Canada-based TSO3, an innovator in sterilisation technology for medical devices, says it has received approval to label its new generation sterilisers with the CE Mark, required for marketing products in the European Union.
The notification from the European Notified Body says that its steriliser conforms to the new Medical Device Directive for Class IIb medical devices, an enhanced European standard to be enforced from April 2010. “We are pleased that a review of our quality system, electromechanical design and microbiological data has been independently validated as meeting the new Medical Device Directive (M5). “Our new steriliser is among the first to comply with this enhanced mandatory standard, a requirement all steriliser manufacturers will need to meet,” said Ric Rumble, president and ceo of TSO3. “The ability to label our product with the CE Mark is consistent with our plans to commercialise our sterilisation technology globally.”
Back in December 2009, TSO3 announced a global channel partnership with 3M Infection Prevention Division for the exclusive supply and distribution of its new steriliser under the Optreoz brand. TSO3 has now received authorisations from both Health Canada and the European Notified Body. Regulatory clearance in the US is currently under review.
The new steriliser offers three sterilisation cycles in a single unit and is able to sterilise packaged medical devices quickly and gently – from surgical instruments to complex multi-channel devices.