
(6) Manufacturers indicate their names, registered trade names or registered trademarks and the addresses where they can be contacted about the product on the device or, where this is not possible, on the device packaging or in a document supplied with the device. Only one address is shown where the manufacturer can be contacted. Contact information must be in Turkish or in a language that end users will understand and the Ministry will accept.
(7) Manufacturers shall ensure that instructions and safety information are provided with the device in Turkish. Such instructions and safety information and all labels must be clear, understandable and legible.
(8) Where manufacturers know or should know that a device they have placed on the market does not comply with this Regulation, they shall immediately take the necessary corrective measures to bring the device in question into compliance, withdraw it from the market or, if necessary, recall it. In addition, in cases where the device poses a risk, manufacturers shall inform the Ministry in detail and promptly, especially regarding non-conformity and all corrective measures taken.
(9) Upon a reasoned request, manufacturers shall submit to the Ministry all necessary information and documents showing the compliance of the device with this Regulation, in printed or electronic form, in Turkish or in a language acceptable to the Ministry. Manufacturers cooperate with the Ministry, upon request, in activities aimed at eliminating the risks posed by the devices they place on the market.
Authorized representatives
ARTICLE 10 – (1) Manufacturers may appoint an authorized representative with a written authorization document. The obligations set forth in the first paragraph of Article 9 and the obligation to prepare the technical file specified in the second paragraph of Article 9 are not among the powers of the authorized representative.
(2) The authorized representative performs the duties specified in the authorization certificate received from the manufacturer. With the authorization certificate, the authorized representative is allowed to do at least the following:
a) To keep the EU declaration of conformity and technical file to be submitted to the Ministry upon request for 10 years after the device is placed on the market.
b) To submit to the Ministry, upon reasoned request, all the information and documents required to prove the conformity of the device.
c) To cooperate with the Ministry upon request of the authorized representative regarding any measures taken to eliminate the risks posed by the device included in the authorization certificate.
Obligations of importers
ARTICLE 11 – (1) Importers shall place on the market only devices that comply with this Regulation.
(2) Importers shall ensure that the manufacturer has carried out the necessary conformity assessment procedure specified in Article 16 before placing the devices on the market. It ensures that the manufacturer has prepared the technical file, that the device bears the CE marking, that the necessary documents are provided with the device and that the manufacturer fulfills the requirements specified in the fifth and sixth paragraphs of Article 9. If the importer knows or should know that the device does not comply with the essential requirements set out in Annex I, he cannot place the device on the market without making it conform. In addition, if the device poses a risk, the importer informs the manufacturer and the Ministry.
(3) Importers indicate their names, registered trade names or registered trademarks and the addresses where they can be contacted about the product on the device, or, where this is not possible, on the device packaging or in a document supplied with the device. Contact information must be in Turkish or in a language that end users can easily understand and that the Ministry will accept.
(4) Importers shall ensure that the instructions and information mentioned in Article 20 are provided with the device in Turkish.
(5) Importers shall ensure that, while the device is under their responsibility, storage and transport conditions do not jeopardize its compliance with the essential requirements set out in Annex I.
(6) In cases where importers know or should know that a device they have placed on the market does not comply with this Regulation, they shall immediately take the necessary corrective measures to bring the device in question into compliance, withdraw it from the market or, if necessary, recall it. In addition, in cases where the device poses a risk, importers shall promptly inform the Ministry in detail about non-conformity and all corrective measures taken.
(7) Importers shall keep a copy of the EU declaration of conformity ready to submit to the Ministry for 10 years from the date the device is placed on the market and ensure that the technical file is submitted to the Ministry upon request.
(8) Upon a reasoned request, importers shall submit to the Ministry all information and documents showing that the device complies with this Regulation, in printed or electronic form, in Turkish or in a language acceptable to the Ministry. Importers cooperate with the Ministry, upon request, in activities aimed at eliminating the risks posed by the devices they place on the market.
Obligations of distributors
ARTICLE 12 – (1) Distributors act with due care in terms of the requirements of this Regulation while placing the device on the market.
