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.