Validation

Validationalidation is carried out according to the TS EN ISO 17665-1 : 2006 (EN 554) standard and to your wishes. Our quality system is implemented in full conformity with the requirements of the Medical Devices Directive (93/42/EEC).
SUPERIOR VALIDATION TECHNOLOGY
  • Whether there is air remaining within the sterilization,
  • Steam penetration,
  • Early warning system,
  • The determination of the sources of problems, if any,
  • Whether there is overheated steam,
  • Calibration checks,
  • Electronic calculation of the bacterial death curve,
  • Wet steam,
  • Non-condensable stearn,
  • Superheated steam,
  • Superheat,
  • Air leak,
  • Dilution value,
  • Dryness value

parameters are tests by Electronical Test System.

EBRO Validation System
Wireless Validation and Process Monitoring with Data Loggers

Trans by Getinge uses EBRO Validation systems for validation processes. EBRO® Winlog validation system is a combination of high accuracy wireless measurement technology and powerful programming and reporting tools.. System attributes are:

  • Data transfer in realtime by means of wireless technology
  • Temperature resistant up to +150°C (302°F)
  • High accuracy
  • Fast data transfer
  • Battery exchangeable by user

For more information, visit the company web site. ( http://www.ebro.com/ )