Safety and performance of electro-medical devices according to IEC 60601

Services offered

The LNE offers a comprehensive range of services:

• Tests,
• Risk literature review,
• Fitness for Use Management Record,
• Software Development File...

To meet the safety and performance requirements of the 60601 series standards:

• General Standard (60601-1)
• Collateral Standards (60601-1-xx)
• Special Standards (60601-2-xx)

What are the standards applicable to electro-medical devices?

Whatever the electro-medical device, three standards are essential. They form a common basis for all evaluations.

• IEC 60601-1: Called the general standard, it concerns requirements and tests relating to hazards of electrical and mechanical origin, radiation, excessive temperatures, software, performance and markings.
• IEC 60601-1-2: it concerns requirements and tests relating to electromagnetic compatibility (immunity, emission).
• IEC 60601-1-6: it concerns the risks associated with the use of medical devices. It is directly related to the IEC 62133 standard.

Depending on the area of use or the design of the device, other standards may be applied, for example:

• IEC 60601-1-8: Medical devices using alarms. It concerns the requirements related to the use of both visual and auditory alarms.
• IEC 60601-1-11: Medical devices for home use. The requirements of the first 3 standards are reinforced. It also requires specific mechanical and climatic tests.
• IEC 60601-1-12: Medical devices in emergency services. As with medical devices for home use, it increases requirements and requires additional testing.

Finally, if the device is directly concerned by a product standard, the latter must also be applied, for example:

• IEC 60601-2-10 Nerve and muscle stimulators
• IEC 60601-2-22 Laser
• IEC 60601-2-52 Medical Beds
• IEC 60601-2-57 Non-Laser Light Sources

A single site for all trials

Thanks to its multidisciplinary approach and its testing resources, the LNE is able to effectively support all manufacturers in the evaluation of the safety and performance of their electro-medical devices. Its equipment makes it possible to conduct evaluations on a single site and to facilitate the management of trials for manufacturers

Means 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 N°1-0606 (in french)
• CB SCHEME accreditation

*List of accreditations, sites and scopes available on www.cofrac.fr

Why choose LNE 

• A single point of contact and a single site to carry out all your tests: a single shipment and recovery of the samples to be tested, saving time and reducing costs.
• A renowned multidisciplinary player in the medical-health field thanks to its extensive expertise (regulatory compliance tests, calibration, technical-regulatory assistance, packaging qualification, medical biology reference materials, etc.), and its subsidiary GMED, a certification body and notified body, a major player in the sector.
• An organization recognized by national and international regulatory bodies, with more than 20 years of experience in the medical field and the majority of its services accredited by COFRAC*.
• Quality and usable test reports to facilitate presentation to the notified body.
• ISO 17025 accredited testing laboratories by COFRAC*.

* List of accreditations, sites and scopes available on www.cofrac.fr