Norms And Standards Regulations - Siare Falco 202 Evo User Manual

1.5

Norms and standards regulations

The Falco 202 Evo (10.4") lung ventilator is made in compliance 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 601-2-12:2007
ISO 80601-2-12:2011
EN 62304:2006/AC:2008 Medical device software - Software life cycle processes.
ISO 10993-1:2009
IEC 62353:2014
ISO 15223-1:2016
2011/65/CE
D.Lgs 49/2014
ISO 14971:2012
UNI EN ISO 4135:2001
93/42/EEC (2007)
1-6
Medical electrical equipment. General requirements for basic safety and
essential performance.
Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests.
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 Electrical equipment - Part 2-12: Particular requirements for the
safety of lung ventilators - Critical care ventilators.
Medical electrical equipment - Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators.
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 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.
European Medical Devices Directive.
User manual, DU3104101