TRaC Gains Full Accreditation For IEC/EN60601 Medical Device Testing

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 products that fall within the scope of the European In Vitro Diagnostic (IVD) Medical Devices Directive: In Vitro Devices are items of diagnostic equipment that carry out medical tests on samples obtained from the human body, but that do not have direct contact with the body. Now, with this latest development, TRaC is able to extend its test services offering to products designed to operate with direct patient contact.

Having accreditation under the very latest versions of the relevant standards equips TRaC not only to conduct tests of new equipment designs, but to update approvals on previously-tested products: TRaC can also offer guidance on both new product development, and on any necessary updates to bring older design into compliance with the most recent standards.