CETECOM
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CETECOM expands capabilities to support health care industry

CETECOM continuously expands its capabilities, and thus supports the health care industry through comprehensive test services, ensuring compliance with increasing requirements of health standards.

 

CETECOM is accredited by the German Accreditation Body (DAKKS) according to DIN EN ISO/IEC 17025 and recognized by the ZLG (Central Authority of the Federal German States for Health Protection) regarding medical products in accordance with the directives 93/42/EEC, 90/385/EEC, 98/79/EC and 93/42/EWG.

Through high added-value services, CETECOM helps industrials of the medical sector to face an array of complex local and international regulations challenges, speed-to-market, and the demands of progressively more sophisticated customers. In this way, we secure the mutual success for our business partners and customers in the long term.

CETECOM provides exhaustive test services, ensuring that the characteristics of medical electrical equipment products are compliant with the following specifications:

  • DIN EN/IEC 17025
  • DIN EN/IEC 60601-1
  • DIN EN/IEC 60601-1-2
  • DIN EN/IEC 60601-1-8
  • DIN EN/IEC 60601-1-11
  • DIN EN/IEC 61010-2-040
  • DIN EN/IEC 61010-2-101
  • DIN EN/IEC 60118-13
  • DIN EN/IEC 61326-2-6
  • BS EN/IEC 60601-2-66

We also like to mention that the „EN 60601-1-2:2007/AC:2010” standard remains valid during the transition period until 31.12.2018 and is replaced by the new version of the EMC-Standard for medical devices also known as IEC 60601-1-2:2014 Edition 4.0, which was harmonized under EN 60601-1-2:2015 and implemented for Europe.

For further information, please contact us directly. We will be glad to answer your questions. Let us help you identify any gaps that may threaten your business and its valued assets.