The IEC 60601-1 standard – which addresses many of the risks associated with electronic medical devices – has become a de facto requirement by most companies for electromedical products.
TÜV Rheinland offers medical testing for compliance with this standard. We can also issue the cTUVus mark, the T-Mark, and the Bauart mark after successful product testing against applicable standards. We can also provide test reports for your technical files for European and U.S. Food and Drug Administration (FDA) approval submissions.
With IEC 60601-1 compliance testing from TÜV Rheinland, you can be sure of:
Delivered by knowledgeable and experienced experts, our services comprise:
Our services cover electromedical products.
The IEC 60601-1 standard defines electromedical products as “equipment provided with no more than one connection to a particular supply mains and intended to diagnose, treat or monitor the patient under medical supervision, and which makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient.”
IEC 60601-1 has become the global benchmark for medical electrical equipment, and many companies view compliance with IEC 60601-1 as a de facto requirement for most markets for product registration; “CE,” “UL,” and “CSA” markings; contract tenders; defense against claims in event of problems; and so on. Clause 1.3 in the latest edition, IEC 60601-1:2005, requires compliance with all collateral standards to maintain compliance with the main standard IEC 60601-1.
Some of the risks associated with medical equipment include:
Some of the requirements of the standard include:
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