(2) Before placing the device on the market, distributors verify that the device bears the CE marking, that the necessary documents and the instructions and other information specified in Article 20 are provided with the device in Turkish, and that the manufacturer and importer fulfill the requirements set out in the fifth and sixth paragraphs of Article 9 and the third paragraph of Article 11. If the distributor knows or should know that the device does not comply with the essential requirements set out in Annex I, it cannot place the device on the market without making it conform. Additionally, when the device poses a risk, the distributor informs the manufacturer or importer as well as the Ministry.
(3) Distributors shall ensure that, while the device is under their responsibility, storage and transport conditions do not jeopardize its compliance with the essential requirements set out in Annex I.
(4) Where distributors know or should know that the devices they have on the market do not comply with the requirements of this Regulation, they shall ensure that the necessary corrective measures are taken to bring the device in question into conformity, withdraw it from the market or, if necessary, recall it. In addition, in cases where the device poses a risk, distributors shall promptly and in detail inform the Ministry specifically about the non-conformity and any corrective measures taken.
(5) Upon reasoned request, distributors shall provide the Ministry with all information and documents showing the compliance of the device with this Regulation in printed or electronic form. Distributors, upon request, cooperate with the Ministry on any measures taken to eliminate the risks posed by the devices they keep on the market.
Situations where manufacturers' obligations apply to importers and distributors
ARTICLE 13 – (1) An importer or distributor who places a device on the market under its own name or trademark, or who modifies a device already placed on the market in a way that affects its compliance with the requirements of this Regulation, is considered a manufacturer for the purposes of this Regulation and is subject to the manufacturer obligations specified in Article 9.
Identification of economic operators
ARTICLE 14 – (1) Economic operators provide the Ministry with information regarding the identification of the following persons upon request:
a) All economic operators who supply devices to them.
b) All economic operators to whom they supply devices.
(2) Economic operators must be able to provide the information specified in the first paragraph for 10 years after the device is supplied to them and for 10 years after the device is supplied to them.
CHAPTER FOUR
Suitability of Hardware
Assumption of suitability of hardware
ARTICLE 15 – (1) Products that comply with the harmonized standards whose reference numbers have been published in the Official Journal of the European Union or the corresponding Harmonized Turkish Standards or their relevant sections are assumed to comply with the basic requirements specified in ANNEX-1 within the scope of these standards or their relevant sections.
Conformity assessment procedures for devices
ARTICLE 16 – (1) The compliance of the devices with the essential requirements specified in Annex I is proven through one of the following two conformity assessment procedures:
a) Internal control of production regulated in Annex II.
b) EU type examination followed by a conformity assessment based on internal control of production, set out in Annex III.
(2) The manufacturer may choose to limit the application of the procedure referred to in paragraph (b) of the first paragraph of this article to certain aspects of the essential requirements, provided that the procedure in paragraph (a) of the first paragraph is applied for other aspects of the essential requirements.
EU declaration of conformity
ARTICLE 17 – (1) The EU declaration of conformity states that the basic requirements set out in Annex I are met.
(2) The EU declaration of conformity is prepared and constantly updated as included in Annex IV, including the matters specified in the relevant modules in Annex II and Annex III. In cases where it is issued in other languages, a Turkish translation is also added to the EU declaration of conformity.
(3) If the device is subject to more than one legislation requiring an EU declaration of conformity, a single EU declaration of conformity shall be prepared for all of this legislation. The EU declaration of conformity contains the name of the legislation, the date of publication and a description of the relevant legislation, including publication references.
(4) The manufacturer is deemed to assume responsibility for the compliance of the device with the requirements set out in this Regulation upon issuing the EU declaration of conformity.
General principles of the CE marking
ARTICLE 18 – (1) CE marking is subject to the principles specified in the “CE” Marking Regulation put into effect by the Council of Ministers Decision No. 2011/2588 dated 16/12/2011.
Rules and conditions for affixing the CE marking
ARTICLE 19 – (1) The CE marking shall be attached to the device or its data plate in a visible, readable and indelible manner. If this is not possible or guaranteed due to the nature of the device, the marking is affixed to the product packaging and accompanying documentation.
(2) The CE marking is affixed before the device is placed on the market.
(3) The Ministry takes current practices as a basis to ensure the correct implementation of the process for affixing the CE marking and takes the necessary action in case of inappropriate use of this marking.
