Quality & Standards

The Quality Management System of Biohit has been awarded both the ISO 9001 and the ISO 13485 certificate, as well as the ISO 14001 Environmental standard by Det Norske Veritas (DNV). In March 2006, the ISO 13485 certification was extended to cover also the liquid handling business area, in addition to ISO 9001. Biohit's diagnostics has been ISO 13485 certified since 2003. Biohit Oyj's pipette calibration laboratory is ISO 17025 certified by FINAS (Finnish Accreditation Service

• ISO 9001 & ISO 13485 certificate
• ISO 9001-2000 Certificate for China
• ISO 13485 CMDCAS(Canada)
• ISO 14001 certificate
• ISO 14001-2004 Certificate for China

Product specific certificates

Electronic pipettors

Biohit electronic pipettors and stands are CE/IVD marked. Electronic pipettors fulfil the requirements of the EMC standards EN 55014, 1993 and EN 55104, 1995.

• Biohit eLINE
• Biohit Proline Electronic
• Biohit ePET Electronic 
• Biohit Proline Plus

Mechanical pipettors

• Biohit mLINE
• Biohit Proline

Special Applications

• Biohit Midi Plus
• Biohit Midi Pro
• Biotrate Digital Burette

Pipettor Tips

Diagnostics

• Pepsinogen I
• Pepsinogen II
• Gastrin-17
• H-pylori
• SLE
• Quick Test H.pylori
• HPQT Control+
• QuickTest Lactose Intolerance
  

WEEE & RoHS

Biohit products comply with the WEEE & RoHS directives that came into effect on 13th August 2005.

• RoHS - Certificate of Compliance 
• SELT Member Certificate
  

Accredited calibration laboratory Biohit Oyj

The calibration laboratory for volumetric instruments of Biohit Plc. has been accredited as a result of the evaluation made by The Finnish Accreditation Service, FINAS, which belongs to the Centre for Metrology and Accreditation. FINAS is a member of the European Cooperation for Accreditation (EA), and one of the signatory of all existing international Multilateral Recognition Agreements (MLA).

• Accreditation certificate (pdf-file)