FCC conformity assessment done right, this is how product conformity works in the United States.

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Willy Lebherz

Director & founder of easyCE GmbH

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Declaration of conformity done!

Receive your CE declaration of conformity ready for signature.

Risk assessment completed!

CE mandatory risk analysis conducted.

Relevant directives & standards applied!

Your product evaluated against relevant directives and standards.

Technical documentation created!

Receive a pragmatic, user-friendly operating manual.

CE mark attached!

Simply affix the CE mark and you're done.

routines differ depending on your role CE marking

CE AS PRODUCER

The main focus of the FCC is on high-frequency devices that emit frequencies between 9 kHz and 3000 GHz. Any device that can emit high frequency energy by radiation, conduction or otherwise is considered a high frequency device. Examples are: Digital computer and (by radiation emission) Mixer with DC motors (by arcing on brushes) TVs (through digital circuits)

The experts at easyCE will be happy to help you place your products on the market and assess special cases. We are happy to support you with CE, UKCA and other labelling.

+49 7248 45230405

FAQ

What is Electromagnetic Compatibility (EMC)?

Electronic systems emit both conduction fields and device radiation. Directives and regulations on electromagnetic compatibility (EMC) are intended to prevent them from interfering with the electromagnetic environment.

What are the CISPR-22 standards?

The basic EMC requirements are similar in many countries. More and more nations, most of them in Europe, are accepting the international standards for EMC requirements, the so-called CISPR-22 standards. These standards were developed in 1985 by the CISPR (International Special Committee on Radio Interference).

What is FCC certification and where does it apply?

Due to the enormous market growth of computers and other digital devices, the Federal Communications Commission (FCC) set limits for electromagnetic interference in radio and wire communications.

For which products must FCC conformity be demonstrated?

The main focus of the FCC is on high-frequency devices that emit frequencies between 9 kHz and 3000 GHz. Any device that can emit high frequency energy by radiation, conduction or otherwise is considered a high frequency device. Examples are:

What is an (un-)intended spotlight?

Intended radiators are devices that emit spark energy as part of their operation, such as smartphones. Unintended emitters are products that generate radio signals as an unintended by-product of their operation, such as a digital camera.

How does the FCC allocate digital devices?

The FCC names two classes for digital devices. Class A products are marketed for use in commercial, industrial or business environments, while Class B digital devices are marketed for use in private environments. The requirements for Class B products are stricter than for Class A products.

Which FCC class do PCs belong to?

Personal computers are considered a special category of Class B devices and are subject to stricter regulations than other digital devices. In particular, computer manufacturers must submit their test results to the FCC, while manufacturers of other digital devices of the same class certify their product themselves.

What is the difference between the FCC and CISPR 22 regulations?

The FCC and CISPR-22(-International-EMC) regulations for radiated emissions differ significantly in the regulated frequency range for conducted emissions. The scope of the CISPR-22 regulations starts at 150 kHz;

How does the FCC differ from the EMC Directive (for CE conformity)?

The EMC Directive of the European Union requires the testing of radiated immunity, conducted immunity and electrostatic discharge (ESD).

What is radiation immunity?

Radiation immunity is the ability of products to operate in the environment of high-power transmitters such as AM and FM transmitters and airport surveillance radars.

What is conducted immunity?

Conducted immunity is the ability of a product to function despite a variety of interference coming into the device via the power cord. An extreme example of this disturbance is a surge of current caused by a lightning strike.

What is electrostatic discharge?

Electrostatic discharge occurs when static charge builds up on the human body or furniture and then discharges onto the product with which it comes into contact, causing a momentary surge of current. Such static voltages can cause resetting of devices or erasing of IC memories, etc.

Are there military EMC regulations?

EMC is particularly important for military applications, as military equipment must be immune to unwanted interference. Therefore, the military regulations are more stringent than the FCC or CISPR regulations and include a larger frequency range with multiple subdivisions. In addition, the EMC requirements of the FCC are not binding for certain military applications.

What does FCC compliance mean?

As part of the FCC approval process, the device is tested for its suitability before it is placed on the market. It is tested for interference with other devices and transmission in the correct radio frequency range. One of the three FCC modes of verification, declaration of conformity or certification is used to monitor compliance.

What is the FCC compliance check?

The verification shall be used for digital devices as defined in Part 15 which are not intended to emit radio frequency energy wirelessly by radiation or induction. These devices can be tested by the manufacturer himself and do not require formal FCC approval. Examples that require verification include TV and FM receivers.

What is the Declaration of Conformity (DoC) for FCC conformity?

In this stricter procedure than the verification, an accredited laboratory must test the high-frequency energy for the product to be placed on the market. A compliant product must bear the FCC logo on its label, and the FCC will receive the FCC's compliance data upon request. Examples of devices subject to DoC include class B personal computers and peri

What is FCC Compliance Certification?

The FCC certification is the strictest approval procedure in which the applicant must submit test data to the Commission. Only devices that can interfere with other devices and signals require this procedure.

How do I get FCC compliance?