Information on using the device
ARTICLE 20 – (1) When the device is put into service, information regarding all specific precautions to be taken during the assembly, installation, maintenance or use of the device to ensure that it complies with the basic requirements specified in Annex-I shall be provided with the device.
(2) A clear statement regarding such a use restriction shall be included with the device whose compliance with the essential requirements specified in Annex I cannot be ensured in residential areas. Additionally, if appropriate, this statement is also included on the packaging.
(3) Information required to ensure that the device is used for its intended purpose is included in the instructions supplied with the device.
fixed installations
ARTICLE 21 – (1) Devices that are available on the market and can be included in a fixed installation are subject to all relevant provisions specified in this Regulation. However, the requirements of Articles 6, 9 to 14 and 16 to 20 shall not be mandatory in the case of devices designed for inclusion in a specific fixed installation and not otherwise available on the market. In such cases, the accompanying documentation identifies the fixed installation and its electromagnetic compatibility characteristics and indicates the measures to be taken for the device to be incorporated into the fixed installation, so as not to compromise the suitability of that installation. The documents also include the information specified in the fifth and sixth paragraphs of Article 9 and the third paragraph of Article 11. The good engineering practices specified in Annex-I are documented and the relevant documents are kept ready for the disposal of the Ministry by the relevant person or persons as long as the fixed installation in question is in operation.
(2) In case of indications of non-conformity of the fixed installation, in particular in case of complaints about the deterioration caused by the installation, the Ministry may request evidence of the suitability of the fixed installation and, if necessary, initiate an evaluation. In case of non-conformity, the Ministry may require appropriate measures to be taken to bring the fixed installation into compliance with the essential requirements set out in Annex I.
(3) The Ministry shall regulate the necessary provisions to determine the person or persons responsible for ensuring that a fixed installation complies with the relevant basic requirements.
CHAPTER FIVE
Conformity Assessment Bodies
Notification
ARTICLE 22 – (1) The Ministry notifies the Commission and EU member states through the Ministry of Economy about the organizations authorized to carry out third party conformity assessment tasks under this Regulation.
Authorized organization
ARTICLE 23 – (1) The Ministry is authorized to organize and implement the necessary procedures for the evaluation of conformity assessment bodies, including compliance with Article 28, and the assignment and supervision of these organizations.
Principles regarding the authorized organization
ARTICLE 24 – (1) Appointment, evaluation and monitoring procedures of conformity assessment bodies;
a) In a way that does not allow conflict of interest with conformity assessment bodies,
b) Within the framework of the principle of impartiality,
c) To ensure that the expert personnel who will make decisions regarding the appointment of conformity assessment bodies and the personnel who will evaluate these organizations are different,
ç) In a way that the activities or consultancy services carried out by conformity assessment bodies are not offered in a commercial or competitive manner,
d) By taking care to protect the confidentiality of the information obtained,
e) By employing a sufficient number of expert personnel required to perform the relevant duties properly and completely,
is executed.
Obligation to inform
ARTICLE 25 – (1) The Ministry shall notify the Commission, through the Ministry of Economy, of the principles regarding the evaluation and assignment of qualifications of conformity assessment bodies and the supervision principles of approved organizations and any changes in these principles.
Requirements for notified bodies
ARTICLE 26 – (1) The following qualifications are required for the conformity assessment body to be appointed as an approved body.
(2) The conformity assessment body must be established in accordance with national legislation and have legal personality.
(3) The conformity assessment body must be a third party organization independent of the device or institution/business it will evaluate. An organization affiliated with an industrial, commercial or professional chamber, union or association or professional federation representing businesses involved in the design, manufacture, supply, installation, use or maintenance of the device it is evaluating may be considered a third party organization, provided that its independence and no conflict of interest can be proven.
(4) The most senior managers of a conformity assessment body and its personnel responsible for carrying out conformity assessment duties cannot be the designer, manufacturer, supplier, assembler, purchaser, owner, user or maintainer of the devices they evaluate, or representatives of any of these parties. This does not prevent the use of devices necessary for the work of the conformity assessment body or the use of such devices for personal purposes. A conformity assessment body, its chief executives and its personnel responsible for carrying out conformity assessment duties may not be directly involved in the design, manufacture, construction, marketing, installation, use or maintenance of such devices or represent parties carrying out such activities. These organizations cannot engage in or participate in any activity that may negatively affect the independence of decision-making regarding the conformity assessment activities for which they are authorized and the ability to properly fulfill the requirements of the profession. This also applies to consultancy services. Conformity assessment bodies prevent the activities carried out by their branches, representatives or contractors from affecting the confidentiality, objectivity or impartiality of their conformity assessment activities.
