Product Certification

2006/42/EC Machine Safety Regulation

Safe machines provide legal assurance for manufacturers and users. Machine users expect only safe machines or devices to be produced. This expectation is world wide and there are regulations to protect machine users worldwide. These arrangements vary according to regions and countries. Nevertheless, during the construction and retrofitting of machines there is widespread agreement on the following procedure:

The machine manufacturer shall determine and assess all possible dangerous and dangerous locations for risk assessment during machine construction.

The manufacturer shall, in accordance with this risk assessment, remove or reduce the risks by appropriate measures. If the risk can not be removed by documentation measures, or the remaining risk can not be intolerabled, the machine manufacturer will select and apply appropriate safety devices and if necessary, information on remaining risks.

Completely approval process will be performed for to be ensure that the necessary anticipated measures. This total validity will assess both documentation, technical and organizational measures within the general condition.

MACHINERY DIRECTIVE (2006/42/EC)

The Machinery Directive 2006/42 / EC is directed to the manufacturers and their suppliers of machinery and safety parts. Describes the tasks for the elimination of trade obstacles within Europe and the fulfillment of health and safety requirements for new machines to ensure high safety and health protection for users and operators. The same applies to the production of machines, and also to the production of safety components which are brought to the market, as well as to used machinery and equipment which will be transported to the European market for the first time from third countries (eg USA or Japan).

WHAT DOES THE MACHINE MANUFACTURER’S DUTIES?

Designing the Machines of Trustworthy

Manufacturers have to design their machines in accordance with the basic safety and health requirements of the Machinery Directive. The producers consider the safety integrity during production. This means that, the designer must perform a risk assessment at the development stage. Measures to be taken from here can be included directly in production.

Preparing Operation Guide

The machine manufacturer has to prepare an operating guide called “original operating instructions”. An operating guide will be provided in the official language of the country to be used with each machine. The operating guide should clarify how the machine should be used and what should be considered.

Preparing Technical Documents

The manufacturer has to prepare technical documentation of machine. These technical documents:

Contains all plans, calculations and documentation of the fulfillment of the basic safety and health requirements of the Machinery Directive.

Technical documentation of the machine (or machine type); shall be kept for at least 10 years from the last day of production.

Technical documentation will be submit to competent authority according to legal request.

Preparation of Declaration of Conformity

If the the machine has been manufacture properly, it will approve the declaration of conformity and the marking of the machine (CE Mark) in a legally binding manner that fulfills the requirements. The machine can then be launch to the European market.

ECP wish to be a solution partner of from the safety manufacturing to during the certification process, at every stage. ECP provide professional service for a product which covered within the Machinery Safety Directive all of your product testing, inspection and regulation of product technical file, inspection and documentation by technical knowledge with engineers and sector experience.

2014/35/EU LVD (Low Voltage) Regulation

All electric vehicles with voltage values between 50V – 1000V AC and 75 – 1500V DC be included in the scope of Low Voltage Directive 2014/35 / EC (ex. 2006/95 / EC). The safety of the components located at the base of some electric vehicles depends on the integration process of these components into the product. Such components, which form the basis of electric vehicles, are excluded from the scope of the regulations and not carry CE marking.

Electrical components; if used as a component of an electrical device, are covered by the new LVD Directive (The Low Voltage Directive). Transformers and electric motors are one each component. In the use of all such components, some safety assessments are required. Many of these components have applicable special European standards. İlgili standarda göre gerekli elektriksel güvenlik testlerinin yapılması ve raporlanması gerekmektedir. Manufacturers must preserve the test reports of have tested products done which one is under the Directive 2014/35 / EU LVD in the technical files they have created for CE marking.

For low voltage devices without test reports in the technical file, the CE marking will not supply with the legal requirements. The manufacturer must conduct electrical safety tests of the devices and keep the test reports in the technical files of the relevant product because of in order to avoid penal sanctions in the market surveillance performed by the Ministry of Science and Technology and Ministry of Industry.

