SALIN devices’ manufacturer, S.C. TEHNO BIONIC SRL, with its registered office in 55 Agriculturii Street, Buzău / Phone: 0238 725 321, declares on its own responsibility that the product: SALINE AIR PURIFICATION DEVICE, “SALIN” TYPE, CLASS I, referred to in this declaration, observes the protection requirements and complies with the following standards:
GD 54/2009 on the conditions for placing medical devices on the market, Schedule I and Schedule VII.
The following harmonized standards, SR or technical specification:
- SR EN 60601-1: 2007, Medical electrical equipment.
Part 1-1: General requirements for basic safety and essential performance:
- SR EN 60601-1-2: 2007, Medical electrical equipment.
Part 2: General security requirements. Collateral standard: Electromagnetic compatibility. Requirements and tests:
- Technical specification no. 4/2011.
The devices are registered as medical devices by MSP with certificate no. RO / I-020-019-2007.