Accreditations and certifications

DAkkS Accreditation Biology Laboratory Liptingen

Our laboratory is accredited by the German Accreditation Body according to DIN EN ISO 17025:2018 in the field of medical devices and we have been approved by ZLG according to Regulation (EU) 2017/745 (MDR).

Our testing 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 basic materials (active and auxiliary substances) and intermediate products of medical devices according to § 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 verification 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, the accreditation under the registration number D-PL-19887-01 covers microbiological-hygienic tests of surfaces and air in the field of health care (hygiene/hospital hygiene) using contact plates and sedimentation plates.

The accreditation confirms that the testing laboratory meets international normative quality and competence requirements and that the test results are thus internationally comparable and recognized. It is an objective proof of the quality and competence of a testing laboratory's activities. The commissioning of an accredited testing laboratory is indispensable, among other things, for validations and in approval procedures, so that the results are recognized in audits.

GLP recognition Biology Laboratory Liptingen

Our test facility is in the national GLP monitoring procedure and is regularly monitored for compliance with GLP principles according to the Chemicals Act or Directive 2004/9/EC.

Good Laboratory Practice (GLP) is a quality assurance system for laboratories performing non-clinical testing in the health and environmental fields. GLP recognition allows tests performed according to the principles of GLP to be mutually recognized by the regulatory authorities of OECD member countries*, and thus test results are also accepted by the FDA.

* Europe, USA, Canada, Japan, Mexico, Australia, and others

ZLG Recognition Biology Laboratory Liptingen

The ZLG has recognized the competence of our laboratory for biological and microbiological-hygienic testing of medical devices in accordance with the applicable directive..

The recognition by the ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten) is a confirmation of the fulfillment of the requirements for a testing laboratory according to the directive (EU) 2017/745 [MDR] as well as DIN EN ISO/IEC 17025:2018.