The Low Voltage Devices Directive carries out the CE Certification works for the products covered by Directive 2014/35 / EU (ex. 2006/95 / EC) (LVD) and the following electrical safety tests for the products in this scope:

-Leakage Current Test

-High Voltage Test

-Insulation Resistance Test

-Continuity Test

-Function Test

2014/35 / EC Regulation on Electrical Equipment designed to be used within certain voltage limits; includes electrical equipment designed for use in rated voltages ranging from 50 volts to 1000 volts for alternating current and 75 volts to 1500 volts for direct current.

The equipment and conditions specified in Annex II of the Regulation are outside the scope of regulation.

Safety Requirements, Standards, CE Conformity Mark

The electrical equipment covered by the Regulation must supply with the basic safety requirements laid down in Annex I.

If international safety provisions or national safety provisions establishing safety requirements not exist, it shall be deemed to have provided the provisions and safety requirements of the relevant Regulation on electrical equipment supplied to the market in accordance with harmonized European standards.

Product can be supplied to the market of electric equipment that does not jeopardize the safety of people, pets and goods, when used in accordance with the appropriate standards for the current product and the intended purpose, properly installed and maintained.

The Ministry shall publish in the Official Gazette the names and numbers of the relevant harmonized national standards determined by the TSE and the harmonized European standards for the electrical equipment covered by the Regulation and the related amendments to the Regulation. The Ministry shall notify this information to the Undersecretariat for submission to the Commission.

If the harmonized standards referred to in the first paragraph of this Article are not present in harmonized European standards, it shall be deemed to comply with the provisions of the Regulations of electrical equipment fulfilling the safety provisions of IEC or CEE published in the Official Journal of the European Communities.

The TSE and the Ministry shall make the necessary provision to apply the safety provisions determined by the CEE or IEC and to publish them in the Official Gazette.

In the case of submitting and free movement to the market, where harmonized European standards or international safety provisions as determined by CEE / IEC do not yet exist, if the national standards provide the level of safety required by the Regulation, it shall be deemed that the electrical equipment produced in accordance with the provisions of the applicable national standard is in accordance with the provisions of the Regulation.

CE Conformity Mark

Using the CE conformity marking and for attaching the electrical equipments are below:

Before being put on the market, Concerning the electrical equipment falling within the scope of the Regulation, the conformity assessment procedures specified in Annex IV are followed, Declaration of Conformity on the basis and form in Annex III is declared to be in conformity with the provisions of the Regulations of electrical equipment and the electrical equipment is affixed with the CE conformity mark in accordance with the principles in (c) of this Article.

In the case of an objection or doubt, the manufacturer or importer may submit a report prepared by an organization notified in accordance with the procedure laid down in paragraph (d) of Article 13 that the electrical equipment conforms to the provisions of the Regulation.

For example; CE conformity marking as given in Annex III should be added or printed on electrical equipment by manufacturer or authorized representative established in Turkey, if this is not possible, CE marking should be added or printed on the packaging, instruction manual or warranty card in the same way visible in a way that is attached legible. Also CE marking should be added or printed indelibly.

Electrical equipment, can not be affixed any other signs and texts that mislead third parties because of occasioned meaning CE marking. However, other marks indicating compliance with national or international standards or other regulations can be printed or affixed to the product, packaging, manual or warranty document, so long as not prevent the visibility and readability of the CE conformity mark.

If the electrical equipment is also subject to other regulations stipulating the affixing of the CE conformity mark in other respects, the CE conformity mark shall be deemed to comply with the provisions of the other relevant provisions of the electrical equipment. However, where one or more of the regulations give the manufacturer a choice of practice during a transitional period, the CE conformity mark indicates that the manufacturer only complies with the provisions of the directive (s) / regulation (s) selected by the application. In this case, the relevant details and provisions of the applicable directive (s) shall be given in the documentation of the electrical equipment and in the instructions for the exciter of use, provided for in the use manuel.

