Applicable Norms - Siare Morpheus E User Manual

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Applicable norms

The MORPHEUS anaesthesia unit is made in accordance with the following norms
and it is manufactured according to UNI EN ISO 13485:2016 standards.
EN 60601-1 :2006/A1 :2011/A1 :2013
EN 60601-1-2:2015
EN 60601-2-13:2006
IEC 60601-1-6:2013
IEC 601-1-8:2012
EN 62304:2006/AC:2008 Medical device software - Software life cycle processes.
ISO 4135:2001
2011/65/CE
D.Lgs 49/2014
93/42/EEC (2007)
ISO 14971:2012
ISO 10993-1:2009
MORPHEUS
Medical electrical equipment. General requirements for
basic safety and essential performance.
Medical electrical equipment. General requirements for
basic safety and essential performance. Collateral
standard. Electromagnetic disturbances. Requirements
and tests.
Medical electrical equipment. Particular requirements for
the safety and essential performance of anaesthetic
systems
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.
Anaesthetic and respiratory equipment - Vocabulary.
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).
European Medical Devices Directive.
Medical devices. Application of risk management to
medical devices.
Biological evaluation of medical devices – Part1:
Evaluation and testing within a risk management process.
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