Acteon X-MIND prime 3D ceph - Page 57

Service Manual – Technical characteristics
SERVICE MANUAL • X-MIND prime 3D • (19) • 11/2019 • NXMPEN080A
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IEC 60825-1:1993 (1nd ed.)
Safety of laser product – Part 1: equipment classification and requirements.
IEC 60825-1:2007 (2
nd
ed.)
Safety of laser product – Part 1: equipment classification and requirements.
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/I2012 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 3D with Directives
93/42/EEC (as amended), 2011/65/EU, 2006/42/EC.
Classifications
X-MIND prime 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.