Illegal Affix of CE Conformity Mark

The provisions, b clause of 13th issue and 12th issue of Regulation under the seal of secrecy:

If it is determined that unfairly attached to the CE marking is required by the manufacturer or to ensure compliance with the provisions relating to CE marking of an authorized representative products in Turkey and the termination of the violation within the terms set by the Ministry.

The Ministry shall take all appropriate measures to ensure that such non-conformity continues to restrain or prohibit the supply of such electrical equipment to the market or to ensure that it is seized from the market in accordance with the regulations laid down in, b clause of 13th issue and 12th issue.

Technical File, Placing on The Market, Market Surveillance

Technical File

Copy of the Technical File which is prepared by The manufacturer or his authorized representative established in Turkey, which has been arranged to contain information describing the design, production and operation of the product, according to Regulation Article 7 (a) Declaration of conformity specified in Annex I and with the conformity assessment results provided in paragraph IV, is available for inspection by the Ministry when requested. The Ministry may authorize an organization to examine this issue when necessary.

Placing on The Market

Placing electrical equipment to the market can not be restricted, prohibited or prevented if it is produced in accordance with the provisions of the Regulations and the required safety standards.

Market Surveillance

Market surveillance of electrical equipment, Regulation on the Market Surveillance of the Products which is put into force by the Decree of the Council of Ministers numbered 2001/3529 and Regulation on Market Surveillance and Supervision to be realized by the Ministry of Industry and Commerce published in the Official Gazette dated 9/5/2003 and numbered 25103 Procedures and Principles in accordance with the provisions of the Regulation. Denetim sonuçlarının olumsuz olması halinde, Yönetmeliğin 16 ncı maddesi hükümleri uygulanır.

Measures and Notifications

Measures

If the electrical equipment falling within the scope of the Regulation does not fulfill the safety requirements stipulated in the Regulation and the requirements specified in Annex I, the harmonized standards referred to in Article 6, the provisions referred to in Article 7, or the safety standards referred to in Article 10, prohibite placing electrical equipments to the market and prevent free movement, by the Ministry.

Judgments relating to notifications are given below:

When regulations entry into force, be notified by Undersecretariat to The Member State of the European Union and the Commission.
Due to safety reasons; if placing electrical equipment to the market or the free circulation is prevented by the Ministry, the reasons for the decision, in particular the inconvenience to the 10th item, the harmonized standards specified in the 6th item or the deficiency in the 5th item, with this immediately be notified the Commission and the Member States concerned by Undersecretariat.
If no consensus is reached within three months from the date of the notification referred to in paragraph (b) of this Article, the opinions and recommendations of the Commission are evaluated.
After consulting Member States with regard to the safety provisions referred to in Article 5 of the Regulation and the third paragraph of Article 6, the Commission shall notify the Commission through the Undersecretary within three months of any possible objections to the notified provisions,
Ministry;
Directive informs the name and address of the unit which is authorized in accordance with the 7th article and the unit which is responsible for implementation.

Shall notify to the Commission and the member states, the name and address of the institution which one set the standards, by the Undersecretariat.

Shall inform the Commission and the Member States about any amendment that may be in the above information by the Undersecretariat.

Annex I

USE ONLY INCLUDING SPECIFIC VOLTAGE LIMITS

RELATED TO DESIGNED ELECTRICAL EQUIPMENT

BASIC FACTORS OF SAFETY OBJECTIVES

1) General conditions

The basic features that will enable the recognition of the electrical equipment to be used safely and appropriately for the purposes of the installation will be given on the equipment or, if this is not possible, accompanied by a warning notice in Turkish.
The manufacturer or brand name or trademark must be printed on electrical equipment or, if this is not possible, legibly on the packaging.
The electrical equipment with all components must be assemble for provide to connect safety and properly.
Electrical equipment shall be designed and produced in such a way as to protect against the hazards specified in paragraphs 2 and 3 of this Annex, just on condition that to be used in accordance with the purpose for which it is intended and to be adequately maintained.
2) Protection against hazards arising from electrical equipment

