Norms And Standards Regulations - Siare Falco 101 User Manual

1.5

Norms and standards regulations

The Falco 101 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 62304:2006/AC:2008 Medical device software - Software life cycle processes.
ISO 10993-1:2009
IEC 62353:2014
ISO 15223-1:2016
ISO 4135:2001
EN 60601-1-11:2015
ISO 14971:2012
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.
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
Anaesthetic and respiratory equipment - Vocabulary
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. Application of risk management to medical
devices
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, DU3111103