Airofit PRO - Page 20

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The Airot system complies with the EU Directive on personal data security -
2016/680/EU.
The major standards applied are:
Standard Title Date
IEC 60601-1 (ed. 3.1) Medical electrical equipment
General requirements for basic safety
and essential performance
2012
IEC 60601-1-2 Medical electrical equipment
Electromagnetic compatibility
requirements and tests
2014
ISO 13485 Medical devices
Quality management systems -
Requirements for regulatory purposes
2016
ROHS (2011/65/EU) Restriction of Hazardous Substances
in electrical and electronic equipment
2011
REACH (EC 1907/2006) Registration, Evaluation, Authorisation
and Restriction of Chemical
substances
2006
WEEE Diretive 2012/19/EU 2012