Trac Now Delivers Medical Product Testing Services

Trac, a provider of testing, certification and approvals services, has been fully accredited by UKAS to test medical equipment in accordance with the IEC/EN60601 standard. The IEC/EN60601 standard governs the safety of electrical medical equipment and is identical to the International IEC 60601 standard; 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 worldwide.

The standard sets minimum requirements for basic electrical safety and for electromagnetic compatibility (EMC) and mechanical safety, as well as a range of other parameters according to the particular technology employed in any 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.

The company already holds accreditation to carry out the safety testing of all medical diagnostic products that fall within the scope of the European In Vitro Diagnostic 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. The company can conduct tests of new equipment designs and update approvals on previously tested products. Finally, Trac can offer guidance on both new product development and on any necessary updates to bring older design into compliance with the most recent standards.

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