(5) Conformity assessment bodies and their personnel carry out conformity assessment activities in a way that they have the necessary technical competence and professional equipment at a high level, and at the end of these activities, they act independently of any pressure, incentive and person or persons who may be affected by the results of the activity, especially when making decisions regarding financial matters.
(6) The conformity assessment body must have the capacity to carry out all conformity assessment tasks assigned to it and authorized by Annex III, whether carried out by the conformity assessment body itself or on its behalf and under its responsibility. The conformity assessment body must always have the following mandatory requirements for each conformity assessment procedure and for each category and type of device for which it is authorized:
a) Personnel with technical knowledge, sufficient level and appropriate experience to carry out conformity assessment duties.
b) Appropriate policies and procedures to ensure the transparency or reproducibility of the conformity assessment procedures, descriptions of the procedures taken into account when carrying out the conformity assessment and the distinction between the duties performed by the conformity assessment body as a notified body and its other activities.
c) The methods required to carry out the activities taking into account the size of the work undertaken, the sector in which it operates, the organizational structure, the degree of technological complexity of the product in question and the volume or quality of the production process.
d) Having the necessary tools to properly perform the technical and administrative tasks associated with conformity assessment activities; Possibility of access to all necessary equipment or facilities.
(7) The personnel responsible for carrying out conformity assessment activities must have the following conditions:
a) Adequate technical and professional training covering all the conformity assessment activities that the conformity assessment body is tasked to carry out as a notified body.
b) Sufficient knowledge of the requirements of the assessments they carry out and the authority required to carry out these assessments.
c) Appropriate knowledge and understanding of the essential requirements set out in Annex I, applicable harmonized standards and relevant provisions of EU legislation and national legislation.
d) Ability to issue certificates, records and reports proving that the activities carried out have been carried out.
(8) It guarantees the impartiality of conformity assessment bodies, senior managers of these organizations and personnel responsible for carrying out conformity assessment activities. The remuneration of a conformity assessment body's most senior managers and staff responsible for carrying out conformity assessment tasks may not depend on the number of assessments carried out or the results of those assessments.
(9) If the responsibility is not assumed by the public according to national legislation or the Ministry itself is not directly responsible for conformity assessment, conformity assessment bodies shall obtain professional liability insurance.
(10) The personnel of the conformity assessment body shall observe professional confidentiality regarding all information obtained during the performance of their duties within the scope of Annex III or any provision referred to by national legislation, except for cases related to the Ministry. Property rights are protected.
(11) Conformity assessment bodies participate in the relevant standardization activities and the work of the group established by the EU within the scope of the relevant technical regulation for the coordination of notified bodies, or ensure that the personnel carrying out the evaluation activities are aware of these activities. The documents prepared with the decisions resulting from the work of the group established for the coordination of approved organizations are used as a guide.
Presumption of conformity of notified bodies
ARTICLE 27 – (1) If a conformity assessment body proves its compliance with the criteria determined in the harmonized standards whose reference numbers are published in the Official Journal of the European Union or their relevant sections, it is deemed to comply with the requirements set out in Article 26, provided that the applicable harmonized standards cover these requirements.
Branches, representatives and subcontractors of approved organizations
ARTICLE 28 – (1) If the approved organization assigns certain tasks related to conformity assessment to a subcontractor or uses a branch/representative office for these activities, the organization in question ensures that the subcontractor or branch/representative office meets the requirements specified in Article 26 and informs the Ministry on the subject.
(2) Notified bodies take full responsibility for the tasks performed by subcontractors or branches/representatives where these tasks have been identified.
(3) Activities to be carried out by approved organizations can be outsourced to a subcontractor or carried out by a branch/representative office only if the customer approves.
