Regulatory Compliance and Standards
At Kube Innovation, we are committed to delivering safe and high-quality medical devices. Our compliance with international regulations and standards demonstrates our dedication to patient safety, product reliability, and ethical practices.
Global Regulatory Compliance
Jurisdictions and Regulations
We adhere to the regulatory requirements of the following jurisdictions:
Standards Compliance
We design, manufacture, and software installation as well as service of our devices according to internationally recognized standards:
Innobyte was manufactured in a plant whose Management System is certified under Medical devices — Quality management systems as being in conformity with ISO 13485: 2016 MDSAP by Intertek. (Certificate number: 0098685)
Safety standard:
- CSA 22.2 IEC 60601-1 3 Rd Ed
- UL IEC 60601-1 3 Rd Ed
EMC standard:
- IEC60601-1-2 4 th Ed.
EMC Test standards and methods:
CISPR 11:2009 + A1:2010: Radiated radio frequency (RF) Emissions
IEC 61000-4-3:2006 + A1:2007 + A2:2010: Radiated RF EM Field
IEC 61000-4-3:2006 + A1:2007 + A2:2010: Proximity fields from RF wireless communication equipment
IEC 61000-4-2:2008: Electrostatic Discharge
IEC 61000-4-6:2013: Conducted disturbances induced by RF fields
IEC 61000-4-8:2009: Power-Frequency Magnetic Field
EMC Test Parameters:
CISPR 11:2009 + A1:2010: Group 1, Class B Device
IEC 61000-4-3:2006 + A1:2007 + A2:2010: 3V/m, 80MHz to 2.7GHz, 80% AM at 1kHz
IEC 61000-4-3:2006 + A1:2007 + A2:2010: See Table 1
IEC 61000-4-2:2008: ±8kV contact, ±15kV air
IEC 61000-4-6:2013: 3V/m, 6V/m in ISM band, 150kHz to 80MHz, 80% AM at 1kHz
IEC 61000-4-8:2009: 30A/m, 50Hz and 60Hz
