FAQ

The calibration interval is determined by the user of the instrument according to the purpose of the measurement, the accuracy required, the stability of the instrument, the history of previous calibrations, the frequency of use, the environmental conditions and the requirements of the quality management system.

In many operations an interval of one to two years is used, but the appropriate period must be based on the specific risk and significance of the measurement. For critical measurements, intensively used instruments or instruments exposed to demanding environments, a shorter interval may be appropriate.

We will help you set appropriate calibration intervals and a system for keeping records of measuring instruments according to the nature of your activities.

Yes. We can carry out calibrations both in our laboratory and directly at the customer’s premises, provided that this is permitted by the nature of the instrument, the required metrological traceability, the environmental conditions and the equipment available.

EZÚ is calibration laboratory No. 2294, accredited by the Czech Accreditation Institute according to ČSN EN ISO/IEC 17025. We calibrate, for example, electrical measuring instruments such as multimeters, voltmeters, ammeters and oscilloscopes, as well as instruments for photometric quantities, electronic thermometers and instruments for time and frequency.

The specific scope of calibrations, the measuring ranges and the measurement uncertainties are set out in the current scope of accreditation and in the laboratory’s offering. Calibrations cover areas such as high voltage, high currents and temperature measurement; we will assess the suitability of a particular service according to the type of instrument and the required parameters.

An importer placing a product from a country outside the European Union on the EU market must, before doing so, verify that the manufacturer has fulfilled the applicable requirements. In particular, the importer verifies whether the manufacturer has carried out the required conformity assessment, whether the product bears the required marking, whether the required documentation has been drawn up and whether that documentation can be made available to the competent authorities on request. The importer also ensures that the product bears its identification details where the applicable legislation requires this.

A distributor must act with due care when making a product available on the market. In particular, the distributor verifies whether the product bears the required marking, whether it is accompanied by the necessary information, instructions and safety instructions, and whether there is no reasonable suspicion that the product fails to meet the applicable legal requirements. The distributor also cooperates with market surveillance authorities in providing the necessary information.

If an importer or distributor places a product on the market under its own name or trademark, or substantially modifies the product, it may assume the obligations of the manufacturer.

EZÚ can assist with verifying the technical documentation, testing the product and determining an appropriate scope of assessment before the product is placed on the market.

For electrical and electronic products, the requirements that frequently apply are those for electrical safety under the Low Voltage Directive (LVD), for electromagnetic compatibility under the EMC Directive, for the restriction of the use of certain hazardous substances under RoHS and, for radio equipment, the requirements of the RED Directive.

Depending on the type of product, its intended use and the target market, legislation on machinery, construction products, medical devices, batteries, ecodesign, energy labelling or the cybersecurity of products with digital elements may also be relevant.

For products with digital elements it is advisable to take into account already now the requirements of the regulation on the cyber resilience of products, known as the Cyber Resilience Act. Its main obligations will generally apply from 11 December 2027; some obligations apply earlier. For selected radio equipment, the cybersecurity requirements under the RED Directive have applied since 1 August 2025.

For a specific product we will help you identify the relevant legislation, harmonised standards and a suitable conformity assessment procedure.

This depends on the particular product, the applicable legislation and the conformity assessment procedure. For many electrical products the manufacturer may carry out the conformity assessment itself under internal production control, provided that it meets all the requirements laid down and compiles the necessary documentation and testing.

The involvement of a notified body is mandatory only in those cases where it is required by the applicable legislation or by the chosen conformity assessment module. Typically this may concern, for example, certain construction products, medical devices or selected situations involving radio equipment.

EZÚ will help you determine which legislation, standards and conformity assessment procedure are relevant to your product and whether a notified body needs to be involved in your particular case.

A notified body is an organisation designated by a Member State of the European Union and notified to the European Commission to carry out conformity assessment under specific European Union legislation.

