1.5
Norms and standards regulations
The Falco 202 lung ventilator is made in accordance with the following norms (and following
updates) and it is manufactured according to UNI EN ISO 13485:2004 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 60601-1-11:2015
ISO 15223-1:2016
EN 62304:2006/AC:2008 Medical device software - Software life cycle processes.
ISO 10993-1:2009
IEC 62353:2014
ISO 14971:2012
EN ISO 4135:2001
DIR. 93/42/EEC
DIR. 2011/65/CE
D.Lgs 49/2014
1-6
Medical electrical equipment - Part 1: General requirements for
safety.
Medical electrical equipment. General requirements for basic
safety and essential performance. Collateral Standard.
Electromagnetic disturbances. 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 1-11: General requirements
for basic safety and essential performance - Collateral
standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare
environment.
Medical devices – Symbols to be used with medical device
labels, labelling and information to be supplied – Part 1:
General requirements
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. Application of risk management to medical
devices
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).
User manual, DU3222102