Renewal of accreditation according to DIN EN ISO/IEC 17025:2018

Medical

In the course of the renewal of our accreditation in 2020, the revision of DIN EN ISO/IEC 17025:2018 was implemented in connection with the adaptation of our quality management system to the new requirements.

Our test laboratory is now accredited according to DIN EN ISO/IEC 17025:2018 for biological, chemical and microbiological-hygienic tests of medical devices as well as microbiological-hygienic tests of starting materials (active and auxiliary materials) and intermediate products of medical devices according to ยง 3 number 2 MPG as well as hygienic environmental monitoring.

New in the scope of accreditation are now also chemical tests for the determination of TOC within the scope of chemical characterization according to DIN EN ISO 10993-18 or within the scope of cleanliness proof according to ISO 19227. Furthermore, the scope of accreditation was extended by microbiological-hygienic tests within the scope of routine monitoring by means of bioindicators of washer-disinfectors with chemical or thermal disinfection, also for thermolabile endoscopes. 

In addition to this, the accreditation under registration number D-PL-19887-01-01 covers microbiological-hygienic tests of surfaces and air in the field of health care (hygiene/hospital hygiene) using contact plates and sedimentation plates.

The current accreditation certificates can be found here...

 

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