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In the latest of our series of Lab Focus articles we explore the facilities of SGS CEBEC our electro medical devices lab in Brussels, Belgium.

SGS CEBEC was established in 2001 and provides professional one stop testing and certification services for electrical and electronic (EE) medical devices. Services include:

  • Testing services
  • Certification services
  • Regulatory Compliance services

Established: 2001
Employees: 20

Laboratory features


SGS CEBEC’s EE medical devices lab helps speed products’ route to market and is accredited to both national and international certification schemes and standards bodies, including:

  • IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components)
  • BELAC (Belgian Accreditation Body, EA, ILAC and IAF member)
  • ETICS (European Testing, Inspection and Certification System)

Key Services For One-Stop Medical Device Certification Quality Marks

SGS CEBEC offers a wide range of marks to help you again access to the global marketplace:

  • USA NRTL (AAMI & UL Standards), SGS US/C certification mark
  • USA Test Reports as part of FDA 510(k) or PMA, FCC
  • Canada (CSA Standards)
  • Europe (CE, EN Standards)
  • Brazil (INMETRO)
  • CB (Global, IEC Standards)
  • SGS Fimko, SGS CEBEC

With extensive experience in the EE medical devices sector, SGS CEBEC lab offers testing against all relevant standards, and certification against:

  • IEC 60601-1 – safety
  • IEC 60601-2-XX – performance
  • IEC 60601-1-2 – EMC
  • IEC 60601-1-6 & IEC 62366 – usability
  • IEC 62304 – software
  • IEC 62471, 60825-1 – LED & laser
  • ISO 10993 series – biocompatibility
  • RoHS & REACH directives
  • Mechanical testing against medical device standards
  • Reliability testing

Factory Inspections

We are qualified to conduct factory inspections to demonstrate compliance with certification schemes including:

  • USA (NRTL)
  • Brazil (Inmetro)
  • Europe

CTS EE Medical Device 

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For further information, please contact:

SGS Belgium
Division SGS CEBEC
Boulevard International 55/D
B-1070 Brussels
t: +32 2 556 00 20
f: +32 2 556 00 36