Testing radiated immunity beyond 6GHz.

EMC expertise to emerging frequencies (5G, Wi-Fi 6E/7) for medical devices targeting the U.S. market.

A new testing methodology, validated by Emitech's innovation department, enables the French laboratory to test the radiated immunity of medical devices beyond 6 GHz—where no standards currently apply—thereby anticipating the expectations of the U.S. FDA.

In the medical sector the Emitech Group supports manufacturers, importers, and distributors in bringing their products to the U.S. market via the FDA 510(k) pathway. Their technical dossier must demonstrate the product’s electromagnetic compatibility, particularly with regard to the collateral standard IEC 60601-1-2 and its FDA-recognized version (ANSI/AAMI/IEC 60601-1-2). However, this standard—like all current EMC standards—covers radiated immunity testing only up to 6 GHz, whereas medical devices now incorporate wireless functions that operate in higher frequency bands: 5G FR2, Wi-Fi 6E, and Wi-Fi 7.

The FDA’s June 2022 guidance on the electromagnetic compatibility of medical devices explicitly requires manufacturers to identify and technically justify the electromagnetic risks associated with their product’s real-world usage environment, even when no standard yet covers them. For devices incorporating these new wireless technologies, this creates a methodological gap: how can a product’s robustness be demonstrated at frequencies that the standard does not test?

It is in this context that the Emitech Group, with the approval of its innovation department, has developed a radiated immunity testing methodology applicable beyond 6 GHz. Its approach mirrors the one Emitech previously applied when the FDA required immunity to RFID readers even though no standardized method yet existed: the same type of modulation, field levels derived from the reference radiated immunity level in IEC 60601-1-2 (ranging from 10 V/m to 28 V/m depending on the severity of the target environment), this time applied to the frequencies of 5G FR2, Wi-Fi 6E, and Wi-Fi 7. “We cannot wait for a standard to be established to meet the FDA’s requirements: our role is to work with our clients to build a well-founded and traceable technical dossier,” emphasizes David Montaulon, EMC & Radio Expert at the Emitech Group.

Technical resources dedicated to high frequencies.
To implement this methodology, the Emitech Group relies on testing resources that are uncommon among players in the medical market. It utilizes resources originally developed for its defense-related activities; its antennas and radio-frequency generators cover frequencies up to approximately 40 GHz, enabling radiated immunity testing on bands not covered by current standards (5G FR2, Wi-Fi 6E/7).

For near-field testing above 18 GHz, the laboratory repurposes a high-precision motorized mast, originally developed for radio frequency measurements up to 140 GHz. This device enables automatic scanning at a distance of approximately 5 cm from the product under test, ensuring uniform exposure and excellent reproducibility. All tests are conducted in an anechoic chamber, covering the entire surface of the equipment.

An approach based on foresight, not on waiting for a standard.
The RFID case study illustrates this philosophy. When a client—a manufacturer of enteral feeding pumps—was faced with an FDA recommendation regarding immunity to RFID frequencies, even though no standardized test bench existed, the Emitech Group developed its own in-house solution. As a result, its teams enabled the client to secure market authorization in the U.S. even before the FDA formally recognized AIM Standard 7351731, which addresses this immunity. Today, the Emitech Group applies the same approach to emerging 5G and Wi-Fi frequencies, convinced that part of this methodology will eventually be incorporated into future regulatory standards as well.

Philosophy rooted in the FDA’s Risk Management Approach.
The FDA does not systematically require additional testing; rather, it seeks to verify that the risk has been identified, analyzed, and technically justified. This is the crux of this methodology: it enables the Emitech Group’s clients to compile a traceable technical dossier that aligns with the spirit of the FDA guidance, rather than encountering a roadblock during the review of the 510(k) application.

For manufacturers, the benefit is clear: by incorporating these tests from the product design phase, they reduce the risk of delays caused by a Request for Additional Information (AFI) during the 510(k) review process.

A longer-term goal.
Beyond this new methodology, the Emitech Group intends to remain a leading player in anticipating electromagnetic risks associated with emerging wireless technologies—whether they involve the next generations of Wi-Fi or future mobile networks. This ability to anticipate risks—already proven in the RFID sector—is a key differentiator that enables the Group to support its clients as soon as new frequency bands emerge, even before they are covered by a standard.

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EMITECH_SA  @mepaxIntPR #Medical #USA #FDA #TandM

Test bench for airship programme.

