As part 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 in accordance with DIN EN ISO / IEC 17025: 2018 for biological, chemical and microbiological-hygienic tests of medical products as well as microbiological-hygienic tests of starting materials (active ingredients and auxiliary substances) and intermediate products of medical devices according to § 3 number 2 MPG as well as the hygienic Accredited environmental monitoring.
New in the scope of accreditation are chemical tests to determine the TOC as part of chemical characterization according to DIN EN ISO 10993-18 or as part of the cleanliness certificate according to ISO 19227. The scope of accreditation has also been expanded to include microbiological-hygienic tests as part of routine monitoring using bio-indicators of cleaning - and disinfection devices with chemical or thermal disinfection, also for thermolabile endoscopes, expanded.
In addition, the accreditation under registration number D-PL-19887-01-01 includes 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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