Ensure that humans and pets are adequately protected against physical injury or other hazards that may be caused by direct or indirect electrical contact,
Do not create heat, arcs or radiation that could lead to danger,
Necessary to ensure that humans, pets and goods are adequately protected against non-electrical hazards that arise from electrical equipment,
Measures shall be taken in accordance with paragraph 1 of this Annex in order to ensure that the insulation is suitable for the predictable cases.
3) Protection from hazards arising from external influences on electrical equipment

The expected mechanical requirements of the electrical equipment will ensure that it does not harm human beings, animals and animals,
Essential that the electrical equipment be resistant to non-mechanical effects in the expected environmental conditions, not to compromise humans, pets and goods beings,
Technical measures must be taken in accordance with paragraph 1 of this Annex to ensure that electrical equipment does not endanger humans, pets and goods in cases of extreme overload that can be predicted.
Annex II

EQUIPMENT AND DUTIES WHICH ONES EXCEPT OF THE REGULATION

Electrical equipment to be used in explosive atmospheres
Electrical equipment for radiology and medical use
Electrical parts of service and passenger lifts
Electric meters
Household plugs and sockets
Electric fence controls
Radio-electrical interference
Special electrical equipment used on ships, airplanes or railways, complying with the safety provisions laid down by international organizations to which the European Union member states belong.
Annex III

CE CONFORMITY MARKING AND DECLARATION OF CONFORMITY

CE CONFORMITY MARKING
The CE conformity marking (logo) shall consist of the initials “CE ” in the form shown below;

If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm;

DECLARATION OF CONFORMITY
The declaration of conformity shall consist of the following basic principles:

Name and address of the manufacturer or authorized representative in Turkey,
Description of electrical equipment,
Reference to harmonized standards if necessary
The technical instructions if necessary
References to other regulations as appropriate if necessary
The manufacturer or authorized representative established in Turkey on behalf of the authorized signatory to enter into commitments identity
The last two digits of the year in which the CE conformity marking is affixed
Annex IV

INTERNAL PRODUCTION CONTROL

Internal production control ensure that the provisions of this Annex 2 fulfilling the obligations under the rules of the electrical equipment manufacturer or Regulation made through an authorized representative in Turkey and a process referred to in paragraph stating.The manufacturer or his authorized representative established in Turkey, must to affix the CE marking to all electrical equipment and draw up a written declaration of conformity.
The manufacturer shall prepare the technical file referred to in paragraph 3 of this Annex. The manufacturer or his authorized representative established in Turkey to provide technical documentation at the disposal of the relevant national authorities for at least the next 10 years in order to retain the manufacture of the final product analyzed. In cases the manufacturer or authorized representative established don’t presence in Turkey, this obligation is the responsibility of the natural or legal persons who supply the electrical equipment for the Turkish market.
The technical document should be able to allow for the appropriateness and designated appropriateness to the requirements of the Regulations of the electrical equipment. Regarding such evaluations, the technical file should contain the following information on the design, manufacture and operation of the electrical equipment.
General description of electrical equipment.
Conceptual design and manufacturing drawings and schematic, subassembly, circuit diagrams, etc.
The list of standards applied to the device in whole or in part is a description of the methods applied to ensure the safety provisions of the Regulation when the standards do not apply.
The results of the design calculations, inspections, etc.
Test reports
The manufacturer or authorized representative shall keep a copy of the CE declaration of conformity together with the technical document.
The manufacturer shall take all necessary measures to ensure that the manufactured electrical equipment complies with the technical file referred to in paragraph 2 of this Annex and in accordance with the provisions of the Regulation.