(4) Approved organizations keep the documents related to the evaluation of the qualifications of the subcontractor or branch/representative office and the evaluation of the activities carried out by them within the scope of Annex III, in order to submit them to the Ministry when necessary.
Application for notification
ARTICLE 29 – (1) Those who want to be appointed as a notified body from conformity assessment bodies established in Turkey apply to the Ministry.
(2) Along with the application document, necessary information about the conformity assessment activities, conformity assessment module or modules and device in which they state that they are competent, as well as an accreditation document, if any, proving that the conformity assessment body meets the requirements regulated in Article 26 and issued within the framework of the seventh paragraph of Article 4 of the Regulation on Conformity Assessment Bodies and Approved Bodies, put into effect by the Decision of the Council of Ministers dated 16/12/2011 and numbered 2011/2621, are submitted.
Notification process
ARTICLE 30 – (1) The Ministry may appoint as notified bodies only conformity assessment bodies that meet the requirements set out in Article 26.
(2) The Ministry notifies the organizations deemed appropriate to be assigned to the Commission and EU member states through the Ministry of Economy. Notification is made using the EU's New Approach Notified Bodies Information System.
(3) The notification contains full details of the conformity assessment activities, the relevant conformity assessment module(s), the device, as well as the competence of the organisation.
(4) Within two weeks from the date of notification to the Commission of a notified body candidate with an accreditation certificate, the Commission or EU member states may request additional information or raise an objection regarding the adequacy of the notified body candidate. Following the assignment of an identity registration number by the Commission to the notified conformity assessment body, the Ministry appoints this organization as an approved body.
(5) The Ministry informs the Commission and EU member states through the Ministry of Economy about the changes in the notified organization's activities and characteristics.
Appointment of notified bodies
ARTICLE 31 – (1) Following the assignment of an identity registration number by the Commission to the notified conformity assessment organization, the Ministry appoints this organization as an approved organization.
Changes in assignments
ARTICLE 32 – (1) If the Ministry determines or is informed that the approved organization no longer meets the requirements regulated in Article 26 or cannot fulfill its obligations, the Ministry restricts the activities of the organization, suspends it or terminates the status of the notified organization, depending on the seriousness of the situation where these requirements are not met or these obligations are not fulfilled. The Ministry, through the Ministry of Economy, immediately informs the Commission and EU member states about this issue.
(2) The Ministry takes appropriate measures to ensure that the records and documents related to the conformity assessment procedures carried out by the notified body whose activities are restricted, suspended, whose notified body status is terminated, or which terminates its activities voluntarily, are processed by another notified body operating in the same field or are kept to be presented to the Ministry, if requested by the Ministry.
Objection regarding the competence of notified bodies
ARTICLE 33 – (1) The Ministry notifies the Ministry of Economy to submit all information that forms the basis for the appointment of the approved organization or that it maintains its competence, to the Commission upon request.
(2) If the Ministry, the Commission or one of the EU member states requests the examination of the technical competence and compliance with the relevant legislation of a notified body assigned by the Ministry, it follows the procedure specified in Article 4 of the Turkey-European Union Association Council Decision No. 1/2006.
Obligations of approved bodies regarding their activities
ARTICLE 34 – (1) The approved body carries out conformity assessments in accordance with the conformity assessment procedure specified in Annex-III.
(2) Conformity assessments are carried out in a way that does not create an unnecessary burden for economic operators. Conformity assessment bodies activities; It carries out the work by taking into account the size of the work it undertakes, the sector in which it operates, its structure, the degree of complexity of the technology of the device in question and the volume or quality of the production process. In doing so, it takes into account the level of protection and degree of care required for the device to comply with this Directive.
(3) If the notified body determines that the essential requirements set out in Annex I, the relevant harmonized standards or technical specifications are not met by a manufacturer, it requests the manufacturer in question to take appropriate corrective measures and does not issue a certificate of conformity.
(4) If, during the monitoring of conformity following the issuance of a certificate, the notified body determines that a device is no longer conforming, it shall request the manufacturer to take appropriate corrective measures and, if necessary, suspend or withdraw the certificate.
(5) If corrective measures are not taken or do not have the desired effect, the notified body shall, as appropriate, restrict, suspend or withdraw all relevant certification.
