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 X-MIND prime with Directives 93/42/EEC
(as amended), 2011/65/EU, 2006/42/EC.
The manufacturer (according to the European Directive 93/42/EEC) of the unit X-MIND
prime is:
de Götzen S.r.l.
Via Roma 45
21057 OLGIATE OLONA (VA) - ITALY
Tel: +39 0331 376760
Fax: +39 0331 376763
Classifications
X-MIND prime 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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