2014/30/EU EMC (Electromagnetic Compatibility) Regulation

The EMC Directive defines electromagnetic compatibility as “the ability to operate satisfactorily, without causing electromagnetic interference, which may be irritating to other devices or facilities present in the vicinity of an equipment or facility in an electromagnetic environment”. The machine and components must be selected and verified to withstand any potential interference. Higher requirements apply for safety devices. Electromagnetic interference may occur because of below stated:

Fast transient electrical interference (Burst)

Pulse voltage (surge), for example stroke of lightning the network.

Electromagnetic fields

High frequency interference (from neighboring lines)

ElectroStatic discharge (ESD)

All electrical and electronic equipment or installations interact with each other, when they are connected or be nearby. For example, television or radio is interfering with when due to the nearby refrigerator or the power line passing above. The EMC conditions are designed to keep these side effects under control at a reasonable level. Similarly, many units in cars are electronically managed and any interaction can lead to incorrect operation. Therefore, important to evaluate these systems by the EMC regulations for quality and functional safety.

EMC standards serve two purposes internationally:

*They regulate the electromagnetic emission from a device.

*They ensure the immunity of the device to electromagnetic interference.

The ECP supports to customers about the documentation, the test report and the technical file according to EMC compliance. Join the ECP family for fast and reliable certification process.

2014/68/EU PED (Pressure Equipments) Regulation

1) The conformity assessment procedures to be applied for the various categories are the following:

I) Category I = Module A

II) Category II = Module A1 – D1 – E1

III) Category III = Module B1 + D, B1, + F, B + E, B + C1, H

IV) Category IV = Module B + D, B + F, G, H1

2)The safety accessories defined in point 4 of Article 2, and referred to in Article 4(1)(d), are classified in category IV. However, by way of exception, safety accessories manufactured for specific equipment may be classified in the same category as the equipment they protect.

3)The pressure accessories defined in point 5 of Article 2, and referred to in Article 4(1)(d), are classified on the basis of:

-their maximum allowable pressure PS,

-their volume V or their nominal size DN, as appropriate,

-the group of fluids for which they are intended

The appropriate table for vessels or piping is to be used to determine the conformity assessment category.

Where both the volume and the nominal size are considered appropriate in the second indent of the first subparagraph, the pressure accessory shall be classified in the highest category.

4)The demarcation lines in the following conformity assessment tables indicate the upper limit for each category.

Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of table 1 shall be classified in category III.

Exceptionally, portable extinguishers and bottles for breathing equipment shall be classified at least in category III.

Exceptionally, assemblies intended for generating warm water as referred to in the second subparagraph of Article 4(2), shall be subject either to an EU-type examination (Module B — design type) with respect to their conformity with the essential requirements referred to in points 2.10, 2.11, 3.4, 5(a) and 5(d) of Annex I, or to full quality assurance (Module H).

Exceptionally, the design of pressure-cookers shall be subject to a conformity assessment procedure equivalent to at least one of the category III modules.

Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of Table 6 shall be classified in category III.

Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling within category II on the basis of Table 7 shall be classified in category III.

2014/33/EU Lift Regulation

CE marking is a legal requirement for companies which manufacture or install elevators. The elevator companies which providing installation, maintenance and revision services are obliged to prepare technical files according to relevant regulations and standards. Obliged to implement the ISO 9001: 2015 Quality Management System at the operations and to certify compliance with the 2014/33 / EU Elevator Regulations of the electric or hydraulic elevator assembly / manufacture / revision have maded to the Notified Body. Can marked CE on the assembly / manufacture / revision of the elevator after the approval of the Notified Body.

Companies of elevator which the manufacture, install or revision should consider the 2014/33 / EU elevator regulations (eg 95/16 / EC). Electrical and hydraulic elevator installation, maintenance and revision should be according to TS EN 81-20 (ex: TS EN 81-1 + A3, TS EN 81-2 + A3) harmonize standard to ensure full compliance.