FCC approval is required for electronic devices that have a frequency of over 9 kHz. The process of admission to the certification level includes the following five steps:

Which activities are not regulated by the FCC? For which products does FCC compliance not have to be proven?

The FCC does not regulate the following points:

How long does FCC approval take?

The FCC certification process can be time-consuming. Therefore, the FCC has authorized several private organizations, so-called TCBs (Telecommunications Certification Body), to issue and facilitate certifications. A TCB can help achieve accelerated FCC certification, probably within 2 weeks.

How does FCC compliance differ from UL compliance?

UL stands for Underwriters Laboratories. It is a private organization that has been setting standards for different product categories and testing products for more than 100 years.

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Approach to CE marking

Type and manner of support

Scope of support

Contact during project processing

Find the easiest way to obtain the CE mark

Abbreviated process for CE derived directly from CE

All-inclusive or modular – whatever you prefer

Personal contact with experts who take your wishes into account

other CE service providers

Often lacking in sound judgement and unnecessarily complicated

Mostly flexible but often bureaucratic

Mostly flexible in terms of support scope

Mostly personal contact

CE Software

Follows standardised process; special circumstances not taken into account

Double burden for you: software management + no support during processing

Only according to software scope and purchased modules

No contact

You want support that lightens your workload and doesn't create more work.

Reference Projects

CE marking of laboratory machines developed in-house

CE marking of laboratory machines developed in-house

In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a laboratory technology manufacturer in ensuring CE conformity for its internally used validation machines for medical equipment. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to safe operation by laboratory staff and the documentation of risk assessments that meet both CE and ISO 45001 requirements.

Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU EN ISO 12100, EN 60204-1

CE marking for a laboratory robot

CE marking for a laboratory robot

In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a medical technology manufacturer in achieving CE conformity for its coagulation robot—a specialized laboratory machine for the automated performance of coagulation cycles for testing purposes. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to the safe handling of electrosurgical components and the documentation of risk assessments that meet both CE and ISO 45001 requirements.

Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1, etc.

CE marking and consulting for laboratory equipment

CE marking and consulting for laboratory equipment

In the context of an upcoming ISO 45001 certification, easyCE supported a medical technology manufacturer with the CE documentation for a specialized testing and calibration machine for insufflators in the laboratory sector. Our specialists developed integrated documentation that covers both the CE requirements and the occupational health and safety aspects according to ISO 45001. Particular attention was paid to the safety requirements for handling various hose systems and connections, which can vary depending on the insufflator model.

Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1 etc.

CE marking for electrical equipment in medical laboratories

CE marking for electrical equipment in medical laboratories

As part of the ISO 45001 certification preparation process, easyCE supported a manufacturer of electrical laboratory equipment in the correct classification and CE conformity of its products. Our experts carried out a precise analysis to distinguish between medical devices and electrical equipment in order to ensure correct classification in terms of occupational health and safety. This clarity was crucial for the ISO 45001 requirements regarding hazard identification and risk assessment in the workplace. Successful documentation and conformity assessment enabled the customer to operate its laboratory equipment in full compliance with occupational health and safety guidelines and to pass the ISO audit without any objections.

Takes into account, among others: EN 55032, EN 55035, EN 60335-1 etc.

CE marking for test station for low-pressure units

CE marking for test station for low-pressure units

In the run-up to an ISO 45001 occupational health and safety audit, easyCE supported an industrial company in compiling CE documentation for an internal test bench for low-pressure units in accordance with occupational health and safety regulations. Our experts first analyzed the regulatory classification of the test bench and were able to prove through precise measurements that the Pressure Equipment Directive was not applicable. This clarification was crucial for the correct risk assessment within the framework of the ISO 45001 management system. The CE documentation subsequently created took particular account of occupational health and safety aspects such as operational safety and emergency procedures. This enabled the customer not only to demonstrate CE conformity, but also to pass its ISO 45001 certification without any deviations in the area of work equipment.

Takes into account, among others: 2006/42/EG, EN ISO 12100, EN 60204-1, EN ISO 4414, EN ISO 13849-1 etc.

Learn more about our project references and success stories

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Step 2

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Step 3

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Trust the experts of product safety and conformity

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Willy Lebherz - Founder and Managing Director of easyCE

  • Expert in product safety and conformity since 1995
  • Recipient of the "Medal of the Order of Merit of the Federal Republic of Germany", awarded in 1983 by the then Federal President Carl Carstens
  • Master of measurement and control technology
  • Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company

easyCE is a digital, dynamic engineering office with a focus on product safety and product conformity - especially CE-marking. We support manufacturers, operators and dealers in designing products safely and offering them on the market in compliance. We are a "full-service provider" and can take over the entire conformity assessment process for you if you wish. To do this, we support you in carrying out risk assessments, researching standards, product analyses, developing suitable safety precautions, preparing user-friendly technical documentation, coordinating tests and all other accompanying measures. easyCE was founded in southern Germany, but is now active globally.

We know what you need to do to get CE-marking done, worry-free.