Vincent Guibout CEO, Flying Whales & Stephan Lassausse, Managing Director, Emitech Group

The Emitech Group has been selected by Flying Whales under an exclusive negotiation agreement for the development and supply of the PowerWhale test bench, a strategic piece of equipment for the LCA60T heavy airship programme. This collaboration is part of a letter of intent (LOI) signed between the two companies, marking a mutual commitment to move quickly toward a final contractual agreement.

A strategic milestone for the Emitech/Flying Whale collaboration.
The letter of intent signed between the two companies formalizes:

• The selection of Emitech as the exclusive partner for the development, manufacture and support of the PowerWhale test bench,
• The launch this summer of an initial engineering study phase, prior to the technical validation (Preliminary Design Review) and contractual stages.

The PowerWhale test bench: a tailor-made test facility for innovation.
The test bench will enable the critical subsystems of the LCA60T airship to be validated in a controlled environment. It will include:

• Powerful energy sources (AC/DC),
• A test bench for the battery included in the electrical chain,
• Active charging systems,
• A set of multi-physical sensors and software supervision,
• A modular architecture to support program developments.

A partnership based on trust and technical commitment.
The Emitech Group and Flying Whales are continuing their joint approach with the aim of:

• Optimizing the technical solutions offered,
• Securing the budgetary aspects of the project,
• Supporting the associated public funding mechanisms (CIR, CEE).

This partnership illustrates the Emitech Group's ability to get involved in groundbreaking industrial projects at an early stage, supporting its customers through all the critical stages: engineering, testing, qualification, and long-term support.

“We are proud of the trust Flying Whales has placed in us through this exclusive agreement. Our teams are fully committed to contributing to the success of the LCA60T program.” — Stephan Lassausse, CEO of the Emitech Group

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 @EMITECH_SA @_FLYING_WHALES_ @mepaxIntPR #Transport #TandM #France 

Testing facilities for electric mobility.

The Emitech Group offers a variety and a number of unique test facilities in France, constantly evolving with the aim of supporting its customers’ innovation, in particular in the field of electric mobility. The Group already has significant test facilities available in this field. For example there is the EMCEM facility, which aims to characterize an electric vehicle motor from the electromagnetic compatibility (EMC) point of view, as well as test benches for high-voltage (HV) batteries, power electronics, calculators etc. It announces new equipment and facilities for tests in the field of hydrogen (fuel cells systems, tanks + valves). The implementation of the hydrogen sector by several stakeholders and regions in France is a strong axis of the energy transition.

Hydrogen activities: EMC, electrical, mechanical, climatic and fire testing
Hydrogen fuel cell testing requires complex facilities that incorporate a large number of constraints. These installations must be secured because hydrogen (H2) is a potentially explosive gas when it reaches a concentration of 4% in the air. Moreover, a power equivalent to 50% of the electrical production of the hydrogen fuel cell system is also dissipated as heat. This is why Emitech, after having selected a hydrogen supplier and installed H2 supply systems, had to fit out its laboratories to secure its installations with H2 sensors and to equip laboratories with dedicated cooling units.

The Group has now two laboratories in France adapted to receive all kinds of equipments, including high power hydrogen fuel cells (45kW testing capabilities now, 100kW in mid-2022). A third laboratory installation more specialized for H2 tank applications testing is also in preparation.

The first electromagnetic compatibility and electrical test laboratory has a 70m² semi-anechoic Faraday cage (H>5m) with facilities dedicated to hydrogen: an H2 supply unit connected to four V18 cylinder racks (4x158m3 of H2 compressed to 200 bars / 15°C), hydrogen detection sensors, an ATEX extractor hood for any vapors and a 45kW cooling unit. In the mechanical and climatic second test laboratory, the climatic chamber has been completely adapted and secured to receive a complete fuel cell system with a H2 supply unit connected to two V18 racks of cylinders (H2 compressed to 200 bars at 15°C) and detection sensors.

The third mechanical and climatic test laboratory has a unique expertise in fire testing as well as tank testing capabilities (hydraulic and pneumatic testing: endurance, pressure resistance, bursting, puncture, impact, overloading). It is currently being adapted to become a type IV H2 tank testing center.

Testing: a first complete 45kVA fuel cell system
Emitech is currently working with one of the leaders in Fuel Cell System in France and Europe on a project for utility vehicles powered by hydrogen fuel cells. The equipment supplier provides the manufacturer with the electrical energy, a fuel cell, for integration into a conventional electric vehicle architecture. It is a complete and complex system that includes cooling system as well as regulators for humidity, air compression, etc. In addition, the fuel cell is completed by a high-voltage battery for transient power requirements such as acceleration and for energy recovery storage, especially during braking.

