IEC 60601 & IEC 61010 testing and certification services*
In the field of active medical devices/electrical equipment, the testing and certification requirements are documented and internationally harmonised under the standard family IEC 60601. Due to identical requirements of IEC and EN 60601, IEC defines the assumption of conformity to the Medical Device Directive (MDD) 93/42/EEC.
In vitro diagnostic medical device testing and certification requirements must be in accordance with IEC 61010-101 which is called up by the In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC.
Eurofins Medical Device Testing laboratories perform safety and essential performance testing according to IEC 60601 and IEC 61010 standards for medical electrical equipment and in vitro diagnostic medical devices. We document the results with test reports and certificates and offer notified body and NRTL services.
Our Eurofins Medical Device Testing and Certification services are provided through our global network of Eurofins Electrical & Electronics (E&E) laboratories, which are supervised by regular inspections of the IEC Assessors and documented within the listing on the IECEE Website.
Our scope of accreditation includes international standards for accessing worldwide markets, including product safety compliance in the United States and Canada (FDA and Health Canada) and OSHA NRTL requirements through Eurofins MET labs including:
Eurofins Medical Device Testing’s certification services also include global market access, notified bodies, NRTL’s, CB Scheme, Medical Devices Single Audit Program (MDSAP) and ISO 13485 Quality Management Systems audits.
The 4th Edition of IEC 60601-1-2 for EMC came into force on the 31st December 2018, superseding the 3rd edition and bringing with it a number of significant changes.. Eurofins Medical Device Testing laboratories and certification services’ compliance experts are on-hand to help you through this process.
*Where IEC standards are referred to, national and regional variations are also applicable including, but not limited to; ANSI/AAMI, UL, ISO, CAN/CSA, JIS, EN, ENV, BS EN, DD ENV and BS IEC. Please enquire on a case-by-case basis.
Testing Services for Safety & Performance | ||
Electrical Safety Tests | Electromagnetic Compatibility /EMC) Tests | Performance Tests |
Radio/Wireless Tests | Environmental Simulation | |