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IEC 60601-1 – Electrical Medical Equipment

IEC 60601-1 – Electrical Medical Equipment

Are Your Electromedical Products Compliant and Safe?

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.

Benefits at a Glance

With IEC 60601-1 compliance testing from TÜV Rheinland, you can be sure of:

  • A global benchmark for electrical medical equipment
  • Conformity to approved standards worldwide
  • Position your products competitively worldwide with an independent third party test mark
  • Reduced risk of company liability with documented safety standards
  • Fast audit times and long-standing experience from a company with a global presence
  • TÜV Rheinland’s exclusive, one-stop service
  • Compliance with local government and legal requirements

Our IEC 60601-1 Compliance Testing Services

Delivered by knowledgeable and experienced experts, our services comprise:

  • Testing
  • Determining compliance with the IEC 60601-1 standard and with the ISO 14971 norm for risk management and essential performance
  • Labeling products
  • Providing needed documents

Products Covered

Our services cover electromedical products.

Contact

Get in contact with us!

Get in contact with us!