Objections to decisions of notified bodies
ARTICLE 35 – (1) The Ministry ensures that an objection mechanism is available against the decisions of approved organizations.
Obligation of notified bodies to provide information
ARTICLE 36 – (1) Approved organizations inform the Ministry about the following issues:
a) Refusal, restriction, suspension or withdrawal of a document.
b) Any situation affecting the scope and conditions of notification.
c) Any information requests they receive from the Ministry regarding conformity assessment activities.
d) Conformity assessment activities carried out, upon request, within the scope of being tasked with any other activity, including cross-border activities and subcontracting a work.
(2) Approved bodies are obliged to provide information about the conformity assessment procedures that resulted negatively and, if requested, resulted positively, to other notified organizations that are assigned within the scope of this Regulation and carry out similar conformity assessment activities for the same device.
Coordination of notified bodies
ARTICLE 37 – (1) Approved organizations participate in or are represented in committees and working groups established by the Ministry and the Commission.
CHAPTER SIX
Market Surveillance and Control, Control of Devices and
Safeguards Procedure
Market surveillance and control of devices
ARTICLE 38 – (1) In the market surveillance and control of devices, the provisions of the Regulation on Market Surveillance and Inspection of Products, put into effect by the Council of Ministers Decision No. 2001/3529 dated 13/11/2001, shall apply.
Procedures to be followed for products that pose a risk at the national level
ARTICLE 39 – (1) If the Ministry has a reason to believe that a device within the scope of this Regulation poses a risk to the protection of public interest within the scope of this Regulation, the Ministry makes an assessment covering all the requirements set out in this Regulation regarding the device in question. Relevant economic operators cooperate with the Ministry for this purpose. If, as a result of the evaluation, the Ministry determines that the device does not comply with the requirements set out in this Regulation, it requests the relevant economic operator to take all appropriate corrective measures to bring the device into compliance with the relevant requirements, to withdraw the device from the market or to recall it within a reasonable time, immediately and within a reasonable time proportional to the nature of the risk. The Ministry informs the relevant notified body about the issue.
(2) For the measures in the first paragraph, the provisions of the Regulation on Market Surveillance and Control of Products and the Market Surveillance and Control Regulation of the Ministry of Science, Industry and Technology published in the Official Gazette dated 2/10/2012 and numbered 28429 are valid.
(3) If the Ministry considers that the non-compliance is not limited to the country, it informs the Commission and the EU member states, through the Ministry of Economy, about the results of the evaluation and the measures they want economic operators to take.
(4) The economic operator ensures that appropriate corrective measures are taken for all devices it has on the market.
(5) If the relevant economic operator does not take adequate corrective measures within the period specified in the first paragraph, the Ministry shall take all appropriate interim measures to prohibit or restrict the availability of the device on the market, withdraw or recall these devices from the market. The Ministry, through the Ministry of Economy, informs the Commission and EU member states about these measures as soon as possible.
(6) The information referred to in the fifth paragraph of this article shall include all available details, in particular the data necessary to identify non-conforming devices, the origin of the devices, the nature of the alleged non-conformity and the risk involved, the nature and duration of the measures taken and the arguments put forward by the relevant economic operator. The Ministry specifically states whether the non-conformance is due to one of the following reasons:
a) The device does not meet the requirements regarding the protection of public interest covered by this Regulation.
b) Deficiencies in the harmonized standards that are deemed to be a presumption of conformity specified in Article 15.
(7) A measure that the Ministry has accepted to be implemented regarding the non-conformity of the device in question, based on information communicated by the Commission regarding a transaction initiated in the EU market, and any additional information in its possession; Additionally, if it objects to the notified measure, it notifies its objections to the Commission and the European Union member states through the Ministry of Economy.
(8) If no objection is made by an EU member state or the Commission against the temporary measure taken by the Ministry within three months after the information provision specified in the fifth paragraph of this article, the measure in question is considered justified.
(9) The Ministry ensures that appropriate restrictive measures are taken without delay regarding the device in question, such as withdrawing the device from the market.
Safeguards procedure
ARTICLE 40 – (1) If there is an objection from the EU member states and the Commission against the measure specified in the fourth and fifth paragraphs of Article 39, and if, in the examination carried out by the Commission, it is determined that the measure in question is not based on justified justification, the measure shall be abolished.
