Introduction
1-6 MORPHEUS MRI
1.5 Applicable norms
The MORPHEUS LT anaesthesia unit is made in accordance with the following
norms:
EN 60601-1 :2006/A1 :2011/A1 :2013
Medical electrical equipment. General requirements for
basic safety and essential performance.
EN 60601-1-2:2015 Medical electrical equipment. General requirements for
basic safety and essential performance. Collateral
standard. Electromagnetic disturbances. Requirements
and tests.
EN 60601-2-13:2006
Medical electrical equipment. Particular requirements for
the safety and essential performance of anaesthetic
systems
IEC 60601-1-6:2013 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance -
Collateral standard: Usability.
IEC 601-1-8:2012 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.
EN 62304:2006/AC:2008 Medical device software - Software life cycle processes.
ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary.
2011/65/CE RoHS Directive (On the restriction of the use of certain
hazardous substances in electrical and electronic
equipment).
D.Lgs 49/2014 RAEE Directive (Implementation of the 2012/19/UE
Directive on waste electrical and electronic equipment).
93/42/EEC (2007) European Medical Devices Directive.
ISO 14971:2012 Medical devices. Application of risk management to
medical devices.
ISO 10993-1:2009 Biological evaluation of medical devices – Part1:
Evaluation and testing within a risk management process.
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