Norms And Standards Regulations - Siare Morpheus ND User Manual

1.5

Norms and standards regulations

The MORPHEUS_ND anaesthesia unit is made in accordance with the following norms and it is
manufactured according to UNI EN ISO 13485:2004 standards.
EN 60601-1 :2006/A1
:2011/A1 :2013
EN 60601-1-2:2007/EC:10;
EN61000-6-1:07; EN
61000-6-3:07/A1:11
EN 80601-2-13:2011
IEC 601-1-6:2010
IEC 601-1-8:2007
EN 62304:2006
EN ISO 5356-1:2015
EN ISO 4135:2001
DIR. 93/42/EEC
DIR. 2011/65/CE
D.Lgs 49/2014
Morpheus_ND
Medical electrical equipment - Part 1: General requirements for
safety.
Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Safety requirements for medical
electrical systems.
Medical electrical equipment - Part 2-13: Particular requirements for
the safety and essential performance of an anaesthetic workstation.
Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability.
Medical electrical equipment - Part 1-8: General requirements for
basic safety and essential performance - Collateral Standard:
General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems.
Medical device software - Software life cycle processes.
Anaesthetic and respiratory equipment - Conical connectors -
Part 1: Cones and sockets.
Anaesthetic and respiratory equipment - Vocabulary.
Medical devices directive.
RoHS Directive ( on the restriction of the use of certain hazardous
substances in electrical and electronic equipment ).
RAEE Directive ( Implementation of the 2012/19/UE Directive on
waste electrical and electronic equipment ).