Shape unsuitability
ARTICLE 41 – (1) Without prejudice to Article 39, if it reaches one of the following findings, the Ministry requests the relevant economic operator to end the non-compliance:
a) Attaching the CE mark contrary to the general principles specified in the "CE" Mark Regulation.
b) Failure to affix the CE marking.
c) Failure to issue an EU declaration of conformity.
ç) Failure to prepare the EU declaration of conformity correctly.
d) Absence or incompleteness of the technical file.
e) The information in the sixth paragraph of Article 9 and the third paragraph of Article 11 is missing, incorrect or incomplete.
f) Except for those stated in paragraph (e), any of the requirements specified in Article 9 or Article 11 are not met.
(2) If the non-conformity specified in the first paragraph of this article continues, the Ministry takes all appropriate measures to restrict or prevent the availability of the device on the market and ensures that the device is recalled or withdrawn from the market.
CHAPTER SEVEN
Miscellaneous and Final Provisions
Committee proceedings
ARTICLE 42 – (1) The Ministry participates in the work of the Electromagnetic Compatibility Committee established by the Commission.
Administrative sanctions
ARTICLE 43 – (1) The provisions of Law No. 4703 on the Preparation and Implementation of Technical Legislation on Products shall be applied to those who act contrary to the provisions of this Regulation.
regulatory authority
ARTICLE 44 – (1) The Ministry is authorized to make regulations regarding the implementation of this Regulation.
Repealed regulation
ARTICLE 45 – (1) The Electromagnetic Compatibility Regulation (2004/108/EC) published in the Official Gazette dated 24/10/2007 and numbered 26680 has been abolished. References to the repealed regulation in other regulations are deemed to be made to this Regulation.
transitional provision
PROVISIONAL ARTICLE 1 – (1) The Ministry does not prevent the equipment that falls within the scope of the Electromagnetic Compatibility Regulation (2004/108/EC) published in the Official Gazette dated 24/10/2007 and numbered 26680, that complies with the said Regulation and that was placed on the market before the date of entry into force of this Regulation, from being placed on the market or put into service.
Force
ARTICLE 46 – (1) This Regulation shall enter into force on the date of its publication.
Executive
ARTICLE 47 – (1) The provisions of this Regulation shall be enforced by the Minister of Science, Industry and Technology.
Two main groups are essential in Electromagnetic Compatibility.
A-Electromagnetic Interference Emission
B-Immunity to Electromagnetic Interference
A set of standards specifically examines both of these unique phenomena for a product or a group of products.
In many cases, both events are mentioned and examined according to one and the same standard.
The standards are grouped as follows:
1-Basic Standards
2-Branch Basic Standards (Generic Standards)
3-Product Family Standards
4-Product Standards
Basic Standards: These Standards generally contain a description, explanation of the event, and description for each Disturbing Wave event.
They contain the detailed test method, description and explanation of the test setup and measuring devices used.
It is the purpose of the basic standards to be specified as a reference in the Main Branch, Product family, Product standards.
The use of these Basic standards does not create the right to affix the CE-Mark.
For this reason, basic standards are not published as "Harmonized Standards" in the official journal of the European Union.
Examples:
-IEC 61000-4 Series: Measurement techniques for immunity to Electromagnetic Interference
-ENV 50140: “Electromagnetic Interference Immunity” tests against Radio Frequency electromagnetic fields
Branch Basic Standards: These standards are, in principle, valid for all products used in the same environment. The standards contain limit values that must be used for EMC phenomena that can be decisive for the products. References are made to the basic standards for inspection methods. "Basic Branch Standards" are taken into account for harmonization and are therefore published in the EU official gazette. The right to affix the CE-Mark can be created from the use of these standards. However, for this, there is no "Product Family or Product Standard" for the product in question. It is a prerequisite. Because such standards have priority over the "Branch Core Standards". The general "Branch Core Standards" are also grouped into four standards related to "Emission of Interference" and "Immunity to Interference", which cover all environmental conditions and the most important EMC phenomena.