A notified body may perform only those activities and cover only those areas for which it has been notified. EZÚ is a notified body with identification number 1014; the specific scope of its notification must always be verified against the relevant legislation and the product concerned.

The EU declaration of conformity is drawn up and signed by the manufacturer on its own responsibility. By means of it, the manufacturer confirms that the product meets the requirements of the relevant European Union legislation.

A certificate is a document issued by an independent third party within a particular certification or assessment scheme. It may confirm compliance with requirements laid down by a standard, a technical regulation or the rules of the certification programme concerned.

A certificate or test report may be an important basis for the technical documentation and the conformity assessment. It does not, however, replace the manufacturer’s responsibility for the correctness of the conformity assessment or for drawing up the EU declaration of conformity.

The EU declaration of conformity is a document by which the manufacturer confirms that a product meets the requirements of the relevant European Union harmonisation legislation. Where the legislation in question requires it, the declaration must be drawn up before the product is placed on the market.

In the declaration, the manufacturer identifies the product, states the legislation and, where applicable, the technical standards on the basis of which conformity was assessed, and assumes responsibility for that declaration. For products imported from outside the EU, the importer verifies whether the manufacturer has fulfilled the relevant obligations and whether the required documentation is available to the competent authorities.

EZÚ can provide testing, expert documentation and other services within the scope of the agreed assignment which may assist the manufacturer in compiling the technical documentation and carrying out the conformity assessment. Responsibility for drawing up and signing the EU declaration of conformity, however, remains with the manufacturer unless the legislation provides otherwise.

The CE marking indicates that the manufacturer has assumed responsibility for the conformity of the product with the requirements of the European Union legislation that applies to that product and that requires the CE marking. It is not a quality mark, nor is it a confirmation issued by an authority or a testing laboratory.

The CE marking is affixed to the product by the manufacturer after carrying out the applicable conformity assessment procedure, compiling the necessary technical documentation and drawing up the EU declaration of conformity, where this is required for the product concerned. In some cases the identification number of the notified body involved in the conformity assessment is given alongside the CE marking; this depends on the specific legislation and the conformity assessment procedure applied.

An overview of valid certificates issued by EZÚ is available on our website under About us → Valid certificates. If you cannot find a certificate in the overview, or if you need to verify its scope, validity or relationship to a particular product, please contact us with the certificate identification.

The validity of a certificate may be affected by a change to the product, to production, to the holder or to the conditions of the certification scheme. We therefore recommend verifying not only that the certificate exists but also its current scope and its relationship to the product being checked.

The period of validity of a certificate depends on the type of certificate and the rules of the scheme concerned; it is stated in the certificate itself or in the related conditions.

Transferring a certificate to another entity may be possible only in selected certification schemes and following an individual assessment of the change. The assessment considers in particular the change of holder, of the place of manufacture, of responsibility for the product, of the technical documentation and of the production conditions.

We will inform you of the specific procedure and the documents required according to the type of certificate and the extent of the change requested.

The CB Scheme is an international IECEE system for the mutual recognition of test results for electrical products according to IEC standards. It results in a CB certificate and a test report in English.

These documents can considerably facilitate obtaining national certificates or approvals in other countries participating in the system. The actual extent of recognition is, however, governed by local legal requirements, the national deviations applied and the rules of the certification body in the target country.

Before testing begins, we will recommend an approach matching your target markets and the intended scope of export.

HAR is a European mark for harmonised cables and wires. It confirms compliance with the requirements of the relevant European standards and with the rules of the HAR system.

The mark facilitates the recognition of cables and wires in the countries participating in the HAR agreement. The specific requirements for marking, certification and placing the product on the market may differ according to the type of cable, the target country and the intended use.

ENEC is a European mark intended for selected electrical products and components. Within the relevant scheme it confirms compliance with the specified safety requirements of European EN standards and with the conditions for using the mark.

ENEC+ extends the assessment to selected functional or performance characteristics of the product in accordance with the rules of the relevant programme.

