1.5
Norms and standards regulations
The Aria 104 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