TRaC accredited for IEC/EN60601 medical device testing
13 August 2010
TRaC, a provider of testing, certification and approvals services, 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.
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.
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.