Test and certification results within the ENEC system are recognised among the participating certification bodies. This may reduce the extent of repeated assessment when placing a product on several European markets; the specific procedure, however, always depends on the type of product, the standard applied and any national requirements.

An EZÚ certificate is a document issued within a particular certification or assessment scheme by which an independent third party confirms compliance with defined requirements for a product, system or process.

The scope, legal significance and conditions of validity of a certificate are governed by the scheme concerned, the standards applied, the contractual terms and, where applicable, legislation. A certificate may serve as supporting evidence for business negotiations, tender procedures, technical documentation or conformity assessment, but it does not replace the manufacturer’s obligations laid down by the applicable legislation.

We offer certification of artificial intelligence management systems according to ISO/IEC 42001. This standard helps an organisation to establish and demonstrate the systematic management of the responsible development, deployment and use of artificial intelligence, including risk management, responsibilities, documentation and continual improvement.

Certification according to ISO/IEC 42001 relates to an organisation’s management system. In itself it does not replace any conformity assessment of a specific artificial intelligence system under the European Artificial Intelligence Act, where legislation requires such an assessment for that system.

Based on the type of your organisation and the intended use of AI, we will help you determine a suitable scope of preparation, audit or certification.

Yes. Penetration and security tests examine the resilience of systems, applications, networks or devices against selected realistic attack scenarios. The scope, the testing rules, the environment tested, the authorisation to test and the protection of live operation are defined in advance in the contractual specification.

The outcome is a report describing the vulnerabilities identified, their severity, their possible impact and recommendations for addressing them. A penetration test is a verification of a defined scope at a particular point in time; it does not guarantee that every possible vulnerability will be discovered.

The Cyber Security Act applies to providers of regulated services as defined by the Act and its implementing legislation. Whether a particular organisation is subject to the Act, and under which regime, depends above all on the nature of the service provided, the sector, the size of the undertaking and other criteria laid down by legislation.

A provider of a regulated service must, among other things, fulfil notification obligations, define the scope of cybersecurity management, implement adequate security measures and comply with obligations relating to the handling of cybersecurity incidents. The specific extent of these obligations differs according to the regime into which the organisation falls.

We will help you make a preliminary assessment of whether the Act may apply to your organisation, identify the relevant obligations and prepare a plan of the necessary steps.

The IEC 62443 series of standards addresses the cybersecurity of industrial automation and control systems. It contains requirements relating, among other things, to the secure development of products, the technical characteristics of components, the security of integration solutions and the management of cyber risks in an industrial environment.

Certification or assessment according to a particular part of the IEC 62443 series can demonstrate compliance with the defined requirements of the scheme concerned. The exact scope depends on whether the subject of assessment is a product, its development process, an integration solution or an operator’s system.

The requirements of IEC 62443 are used in particular in industrial automation, the energy sector, transport and other sectors involving operational technology. The requirements of customers and operators always differ according to the particular market and contractual relationship.

In the field of cybersecurity we provide in particular certification and testing services for industrial automation and control systems according to the IEC 62443 series of standards, expert assessment of the cybersecurity requirements for radio equipment under the RED Directive, security and penetration testing, services relating to the requirements of the Cyber Security Act, attestation of public administration information systems and services in the area of the eIDAS Regulation.

We also offer certification of artificial intelligence management systems according to ISO/IEC 42001. This service focuses on an organisation’s management system and should not be confused with the conformity assessment of an individual AI system under the AI Act.

We always define the specific scope of a service according to the type of product, information system or organisation, the intended objective and the applicable legal or contractual requirements.

The price is determined individually according to the required scope of work, the type of product or system, the number of standards and variants, the complexity of the testing, the requirements for an audit or certification and other specific conditions of the order.

