20
Electrical shock prevention
Electrical safety
Type B
Leakage current
< 0.5mA
EMC
IEC 60601-1-2:2014
EN 60601-1-2:2015
8.3 Standards
The Airocure training system is designed according to the Medical Device Directive - MDD 2007/47/EC. The Airocure system is
manufactured with compliance to medical device
Class I
.
The Airocure 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