The system is tested in EMC, climatic and mechanical domain in Emitech laboratories according to the automotive manufacturer's specifications involved in this project. Emitech is the only one French laboratoy to offer these campaigns and the qualification of the system regarding environmental parameters.

Emitech was able to adapt its laboratories in a few months to meet its customer's needs regarding hydrogen and to conduct these tests. Testing began in autumn 2020 for mechanical and climatic, and then in January 2021 for EMC. Other campaigns are planned and international customers have already expressed their interest for these installations. In order to support the sector's development and the increase in the power of the various equipment manufacturers' fuel cell building blocks, laboratory upgrades are already planned for 2022 to enable tests performance on 100kW FCS (Fuel Cell System).

An expansion of the developing skills
Emitech has become a member of two major networks in France in the field of hydrogen. Emitech has been a member of FRANCE HYDROGENE since january 2021, an association federating the actors (more than 400) of hydrogen and fuel cells in France. EMITECH also belongs to the general H2 circle within the NEOPOLIA network, which brings together more than 250 companies mainly from the French region Pays de la Loire.

At the same time, Emitech actively monitors standards and technical normative working group in order to keep on developping its facilities and adapt them to the customers' future needs while meeting test standards requirements. This is the case, for example, for the use of hydrogen in ports, whether for recreational boating or for the merchant marine in the long term, but also for automotive or aeronautics and its green aircraft.

• Emitech is also referenced as H2 testing laboratory in the "Guide for conformity assessment and certification of hydrogen systems", a reference synthesis document on the subject published in July 2021 by INERIS (National Institute for Industrial Environment and Risks) on behalf of ADEME (French Environment and Energy Management Agency) and FRANCE HYDROGENE.

@EMITECH_SA @mepaxIntPR #Transport #France

Certification Body under the CB Scheme.

Emitech has had its own international certification service called Emitech Certification since 2014. It has now been recognized as an NCB (National Certification Body).

Pascal Bonnenfant - Emitech Certification

As an ISO 17065-accredited product certification body, Emitech Certification has initially become a Notified Body for CE marking. As such, it issues certificates of conformity under the RED 2014/53/EU directive for radio communication equipment, and the EMC 2014/30/EU (electromagnetic compatibility) directive. This involves assessing the conformity of a product for which there are not yet any harmonised standards, extending the validity of a test report to an entire range of products, validating the integration of sub-assemblies by partial tests or a voluntary approach by a manufacturer.

Emitech Certification supports manufacturers who want to market their products internationally. It takes care of the technical and administrative formalities, arranges for local tests to be carried out if necessary to obtain approval, and chooses the most suitable procedure. The CB Scheme (CB Scheme) is thus the most efficient way to approach export markets in more than 50 countries throughout the world. Within the framework of the CB Scheme, Emitech's international certification service has just been recognised as an NCB (National Certification Body). It can now manage its network of CBTLs (Certification Body Testing Laboratories), and deliver, based on their reports, the CB certificates recognized in the member countries.

The CB scheme, a process of mutual recognition of test results between participating countries
The CB scheme is an international certification program for the exchange and acceptance of product test results from recognized participating laboratories, "CBTLs", and National Certification Bodies, "NCBs" in more than 50 countries around the world. The goal of the CB Scheme is to constantly harmonize electrical product safety and electromagnetic compatibility requirements at international level, while also taking national deviations into account.

Thanks to mutual recognition of CB certificates between countries, the tests performed are recognised in these member countries. This makes it easier to place products on the market abroad and opens the way for manufacturers to obtain certification marks (NF, etc.).

Within this context, four of Emitech's laboratories have already been recognized for several years as CBTLs in the categories for medical, laboratory, multimedia and information processing equipment. A CBTL has to depend on a single NCB. Since April 2020, Emitech's certification service has been recognized as a National Certification Body under the NCB scheme. This means that this service can now issue CB certificates from its own CBTL laboratories.

Emitech supports its customers in a global approach to marketing their products abroad. As this process is fully controlled under the framework of the CB Scheme it is largely autonomous and its reactivity is augmented. This recognition is part of the strategy to internationalise Emitech's service offering, established when Emitech created its certification service.

@EMITECH_SA #MEPax#PAuto #TandM