Mobius AIRO Mobile CT System - Regulatory Compliances and Approvals; Summary of Standards Compliance

218 MI-42-0001 Rev. 19
TECHNICAL DESCRIPTION: Regulatory Compliances and Approvals
9.12 Regulatory Compliances and Approvals
9.12.1 Summary of Standards Compliance
List and
Description
AIRO was tested to IEC 60601 requirements for ME systems and complies with the following
regulatory standards:
Performance Standards Description
IEC 60601-1:2005 + CORR. 1 (2006)
+ CORR. 2 (2007) + A1:2012
Medical electrical equipment Part 1: General
requirements for basic safety and essential
performance.
IEC 60601-1-2:2007
IEC 60601-1-2:2014
Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests
IEC 60601-1-3:2008 + A1:2013
Medical electrical equipment – Part 1-3: General
Requirements for basic safety and essential
performance - Collateral Standard: Radiation
Protection in Diagnostic X-Ray Equipment
IEC 60601-1-6:2010 +A1:2013
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 60601-2-44:2009 + A1:2012 +
A2:2016
Medical electrical equipment – Part 2-44: Particular
requirements for the basic safety and essential
performance of X-ray equipment for computed
tomography
IEC 60825-1:2007 Safety of laser products
IEC 61223:2004
Evaluation and routine testing in medical imaging
departments - Part 3-5 Acceptance Tests – Imaging
Performance of Computed Tomography X-ray
equipment.
IEC 62133:2012
Secondary cells and batteries containing alkaline or
other non-acid electrolytes - Safety requirements for
portable sealed secondary cells, and for batteries
made from them, for use in portable applications
IEC 62304:2006 +A1:2015 Medical device software - Software life cycle processes
IEC 62366:2007 + A1:2014
Medical devices – Application of usability engineering
to medical devices
FDA 21 CFR 1020.30
Radiological Health – Part 1020: Performance
standards for ionizing radiation emitting products –
Sec. 30: Diagnostic X-ray systems and their major
components
FDA 21 CFR 1020.33
Radiological Health – Part 1020: Performance
standards for ionizing radiation emitting products –
Sec. 33: Computed tomography (CT) equipment
FDA 21 CFR 1040
Radiological Health Part 1040: Section 10:
Performance standards for light-emitting products:
Laser products
NEMA XR 25-2010 Computed Tomography Dose Check
NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose