Norms And Standards Regulations - Siare Siaretron 4000 User Manual

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Norms and standards regulations

The Siaretron 4000 ICU lung ventilator is made in accordance with the following norms (and
following updates) 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
IEC 601-1-6:2013
IEC 601-1-8:2012
EN 62304:2006/AC:2008
ISO 10993-1:2009
IEC 62353:2014
IEC 601-2-12:2007
ISO 80601-2-12:2011
ISO 15223-1:2016
DIR. 2011/65/CE
D.Lgs 49/2014
EN ISO 14971:2012
EN ISO 4135:2001
DIR. 93/42/EEC (2007)
Siaretron4000e
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 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.
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process
Medical electrical equipment - Recurrent test and test after repair of
medical electrical equipment
Medical electrical equipment - Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators
Medical electrical equipment - Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators
Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General
requirements
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)
Medical devices. Application of risk management to medical devices
Anaesthetic and respiratory equipment - Vocabulary
Medical devices directive
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