A wide range of standardized or specific tests
LNE provides a comprehensive range of tests and technical expertise to characterize your medical devices:
- static and dynamic mechanical tests
- reaction to fire
- environmental stresses: electrical safety, electromagnetic compatibility
- characterization of materials and chemical analysis
- dimensional measurements
Our test methods are based on the harmonized standards implemented by European Directives 93/42/EEC and 90/385/EEC.
We also provide a full range of additional services: LPP procedure (for products covered by the French national health insurance system), training, expert analysis and research.
Are you developing an innovative product?
LNE will develop and set up the specific test protocols you require.
Please contact us at info@lne.fr
LNE/G-MED provides certification for CE marking in accordance with the European Directives on medical devices. More information: www.lne-gmed.com
LNE issues NF-Médical certificates for medical/health products under the authorization of French standardization association AFNOR. For more information see our certification pages.
Products tested
Hygiene and prophylactic products
- condoms
- lubricants
- surgical gloves
- toothbrushes
- toothpastes
- dressings and plasters
- packaging / adhesives
- endocytes
- other hygiene and prophylactic products tested on the basis of test protocols developed with the customer.
NF marks
LNE issues the NF and NF-Médical marks for numerous products, including surgical gloves, toothpaste, condoms, lubricants, medical beds, therapeutic support surfaces, operating tables and patient hoists
Non-active implants
Fatigue test on the head/neck
assembly of a hip prosthesis
- hip prostheses
- knee joint prostheses
- spinal column implants
- osteosynthesis implants
- orthopaedic implants
- dental implants
- breast prostheses and other reconstructive implants
- vascular prostheses
- catheter chambers
- gastric balloons and rings
- gynaecological devices: pessaries, IUDs, vaginal reinforcement implants
- intracranial clips
- other non-active implants tested according to test protocols developed with the customer
Information sheet
Download our Orthopaedic implants : hip - spinal - dental implants sheet (79 kB) for full information on tests performed, standards applied, test conditions and test facilities.
Active implants
- cardiac pacing leads
- cardiac pacemakers
- other active implants tested according to NF EN 45502 standards or on the basis of test protocols developed with the customer.
Electrical treatment and diagnostic equipment
- external defibrillators
- hearing aids
- radiology equipment
- CPAP machines (continuous positive airway pressure)
- respiratory support devices
- electrostimulators
- evoked potential apparatus
- other electrical care and diagnosis equipment tested on the basis of test protocols developed with the customer.
Hospital and home medical care equipment
- medical beds
- therapeutic support surfaces
- operating tables
- patient hoists
- urinary catheters
- syringe pumps and syringes
- catheters and tubing
- infusion therapy devices
- diabetes care products
- collection and ostomy bags
- other hospital and home care equipment tested on the basis of test protocols developed with the customer.
NF marks
LNE issues the NF and NF-Médical marks for numerous products, including surgical gloves, toothpaste, condoms, lubricants, medical beds, therapeutic support surfaces, operating tables and patient hoists
Other self-diagnosis and health devices
- thermometers
- tensiometers
- hearing aids
- scales using an impedance meter
NF marks
LNE issues the NF and NF-Médical marks for numerous products, including surgical gloves, toothpaste, condoms, lubricants, medical beds, therapeutic support surfaces, operating tables and patient hoists
Additional services
- Expert analysis:
- LNE's experts will determine the causes of failure, breakage or deterioration.
- See our [expert analysis] page
- Assessment of equipment:
- LNE tests a range of equipment under the LPP procedure for products and services covered by the French national health insurance system (list published by the National Health Authority HAS).
- Training:
- LNE runs catalogue or made-to-measure training courses covering the standards and regulations applying on European and international markets. The courses are designed for manufacturers, quality managers and auditors, and for engineers and technicians in the medical industry and health care centres.
- [Course catalogue] (in French) and registration
- Research:
- LNE works in close cooperation with France's Health Products Safety Agency (AFSSAPS) and National Health Authority (HAS), as well as with industrial partners, in two areas:
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- - developing test methods for medical or health devices incorporating new materials and for hospital equipment using new technologies
- - developing methods to characterize medical equipment and products and control the reliability of measuring instruments.
- See our [Research / Areas of research] section.
Contact
Customer service