Once we have received sufficient documentation, we will prepare a quotation defining the expected scope of work. If, during the order, additional testing, repeat testing after a product modification or a change of specification proves necessary, we will discuss the impact on the price and the schedule with you before carrying out that work.

We accept samples at the EZÚ headquarters at Pod Lisem 129/2, Prague 8 – Troja. The current opening hours for sample receipt can be found on our website; as a rule, samples can be handed in on working days during the specified times.

Before sending or personally handing over samples, we recommend confirming with your sales representative or the contact person for the order the required number of samples, how they are to be marked, the necessary accompanying documents, any safety information and the method of handover.

Another method of delivery, for example by courier service or directly to a particular laboratory, is possible by prior arrangement.

The lead time depends above all on the type of product or system, the scope of testing, the number of standards applied, the availability of samples, laboratory capacity and the completeness of the technical documentation. Simpler tests may take a matter of weeks; for complex projects, products with several variants or certifications requiring an audit or further assessment, the time required may be longer.

We state the expected completion date in the quotation or confirm it once the technical scope has been specified. If a product change, incomplete documentation or the need for additional testing arises during the order, we will discuss the impact on the deadline and the price with you before the work continues.

The required documents and the number of samples depend on the type of product, the purpose of the order, the standards applied and the scope of testing or certification. As a rule we need in particular the technical documentation, for example diagrams, drawings, a list of the components used, the instructions for use, information on product variants and, where applicable, any test reports or supplier declarations already available.

The number and configuration of samples will be specified in the quotation or during the technical clarification of the order. Unless agreed otherwise in advance, the samples should correspond to the final design of the product intended to be placed on the market.

Complete and up-to-date documentation generally speeds up the preparation of the tests, reduces the need for further submissions and helps to define their scope more precisely.

You can send your enquiry via the online form on our website, by e-mail or by telephone to our sales department. Please provide as much information as possible about the product or the requested service, in particular a product description, the intended use, the target markets, the required scope of testing or certification and the available technical documentation.

Based on the information provided, we will assess the feasibility of the order and prepare a quotation setting out the proposed scope of work, the price, the expected deadline and the requirements for documents or samples. For more complex orders, an expert consultation may take place before the quotation is prepared in order to specify the scope.

Elektrotechnický zkušební ústav, s. p. (EZÚ), is a testing and certification organisation with a tradition dating back to 1926. We provide testing, certification, expert assessment and metrological services within the scope of the relevant accreditations, authorisations, notifications and other entitlements.

Our services cover in particular the testing and assessment of electrical, engineering, construction and medical products, the certification of management systems, services in the field of cybersecurity and trust services, and the calibration of measuring instruments. EZÚ also acts as notified body No. 1014 for a defined scope of European Union legislation.

The specific scope of a service always depends on the type of product or system, the requirements of the target market and the applicable legal or contractual requirements.

In a standard certification cycle, a management system certificate is issued for three years. Its validity is conditional upon successfully completing regular surveillance audits; their interval and scope are set out in the audit programme.

At the end of the certification cycle a recertification audit follows. The specific schedule may differ according to the standard, the scope of certification, the size of the organisation and the rules of the relevant certification scheme.

Certification can help an organisation demonstrate that it has implemented a management system in accordance with the requirements of the standard concerned; the requirements of customers, contracting authorities or regulators must, however, always be assessed separately.

Once the order has been accepted and the contractual terms concluded, the scope of certification and the audit programme are established. The certification audit usually takes place in two stages: first the readiness of the organisation and the basic system documentation are assessed, and then the audit team verifies the implementation and effectiveness of the system directly at the organisation.

If the audit identifies non-conformities, the organisation defines and implements corrective actions. The certificate can be issued only once these have been duly resolved and all the conditions of the relevant certification scheme have been met.

We certify quality management systems according to ISO 9001, environmental management systems according to ISO 14001, information security management systems according to ISO/IEC 27001 and occupational health and safety management systems according to ISO 45001.

