Certification
The following Marks and Certifications can be obtained on the basis of testing performed in the SGS CEBEC laboratory: * CEBEC Mark of compliance with Belgian safety standards. It is widely recognized in Europe and worldwide and generally equivalent to the European EN and International IEC Standards * IECEE/CB International scheme for mutual acceptance of CB test reports and certification, based on IEC standards * ENEC European mark for electrical equipment safety * ENEC+ European mark for performance of electrical equipment * CCA European scheme for mutual acceptance of CCA test reports and certification, based on European standards * LOVAG Agreement for electrical low-voltage equipment used in an industrial environment * HAR European mark for electrical cablesServices
Product categories Products for which certification services are available include: * CABL: electrical cable * CONT: automatic control equipment * HOUS: electrical household appliances * INST: installation equipment * ITAV: information technology Audio Video * MEAS: measuring equipment * MED: electro-medical equipment * OFF: information-processing equipment * POW: power equipment * PROT: protection equipment * SAFE: transformers * TRON: electronics household equipment Special Tests Among others, SGS CEBEC laboratory offers a range of testing services: * Flammability Testing Tests performed on insulating or plastic materials intended to measure the vulnerability of the material and its potential ignition source through Glow-Wire, Needle Flame or HB, V2, V1, V0 and 5V test * IP Testing Tests that classify and rate the degree of protection that mechanical and electrical enclosures provide against solids and liquids as defined in IEC 60529 * IK Testing Tests that define the degree of protection provided by enclosures for electrical equipment against external mechanical impacts in accordance with IEC 62262:2002 and IEC 60068-2-75:1997 * Energy Performance Testing Tests that measure the energy efficiency of consumer electrics such as refrigerators and heaters and compare the Energy Performance ratings * Performance Testing Tests that compare the performance of electrical products in accordance with European Regulations * Surveillance Testing Tests performed on products which are selected on the market or in the factoriesMedical devices
SGS CEBEC provides professional one-stop testing and certification services for electrical and electronic medical devices including: * Testing * Certification * Regulatory Compliance With extensive experience in the EE medical devices sector, SGS CEBEC laboratory 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 testingHealth software
Intended for software only products for health use, hosted or running on generic devices without specific sensors, the IEC 82304-1 Health Software Product certification and the SGS HSP mark allows you to generate evidence towards presumption of regulatory conformity, based on risk assessment HSP Services: * IEC 82304-1 application training * Consumer/health device product certification * Medical device product certification * Pre-evaluation of product readiness and weaknessesSee also
*References
External links