The Elevator Directive specifies the basic health and safety requirements that must be fulfill before supply to the market for elevators and their associated elevator safety components used to transport people, people and loads or just loads.

Creation of Elevator Technical File according to CE Criteria

The companies of which are manufacture and installation of elevator or manufacture of safety components of elevator, are responsible for preparing the technical file for their products. A copy of the technical file which is prepared by the manufacturer, should be at company and other copy should be at Notified Body (if certificated); also one of the other copy should be ready to give when requested by the competent authorities, importer or authorized representative located at that country.

Documents, test reports and other documents submitted in the European Union New Approach Directives should be included in the technical file content.

The recommended documents to be included in the technical file content are below stated:

The general description of the elevator model

Drawings of design and manufacturing, calculations and diagrams

Considered directives and harmonized standards and instruments that are agreed to provide them

A copy of the EU Declarations of Conformity of the safety components used in the manufacture of elevators

Made or get done the results of each experiment and calculations by the manufacturer

A copy of the lift’s handbook

Measures taken at the manufacturing stage to ensure that the manufactured elevators or elevator safety components comply with the legal provisions of this Directive.

Creation of EU Declaration of Conformity

The EU declaration of conformity is a declaration that the manufacturer of the elevator or the manufacturer of the elevator safety components has manufactured the product according to the requirements of the Elevator Directive. The EU declaration of conformity is issued and declared by the manufacturer of the elevator safety components or the elevator.

The content of the EU declaration of conformity, which shall be established for elevators by elevator assemblers, below stated:

The name and address of the company which performed the assembly of the elevator,

The description, the type or serial details and the serial number of the elevator and the address where the elevator is assembled,

Assembly year of the elevator,

All relevant provisions about elevator,

Reference to harmonized standards ascribing,

The name, address and identification number of the notified body which performs the EU type examination of the elevator model,

Ascribing EU type examination document,

The name, address and identification number of the notified body that verifies the elevator,

The name, address and identity number of the notified body which audit the last inspection of the elevator,

The name, address and identification number of the Notified Body which audit the Final Inspection,

The identity of the signature authorized to act on behalf of the elevator assembly,

For elevator safety components, the content of the EU declaration of conformity, which shall be established by the manufacturer:

Name and address of the manufacturer of the safety components,

The description of the safety feature, type or serial details, serial number if any; if can’t be understood, in the safety function of the safety components,

The date of manufacture of the safety components,

All relevant provisions of the safety components,

Reference to harmonized standards ascribing,

The name, address and identity number of the notified body which performs the EU type examination,

Ascribing to the EU type examination document issued by the Notified Body,

The name, address and identity number of the Notified Body which performs the manufacturing inspections,

The name and address of the notified body which controls the quality assurance system.

After all these operations, the CE conformity mark can be affixed to the product. The CE conformity marking must be on the safety components, if it is not possible, must be on the packing on the elevator safety components. At this stage, the elevator or elevator safety component, which has the technical document prepared, the declaration of EU conformity and the CE conformity mark attached, has been supplied to the market according to the Elevator Directive (2014/33 / EU).

How should CE Marking be affixed at elevators?

At the elevators whose assembly is completed, beside the CE conformity mark;

The identification number of the notified body performing the final inspection of the B + F module,

The notified body identification number, which performs product quality assurance inspection of the B + E module,

The notified body identification number, which performs manufacturing quality assurance inspection of the B + D module,

The notified body identification number which perform inspection of the G module,

Mandatory to be the notified body identification number, which inspection the full quality assurance at the H module.

How Should CE Marking be Affixed to Safety Components?

Beside the CE conformity mark of the elevator safety components;

At the modification of the B + C modules, the manufacturer of the safety components will attach the CE conformity marking to each safety components,

At the modification of the B + E modules, the identification number of the notified body, which performs the product quality assurance inspection together with the CE conformity mark,

At the H module, it is mandatory to be the notified body identification number, which performs full quality assurance inspection with the CE conformity mark.