User Manual
– Technical characteristics
NIMXEN020I
Owandy Radiology SAS
37
EN-ISO 14971:2012
Medical Devices - Application of Risk Management to Medical Devices.
CAN/CSA-C22.2 No 60601-1:08
Canadian National deviations to IEC 60601-1.
CAN/CSA-C22.2 No 60601-1:14
Canadian National deviations to IEC 60601-1.
ANSI/AAMI ES60601-1:2005/A2:2010
US National differences to IEC 60601-1.
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012
US National differences to IEC 60601-1.
CFR 21
Code Federal Regulation. Sub Chapter J.
0051
Guarantees the compliance of I-MAX 3D with Directives 93/42/EEC (as
amended), 2011/65/EU, 2006/42/EC.
Classifications
I-MAX 3D is an electrical medical X-ray device classified as class I type B according to EN
60601-1, with continuous operation at an intermittent load.
According to 93/42/EEC Medical Devices Directive, the equipment is classified as class II B.
According to Canadian MDR, the equipment belongs to class II.
According to FDA 21 CFR, the equipment belongs to class II.
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