D-8
Regulatory compliance
Classification
Safety
Protection Against Electric
Shock
Class I
Degree of Protection Against
Electric Shock
Type B
Degree of protection against
ingress of particulate matter
and water given by the enclo-
sure
IP21
Protected against solid objects ≥ 12.5 mm in diameter.
Protected against vertically falling water drops when en-
closure is tilted up to 15°
Mode of operation Continuous Operation
Method of sterilization Not intended to be sterilized
Suitability for use in an
O
2
-rich environment
Not suitable
IEC 60601-1;
2012, Ed. 3.1
Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance
IEC 60601-1-6;
2013, Ed. 3.1
Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance; collateral standard: usabil-
ity
IEC 60601-1-8;
2012, Ed. 2.1
Medical electrical equipment – Part 1-8: General requirements for
basic safety and essential requirements; collateral standard - alarm
systems
IEC 62366-1,
2015, Ed. 1.1
Medical devices - Application of usability engineering to medical
devices
ISO 14971; 2007 Medical devices – Application of risk management to medical de-
vices
EN ISO 14971;
2012
Medical devices – Application of risk management to medical de-
vices
ISO 80601-2-12;
2011
Medical electrical equipment – Particular requirements for basic
safety and essential performance of critical care ventilators
IEC 60529; 2013,
Ed. 2.2
Degrees of protection provided by enclosures (IP Code)
IEC 62304; 2015,
Ed. 1.1
Medical device software - Software life cycle processes
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