Return to home page
Latest update : May 21, 2012
LNE's test and certificate are recognized by all countries participing to CB scheme programme
Home | Services | CB Scheme certification

Medical equipment: CB Scheme certification

The international Electrical Commission System for conformity Testing and Certification of Electrical Equipment, IECEE, has recognized LNE as a National Certification Body (NCB) and a Certification Body and Testing Laboratory (CBTL) in the context of the international CB Scheme covering electromedical devices.

For manufacturers of medical electrical equipment, the admission of LNE to the CB Scheme means that its test and certification services will be recognized by all 49 countries participating in the programme (Argentina, Australia, Brazil, Canada, India, Japan, Korea, Russia, the United States, ...).

Manufacturers may now apply to LNE for a wide range of certificates of conformity to the following IEC standards:

  • IEC 60601-1 ed 3 and ed 2 : General safety and performance requirements
  • IEC 60601-1-1 : Safety and essential performance
  • IEC 60601-1-2 : Electromagnetic compatibility
  • IEC 60601-1-3 : Radiation protection in diagnostic X-ray equipment
  • IEC 60601-1-4 : Programmable electrical medical systems
  • IEC 60601-1-6 : Usability
  • IEC 60601-1-8 : Alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-2-7 : Safety of high-voltage generators of diagnostic X-ray generators
  • IEC 60601-2-12 : Safety of lung ventilators - Critical care ventilators
  • IEC 60601-2-18 : Safety of endoscopic equipment
  • IEC 60601-2-28 : Safety and essential performance of X-ray tube assemblies for medical diagnosis
  • IEC 60601-2-32 : Safety of associated equipment of X-ray equipment
  • IEC 60601-2-37 : Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • IEC 60601-2-43 : Safety of X-ray equipment for interventional procedures
  • IEC 60601-2-45 ed 2 et ed 3 : Safety of mammographic X-ray equipment and mammographic stereotactic devices
  • IEC 60601-2-52 : Safety and essential performance of medical beds
  • IEC 60601-2-54 : Basic safety and essential performance of X-ray equipment for radiography and radioscopy
  • IEC 62366 : Medical devices -- Application of usability engineering to medical devices
  • ISO 80601-2-12 : basic safety and essential performance of critical care ventilators

the recognition also means that manufacturers wishing to obtain the French NF-Medical mark of CE marking for their products may ask LNE to take into account test reports and certificates they have obtained from other member bodies of the CB Scheme.

For further information on CB Scheme certifications rules, download our information notes for applicants:

French version - Contacts & Adresses - Site map - Legal notices  - Webmaster