C U B E 3 0 T O U C H - U S E R M A N U A L
4/56
Rev 1.1 07/2018
Applied directives and regulations:
-
Directive 98/79/EC on in vitro diagnostic medical devices
-
2014/35/EC “Low voltage directive”
-
2014/30/EC “Directive
on the harmonisation of the laws of the Member States relating to
electromagnetic compatibility
”
-
2011/65/EU “Directive
on the restriction of the use of certain hazardous substances in
electrical and electronic equipment
– RoHS2”
-
EN 61010-
1 “Safety requirements for electrical equipment for measurement, control
laboratory use
– Part1: General requirements (CEI 66-5)”.
-
EN 61010-2-081 Safety for electrical equipment for measurement, control, laboratory use
– Part 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes (CEI 66-
8)”.
-
EN 61010-2-
101 “Safety for electrical equipment for measurement, control, laboratory use
– Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment”.
-
EN 61326-
1 “Electrical Equipment for Measurement, Control, and Laboratory Use –
Electromagnetic compatibility requirements
– Part 1: General requirements”
-
EN 61326-2-
6 “Electrical Equipment for Measurement, Control, and Laboratory Use –
Electromagnetic compatibility requirements - Part 2
– 6: In Vitro Diagnostic (IVD) medical
equipment”
-
UNI EN ISO 18113-3 Information supplied by the manufacturer (labelling) - Part 3: in vitro
diagnostic instruments for professional use
-
UNI CEI EN ISO 14971:2012
– Medical devices – Application of risk management to
medical devices.
-
EN ISO 80000-1:2013 Quantities and Units - Part 1: General
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otherwise, for any use whatsoever without prior written permission from DIESSE DIAGNOSTICA
SENESE
S.p.A.