Emitting Electromagnetic Interference:
EN 50081-1: Electromagnetic Compatibility (EMC) Branch Basic standard "Emission of Interference" (Part 1; Devices in residential areas, workplaces, restaurants, hotels and small businesses) (Generic Emission Standard)
EN 50081-2: Electromagnetic Compatibility (EMC) Branch Basic Standard "Emission of Interference" (Part 2; Devices in industrial areas) (Generic Emission Standard)
Immunity to Parasites:
EN 50082-1: EMC; Branch Basic Standard "Immunity to Parasites" (Part 1; Devices in residences, workplaces, restaurants, hotels, small businesses) (Generic Immunity Standard)
EN 50082-2: EMC; Branch Basic Standard “Immunity to Parasites” (Part 2: Devices in industrial areas) (Generic Immunity Standard)
Product Family Standards: “Product family standards” are determined for related product groups. Test levels and limit values are stipulated. These standards are taken into account for harmonization and are therefore published in the EU official gazette. They can be used for certification within the scope of the CE-Mark. If there is a product family standard, only this standard is used.
Example: EN 55015; Limit values and measurement methods for electromagnetic interference of fluorescent lamps (Interference Wave Emission)
Product Standards: These standards are like “Product Family Standards”, but unlike product family standards, they are determined for a certain type of product. “Product Standards” always have priority over “Branch Basic Standards”.
Example: EN 50061: Safety conditions of implantable pacemaker, EN 50091-2: Uninterruptible power supply systems (UPS) (Part 2: EMC-Requirements)
Tests:
The standards in the tests to be carried out are based on the standard description of the product. Meanwhile, the device is envisioned as a “Black Box”.
In Outer Box
Direct Current (DC) and Alternating Current (AC) supply inputs and outputs
Signal, Data, Measurement and Control inputs and outputs
Function Various tests are performed on the ground connection.
Measurement of Interference Emission: In general, the following measurements are made:
•Measurement of Electromagnetic Wave radiation (Radiated magnetic field emission)
•Measurement of parasitic wave voltage (on device connection conductors) (Conducted emission)
•Measurement of interference wave power (Power Disturbance)
•Measurement of brittle parasitic waves that are not uniformly continuous
•Low frequency mains interference waves
•Measurement of Electromagnetic Wave Radiation (Radiated magnetic field emission):
Open Area Test Site (OATS):
Here, the direct electromagnetic wave emission of a device is measured. The field strength is measured with a measuring antenna at a certain distance. These measurements cannot be made in a laboratory. In particular, the requests regarding "Interference Wave Propagation" in EN 55022 and EN 55011 should be examined in an "Open Field Test Facility" (OATS).
Alternatively, an "Absorption Chamber" can be used. This is a non-reflective section made of material that absorbs the walls and ceiling (sometimes even the floor). So much so that "Open Field Test Facility" conditions can be created in this room.
Frequency Range: Electromagnetic wave propagation measurement is generally done in the "open field test facility" in the frequency range of 30 MHz to 1 GHz. However, in many cases, lower and higher frequencies are also valid. Electrical field intensities above 30 MHz and magnetic field intensities below 30 MHz are measured.
•Measurement of Interference Wave Voltage (Conducted Emission):
Here, tests on conductors (mostly electrical network; connection conductors, but may also be communication or load output conductors) on which the high-frequency voltage is measured are in question. This method is generally performed in the frequency range of 9 kHz to 30 MHz.
Measurement of Disturbance Wave Power (Power Disturbance): In some standards, a "Coupling Ring" is used instead of an "Open field test facility" for measurements above 30 MHz in "Disturbing wave power measurement". A "Coupling Ring" is the combination of a current clamp and an absorption filter. In order to determine the maximum value of this "Disturbing wave power", it is moved on the "Mains connection cable". From 30 MHz There is also a measurement in EN55014 that must be carried out with the help of a “Coupling Ring” up to 300 MHz (sometimes up to 1000 MHz).
Measurement of fragile, non-continuous parasitic waves: To measure these pulsed parasitic waves, measuring devices for continuous parasitic waves alone are not sufficient. In addition, the length of the pulse must be determined with an oscilloscope or special pulse "analyzer". This type of parasitic waves are, above all, created by switch components such as "Thermostate".
•Low Frequency Network interference waves:
a-Network Harmonic Distortion:
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