To obtain CE marking under MDR 2017/745 or market authorization, your electromedical devices must demonstrate their safety and performance in accordance with the IEC 60601 series of standards.
LNE supports you at every stage, from defining your regulatory strategy to testing and compiling your technical documentation, helping you reduce timelines, control costs, and ensure regulatory compliance.
Why is IEC 60601 compliance essential ?
The 60601 series is the essential international reference for all electromedical devices. It notably covers:
- Electrical, mechanical, and thermal safety
- Risks related to embedded software
- Electromagnetic compatibility (EMC)
- Use-related risks (usability)
- Alarms, light sources, and specific environments
A rigorous understanding of these requirements ensures patient and user safety, secures your regulatory milestones, limits delays in market entry, and facilitates interactions with notified bodies.
Services: a comprehensive offering to secure your project
To ensure the success of your project, demonstrate the conformity of your devices, and submit a robust technical dossier to notified bodies, LNE offers a comprehensive package that includes all required analyses.
To demonstrate compliance and present a robust technical file to notified bodies, LNE offers a complete range of services covering all required analyses.
Safety and performance testing
- Full testing according to IEC 60601-1, 60601-1-x, and 60601-2-xx
- Cofrac* accredited test reports usable for CE marking
- Preparation of the evaluation plan
- Technical support throughout the testing campaign
- Definition of test methods adapted to your product when no standard methods exist
Regulatory document analysis
- Risk analysis according to ISO 14971
- Documentation review and gap analysis against IEC 60601 to anticipate non-compliance
- Identification and understanding of applicable standards for your product
Usability and software evaluation
- Verification of usability engineering file according to IEC 60601-1-6 / IEC 62366
- Assessment of essential performance to secure critical functions
- Documentation review according to IEC 62304
- Analysis of software/hardware/risk management consistency
Training :
- Train your teams to understand the applicable regulatory framework and identify key technical requirements (SE 55).
A single site for all your testing needs
Thanks to its multidisciplinary expertise, dedicated testing facilities, and metrology laboratories in optics and acoustics, LNE brings together all the expertise required to evaluate your electromedical devices in one place.
- Electrical, mechanical, and thermal safety
Dedicated laboratories covering the full 60601 series. - Electromagnetic compatibility (EMC) and radiofrequency
Anechoic chambers, immunity testing, emissions, and harsh environment testing. - Unique optical expertise
Comprehensive evaluation of your light sources :- Monochromatic or broadband lasers
- Incoherent sources (LEDs, lamps)
- Pulsed lasers
- Classification, risk group, and performance
- Acoustic expertise for alarms
Full testing of visual and audible alarms according to IEC 60601-1-8.
By conducting tests at a single site, you benefit from:
- Simplified coordination,
- Shorter logistics lead times,
- Lower overall costs,
- Greater technical consistency.
As a result, you receive a comprehensive Cofrac* report that complies with regulatory requirements.
Upstream support and technical assistance
Beyond standardized testing, our experts guide you from the design phase:
- Identification of applicable standards
- Drafting of the qualification plan
- Definition of specific test methods when standards are unavailable
- Customized training on IEC 60601 requirements
This early support secures your development and reduces late-stage non-compliances, which are costly and time-consuming.
FAQ
The standards applicable to electromedical devices are defined by the IEC Commission and are divided into three levels : general standards, specific application standards, and product standards.
Basic standards (mandatory for all devices)
- IEC 60601-1 >> Basic safety (electrical, mechanical, thermal, radiation), software, performance, marking
- IEC 60601-1-2 >> Electromagnetic compatibility (emission and immunity)
- IEC 60601-1-6 >> Risks related to use (ergonomics, human factors – link with IEC 62133)
Standards based on the context of use
- IEC 60601-1-8 >> Devices with visual and audible alarms
- IEC 60601-1-11 >> Devices for home use (enhanced requirements + mechanical and climatic tests)
- IEC 60601-1-12 >> Devices for emergency services (enhanced requirements + additional tests)
Product standards (depending on device type)
- IEC 60601-2-10 >> Nerve and muscle stimulators
- IEC 60601-2-52 >> Medical beds
- IEC 60601-2-22 >> Laser devices (surgery, therapy, aesthetics, diagnosis)
- IEC 60601-2-57 >> Non-laser light devices (therapy, diagnosis, monitoring, aesthetics)
Before undertaking full assessments, often costly in terms of time and resources, it is possible to carry out partial assessments. These are particularly suitable for the following situations:
- accelerating technology transfers,
- reducing risks during development,
- preparing the launch of clinical trials,
- addressing identified non-conformities or deviations.
Why choose LNE
- One site, one contact, a global vision
Simplify your processes, reduce costs, and accelerate time to market - Rare multidisciplinary expertise
Optics, acoustics, electrical safety, EMC, software, usability... all competencies in one place - Clear and usable test reports
Structured presentations directly usable by notified bodies - A globally recognized reference organization
ISO 17025-accredited laboratories (Cofrac*) and strong synergies with its subsidiary GMED, a major notified body in the medical sector
*List of accreditations, locations, and scopes available on cofrac.fr
Resources and equipment
- EMC Enclosures
- Patient simulator
- Equipment for transport simulation,
- Defibrillation Shock Bench
- Mechanical test bench
- Electric scalpel test bench
- Climate chambers
Accreditation
- Cofrac* Accreditation No. 1-0606 (in French)
- CB SCHEME Accreditation
*List of accreditations, locations, and scopes available on cofrac.fr
