4.3 Reference standard
Ow-RX complies with the following standards:
IEC 60601-1:1988 + A1:1991 + A2:1995
Medical Electrical Equipment – Part 1: General requirements for safety.
IEC 60601-1-6:2004
Medical electrical equipment - Part 1: General requirements for safety -
collateral standard: Usability.
IEC 60601-1-2:2001+ A1
Electromagnetic Compatibility Requirements and Tests.
IEC 60601-1-3:1994
Gen. Requirements for Radiation Protection in Diagnostic X-ray
Equipment.
IEC 60601-2-7:1998
Particular requirements for the safety of high-voltage generators of
diagnostic X-ray generators.
IEC 60601-2-28:1993
Particular requirements for the safety of X-ray source assemblies and
X-ray tube assemblies for medical diagnosis.
IEC 62304:2006 + Ac:2008
Medical device software - Software life-cycle processes.
ETSI EN 300 220-2 v.2.3.1
ETSI EN 301 489-3 v.1.4.1
Electromagnetic Compatibility and Radio Spectrum matters (ERM).
ISO 14971:2007
Medical Devices - Application of Risk Management to Medical Devices.
CAN/CSA C22.2 No. 601.1-M90 (2nd edition) +A1 + A2
Medical Electrical Equipment - Part 1: General Requirements for Basic
Safety and Essential Performance
UL 60601-1 (1st edition)
Medical Electrical Equipment - Part 1: General Requirements for Safety
0051 Guarantees Ow-RX compliance with Directive 93/42 and as
amended. (subsequent amendments and additions)
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