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Active medical devices

Testing of electrical and non-electrical safety

We test, certify and expertise active medical devices with regard to electrical and mechanical safety as a Dakks-accredited testing laboratory and in the IEC Scheme as a testing laboratory (TL) and certification body (CB). In addition, we have a ZLG authority as a notified body in accordance with the Medical Device Directive (MDD). In addition, DEKRA also checks conformity with the relevant safety standards under EC directives such as the Low Voltage Directive, the EMC Directive and, more recently, the RED Directive.

When compiling the technical documentation as part of the EC conformity assessment procedure in accordance with the essential requirements of Directive 93/42/EEC (MDD), we check whether medical devices meet the requirements of the IEC/EN 60601 series of standards harmonized under this directive. As part of these tests, DEKRA also carries out conformity tests in accordance with IEC 62034 (software life cycle), IEC62366 (usability) and ISO 14971 (risk management). As a global partner for safety, DEKRA does not leave its customers alone in international recognition procedures, such as INMETRO and NRTL approvals.

In particular, we test

  • devices for the therapy of diseases such as high-frequency surgical devices, lithotripters or special light sources, and
  • devices for diagnosing diseases such as endoscopic devices

with regard to the requirements of DIN EN 60601-1, DIN EN 60601-1-1, DIN EN 60601-4, DIN EN 60601-6, DIN EN 60601-8, DIN EN 60601-11, DIN EN 60601-2-2, DIN EN 60601-2-10, DIN EN 60601-2-18, DIN EN 60601-2-36, DIN EN 60601-2-57 and DIN EN ISO 11334-1.

DEKRA – On the safe side

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DEKRA Testing and Certification GmbH
Laboratory for product testing
Fon +49.711.7861-3454
This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact

DEKRA Testing and Certification GmbH
Laboratory for product testing
Fon +49.711.7861-3454
This email address is being protected from spambots. You need JavaScript enabled to view it.