TRaC gains full accreditation for IEC/EN60601 medical device testing
TRaC is now able to offer testing of medical equipment in accordance with the IEC/EN60601 standard. TRaC is fully accredited by UKAS (United Kingdom Accreditation Service) to test equipment in accordance with the international standard.
IEC/EN60601 is a family of standards that govern safety of electrical medical equipment, and is identical with the International IEC standard 60601; approval under the standard is a fundamental requirement before a manufacturer can market any electrical device for patient diagnostics, monitoring or care, in any market world-wide. The standard sets minimum requirements not only for basic electrical safety, but also for EMC (electromagnetic compatibility) and mechanical safety, as well as a range of other parameters, according to the particular technology employed in any particular item of medical equipment.
Developers of medical electrical systems now have a single point of contact for all their safety and EMC testing needs; TRaC is able to offer a cost-effective route to product certification, with good lead-times, in this specialised sector where the necessary expertise has often been difficult to locate.
TRaC already holds accreditation to carry out safety testing of all medical diagnostic

Mark presented papers on the EU ATEX directive and it's synergy with the US Hazloc and the IECEX approvals programmes reviewing the routes to compliance and technical requirements whilst highlighting how time to market can be minimised by engaging with TRaC and MET early on in the programme and ensuring a qualification document and test plan is drawn up to suite all intended markets and avoid duplication. The cost reduction that ATEX factory inspection by MET fully supported by TRaC in the USA was particularly well received.
