Owandy Radiology Ow-RX, User Manual

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USER MANUAL
Technical data
Ow-RX
(Rev. 6)
32
6.3 Reference standards
Ow-RX complies with the following standards:
IEC 60601 1: 2005 + Corr.1 (2006) + Corr.2 (2007)
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-6:2010 (3nd Ed.)
Medical electrical equipment - Part 1-6: General requirements for safety -
Collateral Standard: Usability including IEC 62366: Application of
usability engineering to medical devices.
IEC 60601-1-2:2007 (3rd Ed.)
Electromagnetic compatibility – Requirements and test.
IEC 60601-1-3:2008 (2nd Ed.)
Medical electrical equipment - Part 1-3: General Requirements for
Radiation Protection in Diagnostic X-Ray Equipment.
IEC 60601-2-65:2012
Particular requirements for the basic safety and essential performance of
dental intra-oral X-ray equipment.
IEC 62304:2006 + Ac:2008
Medical device software - Software life-cycle processes.
IEC 62366:2007 (1st Ed.)
Medical devices – Application of usability engineering to medical devices.
EN-ISO 14971:2012
Medical Devices - Application of Risk Management to Medical Devices.
CAN/CSA-C22.2 No 60601-1:08
Medical Electrical Equipment - Part 1: General Requirements for Basic
Safety and Essential Performance.
ANSI/AAMI ES60601-1:2005
Medical electrical equipment, Part 1: General requirements for basic
safety and essential performance
0051 Guarantees Ow-RX compliance with Directive 93/42 and as
amended (subsequent amendments and additions)
CFR 21
Code Federal Regulation. Sub Chapter J
Canadian Medical Device Regulations