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Hemolyzer® 3 NG
Directivas and Estándares
Hemolyzer® 3 NG cumple con las siguientes directivas y estándares que se
enumeran a continuación.
Directives
1.
98/79/EC
2.
2011/65/EU
3.
2014/30/EC
4.
2014/35/EC
5.
2012/19/EU WEEE
Standards
1.
EN ISO 13485:2016
2.
EN 13612:2002
3.
EN ISO 14971:2012
4.
EN ISO 15223-1:2016
5.
EN ISO 18113-1:2011
6.
EN ISO 18113-3:2011
7.
EN 61010-2-101:2002
8.
EN 61326-2-6:2006
9.
EN 62304:2006
on in vitro diagnostic medical devices (IVD)
on restriction of hazardous substances (ROHS)
on electromagnetic compatibility (EMC)
on low voltage (LVD)
on waste electrical and electronic equipment (WEEE)
Medical devices – Quality management systems –
Requirements for regulatory purposes
Performance evaluation of in vitro diagnostic medical
devices
Medical devices – Application of risk management to
medical devices
Medical devices – Symbols to be used with medical
device labels, labelling and information to be supplied
– Part 1: General requirements
In vitro diagnostic medical devices – Information
supplied by the manufacturer (labelling) – Part 1:
Terms, definitions and general requirements
In vitro diagnostic medical devices – Information
supplied by the manufacturer (labelling) – Part 3: In
vitro diagnostic instruments for professional use
Safety requirements for electrical equipment for
measurement, control, and laboratory use – Part 2-
101: Particular requirements for in vitro diagnostic
(IVD) medical equipment
Electrical equipment for measurement, control and
laboratory use – EMC requirements – Part 2-6:
Particular requirements – In vitro diagnostic (IVD)
medical equipment
Medical device software – Software life-cycle
processes
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