We also offer the Quality and Safe Installation certification for installation companies. The availability, scope and conditions of a particular certification are governed by the relevant certification scheme and by the current scope of EZÚ’s entitlements.

GMDN, the Global Medical Device Nomenclature, is an international nomenclature used for the unambiguous identification of types of medical devices. GMDN codes are used in certain regulatory, registration, clinical and commercial processes and are administered by the GMDN Agency.

For European registration and database procedures, the European EMDN nomenclature may also be relevant in certain cases. The correct designation system always depends on the specific obligation, the market and the regulatory process applied.

Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, known as the MDR, lays down the rules for placing medical devices on the European Union market. It progressively replaced the earlier Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices.

The MDR tightened in particular the requirements for clinical evaluation, technical documentation, risk management, post-market surveillance, traceability and the oversight of notified bodies. The specific obligations of a manufacturer differ according to the classification of the device, its intended purpose and its risk profile.

To determine the correct procedure, we always recommend assessing the classification of the device, the relevant general safety and performance requirements and any obligation to involve a notified body.

For manufacturers of medical devices we offer in particular tests of the electrical safety and electromagnetic compatibility of active medical devices, for example equipment for magnetotherapy, laser therapy, high-frequency surgery or electrostimulation.

We also provide expert review of selected parts of the technical documentation and consultations on the scope of the testing required. These services may serve as a basis for the manufacturer’s own conformity assessment or for preparing documentation for dealings with the relevant notified body.

The scope of the testing and documentation required depends above all on the intended purpose of the device, its classification, the technology used and the applicable requirements of the MDR Regulation. Carrying out tests or an expert review of documentation does not in itself replace the conformity assessment procedure that may be required for a particular device under the MDR.

If a product fails the tests, you will receive a test report or other agreed evaluation describing the non-conformities identified and the measurement results. On that basis it is possible to determine which parts of the design, documentation or product marking should be modified.

Once the modifications have been made, the tests can be repeated to the necessary extent. We will assist you with the expert interpretation of the results and with determining the scope of any follow-up testing; the design solution and responsibility for modifying the product, however, remain with the manufacturer.

The IP degree of protection, for example IP44 or IP67, indicates the degree to which the enclosure of a product protects against access to hazardous parts, the ingress of solid foreign objects and the ingress of water.

The first digit denotes protection against the ingress of solid objects and against access to hazardous parts. The second digit denotes protection against the ingress of water. The declared degree of protection can be verified by testing according to the relevant standard.

RoHS restricts the use of certain hazardous substances in electrical and electronic equipment, for example lead, mercury, cadmium, hexavalent chromium and a number of other substances.

Conformity may be demonstrated by reviewing the technical documentation, declarations and information from suppliers, materials management and, in justified cases, laboratory analysis of materials or components. We will help you determine a suitable approach according to the type of product and the documentation available.

Electromagnetic compatibility means that a product does not generate impermissible electromagnetic interference and is at the same time sufficiently immune to interference from its surroundings.

For products subject to EMC requirements, both interference emissions and immunity to interference phenomena are usually verified. The specific scope of testing depends on the type of product, the environment in which it is used and the applicable standards.

In an electrical safety test we verify whether, in normal use and under foreseeable fault conditions, the product does not present an unacceptable risk of electric shock, fire, excessive temperature rise or other hazard.

The scope of testing is determined by the type of product and the relevant technical standard. It may include, for example, verification of protection against electric shock, insulation strength, temperature rise, protective earthing, mechanical strength, constructional design or product marking.

EZÚ carries out tests of electrical safety, electromagnetic compatibility, resistance to environmental influences, IP degrees of protection, mechanical properties, noise and vibration, selected RoHS requirements and specialised tests of medical devices.

The specific scope of testing depends on the type of product, its intended use, the target market, the applicable legislation and the standards applied. We carry out tests within the scope of the relevant entitlements and accreditations of the individual laboratories.