Owandy Radiology i-max touch, Руководство по обслуживанию

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SERVICE MANUAL
Technical data
I-Max Touch 4-6
4.1. Applied safety regulations
The I-Max Touch complies with the following standards:
0051 The symbol CE grants that I-Max Touch complies with
directives 93/42 for medical devices issued by the
European Community.

Canadian Medical Device Regulations

21 CFR Subchapter J (for 110-120V version)

General safety:
IEC 60601-1:1988 + A1:1991 + A2:1995
IEC 60601-1-4:1996 + A1:1999
IEC 60601-2-7:1998
IEC 60601-2-28:1993
IEC 60601-2-32:1994

Electromagnetic compliance:
IEC 60601-1-2:2001

Protection against radiation:
IEC 60601-1-3:1994
IEC 60825-1:1993 + A1:1997 + A2:2001
Classification
I-Max Touch is an electro-medical X-ray device belonging to Class 1 and
Type B as per classification IEC 60601-1, foreseen for a continuous
working at intermittent load.
According to CE 93/42 directive for medical devices, the equipment
belongs to class II B.
According to Canadian MDR, the equipment belongs to class II.
According to FDA 21 CFR, the equipment belongs to class II
(for 110-120V version).